Irish Pharmachem Yearbook 2021

The Irish Industry Buyers Guide 2021

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CONTENTS 2 Minister’s Foreword

70 Brenntag Pharma

Leo Varadkar TD, Tánaiste and Minister for Enterprise, Trade and Employment, pays tribute to Ireland’s life sciences sector for the vital role it played in our response to Covid-19.

Brenntag Pharma offers a comprehensive range of products for the formulation of pharmaceuticals and the chemical synthesis of APIs.

71 Medicines Access and Innovation

4 Sector Overview

Nathalie Moll, Director General, EFPIA, believes that the Pharmaceutical Strategy for Europe has adopted the wrong approach to addressing access and affordability.

Matt Moran, Director, BioPharmaChem Ireland, reflects on the year of the pandemic, noting how the performance of Ireland’s BioPharma sector was a rare shining light amid the darkness, and considers the future challenges and opportunities.

73 Labelling and Bar Codes

The Axicon 15000 series is a fresh approach to labelling.

74 Packaging Innovation

8 Digital Health Solutions

Nessa Fennelly, Senior Executive, BioPharmaChem Ireland, reports on a new campaign jointly launched by the Irish MedTech Association, BioPharmaChem Ireland and Technology Ireland.

12 NIBRT Darrin Morrissey, CEO, NIBRT, discusses accelerating the

next wave of BioPharma in a post-Covid-19 environment.

17 Regulation

Dr Lorraine Nolan, CEO of the HPRA, explains how medicines regulators and the BioPharma industry have worked collaboratively to negate the impact of the Covid-19 pandemic on medicine supply.

20 Access to Medicines

Covid-19 highlighted the fact that Europe needs a resilient and sustainable EU health industry, which means reshoring supply chains for essential medicines, writes Maggie Saykali, Director, European Fine Chemicals Group.

25 Global Business Services

Padraic O’Neill, Vice President of Pfizer’s Global Business Services in Dublin, reveals what GBS means for the BioPharma industry.

32 Diversity

Siobhán Dean, BioPharmaChem Ireland, explains how the BioPharmaChem Ireland Diversity, Inclusion & Belong forum is making huge strides forward for the benefit of all.

38 IT ServiceS

Westbourne IT Global Solutions Ltd work with their client’s IT department as an outsourced extension of their team.

40 IDA Ireland

Ireland must take act now to ensure that we continue to be at the top table of BioPharma development and manufacture, writes Rory Mullen, Global Head of BioPharmaceuticals, IDA Ireland.

42 Cell & Gene Therapy

Cillian Leonowicz and Paul Pierotti from EY Ireland argue that Ireland can become a hub for the global supply, management and manufacture of a new generation of personalised medicines and Cell & Gene Therapy treatments.

47 Pharmaceutical Manufacturing Technology Centre Since its inception in 2013, the Pharmaceutical Manufacturing Technology Centre has established itself as a progressive, agile, strategically relevant and industry-informed research centre.

Nelipak is working with pharma companies to develop innovative packaging solutions for the next generation of medicines.

4 SECTOR OVERVIEW 50 Research & Development

SSPC is a globally recognised research centre for API crystallisation, manufacturing research, modelling and BioPharma expertise.

Fermoy-based Micro-Bio Ireland Ltd is the only Chlor-alkali manufacturer in Ireland and also pioneered the commercial use of Membrane Cell Technology.

82 Process Data

Bonner can help customers to unlock the value within their process data.

52 APIs and Advanced Intermediates

83 Documentation Solutions

54 Outsourced Stability Storage

84 Technical and Engineering Services

TWi offers high-quality, flexible, and scalable documentation solutions for BioPharma and medical device companies.

SK pharmteco combines the skills of SK biotek and AMPAC Fine Chemicals to provide world class production of APIs and Advanced Intermediates.

Outsourcing your stability storage and microbiology testing has a host of advantages, according to Source BioScience.

57 Enterprise Ireland

Indigenous Irish BioPharma firms are taking on the world, writes Deirdre Glenn, Head of Life Sciences at Enterprise Ireland.

Teamwork and knowledge sharing remain key ingredients for success at LotusWorks.

86 Ingredient Solutions

Univar Solutions’ global pharmaceutical ingredients team provides top quality ingredients, unrivalled support and technical expertise to its Irish customers.

60 Laboratories & Analysis

The addition of specialised and advanced equipment at their Ballina facility means that Charles River Laboratories are helping customers to expedite new drugs and therapies to market.

62 Certification

Certification Europe was founded with the simple aim of providing a certification service which goes further than simply ticking the boxes.

63 Pharma 4.0

Luke Kiernan, Director of Technical Services at Innopharma, examines the BioPharmaceutical landscape of the near future as we move through the fourth industrial revolution.

88 GMP Manufacturing

With a state-of-the-art GMP manufacturing facility in Limerick, A&C is the perfect partner for buffer outsourcing and process solution manufacturing.

90 Raw Materials

Alan Looney, Managing Director, NCC, looks at the challenges of the last year and provides insight to ensure continuity of supply of raw materials.

92 Logistics

KWE Ireland offers intelligent ‘best in class’ logistics solutions, overlooking Dublin Airport.

94 Waste Management

Indaver are your partner in safe, innovative and sustainable waste management.

65 Specialist Integrated CDMO

Hovione has 60 years of experience as a Specialist Integrated Contract Development and Manufacturing Organisation.

66 Product Testing

Eurofins BioPharma Product Testing Ireland is expanding its service offering to deliver class-leading support for Advanced Therapeutics, including mRNA based products.

69 Supply Chain

Kuehne+Nagel Ireland have invested in a dedicated Dublin-based facility for a global partnership with West Pharmaceuticals.

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Irish PharmaChem | Industry Buyers Guide 2021

79 Chemicals

96 Ingredients

Barentz offers pharmaceutical manufacturers a range of ingredients to suit every application.

98 Packaging Systems

Goliath Packaging Systems continues to deliver projects for some of the biggest names in the Irish pharma sector.

100 Mechanical & Process Equipment

Flexachem provide mechanical and process equipment solutions to Irish market.

LISTINGS SECTION 101 102 108 120

Chemical Suppliers General Suppliers Company Listings Useful References

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Minister’s Foreword

A massive contribution in a difficult year Leo Varadkar TD, Tánaiste and Minister for Enterprise, Trade and Employment, thanks Ireland’s life sciences sector for the vital role it played in our response to Covid-19, and reiterates the Government’s commitment to supporting the sector going forward.

I want to begin by paying tribute to everyone who has worked in the life sciences sector in Ireland this year. No-one could have expected the year we’ve just had. I want to thank you for your resilience and hard work. Not only have you been critical in our response to the pandemic, but you have kept other, non-Covid 19 related manufacturing operations open and ensured that critical supply chains have been maintained, thereby safeguarding access to life-saving medicines.

We have been attracting substantive operations from major life sciences companies for over 50 years and, as a result, we have a very strong cluster of global names in manufacturing, process development and high-value services, serving global markets. By sharing knowledge and expertise, staff, and supplying vital medicines and other equipment, the sector has made a huge contribution towards supporting Ireland’s national response to the pandemic. That assistance is deeply appreciated within Government.

Foreign direct investment Foreign direct investment is a critical engine of economic growth in Ireland and a significant proportion of that growth is powered by the BioPharmaceutical industry. There are now more than 34,000 people employed in the sector and more than 90 manufacturing sites across Ireland.

The sector is firmly embedded in every region, with substantial manufacturing sites and clusters located right around the country. This includes all the top 10 global pharmaceutical companies and 13 of the top 15 medical technology companies, which is a remarkable achievement.

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Leo Varadkar TD, Tánaiste and Minister for Enterprise, Trade and Employment.

That long track record as a successful home to global businesses is due to many factors. Our continued commitment to the European Union, the single market and Eurozone, are selling points that encourage multinational companies to establish operations and create jobs in Ireland. Our progressive, outward-looking perspective as an open economy means that we have a reputation as a pro-enterprise jurisdiction. Investment in life sciences will continue to be driven by our excellent regulatory compliance record, strong Government support for research & development and excellence in BioPharma manufacturing.

Skilled and flexible workforce However, it is our highly skilled and flexible workforce that is our foundation – and that is something I hear time and again when I speak with the world’s top companies. Our ongoing success is built on the skills and talent of our people.

Those skills have been applied right through the pandemic, with increased productivity, and I want to specifically recognise that contribution.

I also want to recognise the work of IDA Ireland, not just in attracting

Irish PharmaChem | Industry Buyers Guide 2021

Minister’s Foreword

“Ireland has enormous potential in emerging areas such as nextgeneration therapies, the development of Industry 4.0, immunotherapies and genomics. With the right collaboration between industry and Government, we can harness the next wave of innovation while sustaining, and growing, the high levels of investment we have seen over several decades.”

new investment, but also in partnering with companies that have already located here to ensure that those investments are successful. The work of the Agency remains a really important factor in our continued success in promoting Ireland as a preferred location for high-quality overseas investment. Another important element of our ecosystem is the National Institute for Bioprocessing Research and Training (NIBRT).

Through IDA Ireland, the Government invested in NIBRT, which has transformed Ireland’s capacity to support BioPharmaceutical training and innovation.

Earlier this year, the Government established the Covid-19 Products Scheme, which is intended to accelerate the production in Ireland of vital medicines and potential vaccines, along with essential equipment, used in the fight against Covid-19. The Scheme allows for up to €200m in targeted State funding to facilitate the research and development of Covid products, to enable the construction or upgrading of testing and upscaling infrastructures that contribute to the development of

The life sciences sector has been critical in Ireland’s response to the Covid-19 pandemic.

Covid-19 relevant products, as well as to support the production of products needed to respond to the outbreak.

Programme for Government Ireland’s BioPharmaceutical industry employs more than 34,000 people.

As we look to the future, the Programme for Government reflects our commitment to invest in building Ireland’s capacity in future growth areas. This is supported by an increased focus on digitalisation, data analytics, automation and artificial intelligence, which will help ensure that Ireland remains a leading location of choice in what is an increasingly competitive global market for overseas investment.

Technological advancement presents opportunities for Ireland because of our strong base of technology companies, supported by education and research institutions.

Ireland has enormous potential in emerging areas such as next-generation therapies, the development of Industry 4.0, immunotherapies and genomics. With the right collaboration between industry and Government, we can harness the next wave of innovation while sustaining, and growing, the high levels of investment we have seen over several decades.

Finally, I want to underline the Government’s commitment to further growing and developing the pharmaceutical industry in Ireland and to thank you again for your enormous contribution during this most difficult year. I wish PharmaChem Ireland every continued success in 2021.

Leo Varadkar TD, Tánaiste and Minister for Enterprise, Trade and Employment Irish PharmaChem | Industry Buyers Guide 2021

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Sector Overview Matt Moran, Director, BioPharmaChem Ireland, reflects on the year of the pandemic, noting how the performance of Ireland’s BioPharma sector was a rare shining light amid the darkness, and considers the challenges and opportunities facing the sector if Ireland is to continue to operate at the highest level internationally.

2020: A year like no other As we head towards the end of 2020, we can reflect back on an unprecedented year, due to the emergence of the coronavirus, Covid-19, that plunged us all into a global pandemic. The impacts of this on our lives and our economies have been well covered and I do not intend to repeat these but rather to reflect on what it has all meant for the BioPharma sector and more importantly the role of this sector within the economy of this country.

Since the commencement of the measures designed to limit the spread of the virus, the BioPharma sector remained fully operational as it was categorised an essential sector by Government. If anything, output from the sector grew. The publication of the most recent export numbers by the CSO reveal that in 2019, the sector exported goods to the value of €79.4 billion, up by 9% on the 2018 figure of €73 billion. This reflective of a sector that remains robust and one that continues to perform strongly. Most commentators agree that the performance of the sector was a major factor in mitigating the impact of Covid-19 on the national GDP number. No doubt the sector

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remains good for the health of the economy as well as that of the nation’s citizens.

BioPharma Ambition Just before the nation entered lockdown mark one, BPCI hosted its third BioPharma Ambition Conference in Dublin Castle with its partners, The Irish Pharmaceutical and Healthcare Association (IPHA) and The National Institute of Bioprocessing Training and Research (NIBRT). Over 400 delegates debated issues of importance to the sector globally.

A stellar line-up of speakers including the former CEO of US based biotechnology lobby group The Biotechnology Industry Organisation (BIO), The Right Honourable James Greenwood, the Associate Pro-Vice-Chancellor of Queens University Professor Mark Lawler, and CEO of The Health Products Regulatory Authority (HPRA), Dr Lorraine Nolan. A plenary event was preceded by two workshops:  Manufacturing Next Generation Biologics, hosted by NIBRT;  A Taxation Workshop, hosted by PWC. Irish PharmaChem | Industry Buyers Guide 2021

Sector Overview The Plenary Day itself covered three broad thematic areas  Connected Health  Factory 4.0  Future-Fitting biopharma for Best Societal impact The entire event was preceded by a policy forum that was sponsored by the Department of Enterprise, Trade and Employment. This forum, coupled with the conference, which was an All-Island event, as before, provided clear pointers to the industry, Government and the research and medical communities as to where Ireland needed to focus its efforts in the coming years.

Delegates left Dublin Castle energised and ready to focus on the future development of the sector. There was broad consensus that Ireland needed to direct its efforts towards advanced therapeutics such as Cell and Gene Therapies. There was general acceptance that the country needs to invest more in the clinical research area and it was suggested that the country should aim to triple the number of clinical trials that take place here. Ireland needs to take an integrated and end-to-end approach in respect of the manufacture and supply of medicines, spanning advanced manufacturing through to patients gaining access to medicines The post-conference environment was of course dominated by the pandemic and the subsequent lockdown. BioPharma manufacturers immediately mobilised to ensure that they were able to remain operational throughout.

BPCI swiftly transitioned each of its 25-specialist working groups onto virtual platforms. This enabled BPCI to able to continue to support its members, both in dealing with the challenges presented

by Covid-19 but also in sustaining businessas-usual services. Member companies really valued the availability of timely information and the ability to network and support each other.

At the peak of the crisis, the BPCI Board met on a weekly basis to discuss how companies could keep going despite the very challenging environment that they found themselves in.

Cork, who were working with a group known as the Covid Alliance. The Covid Alliance was a coalition of over 40 companies, universities/ Institutes of Technology and hospitals. In response to the shortage of this buffer, the Alliance had developed a new way of manufacturing the buffer. BPCI were informed that a key raw material needed to manufacture the buffer, Guanidine Thiocyanate, was in global short supply. BPCI’s members mobilised immediately and were able to identify a supply of this scarce material on the continent. BPCI member, Clonmel-based Camida brought their expertise in sourcing to bear and through their Sales Director, Orla Heenan, the material was secured. A consortium of companies, including Gilead, Astellas, SK biotek, GE Healthcare, MSD, Allergan, Alexion, Novartis, BMS and WuXi, either underwrote the cost of material or provided technical expertise to the project so the material was provided to the HSE at no cost. The material was milled by A&C Chemicals and the final buffer was synthesised by NIBRT at their campus in Dublin. Initially capacity to support 500,000 tests was covered. Capacity to supply this buffer remains in place and significant amount of Guanidine Thiocyanate are in stock.

The Lysis Buffer Project was an excellent example of how the industry here was able to collaborate and to work with the educational and health sectors to bring very tangible benefit to the country.

This was not the only area where companies provided support to local communities as many of them donated PPE and Hovione manufactured significant quantities of hand sanitiser at their Cork-based chemical synthesis plant.

BPCI and its member companies continually look to the future and scan the horizon for opportunities and threats; at no time can one stand still in this sector, any hint of complacency or even resting on one’s laurels could have very negative impacts on future growth. In order to put some order on this thinking, BPCI regularly publishes industry strategies; these are designed to assist the industry and all its stakeholders, including Government, to futureproof the sector. BPCI met recently to consider phase six of its series of strategy reports. Some of the priorities already identified include:

Advanced Therapeutics: The Alliance for Regenerative Medicines (ARM) estimates that there are over 980 companies worldwide working in the advanced therapeutics space. These range from Cell and Gene Therapy, Car-T, Regenerative Medicines to Cell-based Immuno-oncology. There are around 1,600 clinical trials underway and in 2019 just under $10 billion was invested in the sector.

There is no doubt that this represents the next wave of BioPharma innovation

Reboot and Reimagine campaign BPCI is a trade assocation within Ibec, and Ibec played a central role in presenting the views business to Government, culminating in the publication the Ibec Reboot and Reimagine campaign. This campaign plots a clear course for the rebooting and eventual reimaging of business models as the country recovers from the impact of the pandemic.

Early on in the pandemic, the HSE experienced problems accessing a critical buffer used in the RT-PCR test which is used to identify the Covid-19 virus. This buffer, known as Lysis Buffer, was used to prepare samples for analysis; it actually breaks open the virus. BPCI were approached by Eamon Judge in Eli Lilly in Irish PharmaChem | Industry Buyers Guide 2021

BioPharma Ambition 2020, held in early March 2020, was extremely well-attended and featured a stellar line-up of speakers and panel discussions, including this panel discussion on Connected Health.

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Sector Overview and Ireland needs to be involved. BPCI sees two opportunities, the first being to attract manufacturing in the sector, so called allogeneic production where products are made in a more traditional manufacturing setting. These technologies are still developing, and BPCI has been working closely with a multi-agency group led by Niall Barron of NIBRT to see if Ireland can achieve in this area. Takeda are already manufacturing a stem cell-based product out of Grangecastle and indigenous company Avectas, based out of Maynooth University, have developed an exciting platform technology in the field.

Many of these products are administered in a hospital setting on an individual basis; these are known as autologous products. The second opportunity for Ireland is in this space.

BPCI is working closely with EY and the IDA and number of BioPharma Global Business Hubs to see if there could be an opportunity to digitise these supply chains and locate them out of Ireland. A number of tech companies are involved in this project too, as there is an opportunity to converge BioPharma, MedTech and technology companies in this space; Ireland is uniquely placed to exploit this.

To date, BPCI has worked with TUD and WIT to deliver courses. The BioPharmaChem Skillnet continues to strengthen its activities and is actively pursuing the application of virtual reality in the training world.

was sourced in India; India closed its borders and a shortage emerged. The EU now seems committed to attract such manufacture back, and Ireland, with its expertise in this field, could benefit from such a trend.

Global Business Services:

Pharma 4.0

A number of BioPharma companies have established global business hubs in Ireland.

Traditionally, these served to concentrate financial activities into Ireland. However, they now look to expand into other areas, bringing their core competence to bear into the management of medical information and possibly clinical trials. As mentioned earlier, they could operate in the advanced therapeutic space too.

If Ireland is to win investment in API manufacture from traditionally low-cost locations, it is going to need to bring down its cost of goods significantly. The application of the principles of Industry 4.0 to pharmaceutical manufacture, Pharma 4.0, would help to facilitate this. BPCI has collaborated with local company Innopharma to publish a comprehensive report on the topic. This report contains a number of recommendations for Government.

BPCI also plans to work to support the development of indigenous companies and we intend to work with Enterprise Ireland to help support the further growth of locally based biotech or specialist services companies.

All in all, 2021 will be a year when Ireland exits the pandemic and will be a year of many challenges for this vital sector; plus ca change!

Reshoring of Active Pharmaceutical Ingredient (API) Manufacture: One thing Covid-19 served to highlight was the dependence of the EU on third countries, such as India and China, for many of the key ingredients used in its medicines. This resulted in shortages in some products. For instance, the API used in Paracetemol manufacture

Talent and Skills: Availability of the right talent mix remains a priority for the industry. If newer sectors emerge, such as advanced therapeutics, specific courses will need to be designed.

BPCI has also piloted a non-traditional apprenticeship programme in laboratory science at level 6 and level 7. The idea here is to open up a vocational route into the sector to complement the traditional academic route.

INNOPHARMA PRESENTS

Pharma 4.0: Preparing Ireland’s (Bio)Pharma industry for the fourth industrial revolution An event report in partnership with BioPharmaChem Ireland Publication date: 1st June 2020

Manufact Tech uri ng ghHi Pharmaceutical

MedTech

FoodTech

ICT (Technology)

BioPharmaChem Ireland collaborated with Innopharma to publish a comprehensive report on the topic of Pharma 4.0, including a number of recommendations for Government.

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Irish PharmaChem | Industry Buyers Guide 2021

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Digital Health Solutions

Where digital health thrives

Nessa Fennelly, Senior Executive, BioPharmaChem Ireland, reports on a new campaign jointly launched by the Irish MedTech Association, BioPharmaChem Ireland and Technology Ireland.

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Irish PharmaChem | Industry Buyers Guide 2021

Digital Health Solutions Ireland has the potential to become a leader in the development of digital health solutions, attracting international investment and growth in high-tech indigenous companies. The claim is made as part of a new campaign, ‘Where Digital Health Thrives’, launched jointly by Ibec’s Irish MedTech Association, BioPharmaChem Ireland and Technology Ireland on November 22, 2020.

The vision for this campaign is to enable Ireland to become a recognised global hub for digital health, where companies can develop and well as attract commercialise products, as projects and investments.

Ireland’s unique ecosystem with leading digital health, MedTech, pharma, and tech companies can make us a global digital health powerhouse.

A unique life sciences ecosystem We have a unique ecosystem employing over 100,000 people; 10 of the world’s top BioPharma companies, nine of the world’s top 10 MedTech companies and 10 of the world’s top 10 technology companies have a base here in Ireland. We have a world class talent pool, comprising the most productive employees in the world, cross-disciplinary research activities in key areas for digital health, in addition to a multilingual, multicultural and highly educated workforce.

Ireland is a major healthcare industry exporter with a global outlook and is the location of choice for Foreign Direct Investment. Ireland is an open economy where we think global from the start. Ireland’s government agencies have an international reputation for supporting startups to go global, attracting FDI multinationals here as location of choice, and delivering industry-led training to address changing needs to help businesses here achieve their ambition.

Innovation is a cornerstone of these policies, with supports to ensure that the digital health industry can identify unmet clinical needs, develop disruptive solutions and get them to market. The tech industry is transforming health and enhancing expert driven results.

Computers and artificial intelligence are making an impact, from digital surgery, which offers greater ability to spot subtle problems or changes than the human eye alone, to accelerating drug discovery with analysis of data.

But technology alone cannot revolutionise healthcare; innovation is underscored by partnership with research centres and clinicians. That is why global tech businesses are growing sites in Ireland to develop digital health solutions and tap into international markets.

As a small country, we are making a big impact by working together. Digital health is underscored by collaboration and actionable information. Businesses in Ireland are creating a

new age of digital health solutions through tech companies working with MedTech companies to help devices embed data security, and pharma companies remain compliant as they gather data across platforms. New technologies are empowering patients to manage their own care and encouraging providers to reimburse digital health solution that lead to efficient care.

With cross-sectoral partnerships for success in Ireland, many companies are using Ireland as a testbed to go global.

treatment in an informed and supported manner,” he noted at the launch. “Through connected devices, remote monitoring, apps and other technologies, patients are empowered to manage their health and receive care in the right setting. Digital health is supporting health care professionals by offering insights and providing them with new ways to support and treat patients.

With data from connected devices, HCPs can measure outcomes, personalise healthcare

Delivering better patient care Digital health is the intersection of healthcare and technology and involves the innovative use of technology to deliver better patient care. The goal is to translate the benefits that technology has brought to other industries and bring them to healthcare, resulting in improved outcomes for patients and the providers of healthcare. ‘Where Digital Health Thrives’ aims to raise understanding of the potential of digital health, and Ireland’s potential to be a hub for its growth.

The campaign was launched virtually by Jim O’Donoghue, Chair of the Ibec Digital Health Working Group and President of S3 Connected Health. “Digital health is driving the personalisation of medicine and healthcare, putting the patient at the centre of their

Ireland Where Digital Health Thrives

An Ibec Campaign

Right: ‘Where Digital Health Thrives’, the new campaign which was launched jointly by Ibec’s Irish MedTech Association, BioPharmaChem Ireland and Technology Ireland on November 22, 2020.

Irish PharmaChem | Industry Buyers Guide 2021

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Digital Health Solutions interventions and better connect with patients in multiple care settings. This campaign is about demonstrating how digital health can lower the cost of, and increase access to, healthcare.

This not only leads to improved outcomes for patients and HCPs, but for payers and providers too.”

A global digital health powerhouse Sharon Higgins, Director of Member Services in Ibec, said, “We wanted to capture the scale and scope of the digital health ecosystem already here in Ireland, including nearly 200 companies already delivering digital health solutions, such as telehealth, data, analytics and cyber security, health information technology, connected MedTech, mobile health and many more. Ireland is the seventh most competitive economy in the world. It is a location of choice to start and grow a business. Going global from Ireland is in our DNA. Ireland is small open economy with a global outlook. We are a location of choice for FDI investment and home to world-class start-ups. Our business model is underscored by substance and has helped us achieve a global footprint. We can apply this to digital health by delivering solutions across boundaries and borders.

“Ireland’s unique ecosystem with leading digital health, MedTech, pharma, and tech companies can make us a global digital health powerhouse,” Higgins continued. “Ibec is uniquely placed to support cross sectoral innovation and product commercialisation. The Irish MedTech Association, Technology Ireland and BioPharmaChem Ireland came together to develop and deliver this campaign, which spans a publication, ecosystem map, digital collateral and networking events. Training will be delivered in partnership with Connected Health Skillnet, which was established in Ibec in 2017 to support the drive skills development in this area.”

While Ireland’s productive workforce has helped us to attract international investment and inspire entrepreneurs to found companies here, more must be done to support upskilling, as today’s skills may not be enough to invent

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tomorrow’s disruptive technology. As a competitive knowledge economy, we need to build on our success by doing more to embrace lifelong learning by tapping into supports to help businesses and people achieve their potential, embracing new technologies and careers opportunities in the face of change. The Connected Health Skillnet is an industry-led training network established in 2017 to address the skill needs arising from the convergence of the MedTech, pharma, and technology sectors in the field of digital health. The Network offers subsidised training and cross-sectoral networking opportunities for private sector and commercial semi-state businesses based in Ireland. To date, the Skillnet has engaged with 175 companies to upskill 700+ trainees in key areas such as medical device software regulations, software testing, risk management and validation and also leadership development.

Implications for life sciences Matt Moran, Director of BioPharmaChem Ireland, says that as an association, they aim to further the digital health industry to benefit society at large. “It melds together monitoring

biomarkers within the body, with therapy to help the patient have a better outcome. Sick patients use virtual tools to speak to a doctor to get better, and people are using these tools to make sure they don’t get sick in the first place,” Moran explained. “We already have many examples of how this collaboration is working.

Diabetes is one of the areas where digital health can be especially useful, as it needs to be constantly monitored. We have seen digital health tools such as glucose monitoring tools.

This sees every one of the three industries come together to solve an issue for patients.

That level of engagement is why Ireland is a great place for digital health to progress even further.”

The BPCI Director is confident of the future for digital health: “We can see many more digital health products and services emerging here. To have them commercialised and made in Ireland will help the industry and economy going forward.”

Moran explained that not only will the patient benefit from the use of digital health, but the country as a whole will also benefit from being engaged in this next wave of digital therapeutics. “There are challenges to bringing together the three different industry sectors of BioPharma, MedTech and tech, along with the burgeoning digital health sector,” he admitted.

“But in Ibec, we have representative bodies for these industries all under one roof. This helps with collaboration between all and the Ibec Digital Health Working Group is bringing leaders and experts together to develop the business supports and shape policies for success. The ‘Where Digital Health Thrives’ campaign is the organisation’s first cross-sectoral initiative of its kind and we see great opportunity to use this approach to deliver results that matter to members.”

Irish PharmaChem | Industry Buyers Guide 2021

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NIBRT

Accelerating the next wave of BioPharma in a post-Covid-19 environment Darrin Morrissey, CEO, NIBRT, explains how the Covid-19 pandemic may have accelerated the next wave of BioPharma development, and advises on how Ireland can ensure it is to the forefront of ATMP growth in the coming years.

2020 will no doubt be looked back upon as the year when the Covid-19 pandemic significantly impacted everyone on the planet in a multitude of ways; from personal health, to public health, to broader social effects and the negative impact on the economy. The pandemic has also had the effect, for many, of crystallising the value of science and the importance of sustained investment in new therapies by governments and the healthcare industry. Given that SARS-CoV-2 only emerged one year ago, the massive surge in collaborative research activity around the world and the rapid pace with which clinical research of new therapies and vaccines has happened and regulatory approvals have been granted has been staggering.

Covid-19 and ATMPs A notable feature of many of the Covid-19 vaccines in development is the level of novel and advanced technologies being deployed and adopted for the first time. Within the first wave of new Covid-19 vaccines are the two recently-approved mRNA-based vaccines, while a number of the yet-be-licenced vaccine candidates are incorporating other innovative viral vector and novel recombinant protein technologies. Many of these innovations fall broadly into a category of BioPharma-based technologies known as advanced therapy medicinal products (or ATMPs); a category that also comprises the cell-based therapies (i.e. allogeneic, autologous, non-gene-modified and gene-modified) and the gene-based therapies (i.e. viral-vector and non-viral).

In recent years, there has been dramatic growth in the number of clinical trials and in the level of commercial activity in the ATMP space, and it is widely predicted that these advanced products will collectively constitute

12

the next big wave of BioPharma growth. At the start of 2020, there were over 900 start-up companies operating in this space globally, with increasing numbers of the large pharma multinationals now entering the arena, mainly via the acquisition of smaller biotech players.

In January 2019, the US Food and Drug Administration (FDA) stated that it expected to see more than 200 applications per year requesting permission to begin cell and gene therapy trials by the end of 2020, from a position where the agency already had more than 800 such applications on file. (Source: https://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm629493.htm).

Since 2016/17, there has been a steady rise in the number of ATMP approvals granted by the FDA and European Medicines Agency (EMA) – see figure 1 – and market analysts are predicting that ATMPs will reach global market values of between $10 billion and $60 billion by the mid-2020s. Yet, none of these projections factor in Covid-19 and the direct or indirect impact that it will have on ATMP development, licencing and market uptake.

In the short-term, the pandemic has intensified some ATMP activity, with a number of companies re-purposing their therapeuticfocused technologies towards use in vaccines (most notably Moderna and BioNTech with their mRNA technology). In addition, regulatory agencies having accelerated their hiring of staff in response to Covid-19 and it possible that these new staff can be utilised to meet the pressing need of ATMP evaluations once the Covid-19 crisis abates.

ATMPs: a major opportunity for Ireland Over the last decade and a half, Ireland has established itself as a global centre of excellence and location of choice for the manufacture

of biologics, and in particular monoclonal antibodies. With strategic foresight and investment, including in the establishment in 2007 of the National Institute for Bioprocessing Research and Training (NIBRT), Ireland positioned itself to take a leadership role in what was then the emerging generation of biologics medicines. As a result, Ireland has won over €10 billion in BioPharma foreign direct investment (FDI) in the period 2009-2020, with the number

Figure 1 – Recent Advanced Therapy Medicinal Products (ATMPs) approvals by FDA and EMA Cell therapy approvals (select): Kymriah – the first approved CAR-T therapy from Novartis launched in 2017 and is now licenced for used in a number of B-cell lymphomas and leukaemias.

Yescarta – CAR-T therapy (from Kite/ Gilead) licenced for use in large B-cell lymphoma.

Tecartus– CAR-T therapy (from Kite/ Gilead) licenced for use for mantel cell lymphoma.

Alofisel – an allogeneic cell therapy (from Takeda) approved for treating complications associated with Crohn’s disease.

Zynteglo – CAR-T therapy (from Bluebird Bio) approved in Beta-thalassemia.

Gene therapy approvals (select): Imlygic – a viral-vector based immunotherapy (from Amgen) for melanoma and other cancers.

Luxterna – a viral-vector based therapy (from Spark/Roche) for retinal dystrophy.

Zolgensma - a viral-vector based therapy (from AveXis/Novartis) for spinal muscular atrophy.

Irish PharmaChem | Industry Buyers Guide 2021

NIBRT of BioPharmaceutical manufacturing sites growing to more than 25 nationally. This in turn has contributed over 30,000 direct jobs and over €70 billion in exports to the Irish economy. Much of this success is predicated on the availability of a highly competent workforce, a track record of operational excellence and the existence of a thriving ecosystem supporting the sector.

ATMPs, while broadly similar to the previous wave of biologics, have their own unique challenges in

respect of how they are manufactured and how they are supplied to health systems and patients around the world. Given the high projected growth of the ATMP market, it is a very competitive space and other jurisdictions, most notably the US, UK, Belgium, Netherlands, Spain among others, are now investing heavily to attract and support the multinational industry players.

Ireland has recently been successful in attracting a number of ATMP investments, most notably: 

The opening by Takeda of a manufacturing facility in Grangecastle to produce its allogeneic cell therapy Alofisel.

 The recent announcement by MeiraGTx of

a viral vector manufacturing facility in Shannon to support various gene therapy

products.

To further build on these initial successes and to capitalise on the opportunity in the longerterm, Ireland needs to consider targeted ATMP investments aimed at consolidating its position as a world leader in BioPharma manufacturing and carving out a new position as a location geared towards addressing the challenges associated with ATMP manufacturing.

Manufacturing challenges for ATMPs Firstly, according to recent analysis in the 17th Annual Report and Survey of BioPharmaceutical Manufacturing, the BioPharma industry in a broad sense is heading for a capacity crunch globally (Source: 17th Annual Report and Survey of BioPharmaceutical Manufacturing, April 2020, ISBN 978-1-934106-37-2).

This is driven by the limited number of production facilities and continued growth of the monoclonals / biosimilars market,

Information on the NIBRT training curriculum, both Training online and in-person, Catalogue can be found in the 2021 catalogue, which is 2021 available at: www.nibrt.ie/wp-content/ uploads/2020/11/NIBRT-Training-Catalogue-2021-.pdf.

Irish PharmaChem | Industry Buyers Guide 2021

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NIBRT

The rapid pace with which clinical research of new Covid-19 therapies and vaccines has happened and regulatory approvals have been granted has been staggering.

and is accentuated by the burgeoning ATMP pipeline and Covid-19 production demand.

Decisions will be taken in the coming months and years about where to position new cell therapy, gene therapy and novel vaccine manufacturing sites within the global networks of the multinationals. Ireland can be a prime location for these facilities, but it must continue to invest in relevant infrastructure to enable an ATMP ecosystem; including world class training facilities, research capabilities, supply chain / logistics expertise and digital capabilities.

Secondly, ATMP manufacturing technology is still at a very early stage of development, equivalent perhaps to the manual rollerbottle technology first used for recombinant protein manufacturing in the 1980s. As with monoclonal bioprocessing, the manufacturing technology around ATMPs must improve to ensure that production yields and quality is maximised, that market demand is met, and that advanced medicines and vaccines can be as affordable as possible. Ireland has built significant research capability over the past decade, both at NIBRT and in other research centres around Ireland. Investment in ATMPfocused analytics and manufacturing research can help make Ireland a global centre of excellence for ATMP research and a recognised leader in the optimisation of advanced cell, gene and vaccine manufacturing.

Thirdly, there continues to be a critical global shortage of skills and capabilities to meet the needs of BioPharma manufacturing.

This need for well-trained individuals is even more pronounced in ATMP manufacturing, particularly when the growing need for BioPharma 4.0 skills, in data analytics, informatics, AI, etc, are factored in. NIBRT, with its higher education partners, has built significant

14

strengths in the training and education of top talent for the BioPharma industry over the last 10+ years. This capability must now be adapted and applied to generate the skills needed for the manufacturing of the next wave of advanced new medicinal products in Ireland.

NIBRT – expanding its role, from monoclonals into ATMPs The Government’s strategic vision in establishing NIBRT in the 2000s and ongoing investment since then has been pivotal in helping Ireland to win and sustain the biologics manufacturing investment of the last 10 years.

NIBRT now has ambitions to also play a leading role in attracting the next wave of ATMP investment.

On the skills front, NIBRT has introduced a number of ATMP-related courses into its training curriculum, including:

 E-learning introductory courses in Cell Therapy and Gene Therapy, delivered through the NIBRT Online Academy platform.  A 4.5-day theory and practical based course in Stem cell therapy manufacture, delivered in partnership with CCMI.  Coming in 2021, - Introduction to ATMPs, two-day classroom and practical courses.

- Advanced Cell Therapy Technology, three-day classroom / practical

courses, with Cytiva.

- Fundamentals of Vaccine

Manufacture, four-day classroom / practical course.

More information on all of the NIBRT training curriculum, both online and in-person, can be

found in the 2021 catalogue, which is available at: www.nibrt.ie/wp-content/uploads/2020/11/ NIBRT-Training-Catalogue-2021-.pdf.

In research, a team of researchers at NIBRT has recently commenced a significant industry collaboration, with co-funding from Enterprise Ireland, focused on viral vector characterisation and optimisation of the manufacturing process, with potential applied uses in gene therapy and vaccine manufacturing.

At a national level, NIBRT has played an increasing leadership role through the establishment in 2018 of the Cell and Gene Therapy Forum, along with many stakeholders from industry, academia and Government. The CGT Forum produced a White Paper in 2019 which laid out a series of recommendations for increased investment in workforce development, research excellence and national infrastructure. This paper paved the way for IDA Ireland and the other Department of Enterprise, Trade and Employment agencies, along with European Union funding, to commission an in-depth study on the opportunities for Ireland in ATMP development and manufacture.

The outputs of this study are expected to be published early in 2021.

Moreover, the CGT Forum white paper was important in underpinning a business case that led to a decision, in recent months, to expand the NIBRT facility to incorporate more ATMP research and training capacity. This expansion is currently under planning review and it is anticipated that construction will start in 2021 and will be open for business in 2022.

In conclusion The manufacture of advanced therapy medicinal products, including cell and genebased medicines and novel-modality vaccines, for the supply of global markets represents a major opportunity for Ireland in the coming years. NIBRT looks forward to playing a key role in helping Ireland capitalise on this opportunity and will endeavour to work with BioPharmacChem Ireland, IDA Ireland and all our other partners to ensure Ireland continues its impressive track record of success in BioPharma manufacturing.

Darrin Morrissey, CEO, NIBRT. Irish PharmaChem | Industry Buyers Guide 2021

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Regulation

Working together in an extraordinary year

The unprecedented global health crisis has forced medicines and medical device regulators, in addition to the BioPharmaceutical industry, to adopt extraordinary approaches to ensure continued access to vital health products when needed most. As a result of the pandemic, the manufacturing and distribution capacity of BioPharmaceutical companies have been either directly or indirectly affected and they have had to modify their working procedures and/or regulatory activities to respond to demands.

In an effort to support pharmaceutical companies to maintain regulatory compliance and avoid shortage issues, regulatory bodies have adopted a suite of extraordinary flexibilities to ensure the continued availability of medicinal products. Of particular note, flexibilities have been introduced around manufacturing requirements, importation of finished products and active ingredients, variations requests, pharmacovigilance activities and changes to how good practice (GxP) inspections are performed. The following discussion provides a Irish PharmaChem | Industry Buyers Guide 2021

Dr Lorraine Nolan, CEO of the Health Products Regulatory Authority (HPRA), explains how medicines regulators and the BioPharmaceutical industry have worked collaboratively to negate the impact of the Covid-19 pandemic on medicine supply.

reflection on some of the regulatory flexibilities that were introduced and how medicines regulators and the BioPharmaceutical industry have worked collaboratively to negate the impact of Covid-19 on the supply of medicinal products during 2020. I will also look ahead to the future as the HPRA begins to implement its new strategic plan to 2025.

Remote inspections and distant assessments The Covid-19 pandemic has reemphasised the

resilience of the BioPharmaceutical industry, but also its importance to the Irish economy.

Unfortunately, while the domestic economy has suffered greatly this year, recent data from Economic and Social Research Institute (ESRI) shows medicinal and pharmaceutical product growth contributed a full three percentage point increase in overall exports (Source: ESRI - The lockdown tale of two economies in Ireland: How big tech and pharma bucked the trend).

Given Ireland is the third largest exporter of pharmaceuticals globally, with over 85

17

Regulation pharmaceutical companies located in the state, it is not surprising that the HPRA has accrued considerable expertise around inspections and licensing of BioPharmaceutical manufacturers and wholesalers. Consequently, the HPRA have been particularly aware of the regulatory flexibilities introduced to sustain the availability of medicines and gained considerable experience in engaging with companies on many of these issues. In fact, the HPRA led on the development of an EMA guideline on remote inspections and distant assessments, which was finalised in June for use by inspectorates across the European Union.

The HPRA took the decision to put its onsite inspection programmes on hold in mid-March 2020. We appreciate the co-operation of manufacturers in preparing for and facilitating new approaches to this important work. In some instances, it has been necessary to combine focused onsite inspection with the distant assessment. We acknowledge that the distant assessment process can place new demands and ways of working on all parties, but the continued determination and effort shown by companies to ensure compliance is fully acknowledged and appreciated. The HPRA will continue to liaise with manufacturers and distributors around these issues and will continue to review our approach in line with public health advice.

Shortages Medicine shortages are not new. However, extraordinary geopolitical events and the global pandemic which has enveloped us all for much of 2020 have highlighted many challenges in ensuring medicines supply.

Though Europe’s response has demonstrated strengths, existing vulnerabilities have come into sharp focus. This includes those related to data availability, unilateral national actions, and the availability of manufacturing capacities to adapt and support the production of medicines.

The pandemic also showed that, often, access to complete information about the structure of the manufacturing and supply chains is limited. This was important in understanding the impacts of national decisions on the global supply chain, such as the Active Pharmaceutical ingredient export restrictions in India.

However, the pandemic has also presented opportunities. Generally, the focus of coordinating a response to shortages has been on finding solutions once unavailability occurs.

The experience of Covid-19 illustrates that early communication and collective approaches pay off. Ireland did not experience the same shortage impact as other European colleagues during the pandemic. This was primarily driven by the close communication and aligned strategies among the Health Service Executive, the HPRA and the pharmaceutical industry as a whole, to ensure supply to patients.

Although medicine production is a

18

Regulatory flexibilities and agile approaches agreed by Member State authorities, in conjunction with the EMA and the European Commission, have facilitated the industry throughout the Covid period.

global activity, regulatory authorities and political decisions are still based on national or supranational frameworks. Due to the experiences with the pandemic, steps to achieve a more harmonised EU approach to tackling shortages have been brought forward.

The pandemic ushered in the development of an industry single point of contact (iSPOC), for example. Through the iSPOC system, pharmaceutical companies can report directly to the European Medicines Agency (EMA) any issues related to the availability of crucial medicines being used in the context of Covid-19, whilst also continuing to report to the Member States concerned.

Reflections and lessons learned Regulatory flexibilities and agile approaches agreed by Member State authorities, in conjunction with the EMA and the European Commission, have facilitated the industry throughout the Covid period. It is now important to evaluate the success of these adaptive regulatory practices to identify mechanisms that have added real and substantive value to the regulation of medicines.

It is vital that we as a global community of regulators reflect on how best to integrate new approaches to add value-driven regulation, wherever possible, and replace outdated systems that impede timely access to safe and effective medicines and medical devices.

The combination of exceptional regulatory flexibilities, combined with committed and sustained efforts by the pharmaceutical industry, have helped to ensure continued availability of critical medicines during the pandemic when most required. We very much

look forward to working collaboratively with the Irish BioPharmaceutical industry in 2021 and beyond, and ensure that the health and welfare of the public is central in all that we do.

HPRA Strategy 2021-2025 Looking ahead, the HPRA’s new strategic plan to 2025 sets out our ambition for the next five years to deliver better outcomes for patients and animals. The new HPRA plan is very much aligned with key priorities outlined in both the European Medicines Agencies Network Strategy to 2025 and the European Commission’s Pharmaceutical Strategy for Europe. Central to realising the ultimate goal of each strategy of ensuring continued access and availability of safe and effective medicines, while also enabling innovation, is establishing meaningful partnerships with key health system stakeholders.

The twin challenges of Brexit and Covid have very acutely demonstrated the requirement for meaningful interaction between regulators and the pharmaceutical industry, to ensure continued supply of medicines. This is a testament to the power of partnerships to overcome current, or any future, public health emergencies.

Strengthening existing partnerships, in addition to establishing new relationships with key stakeholders, will position the HPRA as an enabler of innovation, which is vital to ensure Ireland continues to be a world leader in the global BioPharmaceutical sector. While protecting health and wellbeing will always be our highest priority, supporting a thriving pharmaceutical sector from a regulatory perspective only serves to benefit people and animals now and into the future.

Irish PharmaChem | Industry Buyers Guide 2021

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INGREDIENTS

Access to Medicines

Reshaping the European supply chain Europe needs a resilient and sustainable EU health industry, and that means reshoring supply chains for essential medicines, which was brought into sharp focus by the Covid-19 pandemic, writes Maggie Saykali, Director, European Fine Chemicals Group.

EFCG believe that the way to rehape the European supply chain is through a process of selective, holistic and non-exclusive reshoring.

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Irish PharmaChem | Industry Buyers Guide 2021

Access to Medicines The unprecedented global health crisis caused by the Covid-19 pandemic has hit Europe particularly hard and has highlighted the weaknesses of our continent in terms of health autonomy. Formerly the global hub for the synthesis of pharmaceutical ingredients, Europe has gradually lost its ability to manufacture critical molecules that are the building blocks of essential medicines.

Europe’s dependence on other world regions poses an unacceptable risk for the European healthcare system. In recent years, increased occurrences of shortages of essential medicines in Europe constituted a health safety risk for patients and placed a very heavy financial burden on healthcare systems.

EFCG, the European Fine Chemicals Group, represents a strong network of manufacturers across Europe dedicated to the production of Active Pharmaceutical Ingredients (APIs) and their precursors. In 2018, EFCG created a specific task force to tackle the then emerging issue of medicines supply chain risks. Throughout recent months, EFCG members have been working closely with the European Commission to identify the root causes of medicines shortages, map the existing industrial network and propose a series of measures to be rapidly implemented at EU level within the framework of the Pharmaceutical Roadmap.

Europe’s dependency Currently, Europe’s direct and indirect dependency on Asia, in terms of both APIs and precursors, is estimated to be around 74% of total market volume (in kg) and has grown over time, more than doubling since the 1980s (Source: IQVIA Fine Chemicals report, 2020).

Within Asia, China represents the most relevant country, being responsible for almost 70% of total dependency.

Most of the innovative APIs are still manufactured in Europe, as the customers for these APIs highly value European manufacturers’ robustness of supply, including strict compliance with environmental, safety and quality regulations. On the other hand, constant price pressure on generic drug product manufacturers pushed them towards the lowest price API suppliers. Some of these are based outside of Europe, but even those that are still based in Europe must often rely on low-priced precursors sourced in Asia. Stringent environmental and safety regulations within the EU are not respected to the same extent by a fully global industry, creating an uneven playing field for EU companies and decreasing their global competitiveness.

As a result, key processes and technologies to produce essential APIs, such as fermentation, fluorination, chlorination and nitration, have totally or partially moved to Asia, losing the European API supply chain its critical mass.

In addition to this dependency from Asia, other factors expose Europe‘s vulnerability, Irish PharmaChem | Industry Buyers Guide 2021

The pharmaceutical value chain Regulated starting materials

Active Ingredients

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Finished Dosage Form

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National and regional Wholesalers Hospitals and Pharmacies

Patients

such asTo build increasing supplier supply consolidation reinforce the critical strategy mass to: and technological a resilient pharmaceutical chain, we need a coherent European pharmaceutical and the lackRestore of visibility and control on some autonomy of the EU-based pharmaceutical Ensure regulatory flexibility (e.g. fast track and secure the production of the critical approvals),chain to prevent future and strategicleading pharmaceutical components in to overseas producers, to the inability supply and toshortages build due a to solid Europeanunforeseen events or surges in demand Europe identify weaknesses that can lead to shortages based portfolio of technologies that will Coordinate at European level aand list ofaddress essential current and Support investments to boost innovation, further down the line. successfully prevent medicines that need to be available at all times and ensure European industry’s competitiveness future shortages, independently from their root monitor any risks of spikes or shortages globally, whilst maintaining quality, safety As a consequence, Europe high is strongly and and environmental standards causes. sometimes totally dependent on imports for some basic but absolutely essential medicines.

For instance, out of the top 10 molecules Our eight European member companies have production facilities, critical know-how, a highly skilled manpower and Europe’s response highest and environmental standards.for by volumethesold inquality Europe are dependent On November 25, the European Commission more thanWe 80% on Asian imports (Source: IQVIA will actively contribute to building a resilient and sustainable European pharmaceutical supply chain. adopted a Pharmaceutical Strategy for Europe database and IQVIA report for EFCG). In case of to ensure patients have access to innovative global shortage, the impact of this dependence and affordable medicines and to support on European patients would be dramatic. the competitiveness, innovative capacity and sustainability of the EU’s pharmaceutical Reshaping the European supply chain industry. The Strategy will allow Europe to A reshaping of the European supply chain is, cover its pharmaceutical needs, even in times therefore, urgently needed if Europe wants to of crisis, through robust supply chains. A key maintain the strategic autonomy of its health component of building a stronger European system and its global competitiveness. Success Health Union, as called for by President von will depend on Europe’s ability to maintain and der Leyen in her State of the Union speech, develop its existing industrial base, as well as the Pharmaceutical Strategy will help to investing in new technologies to selectively establish a future-proof and crisis-resilient EU reshore supply chains for essential medicines. pharmaceutical system.

For EFCG, the way to achieve this ambitious In the words of European Commission’s goal is through a selective, holistic and nonVice-President, Margaritis Schinas, the ambition exclusive reshoring. EU regulators should of this Pharmaceutical Strategy is to be define regulatory, economic and financial anthropocentric, focusing on patients. It aims incentives applicable to critical medicines, to ensure access to affordable medicines for as well as the percentage of EU demand that patients and to address unmet medical needs. should be covered by EU-based suppliers, with It also highlights the need to support the the balance being supplied from overseas. competitiveness, innovation and sustainability of the EU’s pharmaceutical industry and the To ensure robustness and real independence development of high quality, safe, effective from overseas sources, components of critical medicines should be made in Europe, covering and greener medicines, whilst ensuring a the whole supply chain. The goal should be to strong EU voice in the world, promoting

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Access to Medicines a high level of quality, efficacy and safety standards. It aims to identify vulnerabilities in the global supply chain of critical medicines, raw pharmaceutical materials, intermediates and active pharmaceutical substances through several measures. These include:  Enhancing the security of supply and addressing shortages;  Revising the manufacturing and supply provisions in pharmaceutical legislation to improve transparency and reinforce oversight of the supply chain;  Clarifying responsibilities to ensure overall environmental sustainability, safeguard the quality of medicines, and ensure preparedness for new manufacturing technologies.

It also acknowledges the need to adapt to cutting-edge products, scientific developments and technological transformation and provide tailored incentives for innovation.

To ensure robustness and real ❝ independence from overseas sources, we need to build a solid European-based portfolio of technologies that will successfully prevent and address current and future shortages, independently from their root causes.

Producing a single API is a complex process requiring many steps and raw materials

Producing a single API is a complex process requiring many steps and raw materials.

Practical recommendations for Europe EFCG are in full agreement with the Strategy’s call for actions to strengthen the continuity and security of supply in the EU, and November 2020 saw EFCG present a series of practical recommendations to the European Commission for building a long-term resilient and sustainable EU-based pharmaceutical supply chain and health industry, hand in hand with all relevant links of the value chain (https:// efcg.cefic.org/resources/position-papers/).

European manufacturers of APIs and intermediates represent around 600 sites across Europe. They are the ultimate guarantees of Europe’s health independence and are part

About the Author

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Maggie Saykali is a Director of the European Fine Chemicals Group (EFCG), part of Cefic (the European Chemical Industry Council). EFCG represents over 300 fine chemical sites across Europe, over half of which are dedicated to the pharmaceutical industry. For more information, visit https://efcg.cefic.org.

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Irish PharmaChem | Industry Buyers Guide 2021

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Carbon Group, Ringaskiddy, Co. Cork, Ireland, P43 R772 T: +353 21 4378 988 Contact: Carol Deegan T: +353 86 261 2485 E: carol.deegan@carbon.ie

land’s Ireland’s w Raw aterials Materials ecialists Specialists

49, Baldoyle Industrial Unit 49,Estate, Baldoyle Baldoyle, Industrial Dublin Estate, 13, Baldoyle, Ireland Dublin 13, Ireland 53 1 839 3127 F. T. +353 +353 11 832 839 5746 3127 E. F. info@heterochem.com +353 1 832 5746 E. info@heterochem.com W. www.heterochem.com W. www.heterochem.com

Global Business Services

The potential impact of GBS

Padraic O’Neill, Vice President of Pfizer’s Global Business Services in Dublin, explains the history of the Global Business Services sector in Ireland and what it means for the Pharma/BioPharma industry.

The Global Business Services (GBS) sector, one of the fastest growing and evolving sectors in Ireland, employing over 45,000 colleagues, has often been described as “one of Ireland’s best kept secrets over the last 20 years”.

The sector offers potential to locate highly qualified, skilled, sophisticated global roles in Ireland that will provide sustainable growth for many years to come.

With all the top 10 Pharma companies and 14 of the top 15 Medical Technology Companies having a significant presence in Ireland, GBS has become a significant sector within Pharma and offers great potential for further development in the years to come.

One of the biggest challenges facing the industry is ensuring that Ireland continues to be the location of choice against other very competitive locations. To do this, we must exploit our greatest resource – our talent pool.

Padraic O’Neill, Vice President of Pfizer’s Global Business Services in Dublin.

Irish PharmaChem | Industry Buyers Guide 2021

The development of GBS in Ireland GBS in Ireland first emerged over 20 years ago, when GBS was almost exclusively

focused on cost, relocating various activities from more expensive locations to cheaper ones.

Against major cities like London, Paris Brussels and Rome, Ireland competed well, and this allowed us to develop the first wave of shared service sites, based firmly on transactional processing.

Most GBS centres were originally established to concentrate on the centralisation of financial services, such as order processing, invoice to pay etc. Once centralised, the focus was to standardise and optimise processes, creating further savings.

At this stage, a lot of the activity was ripe for moving again to even cheaper locations like India, China and Central and Eastern Europe. Progressive sites embraced this change, recognising they couldn’t compete on price but instead looked to other opportunities, moving knowledge-based activities to Ireland, while at the same time migrating transactional activity out.

Today, several sites have evolved with the relocation into Ireland of leading global

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Global Business Services

specialist roles in areas including:  Finance knowledge areas such as operational transfer pricing, VAT, statutory accounting and audit, treasury operations, transformation and project management;  Provision of medical information and meeting services;  Market insights, sales force effectiveness, patient access, medical communications, legal compliance and IP;  Training design and delivery;  HR services.

Ireland’s strong reputation for Pharma/ BioPharma GBS: Over the years, Ireland has worked hard to ensure we have a very strong, deep, flexible multinational talent pool, which is knowledge based and has an ability to adapt to the everchanging opportunities that have presented themselves as GBS has grown to encompass more sophisticated support functions.

Ireland, as an English-speaking nation, occupies a bridge-head between the USA and Asia and has been leveraged in a range of areas.

Several centres, such as those from Pfizer, Novartis and Eli Lilly, have demonstrated ability to grow and diversify and have leveraged our very world class universities and third level educational establishments to meet the ongoing needs of our industry.

Increasingly, the Pharma industry is recognising the importance of GBS in developing end-to-end offerings, leveraging

Ireland’s already significant reputation for excellence in Pharma research and manufacturing.

The importance and future of talent Ireland has an incredibly diverse talent pool, with 16.5% of the workforce non-Irish. We’re ranked number one globally for attracting and retaining international talent and ranked first in the world for labour productivity.

Ireland’s education system is ranked in the top 10 globally as ‘Education systems that meet the needs of a competitive economy’, with 56.3% of 30-34 year-olds holding a university level education (against the EU average of 40.7%). There has been a 27% increase in foreign students enrolling in the Irish university education system since 2016 and we have the youngest population in Europe (with 33.3% under 25).

However, we are only as good as our ability to continuously supply the industry with the talent required to meet the needs of an everevolving, expanding and growing industry.

Attraction and retention of the right kind of talent is probably the key threat to the industry as a whole and remains a challenge.

The GBS Masters A wonderful example of how Ireland can lead the way in developing its GBS talent pipeline and talent reputation is the launch of the world’s first MSc (Masters) in GBS. Developed by the industry in conjunction with Skillnet, Ibec, IDA and the American Chamber of Commerce, the

Masters is accredited by Technology University Dublin, while leveraging content from Hackett.

Launched in 2019, the Masters will see the first class completing the programme in 2021, becoming the first and only holders of a MSc qualification in GBS anywhere in the world.

This is adding to the diversity of experience for colleagues, offering networking opportunities, exposure to the world’s leading best practices in GBS, together with a recognised Level 9 GBS qualification

Opportunities for the sector in the future: There are huge opportunities for the sector; however, the GBS function needs to be closely aligned with the BioPharma sector, as opposed to the general shared services sector, leveraging co-location and becoming more integrated with manufacturing sites. It is essential that the centre is a strategic fit both locally and in the wider context of the global network that it serves.

Pharma manufacturing sites should be encouraged to explore any pockets of GBS residing on their own sites and encourage them to align with other GBS centres in the country.

The sector will need to increase the understanding and branding of itself as a vital part of the BioPharma industry, explaining how we no longer represent purely ‘back office’ transactional activities but instead are a truly knowledge-led subset of the overall manufacturing and R&D industry.

There are a multitude of possibilities for

Ireland launched the world’s first MSc in Global Business Services, accredited by Technology University Dublin and developed by the industry in conjunction with Skillnet, Ibec, IDA and the American Chamber of Commerce, with the graduates of 2021 becoming the first and only holders of a MSc qualification in GBS anywhere in the world.

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Irish PharmaChem | Industry Buyers Guide 2021

Te

BioPharm

Biopharmaceutical Services From concept to market

Ensuring the identity, purity, safety and quality of your biopharmaceutical at every stage.

Your trusted partner for: y Raw materials testing y Biopharmaceutical characterisation y Cell-based assays NEW y Nitrosamine impurity testing y Sterility testing y Safety testing y ICH stability testing y Release testing y Troubleshooting and contaminant identification Outstanding quality, scientific excellence and customer satisfaction

For further details contact customer services on: Tel: +44 (0)118 918 4076 Email: enquiries@rssl.com Web: www.rssl.com

BioPharma Ad 285x215.indd 1

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Global Business Services

The emerging and developing area of Cell and Gene Therapy value chains provides an opportunity for Ireland to extend its reach into the life sciences and BioPharma space, whilst simultaneously elevating its status in the value chain and protecting its contribution to GDP. growth and some specific opportunities being developed include:  Utilising Global Business Services

function to enable closer integration with patients to co-ordinate and centralise medical information that could be made available to doctors, and centralising communications;

 Exploring how products and patient

support activities could be better serviced;  Diversification into other areas such as

clinical trials, supply chain, GBS innovation and transformation;

 Leveraging the expertise developed

by the tech industry in the ‘Grand Canal Innovation District’ to provide an end- to-end cohesive value offering of strategic services on a global scale;

 Identification of opportunities to

influence Governmental policy specific to the industry and what support the different Government agencies can provide.

Expanding into other areas How can GBS centres expand their role into other areas such as in Cell and Gene Therapy value chains, personalised medicines, clinical trials and, for example, achieve a control tower status?

28

A great example of how the industry is coming together to propose endto-end solutions for ongoing industry developments is the recent work being undertaken to develop a national strategy in the area of Cell and Gene Therapy and ATMP manufacturing and support..

The emerging and developing area of Cell and Gene Therapy value chains provides an opportunity for Ireland to extend its reach into the life sciences and BioPharma space, whilst simultaneously elevating its status in the value chain and protecting its contribution to GDP. Advanced therapeutics such as Cell and Gene Therapies and personalised medicines will deliver many solutions to unmet healthcare needs in the coming years; over 1,000 clinical trials are currently being conducted in these fields. If Ireland is to maintain its role as a global centre for BioPharmaceutical manufacture and supply, it is going to need to develop expertise in these areas. A new paradigm for manufacture is required though, and Ireland does not yet possess enough capabilities to be considered a natural location for this part of the industry.

The industry has launched a ‘Digital Accelerator’ to identify “what will it take for Ireland to be recognised as a Global COE for CGT and ATMP”.

There is no reason why supply chain

hubs cannot be in Ireland. There is ample connectivity and infrastructure to accommodate this; we should dispel the myth of peripherality. Ireland has excellent experience in the area of temperaturecontrolled supply chains; this will be particularly relevant to Cell and Gene Therapy. The HPRA plays a supportive role in this regard.

Ireland has the skills base to expand the scope of operation. There is no doubt that CGT, with its very specific requirements and supply chain, are very suitable for GBS centres.

This model approach could provide the key to a more cohesive and progressive industry-wide, end-to-end industry strategy and give Ireland a competitive edge over our competitors, going forward.

An exciting time It’s an incredibly exciting time to be involved in Pharma/BioPharma GBS in Ireland today, with wonderful opportunities and challenges. We are uniquely placed to harness the tech revolution and build on 20 years of experience, success and evolution, but it will require all of us coming together as an industry - members, educational and professional organisations and Government - with a greater ‘Ireland alignment’ to ensure not only that we survive but that we continue to thrive.

Irish PharmaChem | Industry Buyers Guide 2021

Pharmaceutical Training Experts

For over 30 years RSSL has been providing high quality training to pharmaceutical professionals. Our reputation as one of the most trusted training providers, gives you the confidence that our training is of the highest standard and tailored to your needs.

• Qualified Person

• QMS Lead Auditor

• Qualified Person • Auditing • Biotechnology • Good Manufacturing Practice • Microbiology • Supply Chain • Validation Key 2021 Training Dates For Your Diary: Biologically Derived Products Manufacture, Testing & Compliance Key Regulatory Updates for the Pharma Industry Responsible Person & GDP

6 to 7 January 15 January 19 March 19 to 21 January 22 to 24 March

QMS Lead Auditor

8 to 12 March

Good Manufacturing Practice

19 to 21 April

New Medical Device Regulation (MDR) 2017/745

24 May

Manufacturing Sterile Products

14 to 15 June

Practical GMP for ATMPs

LIVE VIRTUAL ONLINE TRAINING Find out more at: www.rssl.com/pharmaceutical-training

15 July

RSSL Training Courses 2021 Date

Days

Active Pharmaceutical Ingredients Auditing

11 Jan, 8 Jun

1 day

Auditing to Pharmaceutical Standards

12 Mar, 21 Jun, 7 Dec

1 day

Pharmaceutical Practical Auditing Skills

3-4 Feb, 23-24 Jun, 11-12 Nov

2 days

QMS Lead Auditor for the Pharmaceutical Industry (IRCA Ref: PR330)

8-12 Mar, 24-28 May, 20-24 Sep, 22-26 Nov

5 days

Auditing

Biotechnology Biologically Derived Products – Manufacture, Testing & Compliance Challenges 6-7 Jan, 29-30 Jun, 15-16 Nov Biotechnology Issues

4 Mar, 12 Jul, 13 Dec

2 days 1 day

Good Manufacturing Practice Good Manufacturing Practice – Advanced

19-21 Apr, 13-15 Jul, 23-25 Nov

Good Manufacturing Practice in the Laboratory

11 Mar, 20 Sep

3 days

Management of GMP Inspections

22-23 Mar, 7-8 Oct

Practical GMP for Advance Therapy Medicinal Products (ATMPs)

15 Jul

1 day

New Medical Device Regulation (MDR) 2017/745

24 May, 11 Nov

1 day

Environmental Monitoring – In Partnership with Cherwell Laboratories

8 Mar, 17 Nov

1 day

Manufacturing Sterile Products

14-15 Jun, 18-19 Nov

1 day

Good Distribution Practice

18 Jan, 15 Mar, 17 May, 25 Oct, 6 Dec

1 day

Responsible Person and GDP, Cogent Gold Standard Approved

19-21 Jan, 22-24 Mar, 18-20 May, 1315 Jul, 21-23 Sep, 8-10 Nov

1 day 2 days

Microbiology

Supply Chain

3 days

Validation Cleaning Validation

8 Feb, 19 Jul, 17 Sep

1 day

GxP Computerised Systems Validation and Compliance

20-21 Jan, 5-6 May, 12-13 Oct

1 day

Process Validation & Qualification, including Validation Methods

29-30 Mar, 6-7 Sep

2 days

Data Integrity and Electronic Records and Signatures

4 Mar, 6 Jul, 28 Oct

1 day

Leadership and Influencing Skills for the QP & First Time Managers

19 Feb, 3 Nov

1 day

Quality Risk Management – How to apply ICH Q9 in Practice

27 Jan, 29 Jul, 22 Nov

1 day

Technology Transfer of Pharmaceutical Products

28 Jan, 27 May

1 day

Root Cause Analysis & CAPA

7-8 Jul, 8-9 Dec

2 days

Others

Information is correct at the time of going to print. RSSL reserve the right to make any changes that may become necessary.

As we continue to monitor the safest way to deliver our training courses, the delivery mode is subject to change from face to face classroom training to online training.

RSSL, The Reading Science Centre, Whiteknights Campus, Pepper Lane, Reading, Berkshire, RG6 6LA Telephone: +44 (0)118 918 4076 Bookings: bookings@rssl.com Email: enquiries@rssl.com Web: www.rssl.com

0 30 RSSL Pharma Training Ad A4 Dec 2020.indd 1

Irish PharmaChem | Industry Buyers Guide 2021

27/11/2020 16:56:00

RSSL Q

Qualified Person Training Courses 2021 QP MODULES QP Webshow

1 day

4 Feb, 22 Apr, 17 Jun, 16 Sep, 4 Nov

Role and Professional Duties

2 days

12-13 Jan, 21-22 Jun, 21-22 Oct

Pharmaceutical Law and Administration

2 days

25-26 Jan, 9-10 Jun, 29-30 Sep

Investigational Medicinal Products

2 days

27-28 Jan, 11-12 May, 2-3 Nov

Pharmaceutical Formulation and Processing Part 1* – includes Practical Day (June only)

2 days 3 days

1-2 Feb 14-16 Jun

Medicinal Chemistry and Therapeutics

3 days

8-10 Feb, 13-15 Sep

Pharmaceutical Packaging

3 days

16-18 Feb, 27-29 Sep, 14-16 Dec

Mathematics and Statistics

3 days

23-25 Feb, 20-22 Jul, 15-17 Nov

Biotechnology Issues

1 day

4 Mar, 12 Jul, 13 Dec

Pharmaceutical Formulation and Processing Part 2*

3 days

8-10 Mar, 26-28 Jul

Pharmaceutical Quality Systems

3 Days

16-18 Mar, 28-30 Jun, 26-28 Oct

Pharmaceutical Microbiology

3 days

13-15 Apr, 5-7 Oct

Active Pharmaceutical Ingredients

2 days

31 Mar-1 Apr, 7-8 Jul, 29-30 Nov

Pharmaceutical Microbiology

3 days

13-15 Apr, 5-7 Oct

Analysis and Testing

3 days

27-29 Apr, 18-20 Oct

ADDITIONAL SUPPORT COURSES Demystifying the QP Application Process and Viva Viva Preparation Day Key Regulatory Updates in The Pharma Industry Responsible Person and GDP, Cogent Gold Standard Approved Leadership and Influencing Skills for QPs and First Time Managers Interpretation of Statistical Values Used in GMP Applications and

90 mins 1 day 90 mins 3 days

15 Jan, 19 Mar, 14 May, 16 Jul, 20 Sep, 8 Nov 19-21 Jan, 22-24 Mar, 18-20 May, 13-15 Jul, 21-23 Sep, 8-10 Nov 19 Feb, 3 Nov

4 days

22 Feb, 19 Jul 23-25 Feb, 20-22 Jul, 15-17 Nov

WebTorials Online (Scenarios and Problem Solving)

90 mins

Introduction to Pharmaceutical Microbiology and

4 days

Pharmaceutical Microbiology

Analysis & Testing

14 Jan, 16 Feb, 25 Mar, 20 Apr, 20 May, 15 Jun, 15 Jul, 19 Aug, 14 Sep, 14 Oct, 18 Nov, 14 Dec

1 day

Mathematics & Statistics

QC Chemistry – Crash Course and

14 Jan, 12 Feb, 25 Mar, 26 Apr, 13 May, 18 Jun

26 Feb, 26 Mar, 23 Apr, 21 May, 25 Jun, 9 Jul, 10 Sep, 8 Oct, 12 Nov, 10 Dec 12 Apr, 29 Jul, 4 Oct 13-15 Apr, 5-7 Oct

4 days

26 Apr, 1 Jul, 14 Oct 27-29 Apr, 18-20 Oct

* Please note: to cover the criteria set out in the QP study guide, both Part 1 and Part 2 should be attended.

Information is correct at the time of going to print. RSSL reserve the right to make any changes that may become necessary.

As we continue to monitor the safest way to deliver our training courses, the delivery mode is subject to change from face to face classroom training to online training.

RSSL, The Reading Science Centre, Whiteknights Campus, Pepper Lane, Reading, Berkshire, RG6 6LA Telephone: +44 (0)118 918 4076 Bookings: bookings@rssl.com Email: enquiries@rssl.com Web: www.rssl.com Irish PharmaChem | Industry Buyers Guide 2021

16:56:00

RSSL QP Training Ad A4 Dec 2020.indd 1

31 0 27/11/2020 15:52:58

Diversity

Why diversity makes sense for you As globalisation increases and more people gain access to higher education, countries and organisations are becoming more diverse, in terms of race, ethnicity and abilities. Incidents such as racial-related injustice and those of other minorities are highlighting the need for companies to emphasise the importance in developing and deploying a strong diversity and inclusion strategy. As with all sectors of business and society, there was a recognition in the BioPharmaChem sector in Ireland that diversity, inclusion and belonging needed a stronger focus. This is critical to ensure we build the right cultures, implement the appropriate processes and policies, ensuring a long-term and diverse pipeline of talent which would support the growth of the BioPharmaChem sector in the years ahead.

In 2019, BPCI and 30% Club Ireland engaged with member companies to launch the BPCI Diversity, Inclusion and Belong (DI&B) forum.

From the beginning, it was imperative that the forum be supported by the BioPharma leaders.

32

Siobhán Dean, Executive, BioPharmaChem Ireland, explains the how and the why of diversity and inclusion for your organisation, and explains how the BioPharmaChem Ireland Diversity, Inclusion & Belong forum is making huge strides forward for the benefit of all.

The Group defined their vision and purpose as below:

ambitions, with an initial focus on gender balance.

 Vision: to attract, retain, return & grow the best talent for the BioPharmaChem sector in Ireland;

“The ambition is to be a cohesive, single voice specifically for the Pharma sector in Ireland, to support our sector by enabling resource requirements for the growing BioPharma industry, to improve employee engagement by encouraging belonging and

 Purpose: to be useful to BioPharmaChem businesses in achieving their culture and inclusion

Irish PharmaChem | Industry Buyers Guide 2021

Should you wish to be part of our team in the manufacture of high-quality, affordable medicines, please see all our job openings on the Careers section of our website

www.amneal.com

Diversity to encourage more innovation by enabling a more diverse and creative workforce,” explained Paul McCabe, Alexion, and Elizabeth Collins, Mallinckrodt Pharmaceuticals, who are the BPCI Pharma DI&B Working Group Co-Chairs.

To date, DI&B have agreed on a strategy framework and have established an implementation team to help support the sector on its journey to achieving its diverse culture and inclusion ambitions in three primary areas: awareness and influencing, supporting talent and supporting business.

Awareness and influencing The first strategic area involved creating a greater awareness of the opportunities in the BioPharma sector. Attracting talent from diverse backgrounds opens the doors to a greater talent pool, which research has shown improves decision-making and problemsolving, as well as driving innovation and collaboration.

Therefore, it is important that the sector communicates its purpose and culture. An organisation’s D&I culture and policy is one of the key deciding factors for job seekers, with many seeking out information and insights before they apply for a role.

According to a September 2020 Glassdoor survey, 76% of young job seekers and employees report a diverse workforce as an important factor when evaluating companies and job offers (Source: www.glassdoor.ie).

Industry has a strong history of engagement with education and academia and the DI&B Group are aiming to enhance this engagement by developing strong role models and profiling the different entry routes and career progression within the sector. Encouraging companies to support events like IWish, which

showcases opportunities in STEM to female post-primary students, and engaging with careerportal.ie, the national career information portal, are just some of the initiatives the Group are working on.

Supporting talent The second area of the strategic framework includes supporting talent by encouraging companies to leverage initiatives such as the STEM Teacher Training Intern programme (http://castel.ie/stem-teacher-internships/), and the IMI Mentoring Programme of executive education scholarships (www.imi. ie/insights/news/30-club-scholarship-2018/).

Another goal is the development of a Career Path Program to support career development and to help mitigate against unconscious bias.

The STEM Teacher Training Intern programme is a very innovative programme started by DCU with 30% Club and Accenture in 2016. This programme enables pre-service STEM teachers to gain first-hand experience of what it is like to work in a STEM industry, the diversity of roles that are available to people who pursue these fields and a variety of paths that one can take towards working in the industry. This programme helps to empower teachers with the knowledge they need to inspire their students to engage in STEM and consider a career in the BioPharma sector. The programme has been affected by Covid-19, with many of the participating companies becoming unable to host a teacher. October 2020 saw the launch of the 2021 programme, and the numbers of host companies is very encouraging for next summer.

“Enabling an internship for trainee teachers allows them to see the breadth of STEM careers available in BioPharma companies like ours,

and how they can bring their learnings back to school, build awareness of the sector with their students and ultimately encourage them to aim to work in an industry which is focused on transforming the lives of patients with serious illnesses,“ explained Paul McCabe, Site Leader at Alexion Pharmaceuticals.

The IMI/30% Club Network Mentor programme encourages organisations to participate in a cross-company initiative designed to deliver an exceptional mentoring experience to their high potential talent mentees and their senior executive mentors.

“Mentoring is a critical leadership development opportunity and a key element of any human capital strategy designed to attract, retain, develop, and maximise an organisation’s key talent capability,” according to the Irish Management Institute. “Developmental mentoring also helps your talent with the quality of their thinking on issues that really matter to them and to your organisation.”

Many companies are investing in leadership mentoring programmes as research has proven that it plays an important role in attracting and retaining top female talent.

By working alongside the BioPharmaChem Skillnet, the Group will identify and create training programmes that will support companies on their journey. One such programme is a Returner Programme for people who have left the industry to encourage them back into the workforce. Johnson & Johnson’s Re-Ignite programme, for example, has been hugely successful in attracting top talent into their organisation.

Supporting business The third area of our strategic framework involves supporting business by developing a Inspiring students to engage in STEM and consider a career in the BioPharma sector has to be a real priority for Ireland.

34

Irish PharmaChem | Industry Buyers Guide 2021

Mallinckrodt is focused on improving outcomes for underserved patients with severe and critical conditions. We have a long history of operations in Ireland, having had a presence here for over 25 years.

Since 2016, we have opened new offices, a manufacturing facility and a Global Device Engineering laboratory at the College Business and Technology Park, in Blanchardstown, Dublin15.

www.mallinckrodt.com

Diversity diversity and inclusion toolkit for the sector.

This toolkit will support companies on their D&I journey, by supplying them with guidelines and principles based on Best Practices within our member companies. This will be supported by a series of masterclasses, similar to the ‘Diversity in Recruitment’ masterclass, hosted by MSD in October 2020. Presenters from WorkJuggle (https://workjuggle. com/) ran an interactive session to outline practical and actionable tips to improve diversity in the recruitment process.

Catherine Bebbington, Snr. Specialist, Talent Acquisition in MSD, presented how MSD use their toolkit to inspire and engage a wide range of candidates when posting jobs, recognising that specific types of words and the number of requisite skills in a job description can be a factor in stopping some individuals from applying.

These interactive sessions, where we share best practice and learn from each other, are highly engaging, practical, and relevant to the Irish BioPharmaChem sector. We look forward to a full schedule of masterclasses and workshops in 2021 where we plan to look at the topic of career development and to take a deep dive into how BioPharma companies are deploying their strategy.

If you are developing and/or deploying a diversity and inclusion policy for your organisation and are keen to discover more about this Group, please contact siobhan.dean@ibec.ie.

36

The STEM Teacher Training Intern programme enables pre-service STEM teachers to gain a first-hand experience of what it is like to work in a STEM industry.

If you would like to explore how the resources discussed in this article could be of relevance to your organisation, follow the links below: www.glassdoor.ie https://careersportal.ie/about.php www.iwish.ie/ https://workjuggle.com www.jnj.com/personal-stories/how-johnson-johnson-re-ignite-program-helpspeople-return-to-stem-careers http://castel.ie/stem-teacher-internships/ www.imi.ie/insights/news/30-club-scholarship-2018/ www.ibec.ie/connect-and-learn/research www.mckinsey.com/featured-insights/diversity-and-inclusion/diversity-wins-howinclusion-matters#

Irish PharmaChem | Industry Buyers Guide 2021

Inventing for life

At MSD we have and always will be... Inventing for Life.

These three powerful words reflect our commitment to inventing new medicines and vaccines that save lives by preventing and fighting disease.

MSD Ireland is one of the country’s leading healthcare companies, having first established here over 50 years ago. We currently employ approximately 2,700 employees across six sites.

A member of Guaranteed Irish, we are proud to be one of Ireland’s leading exporters and our Irish sites manufacture approximately half of MSD’s top twenty products, saving and enhancing lives in over sixty countries around the world.

Learn more about the opportunities available in MSD Ireland at www.msd.ie

Copyright © 2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All Rights Reserved.

IT Services

Westbourne’s world: where your critical technologies always work Westbourne IT Global Solutions Ltd work with their client’s IT department as an outsourced extension of their team, delivering short, medium- and long-term projects in their laboratories such as: • Innovation projects – road maps for moving to paperless labs; • Computer System Validation (CSV) and documentation projects; • Lab Application Upgrades – instrumentation / software; • Business Process Improvements - reducing compliance risk, process automation; • LIMS – LabWare / LabVantage upgrades / installation, integration projects; • Pre-audits / site surveys; • Data analytics – forecasting and planning.

Their lab service puts lab users in a data-driven IT environment and at the centre of their business.

They offer In Lab, Near-Lab and Remote-Lab support and provide exceptional right first-time fix rates from their team of IT-enabled scientists and lab savvy IT engineers.

Westbourne IT’s teams provide support for lab applications such as LIMS, LES, Empower, Discoverant and Citrix. Additionally, their people ensure that your IT network is working end-to-end, so laptops, software and infrastructure work together with customer lab systems. The impact of the everincreasing digitalisation of our world at the business

and the social level is increasing expectations on IT support. Always available, “always up” becomes a challenge for labs and IT.

Why Westbourne?

• GxP Compliance o Fully compliant engineers; o Rigorous up-skill training programme: • Driven by forward thinking and highly qualified training department; • GAMP5 and CSV certified.

• Confidence in people supporting your labs o Proven track record of delivering lab projects; o Effective communication (multi-lingual, professional); o Highly qualified and certified staff; o Bench of engineers to ensure uninterrupted service levels; o ITIL and SDI trained.

• Confidence in your IT infrastructure and applications o ITIL driven ticket resolution; o High ‘right first time’ fix levels; o Metric driven continuous improvement initiatives. o Indicative Dashboard below gives a flavour of their approach.

•

Cost effective and flexible o Shared or dedicated service; o Pay only for what you need; o Stand alone or integrate into your existing solution; o Grow as you grow; o Flat reporting structure so greater control over quality of service; o Onsite / off-site.

Who are Westbourne IT? Founded by Chief Executive Officer, John O’Sullivan in 1994, Westbourne IT Global Services Limited delivers multi-lingual technical service desk solutions and lab IT to highly regulated companies in the BioPharmaceutical, med-tech and food sectors, on a global scale.

They are a flexible, niche provider of top-end, high-quality remote and on-site IT services on a 24 x 7 x 365 basis from their delivery centres in Cork and Auckland, New Zealand. The focus is always on putting customer service and ticket ownership at the centre of their service to deliver an exceptional customer experience in over 10 languages, with follow the sun availability.

Client range Westbourne IT’s clients range from start-ups to top 10 pharmaceuticals, biotech and food & beverage companies.

For more information, contact: Westbourne IT Global Solutions Ltd The Atrium, Blackpool Business Park, Cork Tel: (021) 4314310 www.westbourneit.com Contact details: James Symington Email: James.symington@westbourneit.com

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Irish PharmaChem | Industry Buyers Guide 2021

Elite Technical Support 150 engineers, operating on and off site, nativespeakers in 10+ languages, ITIL accredited

Ensure critical enterprise technologies are always available. Our highly skilled, multilingual teams of engineers in Ireland, US, UK and New Zealand deliver a collaborative global service model that drives productivity with excellent customer satisfaction ratings.

Enterprise Service Desk

Lab IT Services

Project Services

24/7/365 remote and onsite support for all your business needs. With offices based in several countries, we can provide technical assistance in all of the top 10 European and Asian languages.

Westbourne provides onsite technical support for all your lab applications ranging from LIMS to CDS. We also offer a remote service for those wanted to save on desk-space.

We support companies for short term projects, from lab based CDS to Windows 10 IT upgrades.

We can provide onsite staff from 1-9 months to support you through your project.

Westbourne IT - Experts in Global Enterprise Service Desk including Manufacturing and Labs IRELAND | USA | New Zealand, www.westbourneit.com, James.Symington@westbourneit.com +353 (0)21 431-4310

IDA Ireland

Maintaining Ireland’s place as a BioPharma leader Ireland must take advantage of its strengths and act now to ensure that we continue to be at the top table of BioPharmaceutical development and manufacture, writes Rory Mullen, Global Head of BioPharmaceuticals, IDA Ireland.

40

The ongoing Covid pandemic has focused attention on the global BioPharmaceutical sector. The rapid development of vaccines targeting the virus has highlighted the capability of the industry and will hopefully allow societies to return to some normality during 2021, but how will this affect the industry in Ireland? Thankfully, Ireland has a very strong BioPharmaceutical sector, with a globally recognised manufacturing cluster.

We have major global companies who have confidence in Ireland as part of their global supply chains, making sure that new innovative medicines get to patients.

Covid-19 has highlighted the risks inherent in these global supply chains. Some commonly used medicines and ICU drugs have been in short supply, due to lengthy supply chains involving Asia, mainly China and India. This may lead to opportunities for Ireland, as we are more likely to see some of these products being manufactured in Europe and US in the future.

However, as BioPharma is one of the few global economic sectors showing resilience during this pandemic, we are seeing increased global competition for new mobile FDI investment in life sciences.

Particularly in the last decade, Ireland has seen the rise of biologics, with significant capital investment resulting in the development of 20 state-of-the-art manufacturing plants. The impact this has on the Irish economy cannot be understated through the value of exports, the purchase of both equipment and services, in addition to the salaries of those highly skilled employees at plants all over the country.

If we look at the impact this has across the country, there are now many clusters around our key towns and cities. Both Cork and Dublin have had strong clusters for a long time, but we now also have clusters in Waterford, Athlone, Sligo and Dundalk, along with major investments in Limerick, Carlow and Westport.

These can, in many cases, be the backbone of these regional economies. We consider Ireland, Irish PharmaChem | Industry Buyers Guide 2021

IDA Ireland which is smaller than some US states, as one cluster within the global BioPharmaceutical landscape.

Why Ireland?

Why Ireland and what do Irish people bring to the picture? As previously mentioned, we have seen strong investment in more recent years in biologics. We are now seeing expansion projects from companies that invested in new biologics operations six, seven or even 10 years ago. This shows the continued confidence companies have in Ireland. Much of this, in IDA’s opinion, is down to two key elements: skills and our regulatory environment.

Taking skills first, we originally saw this as the key differentiator back in the mid-2000s, understanding that if we could produce the skills for this sector, we would win more investment. With the launch of NIBRT (National Institute for Bioprocessing Research and Training) in 2007, we instigated a plan that has become a central attractor in Ireland’s success.

NIBRT today trains over 4,000 people annually in all types and lengths of courses around biologics manufacturing and collaborates on research specifically related to industry problems. Skills are the key currency in future success for global BioPharma companies and Ireland leads in this area.

Our second strength is our regulatory environment, which is second to none on a global basis, led by the Irish regulator, the HPRA (Health Products Regulatory Authority).

The HPRA is a strong and committed member of the European EMA network, chairing several key committees and engaging on all topics relevant to the growing community of companies in Ireland. It is clear also from the companies based in Ireland that they gain clear direction from our regulator and receive thorough audits of their manufacturing sites, which keeps all companies vigilant. It is also important that this culture of professionalism has permeated across all the companies in Ireland, with employees in each company understanding that their actions affect every company and not just themselves. With Brexit, this has seen an increased understanding of the regulatory needs of our country, and the readiness also to make sure that Irish patients get the medicines they require.

An inflection point This has all been very positive for Ireland, but we are now at an inflection point on a number of fronts. Biologics is becoming a mature sector, API is a tried and tested manufacturing process and there is a move to more personalised medicines, particularly in the Cell and Gene Therapy areas. What must Ireland do to make sure the future is as successful as what we have to date achieved?

For API in particular, but pharmaceuticals in general, we need to see constant transformation of our manufacturing sites, Irish PharmaChem | Industry Buyers Guide 2021

making them flexible enough to handle the future small molecule products that will still account for more than 50% of global new medicines. Transformation of sites will, of course, require the constant upskilling of staff and then the site investments in terms of new equipment, technology platforms and manufacturing processes. We in IDA Ireland will continue to work with our clients on an ongoing basis to support training, process and R&D requirements across the country..

I mentioned maturity in biologics already and spoke of the expansion projects we are now seeing. There are still some major new plants under construction or validation: MSD in Dunboyne and Swords and WuXi in Dundalk, to name a few. Each of these have been major construction projects but what is next?

As we look out across the global landscape, we appear to be reaching a stage, for the major companies at least, where there is now sufficient manufacturing capacity in place. With the continued growth of the CDMO model, however, it will be interesting to see what is next. We are already seeing this trend in small molecule with SK biotek acquiring the BristolMyers Squibb API plant in Dublin and Thermo Fisher acquiring the GSK API facility in Cork. In this context, the first biologics CDMO in Ireland will be WuXi Biologics. We believe there is space for more, as many global CDMOs already have relationships with our clients elsewhere on the globe. The increased demand for vaccines may also provide opportunities.

Transforming the industry In the long term, however, cell and gene therapies or ATMPs (Advanced Therapeutic Medicinal Products) are likely to transform the industry. With the commercialisation of two autologous CAR-T therapies and the recent approval of a spinal muscular atrophy (SMA) gene therapy product, these therapeutic products offer treatments for patients with unmet needs and are increasingly coming into focus. However, there are significant price-tags associated with these therapeutics, ranging from $400k to $2.1 million dollars.

These therapeutics have many characterisation and manufacturing challenges. This presents opportunity for product innovators, suppliers and academics to collaborate and design process technologies to streamline the manufacturing steps. Developments are aiming to offer alternative options and more scalable solutions; for example, the development of allogeneic products using donor cells, which should over time start to see the development of a more defined manufacturing process. This will again play into the skills and experience of Ireland, where manufacturing is our sweet spot and where we have gained our international reputation for delivery.

Who will the future players be in this new scientific area, which promises so much for patients? We have already seen significant mergers and acquisitions in the ATMP space.

“We must put our hand up now in our companies, our educational institutions and with Government to make sure everyone is aware of the opportunity and the imperative that our country continues to lead in future medicines manufacture.”

Gilead acquired Kite for US$11.9 billion and Celgene acquired Juno for US$9 billion. Roche acquired Philadelphia-based Spark for US$4.3 billion in 2019. There have also been some major investments by Pfizer in gene therapy capabilities. These give some indication that the major global BioPharma companies will be developing in this space.

In addition, with the personalised nature of these medicines and the exciting opportunities in new more targeted disease areas, there is a group of new companies that are developing independently in this space.

Ensuring that Ireland continues to lead Ireland’s skill base, track record and regulatory reputation will allow us to be a strong player in this new sector over time, but we must put our hand up now in our companies, our educational institutions and with Government to make sure everyone is aware of the opportunity and the imperative that our country continues to lead in future medicines manufacture.

This area today has over 1,000+ potential products in clinical trials, and it is now that these companies will be deciding where to do further development work, where to manufacture and when to internationalise from their home base for these new products.

NIBRT and a cohort of stakeholders within the Irish ecosystem have already been working on the requirements for Ireland to be successful, along with the first training programmes. A key stakeholder is The Regenerative Medicine Institute (REMEDI) in Galway, where its research team have been doing pioneering work in the cell therapy space.

Let us not lose sight of our success and the continued growth in the sector but let us also grasp this new opportunity to be a player in next generation medicines for all.

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Cell & Gene Therapy

Staking a claim to the next pharmaceutical frontier

Ireland has an opportunity to become a hub for the global supply, management and manufacture of a new generation of personalised medicines and Cell & Gene Therapy treatments, but only if we can build on the foothold of the industry to catch these innovations as they scale to production level, write Cillian Leonowicz, Director, and Paul Pierotti, Partner, EY Ireland.

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Irish PharmaChem | Industry Buyers Guide 2021

Cell & Gene Therapy Ireland has a track record as a centre of excellence for pharmaceutical and BioPharma manufacturing and Global Business Services which is envied across the world. In the last decade alone, more than €10 billion has been invested in BioPharma manufacturing facilities in this country. More than 30,000 people are now employed in the sector, which contributes more than €40 billion in exports annually and accounts for around 27% of GDP. That success has been built on a legacy which dates back to the 1950s and has seen Ireland move consistently up the value chain away from basic bulk manufacturing and through to higher-value finished pharmaceuticals and the latest highly complex biologic therapies.

Ireland has managed to move ahead of each wave of innovation as the manufacturing base here took on ever more complex mandates.

The industry is now in the midst of the next wave of innovation; Cell & Gene Therapies or Advanced Therapy Medicinal Products (ATMPs), as they are also known within the industry, are potentially transformative with live-saving, lifeextending and curative properties for many diseases which were either extremely difficult or impossible to treat up until now. Simply, Cell & Gene Therapies will enable many, many thousands of individuals to live and thrive.

Cell & Gene Therapy explained Gene therapy is the delivery of a copy of a gene that a patient lacks or the suppression of a gene that is causing disease. For example, the Factor IX gene when delivered to liver cells helps with blood clotting, while the RPE65 gene is associated with Leber’s disease, which

causes blindness. The delivery of one and the suppression of the other treat the underlying problem.

Unsurprisingly, Cell & Gene Therapy investment is growing four times as quickly as the rest of the pharmaceutical industry.

Of course, this is not to suggest that it is the only growth area in BioPharma, but it will be increasingly important in the coming years. There is, however, a capacity challenge for Cell & Gene Therapies, which is being exacerbated by the production of products, vaccines and therapeutics for Covid-19, which has the potential to present a Foreign Direct Investment opportunity.

For Ireland, this represents a new challenge.

Recognising its potential

“There may never be a better set of conditions for Ireland to play a central role in this next evolution of life sciences and help improve patient outcomes.”

Irish PharmaChem | Industry Buyers Guide 2021

Other countries have recognised the potential of this new frontier and have been busy preparing for it. For example, the UK created its Cell & Gene Therapy Catapult more than 10 years ago. This is aimed at giving the country a lead position to attract Cell & Gene Therapy investments and building a £10 billion industry.

The Catapult also offers development and production capacity to UK start-ups. As a result, a significant proportion of European SMEs active in Cell & Gene Therapies are based in the UK. To date, the programme has delivered more than 4,000 industry collaborations and over 1,100 academic collaborations. More tellingly, the UK now effectively has a 10-year start on Ireland when it comes to establishing itself as a hub for the global Cell & Gene Therapy sector.

There may never be a better set of

conditions for Ireland to play a central role in this next evolution of life sciences and help improve patient outcomes. Brexit, regardless of the nature of any trade deal struck between the parties, can only diminish the UK’s attractiveness as a location for European Cell & Gene Therapy companies. Add to that Ireland’s long track record as a manufacturing location for highly complex BioPharma products and the scale-up and batch production of new medicines, as well as this country’s position as the only remaining English-speaking, Common Law EU member state, and you have quite a compelling proposition for the next wave of Cell & Gene Therapy firms.

Furthermore, the increasing presence of Global Business Centres and the even more significant presence of the technology sector means Ireland is uniquely placed to deal with the complex data, quality, regulatory and supply chain issues associated with supporting the Cell & Gene Therapy sector.

Missing out on this opportunity could not only put a brake on the growth of the overall BioPharma industry in Ireland, it could see it go into reverse and put at risk all that we have built up over the years. Ireland’s secret for the past several decades has been to move on, as lower value elements of production were shifted to lower cost locations. Failure to keep pace on this occasion could see a slow drain of existing Pharma and BioPharma operations to other seemingly more attractive locations.

If we are to avoid that happening, we need to emulate and surpass the UK by formulating and implementing a coherent strategy which will

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Cell & Gene Therapy

position Ireland as an attractive location for Cell and Gene Therapy development, production and management.

Convergence of stakeholders One of the key drivers of the Cell & Gene Therapy revolution is the convergence of the IT, medical technology and pharmaceutical sectors.

The Government should now take a lead in bringing about a similar convergence of the various stakeholders, including development agencies, academia, the education system, the research community, industry, and other partners to leverage our existing strengths and build the new ones required to make Ireland a competitive location for this exciting area.

Ireland also needs to up its game in the critically important area of clinical trials. Legal and regulatory barriers must be removed in order to speed up patient recruitment and cut down on administrative costs for hospitals and companies. Our poor showing in this area does nothing to burnish our reputation as a location for this research-intensive industry.

Training and education are also critical, and Ireland must invest in the development of new higher and further education programmes,

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which will deliver the new generation medical research talent who will combine clinical expertise with skills in areas like AI, genomics and digital therapeutics.

Consideration should also be given to the establishment of a new national research centre for Cell & Gene Therapy under the aegis of Science Foundation Ireland.

Beyond Government, industry stakeholders and senior leaders will need to collaborate to identify the white space for growth and build their business models to take advantage of this new paradigm and converge to the future.

Bringing key stakeholders together As a firm, EY is committed to playing its part by facilitating key stakeholders to come together and mobilise through a series of industry round-tables. The seeds for this collaboration were sown with the IDA, BioPharmaChem Ireland and industry leaders establishing Cell & Gene round-tables in both January and June of this year. These round-tables debated the critical requirements for success. This includes producing the skills required by the industry, having the research base in place to support its

ongoing development here, and bringing other key areas such as our clinical trials infrastructure up to scratch internationally and attracting new FDI companies who will play a critical role in the delivery of these treatments.

We are excited to confirm that, after conducting these successful industry roundtables, there have been positive developments in this space. This has culminated in the creation of a consortium of more than 20 parties from across the value chain who are collaborating to develop a digital accelerator to focus efforts around CGTC and ATMP. The goal of this digital accelerator will be to develop a feasibility study. This study will seek to answer the question, ‘What will it take for Ireland to emerge as a Global Centre of Excellence for CGT and ATMP?’ In addition, the group will develop two flagship proof of concepts, the first for ‘Chain of Custody and Identity in the Supply Chain’ and the second for ‘Order Management’.

We look forward to presenting our findings and insights to industry stakeholders in H1 2021!

We look forward to presenting our findings and insights to industry stakeholders in H1 2021!

Irish PharmaChem | Industry Buyers Guide 2021

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Pharmaceutical Manufacturing Technology Centre

Driving innovation in manufacturing technology Now approaching the mid-point in its second funding phase from Enterprise Ireland, the Pharmaceutical Manufacturing Technology Centre (PMTC), based at University of Limerick, is continually expanding its offering to the Irish pharmaceutical manufacturing landscape.

While placing focused emphasis on collaborative engagement with its industrial partners, the Centre is strategically positioned to address real-world challenges arising within the pharmaceutical manufacturing sector, while furthermore ensuring that the needs of this important sector are supported into the future.

Sitting at the interface of industry and academia, the PMTC supports the pharmaceutical manufacturing industry and its supply chain to solve problems, while differentiating itself by focusing on industry-informed research, where programmes are driven by real market needs defined by industry. Led by an Industry Steering Committee with an active research programme and championed by its industry members, the PMTC is well placed to support companies across the pharmaceutical manufacturing sector in optimising their manufacturing facilities within the framework of its three core research areas:

1. Pharmaceutical Plant Cleaning - including containment, changeover, and validation; 2. Process control and optimisation; 3. Applied data utilisation/analytics.

Irish PharmaChem | Industry Buyers Guide 2021

Since its inception in 2013, the Pharmaceutical Manufacturing Technology Centre has established itself as a progressive, agile, strategically relevant and industry-informed research centre, focused on developing advanced technology solutions for all stages of pharmaceutical manufacturing, writes Marlo Kearney, Business Development Manager, PMTC. Delivering efficiencies and innovation PMTC researchers have delivered improved efficiencies and achieved process innovation to deliver significant economic impact to member companies. Improved efficiencies and process innovation have been major drivers of the reported economic impact of PMTC, with a number of companies reporting significant savings to implementation of the centre’s research outputs.

Our research outputs include plant cleaning methodology, which delivered significant impact when deployed across the some of the world’s largest pharma manufacturing companies by reducing cleaning changeovers by an estimated

10% per annum and by reducing solvent usage by 40% and allowing faster changeover times, reducing by an average of two weeks. In one example, the plant cleaning efficiency result saved an innovation partner company 28 days on an equipment cleaning regime, resulting in significant cost savings and freeing up valuable production time.

The growth of PMTC continues, supported by ongoing investment by Enterprise Ireland, such as the recently awarded capital equipment grant of €250k to build a cleaning rig to mimic typical plant cleaning process operations. PMTC’s new capability will support offline development and the transfer of ‘right first time’ cleaning processes to pharma plants, which will help Irish based pharma manufacturing assure science-based cleaning processes, whilst allowing better utilisation of their high value plants, thus maximising the processing time to achieve optimal productivity for companies.

Data analytics As the industry strives toward the next industrial revolution, Industry 4.0, it is evident that there is an increasing worldwide drive for organisations to readily access, analyse and derive value from their data to assure business growth.

Greater implementation of data analytics across the pharmaceutical and BioPharmaceutical manufacturing sectors has the potential to deliver

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Pharmaceutical Manufacturing Technology Centre more value for both business and patient. The PMTC, in collaboration with industry partners, has produced a guide which describes real world case studies and reflects on these in the context of extensive literature review with due regard for current regulatory requirements.

The guide has been created with over 400 hours of industry interactions, written case studies and reviews. To capture the current needs and expectations of the wider pharma industry, the format, content and objective of the guide was informed through industry focus groups, surveys, workshops, interviews, and case studies. The manufacture of safe medicines requires considerable regulatory oversight, adding complexity which is not reflected in other sectors, and so, the guide was also reviewed in consultation with the Health Products Regulatory Authority of Ireland.

This initial PMTC research output on data analytics serves as a starting point; the practices described in the guide aim to support the pharma and BioPharma manufacturing sectors to extract new knowledge for faster, data-driven decision making that goes further to improve and secure the supply of medicines, both now and in the future. PMTC is seeking to continue to benchmark the utilisation of data analytics, both within pharma and across other sectors and to support companies to navigate some of the complexities and regulatory considerations unique to the pharma context.

The PMTC currently partners with 30 industry members and while the benefits of centre membership are multi-faceted and include a strong emphasis on collaboratively delivering access to highly relevant research, one of the key benefits of membership is the retention of preferential right of first sight of research outputs.

This enormous benefit, coupled with worldclass facilities and wide-reaching competencies, ensures that PMTC members are very much placed at the centre-point of all of the research endeavours carried out within the centre.

Emphasis on collaboration Collaborative engagement is at the core of the PMTC and this drive towards industry-led, highly engaged collaborative research strongly translates to the delivery of real impact for member companies through the research outputs delivered by the centre.

This strong emphasis on collaboration within the PMTC is not limited to the relationship between the Centre and its members, but more importantly, supports company-to-company engagement and collaboration across the Irish pharmaceutical manufacturing sector as a whole. In recognising this strong need for meaningful engagement, the PMTC supports the development of communities of practice, whereby collaborative work between SMEs and MNCs is delivered as commonplace.

Additionally, PMTC network events have generated significant B2B opportunities for our partners; in one case, business generated through a PMTC event accounts for 40% of the company’s turnover.

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In response, the PMTC can support companies in identifying critical skills needs and partner with them to develop targeted training programmes to bridge the gaps.

Broadening the SME membership base

In order to support strong industry engagement, the PMTC provides opportunities for companies to network and stay abreast of new technology developments though events such as the PMTC Knowledge Day, as well as technical workshops and training events. In September 2020, the centre delivered its first SME members’ day, which albeit virtual in nature, provided a successful platform for the Centre’s SME member base to network and to share best practice amongst peers.

In the same way that innovation, collaboration and the delivery of impactful research outputs are at the core of the PMTC, the Centre also identifies the strong need for knowledge sharing across the PMTC community and in this way the PMTC is strongly focused on talent and capacity development across the pharmaceutical sector in Ireland, with a view to raising the level of innovation in the Irish pharma landscape and to develop a pipeline of individuals equipped with the skills and expertise to deliver on the pharma research agenda.

As the centre evolves through Phase 2, one of its key areas of emphasis will be to look towards the broadening of its SME membership base, and in doing so, it aims to provide Enterprise Ireland clients with unrivalled interaction with BioPharma multinationals, enabling SMEs to grow through delivery of new technologies and solutions to MNCs in Ireland and beyond. In essence, the Centre provides an introduction platform and a highly relevant place at the table for our SME members so that they can directly engage in technical discussions with MNCs, which is a key enabler for those indigenous companies.

The PMTC aims to grow its membership and work more closely with those existing members so that we understand their long-term business needs and can quickly position ourselves to meet those opportunities.

At PMTC, we pride ourselves on our capabilities.

Situated within the Bernal Institute at the University of Limerick, we reside in a world class facility, whilst operationally we collectively have over 50 years’ industry experience and our research team are experienced post-doctoral researchers with extensive industry relevant experience in a combination of manufacturing and research contexts. Added to that, PMTC has a number of affiliated research performing organisations and research centres to ensure we can place the industry need with the best academic talent and capabilities nationally.

The combination of capabilities and experience within PMTC allows the Centre to be relevant, agile and highly responsive to the unique and growing needs of our member companies.

The PMTC, in collaboration with industry partners, has produced a guide on the greater implementation of data analytics across the pharmaceutical and BioPharmaceutical manufacturing sectors.

Irish PharmaChem | Industry Buyers Guide 2021

Research & Development

SSPC solving key industrial challenges SSPC, the Science Foundation Ireland (SFI) research centre for pharmaceuticals, is a globally recognised research centre for API crystallisation, manufacturing research, modelling and BioPharma expertise.

Founded in 2007, SSPC’s success is defined through its strong collaboration abilities and through its track record of building R&D excellence in one of Ireland’s largest industries. Industry members guide SSPC to both respond to the current needs of the sector and anticipate the skills and training necessary to mentor future research leaders. SSPC has 70 investigators and 113 researchers based across Ireland in University of Limerick, the host institution, as well as University College Cork, National University of Galway, Trinity College Dublin, Royal College of Surgeons, Dublin City University, University College Dublin, Waterford IT and Maynooth University.

SSPC’s culture of collaboration is helping the global pharmaceutical and BioPharmaceutical industry to develop more environmentally sustainable methods for drug manufacturing, to increase the range of medicines available to the public, and to reduce drug manufacturing costs.

SSPC’s advanced research programme extends from molecule, materials and medicine into two focused areas: manufacturing and modelling.

SSPC believes strong relationship management is key to retaining industry members and good communication processes and platforms help to maximise industry engagement across all aspects of the centre. A service-dominant logic approach, which proposes the co-creation of value through exchange, is the preferred approach to SSPC industry relationship management. Industry members, through their increased involvement with centre activities, can augment opportunities to co-create value for their organisations.

Research programme and capabilities SSPC researchers work in partnership with the international pharma and BioPharma sector to solve key industrial challenges, enabling novel

and efficient methods of manufacturing safer and cheaper, while ensuring the delivery of more effective medicines for the future. SSPC has a proven track record in delivering excellent research that is critically informed by the needs of the pharmaceutical sector. SSPC can support your research and development activities with particular emphasis on:  Reducing time to market in drug development;  Advancing manufacturing process and technologies;  Improving efficacy of drug products;  Addressing the needs of new, more complex active ingredients.

SSPC research is truly multi-disciplinary, leading to innovation in chemistry, process engineering, data analytics, designer drug hybrid medicine (drug-antibody, peptide, oligonucleotide and glycoside conjugates), and mathematical modelling. Industry requires manufacturing systems that have full feedback control and which are self-correcting. In response, SSPC’s research advances process modelling, PAT, and statistical modelling for model predictive control of pharmaceutical manufacturing.

The new industry membership programme continues SSPC’s strong track record with local pharmaceutical industry partners. To date, 16 industry partners have signed: Eli-Lilly, Janssen, Sanofi, MSD, Alkermes, APC, Pfizer, SK Biotek, Scale-Up Systems, Clarochem, Innopharma, M Star, Magritek, Kapaji and most most recently, Glantreo and Canty.

Highlights and impacts SSPC Co-Directors and Bernal Professors, Gavin Walker and Michael Zaworotko.

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SSPC’s vision was to expand the research and industry engagement focus to include the BioPharma sector. Consistent with this vision, SSPC successfully on-boarded its first BioPharma Irish PharmaChem | Industry Buyers Guide 2021

Research & Development company, Sanofi, as a member. Other SSPC BioPharma collaborations include Janssen, Eli Lilly, MSD, Pfizer, Regeneron and BMS as partners.

Its range of bio capabilities includes protein engineering, drug hybrid conjugates, protein production, gene & cell therapy and modelling.

A full range of project topics can be found at https://sspc.ie/our-research/bio-capabilities/.

A key impact of SSPC is the development of a unique talent pipeline, with the transition rate of SSPC researchers to industry currently standing at 70%. One of the key drivers facilitating the high number of transitions to industry is the SSPC PhD industry placement programme, which bring students into the industrial environment for a three-month placement aligned with their research area.

McCrystal, now available at https:// sspc.ie/mccrystal-registration/, is a freeaccess calculator of the crystallinity index of microcrystalline cellulose (MCC) from Raman spectral data. The final design includes an online calculator and has free access for researchers and industry personnel all over the world. They can use the crystallinity information generated by McCrystal to understand the difference between batches of MCC and adjust the process in which those batches are going to be used to account for these differences when necessary.

SSPC modelling lead, Dr Damien Thompson, and team The Materials Modelling Group, based in the Bernal Institute at UL, discovered a new device to end overheating in portable devices and

Irish PharmaChem | Industry Buyers Guide 2021

and had one MSCA IF success (MODSIM), scoring 100%, a first for Ireland.

SSPC’s Education and Public Engagement (EPE) team has adopted a new community engagement approach as a way of delivering more long-term sustained societal impacts. SSPC was successful in a bid for Science Week funding from SFI to create the ‘Medicine Maker’ workshop, a workshop that truly focused on quality control and manufacturing of pharmaceuticals. Research was enacted to examine the potential for a workshop developed around the pill plate through a handson active engagement. prolong battery lifetimes. Co-Director, Professor Michael Zaworotko developed a crystalline material, known as ROS-037, that “could help solve the global water crisis” by producing water from air, even in the most hostile of locations.

An investment of over €3 million, awarded to both SSPC Co-Directors and Bernal Professors, Gavin Walker and Michael Zaworotko, will facilitate industrial collaboration and support SSPC research projects with industry partners. Professor Walker will receive €1.9 million to develop a national advanced drug product manufacturing facility and Professor Zaworotko will receive €1.4 million to develop a Centre for In-Situ Characterisation of Advanced Materials (CISCAM): In-Situ Powder X-ray Diffraction Suite.

SSPC secured €6.2 million of additional research funding from EU (MCSA-Individual Fellowships)

Working with SSPC Currently, SSPC has an extensive portfolio of targeted research projects underway (mainly single industry directed). Industry projects can be supported in a number of ways in SSPC. 1. Companies have the option to initiate fully funded industry specific research projects and own all project IP, thanks to a flexible Irish IP protocol that facilitates industry-led project collaborations with Irish research performing organisations.

2. Companies can also avail of SSPC Co-Funding (max. 50%), providing organisations with the opportunity to licence back any IP arising.

For more information on how SSPC can work with you, please contact Industry Engagement Manager, Aisling.Arthur@sspc.ie.

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APIs and Advanced Intermediates

SK pharmteco: a force to be reckoned with SK pharmteco is the single market-facing team comprised of SK biotek, AMPAC Fine Chemicals and AMPAC Analytical. This new force within the API CDMO space provides customers with world-class world class facilities and state-ofthe art technology with the highest-quality services.

They specialise in commercial and clinical production of APIs and Advanced Intermediates. They have extensive expertise in highly potent APIs, controlled substances, energetic chemistry, chromatographic separations, particle engineering and continuous processing.

Leaders in continuous manufacturing “Our scientists and engineers are leaders in continuous manufacturing methodologies, having successfully developed processes from kilogrammes through metric tonnes,” explains Steve Barr PhD, VP Business Development, SK pharmteco. “We have implemented this successfully in our many years of developing processes that utilise energetic reactions.”

They are also leaders in Simulated Moving Bed (SMB) chromatography and offer this powerful technology from lab through pilot to large commercial scale.

The SK pharmteco offering includes process research and development, analytical method development, scale-up and optimisation, validation and stability within their global network. They also provide the same analytical service as a stand-alone business at their analytical services facility in California.

SK pharmteco combines the skills of SK biotek and AMPAC Fine Chemicals to provide world class production of APIs and Advanced Intermediates.

“The global presence of our highly skilled and experienced team offers total support from development through to commercial production, including seamless project transfer and management.”

All SK pharmteco plants have been approved by global regulatory agencies including the FDA, EMEA, PMDA and Korean MFDS. They provide PAI and full regulatory support, as well as complete confidentiality.

They have a strong record of environmental, health and safety performance.

our customers’ viewpoint’ is a proud facet of SK pharmteco’s culture.” With more than 960m³ across six cGMP manufacturing and development sites in the USA, Korea and Ireland, SK pharmteco offers customers flexibility and choice.

A one-team approach

“Whether it is continuous manufacturing or batch, we have a number of locations and capabilities to support all your API and Intermediate needs across the full lifecycle,” Barr explains. “We will stand over your product as if it were our own. We have been producing many of the world’s most recognised drugs for over 75 years.

“At SK pharmteco, we believe in a ‘one team’ approach, regardless of geographical location, ensuring open lines of communication and multi-disciplinary collaboration,” Barr reveals.

“Taking a ‘sense of ownership together with

“If you are looking for a CDMO that combines the above with a stellar inspection record and commitment to ‘Safety first, quality always’, then give us a call!”

SK pharmteco has more than 960m³ across six cGMP manufacturing and development sites in the USA, Korea and Ireland, offering customers flexibility and choice.

Global presence “We are leaders in operational excellence and continuous improvement and boast exceptional technical capabilities,” Barr notes.

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Irish PharmaChem | Industry Buyers Guide 2021

Not your average CDMO‌ SK pharmteco provides both consultancy and guidance through the clinical development pathway, focusing precisely on every step but never forgetting the end goal.

We offer a partnership rather than a supplier relationship... we are committed to work with you and stand over your product as if it were our own!

SK pharmteco is the single customer-facing team comprised of SK biotek and AMPAC Fine Chemicals. Creating substantial market synergies in the API CDMO space by combining highly complementary assets and expertise, this union enables us to provide the highest-quality services to our customers.

With world-class state-of-the-art facilities and technology, increased capabilities: energetic chemistry, continuous flow process, controlled substances, particle engineering, high potency - with world-class potent handling capability (down to low nanogram per cubic meter levels).

We have multiple cGMP manufacturing and development sites, with ~1000 mÂł of capacity among 6 sites including USA, Korea and Ireland and a dedicated Analytical Services Facility in California.

USA | Ireland | Korea skbiotek.com | ampacf inechemicals.com skpharmteco@sk.com

Outsourced stability storage

Why outsource your stability studies?

Stability studies are an inherent part of the life cycle of a drug product as manufacturers will not get marketing authorisations without proving efficacy and viability. Studies typically involve exposing products to a variety of parameters, including temperature, relative humidity, and light. Studies of this nature require specialised equipment and skilled personnel to execute the studies.

Outsourcing your stability storage and microbiology testing has a host of advantages, according to Source BioScience. operational budget. Typically, a customer pays only for the space they use.

and inventory reports can be provided with a few clicks of a mouse.

ICH guidelines

Microbiology and sterility testing

While stability studies are conducted in a highly regulated environment, they do not require a lot of manufacturer oversight and this makes them perfect for outsourcing to stability experts who understand the ICH Guidelines inside and out.

Source BioScience have a range of walk-in rooms and cabinets and can provide dedicated storage if required. They offer all the typical ICH conditions, accelerated studies and can assist with a wider range of environmental conditions, photostability and thermal cycling studies.

Microbiology and sterility testing being provided by your outsourced stability storage partner can be an advantage. Samples can be moved from the stability chamber directly to the microbiology laboratory, reducing the risk to samples by limiting transportation.

Storage space

Complete sample management

Disaster recovery EN 22301

Environmental chambers are often of a large footprint and take up valuable floor space that could otherwise be used for revenue generating production. Outsourced stability storage providers work in a highly regulated environment and are frequently audited by customers and competent bodies; therefore, their processes are validated and the equipment will be qualified to exacting standards.

State-of-the-art LIMS help manage your samples and pull calendars. Room performance

Outsourced stability storage providers can be engaged to assist with business continuity in the event of a crisis which impacts on stability or controlled storage.

The requirements mean having a longterm relationship with a strategic partner you trust. Things to check for when choosing an outsourced stability storage provider, include:  GMP/GLP compliance;  Knowledge of regulations;  Adaptability to suit your specific needs with bespoke study types;  An exemplary track record and transparency about activities.

Core competencies Stability studies are a long-term commitment, in some cases up to five years. In-house stability testing is a cost-effective option when many studies are being run in parallel, however, can you afford to divert your team away from their other projects? Outsourcing frees up core competencies, leaving the team available for other projects.

Transform CAPEX to OPEX Instead of large Capital Expenditure Projects, manage your stability projects as part of an

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For more information on Outsourced Stability Storage or Microbiology Testing contact Source BioScience on (051) 338435 or email salesIreland@sourcebioscience.com.

Redundancy and back-up Back-up generators are installed to preserve the integrity of the sample storage area in the event of a power loss. Walk-in rooms and cabinets are validated across a range of temperatures to provide redundancy in the unlikely event of a room failure.

Irish PharmaChem | Industry Buyers Guide 2021

Building Ingenuity

Ireland’s Leading Modular Building Company for the Biopharmaceutical & Pharmaceutical Sectors 1 Dunshaughlin Business Park Dunshaughlin Co. Meath A85 FX60

T +353 1 825 0622 E info@cpacmodular.com W www.cpacmodular.com

Enterprise Ireland

Indigenous BioPharma firms take on the world Faced with the greatest challenge of modern times, indigenous Irish life sciences companies have more than risen to the occasion, writes Deirdre Glenn, Head of Life Sciences at Enterprise Ireland.

Irish PharmaChem | Industry Buyers Guide 2021

Flexible and agile by nature, homegrown BioPharmaceutical and MedTech firms have been able to pivot and respond to the Covid-19 pandemic.

Whether it’s optimising clinical trials, developing innovative diagnostics or developing artificial intelligence solutions to improve vaccine development processes, local Irish BioPharmaceutical and MedTech firms have shown not only resilience and flexibility this year, but true innovation and a world-class response to the Covid-19 crisis.

Moreover, Irish firms in the BioPharma subsector are innovating far beyond issues related to Covid-19. They are shining when it comes to optimising pharma and biotech supply chains, furthering the clinical trials agenda, excelling in R&D, and engaging in drug manufacturing and production.

Global businesses are operating in a new world: complex, fast-moving, and turbulent. Irish life sciences companies are ready for the challenge; innovative and resilient, they are helping their customers adapt and compete worldwide.

These firms may have been born in Ireland, but they are world class in terms of the products

and services they provide to their global clients.

Overall, the Enterprise Ireland life sciences sector accounts for €2.4 billion in annual sales, with exports accounting for €2.1 billion of that and the remaining €300 million primarily going in sales to multinational customers in Ireland.

Trusted by world-leading firms Blue-chip businesses around the world recognise Irish BioPharmaceutical firms as trusted partners, not only because our high regulatory standards in this country can be taken as a given, but also because these businesses are committed to quality and they act with integrity. With a nimble approach as standard, they can be flexible in adapting to the needs of clients and they always deliver as promised.

Their dynamism and adaptiveness is largely fuelled by their innovation agenda. Innovation is a key source of competitive advantage and Irish companies have a leading position worldwide.

These companies are hugely R&D intensive and focused on providing imaginative responses to challenges, including and beyond the pandemic.

Customers of Irish companies worldwide are leveraging this innovation to improve operational

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Enterprise Ireland

Irish BioPharmaceutical and MedTech firms have shown true innovation and a worldclass response to the Covid-19 crisis. efficiency and productivity, as well as enhancing their own product portfolios

Supporting and inspiring indigenous pharma Along with supporting our clients’ in-house R&D work, Enterprise Ireland also connects them to the fantastic capabilities and expertise happening within third level education in Ireland.

For the past 10 years, Irish-based companies have benefited from market-focused strategic research and development, carried out by a network of technology centres jointly sponsored

by Enterprise Ireland and IDA Ireland. The centres allow Irish companies and multinationals to work together on R&D projects in collaboration with research institutions. Centres of particular importance to the BioPharma industry include the Pharmaceutical Manufacturing Technology Centre (PMTC) addressing pharma advanced manufacturing issues, the CeADAR centre for applied data analytics and machine intelligence, and the Irish Manufacturing Research (IMR) centre in Mullingar, tasked with helping to make Ireland a world leader in advanced manufacturing operations.

We also work with these firms to inspire and support them to scale internationally. While this can include grant aid, most clients say it is the non-financial supports they receive which provide them with the greatest value. These can include, for example, connecting them with international experts and helping them to explore and enter new markets.

We are also proud that indigenous pharmaceutical firms are based throughout Ireland, with 65% of our life sciences clients based outside Dublin.

Pharmaceutical services Among the indigenous Irish firms that are now global players in this area are Icon, which

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was recently recognised Best Clinical Research Organisation (CRO) at the Vaccine Industry Excellence (ViE) Awards. Not only that, but this was Icon’s third time winning this global award, for which it has been a finalist for 10 consecutive years.

Icon is a global provider of outsourced drug and device development and commercialisation services to pharmaceutical, biotechnology, medical device industries, and government and public health organisations Another Irish firm, APC, is also at the forefront of vaccine research. It focuses on bringing new drugs to market at speed by designing, developing and implementing engineering platform technologies.

It recently partnered with Australian biotech firm Vaxine Pty to progress a coronavirus vaccine.

Along with this Covid-19 vaccine, APC is also working on technologies to support medicines for a variety of cancers, respiratory diseases, Alzheimer’s disease and HIV. Dublin-based Innopharma, meanwhile, brings its advanced data-led technologies to bear on simplifying real-time process intelligence in pharma development and manufacturing. Its SmartX platform and other products are used in 25 countries. Innopharma points out that SmartX could help get vaccines to market faster as it provides opportunities for improved risk mitigation, thereby improving efficiency and reducing the timeline for delivery.

Drug discovery & development We are increasingly seeing high-calibre firms emerging from our vibrant and growing start-up ecosystem.

Among these are Atxa Therapeutics, a University College Dublin spinout company, which is developing novel small molecule therapies to tackle pulmonary arterial hypertension, which is a rare progressive disorder that costs health systems globally as much as €4.2 billion every

year. It announced last July that it is seeking to raise USD$30 million (€25.7 million) to bring its treatment through clinical trials and get regulatory approval.

Another precommercial firm in this field is ONK Therapeutics, an NUI Galway spinout developing enhanced natural killer cells in the immune system to target solid and hematological cancers.

These drugs would be off-the-shelf, meaning they could be used by many different patients, as opposed to the personalised treatments often used. ONK raised USD$14.6 million in two funding rounds in 2020.

Moving on to firms producing over-the-counter products, we come to Cork-based Solvotrin, the developer of the ActiveIron range of products, which enable much higher iron absorption than traditional supplements, while also being better tolerated. It is on target to grow by 50% in the UK in 2020 and deliver 40% turnover growth overall, despite the upheaval caused by the pandemic. It has also been successful in securing funding recently, raising €6.7 million to support its expansion in international markets.

Further scaling internationally is Amryt, a BioPharma company dedicated to developing and commercialising novel therapeutics to treat patients suffering from serious and lifethreatening rare diseases. In fact, it is now one of the biggest Nasdaq-listed companies for orphan drugs. Founded in Ireland, it now has operations in Dublin, London, Boston and Germany, and continues to engage in developing new products.

Generic manufacturers Ireland boasts quite a number of local firms making human finished products.

Leading among these is Chanelle Pharma, Ireland’s largest developer and manufacturer of both human and animal generic pharmaceuticals.

Chanelle is a global company with customers in 96 markets and it is a leading innovator in its space, holding over 4,500 licences worldwide.

Key to Chanelle’s success has been its focus on Innovation and R&D and its ability to identify, develop and launch new generic pharmaceutical products.

Xeolas Pharma is a novel developer and producer of liquid formulations of proven prescription medicines. Its products are designed for specific patient populations with swallowing difficulties. In 2020, it launched the first licenced liquid formulation of Omeprazole, the standard treatment for gastroesophageal reflux disease, on the market. Xeolas plans further launches across the EU in 2021 The disruption of the last year has changed the BioPharma industry forever and now every business faces a new set of challenges. There are some truly innovative, resilient Irish biocompanies that are leading the way, working with their global partners to innovate and adapt, turning adversity into opportunity.

Irish PharmaChem | Industry Buyers Guide 2021

Only .01% of all drug candidates entering clinical trials will reach the market.

Budget. Capacity. Technical knowledge.

These are just some of the obsticals that can stand in the way of your biologic’s market approval.

Are you prepared for them? With Charles River supporting 85% of drugs approved by the FDA in 2019, leverage our experience and expedite your time to market. We can provide the services, capacity and know-how that can help you bring your therapies to those who need them most.

Improve your odds at criver.com/biologics.

Laboratories & Analysis

Technological additions highlight Ballina upgrades at Charles River

A host of specialised and advanced equipment at their Ballina facility means that Charles River Laboratories are helping their customers to expedite new drugs and therapies to market.

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Irish PharmaChem | Industry Buyers Guide 2021

Laboratories & Analysis

With innovative equipment and expanded lab capabilities, Charles River Laboratories are helping their customers to expedite new drugs and therapies to market.

Since its establishment in 2018, Charles River Laboratories’ analytical laboratory in Ballina, Co. Mayo, has doubled its laboratory footprint.

The addition of new laboratory space has enabled the company to bring in specialised and advanced equipment, such as the Maurice system from Protein Simple, PDA, CAD, and ELS detectors, and Droplet Digital PCR (ddPCR) methodology. To better serve their customers, they also offer same-day sample delivery and/ or collection when scheduled in advance (available to/from Ireland/UK). Additionally, they are working on establishing labs to support Biosafety Level (BSL) 3, which will be qualified and ready for use in late Q1, 2021.

Their enhanced lab capabilities support QC release testing, in addition to early-stage testing, to promote purification efficiency, formulation development, and the quantification of stabilisers for drug development.

The Maurice system The Maurice system is a proven innovation in capillary electrophoresis (CE) technology. It allows for the automated protein profiling of products either by size (CE-SDS) or by charge (cIEF). The cIEF and CE-SDS analyses can be used for a wide variety of products, such as mAbs, ADCs, vaccines, or virus-like particles.

Maurice employs ready-to-use cartridges and analyses samples either directly from vials or from a 96-well plate. It produces pI and charge heterogeneity data in less than 10 minutes and size-based CE-SDS data in 35 minutes, reducing testing time significantly.

The team at Charles River strives to anticipate the needs of their clients, and have invested in a number of new detectors which supplement and add to the applications of their HPLC instruments (e.g., PDA, ELS, and CAD). These detectors facilitate the quantification of stabilisers, such as EDTA or polysorbate 80, which may be added to drug products.

Charles River Laboratories employ more than 17,000 people worldwide, operating more than 90 facilities in over 20 countries across the globe. or large sample. It is a useful application for products relating to gene therapy, which is rapidly gaining ground. The field saw a 32% increase in venture funding in 2019.

In addition, Charles River Laboratories have recently introduced water testing capabilities to their analytical laboratory, which complements their well-established and highly experienced microbiological testing function.

They can test WIFI, purified water, and sterilised water to USP, EP, and JP. Some of the tests they

PURPOSE

METHODS

Physicochemical Characterisation and Identity Confirmation/ Comparability

HPLC/UPLC

Concentration/ Strength/Recovery/ Solubility

Total protein assays (UV, colorimetric)

Potency/Relative Binding/Activity

ELISA

SDS-PAGE CE-SDS Western Blot

HPLC Ion Chromatography

Moisture content Osmolality Conductivity

Charles River Laboratories’ enhanced lab capabilities support QC release testing, in addition to early-stage testing, to promote purification efficiency, formulation development, and the quantification of stabilisers for drug development.

About the company: Charles River Laboratories are passionate about their role in improving the quality of people’s lives. Founded as a one-man operation in 1947, they currently employ more than 17,000 people worldwide, operating more than 90 facilities in over 20 countries across the globe. Their customers includes the world’s foremost Irish PharmaChem | Industry Buyers Guide 2021

Analytical methods Their current analytical methods include the following:

Drug Product Appearance Properties (Liquid and pH Lyophilised forms) Particulates

Pioneering technologies Establishing new and pioneering technologies is one of the primary goals in Charles River Laboratories’ quest to help their clients bring new drugs and therapies to the market. They have recently added ddPCR applications to their service portfolio, which can detect and precisely quantify various types of DNA and RNA alterations, using either a very small

can perform include TOC, pH, appearance, conductivity, and nitrates.

Safety

Endotoxin content

Water Testing

WIFI Sterilised and Purified water to EP, USP and JP

For more information on these assays and what they can do for your programme, or if you’d like to know more about the capabilities of Charles River Laboratories’ Ballina facility, please email askcharlesriver@crl.com.

pharmaceutical, biotechnology, agrochemical, government, and academic organisations, who avail of their research, discovery, safety and efficacy, clinical support and manufacturing skills. Indeed, Charles River supported the development of circa 85% of drugs approved by the FDA in 2019. For more information, visit www.criver.com.

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Certification

An innovative approach to certification Certification Europe was founded with the simple aim of providing a certification service which goes further than simply ticking the boxes. “We wanted to provide a service which went beyond the grey, unemotional check-list approach to auditing and inspection which has typified the industry for far too long,” explains Rob Lyons, Sales Manager.

“As a result, we have constantly endeavoured, and will continue to strive to introduce new, cutting edge and innovative approaches to meet the needs of our clients.”

Pushing the boundaries of certification Their innovation is not just bounded to the delivery of their service. As

an organisation, they have always sought to push the boundaries of certification by pioneering the certification of new standards in both the national and international market place:  Certification Europe launched the first accredited certification scheme for information security in Ireland and certified the first organisations in the country to both BS 7799 and ISO 27001;  Certification Europe was the first certification body in the world to offer accredited certification for energy management (ISO 50001, EN 16001 and IS 393);  Certification Europe pioneered the certification of electronic

signatures and was the first certification body in the world to be accredited under EU Directive 1999/93/EC.

First class customer service “We always strive to provide first class customer service and to go the extra mile in everything we do for our clients,” Lyons stresses. “We

Services include:

want to ensure that customers feel that through our work, our company has positively contributed to the success of their organisation in a positive and supporting way. Our aim is to give you an advantage over your competitors through your ISO training, certification, and consistent implementation of management systems best practices.”

Certification Training Environmental & Inspectorate Division

Telephone: +353 1 642 9300 Email: Info@certificationeurope.com Website: https://www.certificationeurope.com 62

Irish PharmaChem | Industry Buyers Guide 2021

Pharma 4.0

People and skills will be the heart of Pharma 4.0 Luke Kiernan, Director of Technical Services at Innopharma, examines the BioPharmaceutical landscape of the near future as we move through the fourth industrial revolution, and explains the changes needed in Europe, and Ireland, to remain competitive.

Technological evolution and innovation will always disrupt industries and economies.

The arrival of the fourth industrial revolution, Industry 4.0, is somewhat the perfect storm with the merging of digital, physical and virtual worlds, which has the power to transform manufacturing systems into digital ecosystems, through the integration of global value chain and the advanced networking of production systems.

As we move into the fourth industrial revolution, technology and other factors will alter industries, jobs, and workforce requirements of the future. People are the centrepiece of Industry 4.0. People will be core to this change. The core ability of humans is the capability to change, learn and adapt, which is more evident than ever before.

Pharma 4.0 describes the fourth industrial revolution taking place in pharmaceutical manufacturing. The future of digitally enabled production will significantly change how we do things, utilising emerging disruptive technologies to enable ‘Smart Factories’ of the future, creating Irish PharmaChem | Industry Buyers Guide 2021

the possibility for fully integrated and networked ‘Smart Factories’, with machines operating in an intelligent way, resulting in the minimal need for manual labour.

As manufacturing transforms, the Internet of Things and ‘Big data’ will play a significant role, as organisations will adapt to a digital strategy. As more devices are equipped with sensors, more data will be generated. According to a 2018 PwC survey, 60% of (Bio)Pharma CEOs globally are concerned about a digital talent shortage and one of the key challenges of ‘Big Data’ analytics is the visualisation of the results and the employees’ ability to utilise the vast amount of data to support operational decision-making.

The challenge for Europe Pharma 4.0 challenges Europe’s BioPharmaceutical sector to remain competitive.

The BioPharmaceutical sector in Europe is extremely strong. There are 750,000 people directly employed and up to four times more employed indirectly. Europe is home to the BioPharma

industry, being the oldest manufacturer of drugs.

Ireland is a key part of the strong pharmaceutical presence in Europe, as an island of developers and manufacturers. According to the IDA, the industry has made a capital investment of €10 billion in new facilities in Ireland over the past 10 years, which represents close to the biggest wave of investment in new Biotech facilities anywhere in the world.

As we move into the fourth industrial revolution, which is driven by advancements in technology, we must remain competitive in this sector due to the high percentage of high-tech manufacturing in Europe that already exists. The challenge is how do we do this? And how do we retain the strong position that we hold when we are competing against countries like China and India? For example, India plans to upskill 2.1 million in the life sciences sector.

However, Europe and more significantly, Ireland, has a deep pool of talent. This is our greatest natural resource. We must use this to our advantage when shaping our future.

Identifying the skills shift To stay competitive, we must identify the skills shift that is needed to support the changes brought by Industry 4.0. Industry 4.0 will lead to a substantial increase in automation of routine tasks, as digitalised production networks act

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Pharma 4.0

autonomously, in turn resulting in many employee roles becoming obsolete. At an employee level, workers will increasingly focus on creative, innovative and complex problem-solving activities, and the key to developing this knowledge and skill within graduates is the quality, relevance and responsiveness of an economy’s education and research system, particularly at a higher education level.

The complex technology of the future will require a curriculum designed for developing greater vocational skill and knowledge through education, encouraging practical and collaborative competencies for a highly technical, automated space.

There is no doubt, that these emerging technologies, such as the Industrial Internet of Things (IoT), advanced robotics, artificial intelligence (AI) and Big Data Analytics will significantly impact on education, programme design and apprenticeships, requiring the development of new educational programmes to adequately prepare graduates for complex work environments of the modern world. People will need knowledge of artificial intelligence, data analytics, process modelling, automation and data transferring of machinery, to name just a few. Soft skills, such as technical skills, transferable skills, being able to summarise data and the ability to communicate with people will be important too.

Like many industries, the pharmaceutical industry is only at the beginning of its 4.0 journey.

The rate of adoption of these technologies will increase significantly over the next decade as returns on investment in change become more tangible. The extent and depth of these changes are a sign of transformation to the entire production, management and governance systems.

fill these roles. People’s ability to be collaborative and agile will be key.

In today’s digitised work environment, agility equals competitiveness. As markets compete to capture a growing share of Industry 4.0 manufacturing investment, economies with the deeper talent pool of skilled graduates will gain an early advantage.

Investment in higher education Investment in higher education is critical in this development of an innovative next generation of skilled workers, researchers, engineers, technicians and teachers. Advances in technology can now allow education providers the opportunity to deliver to learners at different times through eLearning platforms, while optimising new learning devices incorporating virtual reality to replicate a production environment, by consolidating the elements included in Industry 4.0.

As well as higher education, industry involvement in programme design, with increased collaboration approaches to optimise the reliance and synergy between industry and education partners, will provide greater potential to provide

graduates within a skill-set that industry requires, and greater alignment to labour market needs.

The fourth industrial revolution will not only disrupt industries but also presents the opportunity for improvements and for higher education to act as a solution in the adaption to the complex and changing environment, by providing a platform for people to upskill and train to keep up with the pace of change and meet the standards of the digital environment.

Advanced manufacturing sectors, which are key contributors to the Irish economy, depend upon a skilled and competent workforce to attract investments and mitigate against the loss of potential projects due to a skills deficit.

No change will happen without the support of the larger bodies. By Government investing in an inclusive, lifelong learning approach to skills development, this will support making the changes needed to sustain the strong position of high-tech manufacturing in Ireland and Europe.

Irish businesses can plan growth strategies and in turn, global organisations will identify Ireland as a centre for exceptional talent, with skilled teams leading the revolution.

The importance of upskilling PWC’s 2020 survey found that CEOs who have embraced the importance of up-skilling are realising the rewards through higher workforce productivity and innovation. Data Analytics has become critical to the (Bio)Pharmaceutical industry. Data Analytics within a (Bio)Pharma context includes how the data is generated, accessed, stored, analysed and how it is used to make product-related decisions. All these needs are not un-related to other industries.

However, the additional regulatory requirements and data security issues that arise within the BioPharmaceutical context are unique. Therefore, we must provide our people with the skills necessary to meet the expectations of Pharma 4.0.

The strength of the skills and talent in Ireland and across the EU needs to be carefully managed and expanded on, while moving into the future.

We must be innovative and adapt to the new trends that Industry 4.0 brings by providing the people with the necessary skills; otherwise, we will be left behind. The need to be innovative in coming up with impactful and scalable ways to up-skill and cross-skill our employees is critical.

10 million new jobs will be created as a result of advanced manufacturing and the change in the industry, so we need to provide the right skills to

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The pharmaceutical industry is only at the beginning of its 4.0 journey, and the next decade will bring huge adoption of new technologies in the Smart Factories of the future, with companies like InnoPharma and their SmartX platform leading the way.

Irish PharmaChem | Industry Buyers Guide 2021

Specialist Integrated CDMO

Hovione: endto-end solutions from one site Hovione has 60 years of experience as a Specialist Integrated CDMO (Contract Development and Manufacturing Organisation), with a range that includes drug substances, drug product intermediates and drug products. With four FDA inspected sites in the US, Macau, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, the company provides branded pharmaceutical customers with services for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds.

For generic pharmaceutical

customers, the company offers niche off-patent API products.

Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services. As a leader in spray drying, Hovione has the largest capacity, the best scale-up science and the most experienced team to take your project from development to market.

With a view to helping customers solve complex problems, Hovione has invested in building know-how and expertise in particle design

and formulation development for highly sophisticated inhalation APIs. They apply QbD principles in every carrier-based or composite particles formulation development endeavour, ensuring early-on scalable processes to their partners.

Hovione offers end-to-end solutions at a one-site-stop, from drug substance to drug product intermediate to drug product, which means API synthesis, particle engineering, formulation and powder filling can all be developed, characterised and GMP manufactured on the same site. These integrated services can

minimise risk, save cost and time on development and manufacturing processes.

For more information, please see www.hovione.com.

hovione.ie

Irish PharmaChem | Industry Buyers Guide 2021

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Product Testing

Eurofins expands BioPharma product testing in Ireland 2021 is set to be an exciting year for Eurofins’ BioPharma Product Testing Laboratories in Dungarvan, Co. Waterford, as it continues to support an ever broadening range of high efficacy cutting edge therapeutics through addition of the latest analytical technologies, in partnership with some of the world’s most innovative companies.

This service expansion follows on from the 2018 increase in capacity from 2,700m2 to 9,000m2, when an additional 4,400m2 was designated specifically for Bioanalytics & Molecular Cell Biology; in addition to the existing 2,700m2 laboratory. The additional 1,800m2 second site on the campus has been instrumental in the provision of services for medical devices, storage of controlled substances and provision of dedicated training lab space.

Rising to the challenge 2020 provided many challenges to the industry but Eurofins’ Dungarvan laboratory adapted to minimise service disruption and ensure continuity of delivery to their clients, meeting the most challenging of deadlines.

As client internal priorities shifted to support the acceleration of Covid-19 therapies to market,

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Eurofins BioPharma Product Testing Ireland is expanding its service offering to deliver class-leading support for Advanced Therapeutics, including mRNA based products.

Eurofins’ laboratories flexed and rose to meet the urgent demands for raw material, intermediates and finished product analyses. “With the challenges of new and prioritised product types, where time means lives and not just money, comes a renewed focus on delivering the most appropriate technological solutions,” reveals Dr Colin Crowley, Director. Business Development UK & Ireland. “Our microbiology labs will soon leverage the specialist competencies of our continental EU and US labs to introduce rapid sterility & mycoplasma testing in 2021.”

Demand for Eurofins’ BioPharmaceuticals and cell/gene therapies support will continue to grow in 2021 but Eurofins Dungarvan is positioning itself to be the trusted full solution provider to their broader national and international clientele.

Its central position within the harmonised global network of 37 labs in 19 countries delivers efficiencies for their multi-national client base and access to unique technological solutions in all major geographies. “A method developed at our sites in Asia, continental EU or the US is readily deliverable in Ireland under our global

harmonised quality and informatics system, and vice-versa,” Dr Crowley explains.

Amongst Eurofins’ key strengths is an unmatched level of operational resiliency, derived from a global reach and ability to transfer projects internally to mitigate unforeseen risks. In light of the recent pandemic challenges, their clients have greatly valued Eurofins’ interoperability, with group labs in all geographies to keep their products on the market.

Global Is local Eurofins Dungarvan is very well placed to assist the diverse Pharma and BioPharma operations in Ireland and beyond, irrespective of the stage of product development. “Our access to world leading centres of excellence for specialist/niche services such as assay development, structural characterisation, process and product impurity profiling and GMP nuclear magnetic resonance has resulted in increased efficiency, product safety and ultimately profitability for our partners,” Dr Crowley states.

Eurofins BioPharma Product Testing’s local Irish PharmaChem | Industry Buyers Guide 2021

Product Testing

virology, chemistry and microbiology.

Operating under strict, harmonised quality procedures, their laboratories offer a broad range of methodologies under GMP authorisation, ISO 17025 accreditation and ISO 9000 certification, and all analyses are performed according to European and British Pharmacopoeia (EP), United States Pharmacopoeia (USP) and Japanese Pharmacopoeia (JP), as well as specific customer methods.

Collaboration drives cost-effectiveness

Eurofins Dungarvan is very well placed to assist the diverse Pharma and BioPharma operations in Ireland and beyond, irrespective of the stage of product development. presence ensures personal service, backed by the unique global breadth of harmonised capabilities that support all functional areas of bio/pharmaceutical drug development and manufacturing. With a global network of 37 facilities located in 19 countries, their network of GMP laboratories and vast experience allows them to support projects of any size, from conception to market. Furthermore, Eurofins have teams of scientists placed at more than 70 client facilities worldwide through their award-winning Professional Scientific Services (PSS) insourcing programme.

At Eurofins BioPharma Product Testing, the fundamental philosophy is to help clients efficiently allocate research and manufacturing expenditures by strategically engaging them to meet unique outsourcing needs. As your project progresses, to further enhance open dialogue and assist your decision making, they provide timely and secure access to comprehensive laboratory information through their innovative, 24-hour online data access tool, LabAccess.com.

Eurofins BioPharma Product Testing offers the flexibility to manage your testing programmes more efficiently through your choice of three unique service models, including their award- winning Professional Scientific Services (PSS), Full Time Equivalent (FTE) or traditional fee-for-service. You can choose the best, most cost-effective service solution for your project goals and transition as your need grows. Their breadth of services includes:  Method establishment, including method

Class-leading expertise and global regulatory compliance Eurofins BioPharma Product Testing offers complete CMC Testing Services for the bio/ pharmaceutical industry, including all starting material, process intermediates, drug substance, drug product and manufacturing support, as well as broad technical expertise in biochemistry, molecular & cell biology,

development, feasibility, optimisation, cGMP qualification and validation, as well as verification of compendial methods;

 Comprehensive stability and release

programmes for clinical and marketed products;  Complete biochemical and chemical

characterisation and microbial identification;

Eurofins BioPharma Product Testing offers complete CMC Testing Services for the BioPharmaceutical industry.  Raw material and excipient testing (USP/ NF,

EP, JP);

 Production and non-production cell banking,

including full characterisation;

 Lot release/unprocessed bulk testing;  Process/facilities validation, including

viral clearance, residual impurities testing, extractables & leachables, water testing, environmental monitoring, disinfectant efficacy and on-site sample collection;  Consulting/protocol writing;  GMP manufacturing.

“Eurofins Dungarvan has the physical and technical capacity to be your partner of choice for your most critical projects,” concludes Dr Crowley.

“We welcome your enquiries and look forward to delivering best in class service. When the world awaits your product, choose the laboratory that provides complete capabilities and rigorous quality systems you can trust.”

Eurofins’ BioPharma Product Testing Laboratories in Dungarvan continue to support an ever broadening range of high efficacy cutting edge therapeutics.

Irish PharmaChem | Industry Buyers Guide 2021

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capacity chillers to medical storage cabinets and temperature control systems.

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Logistics/Supply Chain

Pictured are: Pamela Quinn, National Manager, Kuehne+Nagel Ireland (front, centre); Tom Clarke, Site Director, West Pharmaceuticals (front, right); Martina Doyle, Business Development Director, West Pharmaceuticals (back, right); Larry Travers, Materials & Logistics Manager, West Pharmaceuticals (back, left); and Adam O’Sullivan, Head of Pharma & Healthcare, Kuehne+Nagel Ireland (front, left).

Kuehne+Nagel delivers for West Pharmaceuticals Kuehne+Nagel Ireland have invested in a dedicated Dublin-based facility for a global partnership with West Pharmaceuticals.

Kuehne+Nagel Ireland has signed a multiyear contract with West Pharmaceuticals, a leading global manufacturer in the design and production of technologically advanced systems for the world’s top pharmaceutical and biotechnology companies.

Furthermore, Kuehne+Nagel Ireland has invested in a custom-built facility dedicated to the management of West Pharmaceuticals’ contract logistics and road logistics services.

The bespoke warehouse boasts racking for 30,000 pallets and has a full temperaturecontrolled system to accommodate the unique requirements pertaining to West Pharmaceuticals’ complex operation. The 100,000 square feet facility is fully HPRA (Health Products Regulatory Authority) approved.

West Pharmaceuticals can often take a long time. From the very beginning of our relationship with West Pharmaceuticals, we were committed to investing the time to understand their full logistical requirements.

Our strength lies in our ability to offer innovative solutions to customers on a wide range of logistical services.”

Ireland is one of the largest exporters of pharmaceutical products globally and the commitment from Kuehne+Nagel Ireland stretches further than the dedicated West Pharmaceuticals facility, with a further nine locations in Ireland also devoted to the pharmaceutical and MedTech industries.

Complex supply chain solutions

Customer-focused approach

“When engaging with customers, we have a collaborative method, working in partnership to derive bespoke solutions that will work for our customers’ needs,” says Pamela Quinn, Managing Director at Kuehne+Nagel Ireland. “The set-up of complex supply chain solutions for a large company like

Michael Moes, Vice President, Global Supply Management of West Pharmaceuticals, says that the customer-focused approach of Kuehne+Nagel Ireland was an appealing strategy that offered many benefits.

“West and Kuehne+Nagel have embarked on a critical and global partnership for

Irish PharmaChem | Industry Buyers Guide 2021

both contract logistics and overland transportation,” Moes reveals. “We’ve specifically engaged with Kuehne+Nagel Ireland’s leadership team and benefitted from their expertise and personalised customerfocused approach, while at the same time leveraging the breadth and depth of the global Kuehne+Nagel team – it’s a winning approach.

“Particularly, we worked closely with the Kuehne+Nagel Ireland team on the strategy to secure land, build and manage a dedicated warehouse,” he continued, “allowing our West Pharmaceuticals operations in Dublin to focus and deliver on its core technical and manufacturing competency.”

With over 80,000 employees at 1,400 locations in over 100 countries, the Kuehne+Nagel Group is one of the world’s leading logistics companies. Its strong market position lies in sea logistics, air logistics, road logistics and contract logistics, with a clear focus on integrated logistics solutions.

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Brenntag Pharma

Brenntag Pharma: Your partner for success needs are fulfilled quickly and efficiently.

Customers can confidently focus on their core business, using Brenntag Pharma’s extensive range of products and services, such as: • Excipients (binders, coatings, emulsifiers, flavours); • Intermediates; • Process chemicals; • Solvents; • Filling of liquid excipients.

Supply chain solutions

Brenntag Pharma is the preferred distribution partner in the pharmaceutical, veterinary and healthcare industries.

Brenntag Pharma offers a comprehensive range of products for the formulation of pharmaceuticals and the chemical synthesis of Active Pharmaceutical Ingredients (APIs). Their dedicated team of chemists and pharmacists develops innovative, tailor-made solutions, be it oral dosage administration, e.g. tablets and capsules, or

parenteral administration, such as injections and infusions.

Highest quality ingredients Based on a global network of suppliers, Brenntag Pharma procures the highest quality ingredients on the market, while their global logistics ensure that their customers’ business

Their extensive network of Brenntag sites across the UK & Ireland (including Brenntag Dublin and Brenntag Belfast) is key to their success for providing total supply chain solutions to customers. Their sites are ISO and ESAD certified and their QMS system/ warehouse is regularly audited by pharmaceutical companies.

Brenntag Pharma support their customers’ R&D and product development teams throughout projects and various stages of new product developments, supplying not only products but ideas and information on market trends to create a competitive edge for their formulations.

BRENNTAG PHARMA LOCAL SERVICE NATIONAL IDENTITY GLOBAL POSITION Understanding the Importance of Safety Given the intimate relationship between pharmaceutical products and our health, it is not surprising that safety is a perennial concern for the pharmaceutical industry.

Brenntag Dublin Tel: +353 (0) 1 401 3500 dublin.sales@brenntag.ie www.brenntag.ie Brenntag Belfast Tel: +44(0) 2890 787 450 belfast.sales@brenntag.co.uk www.brenntag.co.uk

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Brenntag Pharma goes to great lengths to ensure that our entire supply chain is reliable, transparent and compliant with industry regulations.

We offer a comprehensive range of products for the formulation of pharmaceuticals and the chemical synthesis of Active Pharmaceutical Ingredients, and will support you in navigating and implementing the industry’s most stringent documentation and regulatory requirements.

3:19:24 PM Irish PharmaChem | Industry12/19/2016 Buyers Guide 2021

Medicines Access and Innovation

Time to act together

Nathalie Moll, EFPIA Director General.

The time for action is now to align Europe’s policies to the twin goals of medicines access and innovation, writes Nathalie Moll, Director General, The European Federation of Pharmaceutical Industries and Associations, who believes that the Pharmaceutical Strategy for Europe has adopted the wrong approach to addressing access and affordability.

the shared goals of access and innovation, ensuring the right policy instrument is used to address the right question and learn the lessons of the pandemic?

In November 2020, Pfizer announced the first interim analysis of its Covid-19 vaccine, developed with German biotechnology firm, BioNTech.

The statement had an almost instantaneous economic impact. The FTSE100 in London rose by 4%, the Dow Jones in the US was up 5.6%, closing at up 3% by the end of the day. There followed announcements of progress from a number of other companies such as Moderna and AstraZeneca. This dramatic sequence of events underlined the inextricable link between our health and our economic prosperity.

Covid-19 is a microcosm of the pivotal role played by new diagnostics, treatments and vaccines in not only saving and improving the quality of our lives, but also facilitating economic stability and then growth. It is why EU President von der Leyen was right to set out, in her mission letter to Commissioner Kyriakides, the dual goals

To re-establish Europe as a world leader in medical innovation, the EU’s industrial strategy must preserve and foster Europe’s world class IP framework and the EU trade strategy should link-in by ensuring strong IP in EU bilateral trade agreements. This will increase strategic resilience of the EU economy. Put simply, investors go where they know they can get a predictable return on their investment. Many of the priority medicines being tested for Covid-19 exist today thanks to the current EU research eco-system that includes stable and predictable intellectual property (IP) rules and other incentives that drove their creation and development and attracted investors.

The recently published Pharmaceutical Strategy for Europe recognises the critical importance of incentives in driving research into areas of unmet medical need. Learning the

Irish PharmaChem | Industry Buyers Guide 2021

of ensuring access to medicines and supporting the European pharmaceutical industry to be a world leader in medical innovation. It is why the EU pharmaceutical strategy, IP Action Plan and industrial strategy are so important.

Europe has issues to address; the region has an innovation problem and there are significant disparities and delays in access to new treatments.

A recent report by IQVIA highlighted that some patients can wait up to six times as long for access to new medicines than their counterparts in a neighbouring European country, and Europe has witnessed a steady haemorrhaging of cuttingedge medical innovation to the US and China.

Just 25 years ago, Europe was the world leader in Research and Development; today, it is not and risks dependency on other regions for medical advances.

The big question is how can Europe achieve

Re-establishing Europe as an innovator

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Medicines Access and Innovation lessons from the Covid-19 crisis, the inclusion in the Strategy of a series of measures to tackle antimicrobial resistance, including pull and even more importantly, new types of incentives for novel antimicrobials, underlines the central role incentives play in finding answers to our health challenges.

Similarly, the pandemic has underlined the importance of health data in driving medical research, managing our healthcare and the supply of diagnostics, treatments and vaccines.

The Strategy includes critical new initiatives to support the effective use of health data, in particular establishing the European Health Data Space and creating an interoperable data access infrastructure to facilitate secure analysis of data across Europe.

On the frontline of the Covid battle The research-based pharmaceutical industry has been on the frontline of the fight against the coronavirus from the very start, by ensuring the supply of all medicines to patients throughout the pandemic, supporting health systems on the ground and researching and finding diagnostics, treatments and vaccines to help the world come out from under the cloud of this global pandemic.

We have made immense and incredibly swift progress in all these areas, and many lessons have been learned, not least in how we regulate the research, development, manufacture and supply of new diagnostics, treatments and vaccines.

There are a series of proposals in the Strategy closely aligned to EFPIA’s Regulatory Road to Innovation, which we look forward to working on with all stakeholders to evolve Europe’s worldclass regulatory system, including strengthening the iterative scientific dialogue and the dynamic regulatory assessment, using RWE in regulatory decision making, creating a pathway to streamline regulation of drug/device combinations and promoting innovative trial designs.

The wrong approach Addressing the disparities, barriers and delays to access to medicines for patients and affordability for health systems is a goal we share with patients, clinicians, Member States and the EU institutions.

However, the approach to addressing access and affordability outlined in the Strategy is the wrong one.

The Strategy suggests destabilising and weakening incentives designed to support innovation in multiple areas, including for medicines for rare diseases and children, as a way of addressing issues of access and affordability of medicines. As well as being ineffective, this risks undermining the overall objectives of the Strategy by creating uncertainty and accelerating the flow of life-science investment away from the EU to the US, UK and China. By adopting the right multi-stakeholder collaborative approach and by choosing the right policy options to address issues of access and affordability, we believe we can

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How can Europe achieve the shared goals of access and innovation, ensuring the right policy instrument is used to address the right question and learn the lessons of the pandemic? avoid these negative consequences and create, faster, more equitable and sustainable access for patients across Europe, while supporting innovation.

In reality, addressing these multi-factorial access issues requires working across all stakeholders. This can be done through a high-level forum on ‘Better Access to Health Innovation’ and by opening the somewhat opaque EU Pharmaceutical Committee to relevant stakeholders, including the industry that discovers, develops and delivers pharmaceutical innovation.

Lessons forged in the Covid-19 crisis have underlined what can be achieved through collaborative approaches and these can be utilised to identify multi-stakeholder solutions for introducing new technologies that can broaden access, reduce delays and mitigate the impact of shortages.

Finding collaborative solutions Covid-19 has focused the regulatory, research and healthcare communities on finding collaborative solutions; solutions to get medicines to patients despite lockdowns, solutions to find new diagnostics, to scan product libraries to find candidate treatments and vaccines, to collaborate in research, development, manufacture, to innovate and deliver.

Despite losing ground to other regions, Europe

has a strong and stable research ecosystem, world class research centres, committed research-based pharma companies large and small, predictable incentives that reassure investors and a newly found regulatory flexibility, tried and tested under Covid-19, that ensures safety and efficacy at pace with trying to beat a global pandemic.

The Strategy makes a number of positive contributions to enhancing Europe’s research, manufacturing and bio-preparedness ecosystem. If collectively we can avoid endangering Europe’s competitiveness by choosing the right policy options to address issues of access and affordability, we can improve outcomes for patients, build resilience and drive our economic recovery.

With governments around the world spending in excess of $11 trillion in fiscal support programmes and GDP in Europe projected to contract by 7% in 2020, it is not just the devasting human cost of the pandemic that is weighing heavily on the minds of politicians and policymakers but also the need to increase Europe’s resilience to future health threats and how to drive the region’s economic recovery. On both fronts, the research-based pharmaceutical industry in Europe has a key role to play and stands ready to collaborate as it has done throughout this pandemic, to build a stronger and more resilient Europe.

Irish PharmaChem | Industry Buyers Guide 2021

Labelling and Bar Codes

Axicon 15000: a fresh approach to labelling

15500 series 1D/2D barcode verifier ISO/IEC compliant Free licence software Data content checking USB Powered

The Falsification of Medicines Directive and Unique Device Identification for healthcare products require global standards for labelling, with traceability data encoded into easily scannable bar codes. The GS1 general specifications define suitable bar codes and bar code sizes for a particular environment in their Application Specification Tables.

The data in the bar codes is encoded in a defined format to allow correct processing. The GS1 system defines a set of fixed length and variable length fields, each labelled by an application identifier. The Axicon 15000 series verifiers from Holfeld Graphics take a fresh approach to labelling standards.

The user can select the Application Specifications that they wish to comply with, including different application identifiers for different international markets. A verifier ‘plugin’ can be chosen to check against a particular application specification table in the GS1 General Specifications.

A user-friendly solution The print quality of the code is verified to ISO/IEC 15415 for 2D bar codes or

to ISO/IEC 15416 for linear bar codes. If there is a conflict (e.g. healthcare retail or healthcare distribution), the software will ask you to make a choice. This is a user-friendly way of ensuring that not only is the bar code readable but that it is the correct symbology, the correct size and that the data is properly formatted.

The use of the verifier and the recording of data can be controlled in a way that is consistent with 21CFR Part 11. Access to the program is restricted by harnessing the security features of the Windows operating system.

To help with Installation Qualification, Operation Qualification and Performance Qualification, Axicon can provide IQ/OQ/PQ protocols and test cards.

The software can be updated freeof-charge from the Axicon website as standards are updated and new features are added. Recently released features include the Laetus Pharmacode and audit trial capability to track changes to settings and electronic records, while Axicon are about to add the ability to verify GS1 DataBar Composite Codes as used in the Japanese market.

The Axicon 15000 series allows the user to choose a verifier ‘plugin’ to check against a particular application specification table in the GS1 General Specifications.

2 year warranty

www.holfeldgraphics.com

Irish PharmaChem | Industry Buyers Guide 2021

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Packaging Innovation

Optimising packaging for injectable drug delivery devices

An Inhaler Handling Tray from Nelipak.

Growth in generics and biologics has led to the increased use of injectable drug device components, including syringes, auto-injectors, insulin pens and wearable devices, with an estimated 30 billion units used annually. This has driven significant growth in the manufacturing of injection moulded drug delivery devices.

While some pharmaceutical companies develop devices in-house, there is a trend toward specialist third-party contract manufacturers to meet increasing volumes and speed to market requirements. Greater use of robots and pick-andplace systems in manufacturing has created a need for dimensionally stable transit trays to meet the demands posed by process optimisation.

Designing for success Developing a solution often involves design authorities, consultants, pharmaceutical companies, device manufacturers and automation partners.

Nelipak’s Design Requirement Specification (DRS) process captures the requirements of the injection moulder, the automation provider, the packaging supplier, and if involved, the contract manufacturer, to specify the needs for both the process and the device before tray design decisions are made.

This programme draws on the company’s unique project management experience, gained from working with pharmaceutical and medical device

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SeĂĄn Egan, Director of Global Marketing & VoC Development at Nelipak Healthcare Packaging, and Angela Shotton, UK Sales Director and Pharma SME at Nelipak Healthcare Packaging, explain how Nelipak is working with pharma companies to develop innovative packaging solutions for the next generation of medicines.

OEMs on packaging, transit trays and automation systems across Europe and the Americas.

Starting with the initial technical project brief, Nelipak designers deliver digital sketches to clarify aspects that are critical for the packaging, such as device orientation in the tray, areas of the device requiring extra protection and how the device will be handled.

Agreement on design concept allows for the development of pallet load studies to visualise quantities per tray, box and pallet to predict overall storage and shipping volumes.

Design and project management teams work closely with automation and filling companies to provide technical drawings, consultation on material specifications, tray tolerances and deliver prototype samples to support machine development, trials and ultimately supply.

Through this process, Nelipak have developed an understanding of what works on their equipment to deliver greater autonomy and shorter lead

times, which has made the company a solution partner of choice for leading automation companies seeking to deliver successful transit tray projects on time.

The capacity to deliver an uninterrupted supply of components is also a critical factor in the supply chain. Pharmaceutical companies build contingency into their processes to ensure they can continue to deliver product to market, should one location go off-line, and they expect the same backup and support from their key suppliers. With 10 facilities worldwide, Nelipak is one of the few thermoform packaging providers that have both the capacity and footprint to support global pharmaceutical manufacturing.

From production to patient Biologics disrupt the traditional drug market through platforms with better efficacy, but also with more effective delivery through new devices that enable healthcare providers to move treatment Irish PharmaChem | Industry Buyers Guide 2021

Trusted to protect…

Life science products that provide care, improve health and save lives We are a global technology provider to the life sciences industry, providing innovative packaging solutions and complementary products and services. We drive our customers’ success by delivering the best total value by combining superior quality and customer support, and the most efficient technology.

Custom Packaging Solutions Focused 100% on Healthcare Custom Medical Packaging solutions that provide superior quality and protection.

Nelipak®-designed device packaging is based on market expertise from concept to the point-of-use.

For more information, contact us: Email: info@nelipak.com | phone: +31.478.529.000

Sealing Machines A range of custom-built medical tray and blister heat sealing machines

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Flexible Packaging Materials A wide range of flexibility in materials and functionalities

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Packaging Innovation from clinical settings to the home environment in order to reduce in-patient costs on hospital systems. While this move is welcomed by both clinicians and patients, it creates new challenges related to patient adherence/compliance; the US healthcare system, for example, spends an estimated $290 billion annually on “otherwise avoidable medical spending” related to nonadherence.

To address this, pharmaceutical companies are developing smart devices that can instruct proper use, report patient uptake, prompt reminders and monitor patients’ conditions. Device developers also examine human factors engineering to ensure ease of handling and intuitive use by the patient, and this approach is more frequently extending to final packaging. If the device is difficult to remove from the packaging, it may affect a patient’s ability to use the device and potentially perception or acceptance of it.

Packaging helps to solve compliance/ adherence issues Whether it is protection in transit, point of use or being part of the procedure or home therapy, packaging continues to be integral to solving adherence and compliance issues. Smart pill packs already monitor usage, while packaging combined with new technology platforms inform patients when their next dosage is due and can

send out reminders to patients and caregivers.

Drugs sensitive to temperature and humidity can be monitored by smart sensors built into the packaging with data tracking. This intelligent packaging can also report on how the packaging and device were handled in transport, and when it was activated.

Once the device has been filled, assembled and labelled, shipping packaging is required.

This may consist of a shipper carton, clamshell, blister, thermoformed tray insert, pouch or a combination of the above. While some devices are hand-filled into packs, volumes generally dictate semi-automated or fully-automated processes in conjunction with automatic cartoning/IFU lines.

Tolerances are critical for the smooth operation of high-volume lines. In this instance, Nelipak employ the same DRS process in the development of thermoformed tray inserts used for transit trays.

Material choice for packaging will depend on several factors, like barrier requirements, protection during transportation, storage requirements and how the packaging is to be accessed to use the device inside. For thermoformed tray inserts, a variety of materials such as APET, PETG, High Impact Styrene (HIPS), Aclar and Eastalite, are available for use. While most shipping packaging is considered secondary and therefore not required to be sterilised, these materials are cleanroom-compatible, making them ideal for aseptic packaging for drug products used within

sterile clinical fields. When matched with Nelipak’s automated tray heat sealers and lidding solutions, pharmaceutical companies have an end-to-end recyclable solution custom-designed by a global provider around their delivery device needs and manufactured to ISO standards.

Smarter packaging for smarter drugs Newer and smarter drug delivery devices require packaging manufacturers to reduce costs, improve compliance, provide tamper evidence, educate users and be sustainable. As a leading provider of medical device and pharmaceutical packaging solutions, Nelipak brings a deep technical understanding of supply chain requirements, particularly in regard to high speed automation for manufacturing and pack-out operations for transit tray and patient packaging solutions to address these market needs.

Nelipak have a track record in designing medical device packaging that is ergonomic and intuitive, protects product up to the point of use and can be part of the procedure delivering benefits to the surgical team. Nelipak also continue to work with pharmaceutical industry partners to learn more about the diversity of the end-user and the environment the packaging is used in to optimise packaging solutions.

To learn more, visit: www.nelipak.com or contact the author: sean.egan@nelipak.com.

A Tray Heat Sealer from Nelipak.

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Irish PharmaChem | Industry Buyers Guide 2021

We understand how leading-edge products and process improvements are critical in your business.

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Chemicals

The BioPharma industry has a requirement for low Chloride Sodium Hydroxide Solution.

Micro-Bio:

committed to quality Established in 1974, Micro-Bio Ireland Ltd has been serving the needs of Ireland’s pharma, dairy, food, water treatment, electronics and brewing industries for more than 45 years from its base in Fermoy, Co. Cork.

Micro-Bio Ireland Ltd pioneered the commercial use of Membrane Cell Technology (BAT) in western Europe and has become a leader in the production of high purity Sodium Hydroxide, Hydrochloric Acid, Sodium Hypochlorite and Brine Solutions.

Micro-Bio (Ireland) Ltd is also the only Chloralkali manufacturer in Ireland. “Being the sole manufacturer here on the Island of Ireland, Micro-Bio offers customers the highest level of security of supply and continuity of supply,” explains Tom Tobin, Sales Director. “Equally important, it offers traceability of the utmost integrity. The supply chain could not be simpler between manufacturer and end user.”

The company is very aware of the need to provide products of a consistently high standard to its wide range of customers. With this in mind, the company adheres to a policy of continuous improvement across all functions within the company, which leads to greater Irish PharmaChem | Industry Buyers Guide 2021

Fermoy-based Micro-Bio Ireland Ltd is the only Chlor-alkali manufacturer in Ireland and also pioneered the commercial use of Membrane Cell Technology. customer satisfaction and a more secure future for all employees.

Product range As Micro-Bio are in control of their process, they manufacture products to suit the exacting standards across a multitude of sectors including BioPharma, pharma, dairy, food, brewing, water treatment etc.

The products manufactured for the BioPharma and pharma sectors include:  Sodium Hydroxide Low Chloride GMP Grade  Sodium Hydroxide USP/NF/BP/Ph. Eur/JP  Hydrochloric Acid USP/NP/BP/Ph.Eur/JP  Brine Solutions  Purified Water The products manufactured for the dairy, food, brewing and water treatment industries include:  Sodium Hydroxide Low Chlorate  Potassium Hydroxide Low Chlorate

 Hydrochloric Acid 36% (or any dilution of )  Sodium Hydroxide 30% (or any dilution of )  Sodium Hypochlorite 14/15% (or any dilution of )  Brine

GMP grade Sodium Hydroxide solutions The BioPharma industry has a requirement for low Chloride Sodium Hydroxide solution (various concentrations) and these are produced in Micro-Bio’s dedicated BioPharma building. “Sodium Hydroxide Low Chloride is produced using USP purified water and is available in various concentrations from 50% w/w down, depending on our customers’ requirements,” explains Denis O’Brien.

Micro-Bio’s BioPharma building is a dedicated facility where Sodium Hydroxide solutions are stored under a Nitrogen blanket to ensure carbonate levels are minimised.

Filling of containers is performed via 0.2 micron

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Chemicals Product range

filtration in a clean-room to ensure the purity of the solutions is maintained. Dedicated bulk tankers (Nitrogen blanketed) are filled from the dedicated dilution tanks through 0.2 micron filters for direct delivery to their customers’ facility.

Micro-Bio’s product range includes the following products, which can be delivered in agreed packaging from 5 litres to bulk tanker: Sodium Hydroxide Low Chloride GMP Grade Sodium Hydroxide Low Chloride is manufactured in Micro-Bio’s membrane cell electrolysis plant, recognised as the Best Available Technology (BAT). This is a dedicated, continuous process where an ultra-pure brine solution is electrolysed, yielding high purity Sodium Hydroxide. This product is suitable for use in the BioPharma industry and is available in a wide range of concentrations, in terms of normality, molarity, % w/w and % w/v.

Building a strong reputation “Micro-Bio is a very strong company and we have built up a very good reputation among all industries we serve,” explains Peter McNamara, Managing Director. “We work with our customers to manufacture what they need and then we deliver it when they need it.

“The reputation and experience we have gained here in Ireland have now afforded us the opportunity to look at and work with other markets,” the MD continues. “Europe and the US are of particular interest to us and this is something we are actively pursuing.”

Micro-Bio employs close to 30 people directly and a further 30 people indirectly. Apart from local employment, Micro-Bio is very much an active part of the community, sponsoring many organisations and events in the local area.

If you would like more information, please contact any of the following: Peter McNamara, Managing Director Tom Tobin, Sales Director Denis O’Brien, Technical Director www.microbio.ie. Tel: (025) 31388

Micro-Bio’s BioPharma building is a dedicated facility with clean-rooms to ensure the purity of the solutions is maintained.

Hydrochloric Acid USP/NP/BP/Ph.Eur/JP Hydrochloric Acid is generated from the burning of chlorine gas in a blanket of hydrogen gas, using a dedicated HCL synthesis unit. Termed ‘synthesis grade’, this product meets the most stringent requirements for all sectors. This product is available in a wide range of concentrations in terms of normality, molarity, % w/w and % w/v.

Sodium Hydroxide Low Chlorate Sodium Hydroxide Low Chlorate is manufactured in Micro-Bio’s membrane cell electrolysis plant. This is a dedicated, continuous process where an ultra-pure brine solution is electrolysed, yielding high purity Sodium Hydroxide. This product is specifically designed for use in the Infant Milk Formula industry and is available in a wide range of concentrations and various pack sizes.

Brine Solutions Micro-Bio manufactures a range of Brine Solutions, tailored to customer requirements. Only high quality, ‘electrolysis grade’ salt and purified water are used in the manufacture of these solutions. This product is available in a wide range of concen­trations, in terms of normality, molarity, % w/w and %w/v.

Purified Water Micro-Bio uses the local municipal water supply at its head­quarters in Fermoy, Co. Cork, to produce high quality Purified Water, which meets USP and EP standards for purity.

Sodium Hypochlorite Sodium Hypochlorite is manufactured through a controlled reaction of chlorine gas with Sodium Hydroxide solution, in Micro-Bio’s membrane cell electrolysis plant. As Ireland’s only manufacturer of Sodium Hypochlorite, Micro-Bio offer a unique service to clients as they can provide bulk deliveries at the concentration required by clients or small batch deliveries as required. This product is available in a wide range of con­centrations in terms of normality, molarity, % w/w and % w/v.

Micro-Bio (Ireland) Ltd offers customers the highest level of security of supply and continuity of supply.

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Irish PharmaChem | Industry Buyers Guide 2021

Astellas Ireland Co., Ltd Kerry Plant Killorglin Co. Kerry

Astellas Ireland Co., Ltd. Damastown Road Damastown Industrial Park Mulhuddart Dublin 15

Process Data

A smarter approach to processing with Bonner These days, everything is getting smarter.

The data we generate every day can now be harnessed to help us live and work in better, more productive ways. This smart technology has entered all aspects of our lives, and the processing industry is no different. However, in Ireland, many factories are still relying on outdated equipment and processes that do not produce usable data; or, if they do, it is often unreliable.

Moving to a modern system that collects process data, analyses it and presents it back in an actionable format can save a business considerable time and money. Process information can be transformed into an asset through data acquisition and control applications, allowing factories to streamline production and identify any non-performing processes. This improves a plant’s Overall

Bonner helps customers to unlock the value within their process data.

Equipment Effectiveness (OEE) by increasing the efficiency of the equipment or area.

Getting more from your data Bonner specialises in the delivery of bespoke, plant-wide systems that help customers get more out of their data in the most effective way. Whether tackling Energy Monitoring, Condition Monitoring, Predictive Maintenance

or Remote Asset Monitoring, the team designs solutions that best meet the needs of each individual plant. And, as the systems can be integrated with new or legacy equipment, Bonner can create a solution to work for any process, traditional or cutting-edge.

Bonner helps customers to unlock the value within their process data, enabling them to make smarter decisions for their business.

We can add the Smart to your factory to help make decisions in real time based on reliable and available data.

Factory automation systems including Process Data Acquisition, Condition Monitoring and Energy Monitoring can improve your factory’s OEE by making data intelligence and predictive maintenance part of your process.

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Irish PharmaChem | Industry Buyers Guide 2021

Documentation Solutions

Reduce human error and enhance training TWi is a leading technical writing and information design service provider, offering high-quality, flexible, and scalable documentation solutions for BioPharma and medical device companies.

Your Challenges

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Producing effective CAPAs to improve your Human Error Reduction (HER) programme; Reducing ambiguity and unnecessary complexity in SOPs, BMRs, and IFUs that may lead to confusion and human error; Creating user-friendly product information documents and user manuals; Achieving resource efficiencies, while maintaining quality and ensuring regulatory compliance; Developing the skills of your team.

• • • •

TWi’s Solutions

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Information design and technical communication expertise; Consultancy and support on documentation and information management; User-focused approach to documentation development; Flexible, scalable, and customised service offerings that can integrate with your teams; Tailored training in technical communication.

• • • •

share the names or project details of our life sciences clients, except in specific situations where we have explicit consent to do so.

However, if you are looking for a reference or client feedback on our service offering, please contact us at info@technicallywriteit.com.

For more information, see www.technicallywriteit.com

Partner with TWi With TWi’s help, your documentation becomes a valuable business asset. We focus on building long-term, robust relationships, so we can deliver the maximum value to our customers. We are proud to serve some of the leading pharma, biopharma, and medical technology companies around the world.

Our relationships are built on trust and client confidentiality, therefore we do not publicly

Documentation Solutions � Reduce human error � Enhance training outcomes � Improve operational efficiency � Improve documentation quality and usability � Standardise SOPs, BMRs, and WIs � Train technical staff to write effectively � ISO 27001:2013 certified

TECHNICAL WRITING INFORMATION DESIGN TRAINING & CONSULTING TRANSLATION & LOCALIZATION

Irish PharmaChem | Industry Buyers Guide 2021

Watch this space for our new brand in 2021!

CONTACT US Ⓣ +353 (0) 21 2428800 Ⓔ info@technicallywriteit.com Ⓦ www.technicallywriteit.com

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TECHNICAL AND ENGINEERING SERVICES

Working together through the pandemic Clear communication and knowledge sharing has ensured that LotusWorks continues to deliver technical support and expertise to the pharmaceutical industry.

Covid-19 has had a major impact on all aspects of our daily lives. From a business and operations standpoint, many companies have faced challenges in the form of significant revenue decreases, supply chain issues and project slowdowns. While uncertainty and ambiguity remain a daily factor, one positive has been cemented within businesses globally; that is the importance of collaboration and unity as an organisation.

Having international operations has meant companies like LotusWorks, an Irish based technical and engineering services provider, have had to implement a number of initiatives to ensure their clients receive the same high standard of service, whilst keeping their employees safe.

“We’re in constant contact with our teams all over the country here in Ireland and in the US. We have a large number of our technical and engineering staff attending to essential work within medical and pharma plants since the pandemic commenced,” said LotusWorks Director, Emer Conroy.

“Our ability to clearly communicate evolving process changes and work area changes required a lot of attention. We changed the amount and mechanism of our communications to ensure messaging and information reached everyone as promptly as possible,” she continued. “Forums to allow people to submit questions for clarification on health issues helped ensure we protected ourselves, co-workers and client staff.”

Teamwork and knowledge sharing remain key ingredients for success at LotusWorks. biologics manufacturers, while cultivating relationships with new entrants into the market.

The company has recently been involved in one of the largest green-field pharmaceutical projects in Europe, working in partnership with their client to ensure next-generation processing technology. For LotusWorks’ 470+ workforce, knowledge sharing remains an essential part of their business, even during uncertain times.

“Working together and sharing knowledge is part of life at LotusWorks and that culture is standing to us,” Conroy revealed. “Having expert technical and engineering talent spread across Europe and North America constantly sharing expertise, process improvements, key project and technology developments, means our clients ensure operational excellence and stay at the forefront of their industry’s developments.

For LotusWorks, this information sharing means

we can provide the most up-to-date, tailored and technologically advanced solutions to our clients.”

Clear communication & knowledge sharing Covid-19 is likely the biggest and most disruptive force to impact most businesses.

For LotusWorks, although uncertainty is still a contributing factor in daily business operations, clear communication and knowledge sharing has ensured the company has delivered technical support and expertise to the pharmaceutical industry.

“Like all other businesses, LotusWorks has been affected by the pandemic,” Conroy concludes, “but as a company, we are taking comfort in the fact that all our employees are all doing their part and helping keep people safe and well.”

Maintaining long-term relationships LotusWorks experienced significant growth in 2019, growing their workforce by over 25% internationally. The company put their success down to maintaining their long-standing relationships with major pharmaceutical and

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LotusWorks has implemented a number of initiatives to ensure their clients receive the same high standard of service, whilst keeping their employees safe.

Irish PharmaChem | Industry Buyers Guide 2021

Strategic partner of choice to world-leading Pharmaceutical & Biologics organisations for engineering and technical expertise since 1989, LotusWorks provide pharmaceutical facility commissioning, calibration and operations and maintenance services.

Our 470 staff operating in Europe & North America are focused on challenge resolution, process improvement implementation and the delivery of consistent technical expertise to enhance clients’ operational performance.

We value our partnerships and are proud of our very long-standing relationships with major pharmaceutical clients.

Ingredient Solutions

Make it a better day with Univar Solutions

At the intersection of technology, innovation, a premier product portfolio, and dedicated service, the Univar Solutions pharmaceutical team delivers industry-leading technical and ingredient solutions for suppliers and customers, leveraging their unmatched knowledge of global and regional market dynamics to help deliver the ‘better day’.

The Univar Solutions global pharmaceutical ingredients team is dedicated to the success of their customers and suppliers, providing the highest quality ingredients, unrivalled support, and technical expertise in Ireland and across every region they serve. A leading provider of products along the medicinal production chain for more than 90 years, they offer a broad portfolio of:  Excipients  Solvents  Reactants  Active pharmaceutical ingredients (API)  Intermediates

The Univar Solutions team works with customers and suppliers in the human health and veterinary markets worldwide and is committed to helping them innovate and grow while keeping their focus local, with dedicated support right where their customers need them to be.

With a global footprint to drive a greater level of scale in a shorter time span, they have the

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The Univar Solutions global pharmaceutical ingredients team provides top quality ingredients, unrivalled support and technical expertise to its Irish customers. ability to drive pharmaceutical innovations and solutions that are needed locally, regionally, and across the globe. Whether you’re looking for specific specialty pharmaceutical ingredients, have a formulation or technical challenge, need regulatory guidance or are looking for support to scale up and launch in a new and dynamic market, Univar Solutions can help.

“No other ingredients distributor can match our breadth and depth of knowledge, specialty ingredient product portfolio, regulatory compliance expertise, global reach, sales expertise, marketing and customer service, allowing you to rapidly enter the market with new products at scale,” notes Tobias Mesecke, Industry Director Pharma EMEA. Pharmaceutical customers have unique needs requiring custom solutions. Beyond their portfolio and global footprint, the Univar Solutions dedicated team provides a range of essential services, including:  Supplier audits in line with industry standards (e.g., IPEC guidelines for excipients);  Product testing to meet performance specifications;  Regulated product packaging;  Customised supply chain and packaging solutions;

 Pharmaceutical documentation;  Product traceability and process change controls;  Container handling.

“At Univar Solutions, we’re a partner you can trust to provide multi-service solutions, working as an extension of your team, offering technical support, market insights, and expanded industry reach,” Mesecke explains. “With unique, tailored support, we create value by bringing ingredients to life through pioneering concept formulas, technical expertise, and industry-leading distribution capabilities.

Our experienced global pharmaceutical team provides complete support, from knowledge around market and trend research to technical expertise and market insights.

And our global footprint allows us to move faster and be more responsive in helping you streamline your product development process and expedite your time to commercialisation.”

Univar Solutions are committed to continually expanding their ingredients and evolving their offerings and services, to ensure they provide customers with the most optimal access to the highest quality ingredients in the industry.

For more information, visit UnivarSolutions.com/Pharma.

Irish PharmaChem | Industry Buyers Guide 2021

From soothing medicine to calm and comfort the sting of a sore throat, to an extra-strength prescription lotion that relieves itching skin for hours. These are the elements that make up a better day – a day not possible without the right solution.

Leveraging a premier global product portfolio from world-class suppliers, our pharmaceutical ingredients team operates in Ireland and markets around the world, providing access, scale, and speed-to-market.

Working closely with our technical experts, we bring unique insights around the latest market trends, compliance help with regulatory requirements, and new product development expertise to your business.

Wherever you are in the world, partnering with our dedicated pharmaceutical industry experts makes a better day possible.

Find out more at UnivarSolutions.com/Pharma.

GMP Manufacturing A&C, a Canadian-headquartered business opened a sales office in Co. Tipperary in 2015.

With increased sales and demand for localised GMP manufacturing, A&C further expanded its footprint in this region and opened A&C Bio Buffer Ltd in 2018, a state-of-the-art GMP manufacturing facility in Fedamore, Co. Limerick. The Irish plant holds ISO 9001:2015 certification and is dedicated to GMP manufacturing of biological buffers, chemical blends, process solutions, cleaning solutions and water for injection (WFI) for further processing. The site is located in close proximity to pharmaceutical and biopharmaceutical hubs, allowing for safety stocks and rapid delivery times nationwide.

“This GMP production facility has allowed A&C to provide flexible and tailored solutions for buffer and process solution outsourcing to our existing and new clients in Ireland and Europe,” stated Gearoid O’Rourke, Sales & Marketing Director for A&C.

A&C: global outlook, local expertise With a state-of-the-art GMP manufacturing facility in Limerick, A&C is the perfect partner for buffer outsourcing and process solution manufacturing.

2020 saw A&C expanding their Irish plant to include additional services and product offerings.

Buffer outsourcing and chemical blends manufacturing Buffer liquids can constitute an expensive bottleneck in biopharmaceutical downstream processing. Making these fluids in-house requires regulatory oversight, quality management and dedicated space, equipment and staff for buffer preparation and handling.

A&C Bio Buffer can manufacture buffers on their clients’ behalf in their state-of-the-art facility in Co. Limerick. A&C offers cost effective, flexible and tailored solutions for any buffer outsourcing and cleaning solution needs, providing full release testing and supporting documentation.

Product range The A&C buffers and chemical blends portfolio includes a wide range of products, the majority of which are custom blends, solutions or dilutions made under GMP conditions. All products are manufactured with water for injection (WFI) and meet the international pharmaceutical monographs (USP/EP/BP/JP) where applicable.

Custom blends include:  Phosphate buffer solutions  Caustic solutions  Salt solutions  Acid solutions  Solvent blends  Buffer concentrates  Acid blends  Buffering salts

services which mirror those of the two GMP manufacturing facilities in Canada.

GMP blending: A&C can produce a wide variety of powder blends and formulas utilising their state-ofthe-art Matcon blending and V-blending equipment.

 Glass bottles (clear and amber)

GMP repacking of liquids and powders:

 Stainless steel drums (various formats)

A&C Bio Buffer offers custom GMP repacking

 Single-use bioprocess bags

Plant expansion in 2020 Due to the current demand for localised GMP manufacturing, safety stock availability, risk minimisation and reduction of logistic lead times, in 2020 A&C have expanded their Irish plant. This plant now includes additional

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that can be tailored to customers’ batch specific container sizes, ranging from 1L to 1,000L. Packaging formats include:

A&C can produce a wide variety of powder blends and formulas utilising their state-ofthe-art V-blending equipment.

 Phenolic resin lined steel drums  Plastic drums HDPE (various formats)  IBCs

A&C Group A&C is a global GMP manufacturer of excipients, buffers, process solutions and a select number of APIs with offices and GMP production facilities in North America and Ireland. The A&C Group has been servicing the life sciences industry since 1966 and is a service-driven organisation, finding unique solutions to customers’ GMP challenges.

A&C are renowned for their high-quality standards. This is demonstrated through the numerous quality certifications they hold, including ISO 9001:2015, EXCiPACT (GMP and GDP), Drug Establishment Licence for manufacture of APIs, and FDA and Health Canada audited.

For more information, visit www.acggp. com and www.acbiobuffer.com or email euro@acggp.com.

Irish PharmaChem | Industry Buyers Guide 2021

Raw Materials

Securing your raw material supply chain in uncertain times We are living in some of the most unpredictable times that I can recall and there are likely more challenges ahead. This was and continues to be uncharted territory for our industry and of course our pharmaceutical customers. Some notable hurdles have included border closures, shortages of certain chemicals, travel restrictions, global economic uncertainty and potential trade barriers.

Notwithstanding these uncertainties, we have worked hard to minimise the impact on our customers. With that in mind, I have drawn up a list of the important elements in charting a course through turbulent times when it comes to securing your supply chain. Let me be clear, I am not claiming to have all the answers; rather, this a high-level perspective based on our extensive experience

Alan Looney, Managing Director, NCC, looks back on the last 12 months, examining the challenges experienced and providing insight to ensure continuity of supply of raw materials.

Chinese speakers. Their language skills and cultural understanding assist at every stage of the supply chain when it comes to chemical procurement in China. In addition, using the latest communication tools, combined with regular companywide update meetings, is paramount in ensuring that customers’ needs are at the centre of all decision making.

Simplifying complexity

Increased transparency across all areas of the business is vital. With many actors in the supply chain working remotely, it is ever more important, in particular when it comes to the sharing of operational and regulatory information. Utilising digital supply chain tools provides all parties with greater clarity and allows for action to be taken swiftly and decisively.

Managing change control issues can be simplified by partnering with a competent specialist supplier such as NCC. This sourcing supplier should have inhouse research capabilities and be able to conduct manufacturer due diligence, assessments and verification. Added to that, the supplier should also have internal compliance, sourcing and logistics expertise. At NCC, we like to think that we are simply an extension of our customers’ procurement departments; we aim to overcome the difficulties and provide solutions to your challenges.

Communication

Have a contingency plan

It may seem obvious; however, if there is not a clear line of communication, then there are chances that things can be misinterpreted or misunderstood.

That is why we have taken the step to employ native

It is no longer the case of ‘if’ something happens, it is unfortunately becoming vital that organisations have a contingency plan for when something does occur. It is essential that pharmaceutical companies

Visibility and transparency

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partner with a supplier who has second or even third sourcing contingencies. In our experience, many shortages of key raw materials can be anticipated and early concerted action with our customers and suppliers can mitigate the inevitable higher prices, shortages and longer lead times.

Taking steps Though 2020 was a very successful year for NCC, it was also one of the most unpredictable years that I can recall. If anything, it made me realise as a sourcing company how important it is to be resilient, agile and flexible. In addition, it highlighted the importance of having competent, experienced and dedicated employees to support our customers. We are fortunate in NCC to have brought together and grown a superb team.

So, you can mitigate future risk and manage current and future challenges by working with an experienced sourcing partner. NCC has over 50 years of experience. Our excellent track record and in-house experts ensure that our customers receive consistently compliant products, solutions and services that have full supply chain traceability and meet the highest global standards. For further information, call (01) 6131400 or email hello@ncc.ie.

Irish PharmaChem | Industry Buyers Guide 2021

Logistics

KWE Ireland: your logistics partner

KWE Ireland was established in 1998 as a subsidiary of Kintetsu World Express, Inc. and is now a major contributor and trusted partner in the Irish freight and logistics industry.

Long established in the Top 5 Forwarders in Ireland, KWE have developed a well-earned reputation for the provision of quality, tailormade, cost effective logistics solutions.

Temperature-controlled, GDP-certified warehousing KWE Ireland offer full temperature-controlled, WDA/GDP-certified warehousing, and are considered experts in this field, offering a full advisory service and storage solutions to the pharmaceutical industry, including:  Fully validated pharmaceutical WDA/GDP-

certified temperature-controlled facility;

KWE Ireland offers intelligent ‘best in class’ logistics solutions, overlooking Dublin Airport. and externally, to allow them to go beyond industry standards of quality.

KWE are continually and independently audited by internationally renowned and recognised standards authorities and governing bodies.

Exceptionally high standards “Our goal is to make life easier for our clients by taking their headaches and effectively, making

them ours,” explains Karl O’Reilly, Sales Manager/ KWE. “We have built up a large and impressive client base by making their lives easier.”

Zoetis Tallaght, part of the Cross Vetpharm Group Ltd, is one such satisfied customer, as Ronan Fuller, Head of Procurement, explains: “We started working with KWE three years ago; they are a very professional company and we have been hugely impressed by their exceptionally high standards and levels of service throughout this period. They are highly recommended.”

“As a customer of KWE Ireland, you will come to know us as a trusted partner that is always there for you,” O’Reilly concludes. “That’s the level of service we have built our reputation on.”

 Bespoke end-to-end logistics solutions;  Expert in-house commissioning and

validation team;

 All staff are trained to the highest industry

standards, and pride themselves on exceeding customers’ expectations through the quality of service they provide;  RP & Deputy RP on-site.

Always looking to the future and ever seeking to improve, KWE Ireland’s Quality Management System is consistently reviewed both internally

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KWE Ireland are currently offering capacity for both long-term and short-term customers.

For all enquiries, please contact their Sales Team by emailing dubsls@kwe.com or phone (01) 8239600.

Irish PharmaChem | Industry Buyers Guide 2021

Your search is over!

KWE WDA/GDP approved Temperature Controlled facility close to Dublin Airport

Your trusted Global Logistics Partner

Dublin Head Office & Temperature Controlled Warehouse Facility at Harristown, Swords, Co. Dublin.

Tel: (01) 823 9600 Fax: (01) 836 1111 Email: kwedub@kwe.com www.kwe.com Cork Regional Office & Warehouse Facility, Tel: (021) 497 5722 Email: kweork@kwe.com

Waste Management

Responsible and sustainable waste management Indaver are your partner in safe, innovative and sustainable waste management.

As an international waste management company offering sustainable, cost-efficient and tailored solutions to the large-scale industry, Indaver strive to contribute to a clean and safe planet as part of their corporate responsibility. In doing so, they focus on using less primary and fossil feedstocks in order to recover, reuse and recycle materials efficiently.

Thanks to their 30 years of expertise and wide range of in-house facilities and processing possibilities with third parties, Indaver offer a solution for each type of waste. Through improved recycling and maximum recovery of energy and valuable components from waste, Indaver are leading the field in sustainable waste management.

Over the years, Indaver have become an international player in Europe, with facilities and operations in Ireland, the UK, Germany, Belgium and the Netherlands. The Indaver Group manages around five million tonnes of waste per annum. With their Waste-to-Energy installation in Carranstown, Co. Meath, 40,000 homes (equiv.) are supplied with energy, thus

providing a sustainable alternative to fossil fuels.

Continuity safeguarded despite Covid-19 The outbreak of Covid-19 in many parts of the world has caused a challenging situation.

Indaver have taken specific measures to ensure that their essential operations, and therefore your business, remain as undisrupted as possible. “We are doing our utmost to care for your supply chain and serve you and your business as planned,” explains Seamus Flynn, Managing Director, Indaver Ireland. “This includes on-site management at the customer to processing activities, supply chain and commercial relationships.”

Recovering value from waste Indaver’s high-tech facilities have been designed to recover as many valuable materials as possible from the waste they treat.

Innovations such as the chemical recycling of end-of-life plastics or recycling precious metals from hazardous pharmaceutical waste are real breakthroughs. The recovered materials equal the quality of the primary resources and the

Indaver convert waste to energy at their Meath plant, while enhancing the biodiversity of the local area.

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stringent requirements of the market.

The energy they recover through thermal treatment of waste goes to a combination of electricity grids e.g. Meath and steam heating networks such as ECLUSE in the port of Antwerp. This way, they are avoiding and reducing CO2 emissions and reducing dependency on limited fossil fuels, replacing them with renewable energy sources, such as green gas.

Investing in the community Indaver support community projects that contribute to the local community, environment, Irish cultural heritage and many more. One example of this is through their Carranstown Fund Scheme, which to date has provided over €2 million to the local community. “In doing so, Indaver take up our social corporate responsibility as an international environmental company and hope to inspire others to do the same,” explains Flynn.

Supporting healthy ecosystems and biodiversity Indaver recognise the importance of the diversity of the flora and fauna of our ecosystems. Biodiversity is an important part of every Indaver Waste-to-Energy site, whether for a new location, an adjustment or an extension. “Consequently, we can guarantee a focus on biodiversity in and around our sites and throughout the entire chain,” Flynn highlights. An example of this is the creation of new terrestrial habitats at Indaver’s Carranstown facility, such as a wildflower meadow, meadow grasslands, and additional treelines planted with a mixture of native broadleaved trees and Scots Pine, which have led to noticeable increases in populations of native Irish mammals such as hares and foxes.

Indaver are also explicitly committed to the United Nations’ Convention on Biological Diversity.

Irish PharmaChem | Industry Buyers Guide 2021

Your partner in sustainable management of chemical & sensitive waste

On-site manpower

Innovative web portal with reporting

Knowledge & expertise

Integrated total solution in line with your budget and process

Safe ADR transport

Best-in-Class treatment technology

Repackaging, storage & transfer

Material & energy recycling

info@indaver.ie Tel. +353 1 6972900

The circular economy. Together we make it happen. www.indaver.ie

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Ingredients

Barentz offers broad ingredients portfolio

Barentz represents some of the world’s foremost producers of excipients, APIs, nutraceutical, and BioPharma ingredients.

Ingredients distributor Barentz offers pharmaceutical manufacturers a range of ingredients to suit every application.

Barentz is a global life science ingredients distributor specialising in human nutrition, pharmaceuticals, personal care and animal nutrition, creating unique synergies across all fields of expertise.

Founded in 1953, Barentz is now present in over 60 countries, with a global team of more than 1,500 local experts, dedicated to 21,000 customers and with a turnover of €1.4 billion. Driven by the powerful blend of entrepreneurship, partnership, and knowledge, Barentz creates and delivers ‘Always a better solution’.

Barentz acquired Forum Products in 2011 and rebranded it as Barentz Ireland in 2019.

Barentz’s success lies in building long-lasting relationships with suppliers and customers, based on trust, transparency, and reliability, where going the extra mile to provide customer satisfaction is part of the company’s DNA.

Barentz has a skilled team of technical sales managers offering a broad portfolio of

 Local, regional & central (HUB) warehousing;

Excipients for Nutraceuticals Oils, fats, and waxes Preservatives Emulsifiers Permeation enhancers

APIs

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Barentz offers clients:  In-house technical scientists, providing specialist advice on ingredient choices

and functionality;

FILLERS TASTE MASKING

Binders Flavours Diluents Sweeteners Disintegrants Solubilisers Glidants Sugars Lubricants Controlled Release

Anthelmintics Diuretics

Why Barentz is the right business partner for you

High quality ingredients and technical expertise

A broad portfolio of premium quality and high-performance ingredients

Antihypertensives Antiarrhythmics Sedatives

ingredients to suit every application. They are on hand to select the optimum combination of ingredients to assist with solving the formulation challenges and manufacturing demands of customers.

Barentz represents some of the world’s foremost producers of excipients, APIs, nutraceutical, and BioPharma ingredients, including Roquette, Meggle, Dr Paul Lohmann, IFF, Ajinomoto, Abitec, Ohly, IPS & Moehs. Barentz supplies customers producing innovator pharma, generics, OTC, CMOs/CDMOs, BioPharma, medical devices, nutraceutical, and healthcare supplements.

Mineral salts for Atypical & Speciality APIs

 Local sales office, staffed with technical

sales managers and support staff;

 Combined order management and

sampling service with harmonised ERP/ CRM systems;  Fully implemented QA systems, ISO-

9001:2015 and GDP certified.

For more information, contact Barentz Ireland Ltd, Block S, Grants View, Greenogue Business Park, Rathcoole, Co. Dublin, D24 XN60 Tel: (01) 4039518 E-mail: pharmaireland@barentz.com Web: www.barentz.com Irish PharmaChem | Industry Buyers Guide 2021

Always a better solution.

At Barentz, we have made it our business to excel in delivering premium quality and high performance excipients, APIs & nutraceutical ingredients – sourced and provided by our partnered suppliers.

Customers greatly value our deep technical knowledge and extensive product portfolio, our capability to manage quality throughout the entire supply chain and our local presence.

Contact our Dublin sales office at pharmaireland@barentz.com or call us at + 353 1 4039518.

www.barentz.com

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Packaging Systems Goliath Packaging Systems, in business since 2007, supplies and after-sales services a comprehensive range of end-of-line automation, materials handling and industrial washing systems to the Irish PharmaChem sector. With experience gained through many years of successful project delivery for discerning blue-chip customers, the expertise of its international partners / suppliers and the skills of its factory trained staff, Goliath is perfectly positioned to meet the demands of its customer base.

The company recognises the importance of the PharmaChem sector to the Irish economy and concentrates on this critical market segment, with projects successfully delivered during the past 12 months to companies such as Pfizer, Norbrook Labs and GSK, amongst others.

Goliath:

a winning formula

Soco System, one of Goliath’s international partners.

Comprehensive product range The Goliath Pharma product range consists of the following distinct items;  Liquid Filling Systems  Shrink Wrapping, Banding & Over Wrapping  Tablet Counting / Filling  Blistering / Cartoning  Case Erecting, Case Packing & Bag-in-Box Systems  Manual & High Speed Labelling Systems (bottles, tubes, vials, cases etc)  Case Sealing  Cotton & Desiccant Insertion  Conveying Systems  Pallet Inverting & Exchange (Fixed, Mobile & Automatic In-line)  Pallet Stacking / Handling  Scissors & Vacuum Lifting Systems  Materials Handling Systems (Reel, drum & product lifters/manipulators)  Pallet Elevating Systems  Palletising Systems (Gantry, Articulated Arm & Layer types)  Stretch Wrapping  Strapping Systems (Case & Pallet)  Washing Systems (Bottle, Jar, Box, Tray, Drum, Pallet, Keg & IBC etc)  AGV Transport In addition, the following complementary (ancillary) items are provided by Goliath in order to offer a fully integrated turn-key service;  Weighing Systems  Labelling / PharmaCode Reading  X-Ray / Metal Detection Goliath also offers a Project Management / Packaging Consultancy Service to assist in the early determination of customers’ particular packaging equipment requirements, while full validation packages (IQ, OQ, PQ, FAT & SAT etc) are available as required to meet URS demands.

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Goliath serves the following segments of the Irish PharmaChem sector;  Pharmaceutical  BioTech  Chemical  Healthcare  Medical Devices  Contract Packing etc.

Goliath works with a number of internationally known specialist packaging equipment suppliers, including the following;  Filamatic  Soco System  Lantech  Niverplast  Newsmith  Toppy  MJ Maillis  MiR  Global AGV

Goliath Packaging Systems continues to deliver projects for some of the biggest names in the Irish PharmaChem sector.

Centrally located Goliath understands the specific needs of the PharmaChem sector. Through its supply of liquid filling, shrink wrapping / banding, case-packing, labelling / coding, palletising, pallet inverting & high speed washing systems, via partnerships with the above international companies, Goliath has positioned itself as a major provider of packaging equipment to the Irish PharmaChem sector.

Centrally located in Nenagh, Co. Tipperary, Goliath is less than two hours from all major markets, while trained engineers maintain spare parts and service all equipment installed with annual service contracts (reactive / preventative) available as preferred.

Goliath has proudly introduced Global AGV to the Irish market.

To discuss your particular packaging equipment needs, please contact: George O’Leary, Goliath Packaging Systems Ltd, Well Road, Nenagh, Co. Tipperary. Tel: (067) 37893.

Mobile: (087) 1222816.

E-mail: sales@goliath.ie.

Web: www.goliath.ie.

Irish PharmaChem | Industry Buyers Guide 2021

Mechanical & Process Equipment

Flexachem:

efficient process solutions Flexachem are a Cork-based company, providing mechanical and process equipment solutions to the Irish market. They are the localised support for globally installed brands that focus on pumps, valves, mechanical seals and process equipment. This is further supported by their field service engineers for upgrade and site commissioning requirements and an extensive inventory at their Cork office.

Flexachem provide in-house actuation of valves, pump repair/ laser alignment and mechanical seal repair. Their solutions portfolio includes major capital plant used in pharmaceutical, chemical, biotechnology & food/beverage/ dairy markets. These involve cleanin-place skids, food production skids, filter dryers and glass-lined vessels for the production of the chemicals &

APIs, and tank-based solutions such as agitators, tank safety and breathing.

Broader process and utility solutions such as heat transfer, steam, chemical storage and corrosive fluid handling are part of their full package, with safety and reliability at the forefront.

Maximising project capital Their teams include factory-trained specialists to cover the full portfolio with many years’ experience. This can be from component discussion through to complex project and turnkey delivery.

Whether is it refining a control valve, optimising a pump or options on tank agitators, Flexachem enable their clients to maximise their project capital and gain in operating cost reduction through efficient solutions.

Their external specialists will walk

Flexachem provide in-house actuation of valves, pump repair/ laser alignment and mechanical seal repair. through the full technical options per application with extensive experience and deep product knowledge.

For further information, visit www.flexachem.com, email sales@ flexachem.com or call (021) 4617200.

Contacts: Phil Soltan (pumps), Brendan Merrigan (valves), Chris Sheeran (seals), & Michael Bradley (process equipment).

Your on-the-ground team in Mechanical Process Equipment & Technical Support in Ireland For Highly Regulated Industries Ireland’s leading provider for the Design and Sizing of: Mechanical Seals

Hygienic, Industrial & Chemical Pumps

Tank Mixer & Pump Seals including Repairs

For all Transfer Applications

Valves & Actuation

Process Equipment

For Product, Fluid, Steam & Gas Control including Actuation & Feedback

Tank Safety, Mixing & Blending Solutions, Food & Dairy Production Skids, CIP Skids & Tank Cleaning

TALK TO A SPECIALIST AT

100

Flexachem Manufacturing Donnybrook Commericial Centre, Douglas, Cork T12 X68Y Tel: 086 0476178 www.flexachem.com

Irish PharmaChem | Industry Buyers Guide 2021

CHEMICAL SUPPLIERS Acids & alkalis AQS Environmental Solutions Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Chemifloc Ltd Fisher Scientific Ireland Ltd Goulding Chemicals Ltd Heterochem Dist Ltd Micro-Bio Ireland Ltd National Chemical Company Q1 Scientific Solv-Echem Ireland Ltd Univar

Activated carbons Associated Chemicals Ltd Brenntag Ireland Chemco Ireland Ltd Fisher Scientific Ireland Ltd National Chemical Company Univar

ACTIVE PHARMACEUTICAL INGREDIENTS

AbsorboPak Barentz Leo Pharma Micro-Bio Ireland Ltd SK Pharmteco

biochemicals Alexion Arran Chemical Company Associated Chemicals Ltd Barentz Camida Ltd Carbon Group Fisher Scientific Ireland Ltd Micro-Bio Ireland Ltd Pharmalex Univar

biocides Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd Univar

catalysts Arran Chemical Company Associated Chemicals Ltd Camida Ltd Fisher Scientific Ireland Ltd National Chemical Company SK Pharmteco

chiral compounds Arran Chemical Company Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Camida Ltd Fisher Scientific Ireland Ltd Hovione Ltd National Chemical Company SK Pharmteco

excipients A&C Your Global GMP Partner Associated Chemicals Ltd Azelis Barentz Brenntag Ireland Camida Ltd

Irish PharmaChem | Industry Buyers Guide 2021

Chemco Ireland Ltd Corcoran Chemicals Limited Heterochem Dist Ltd Leo Pharma Micro-Bio Ireland Ltd National Chemical Company SK Pharmteco Univar

fine chemicals A&C Your Global GMP Partner AbsorboPak Arran Chemical Company Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Azelis Barentz Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd IDA Ireland Micro-Bio Ireland Ltd National Chemical Company SK Pharmteco Solv-Echem Ireland Ltd

gases National Chemical Company

heterocyclics Arran Chemical Company Associated Chemicals Ltd Camida Ltd National Chemical Company

INDUSTRIAL chemicals Micro-Bio Ireland Ltd

inorganic chemicals Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Chemifloc Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd Langanbach Services Ltd Micro-Bio Ireland Ltd National Chemical Company Solv-Echem Ireland Ltd Univar

laboratory reagents Associated Chemicals Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd IDA Ireland Micro-Bio Ireland Ltd P.J. Bonner & Company Solv-Echem Ireland Ltd Water Chromatography Ireland

Misc. chemicals

AbsorboPak Arran Chemical Company Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Azelis Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Chemifloc Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd

National Chemical Company Solv-Echem Ireland Ltd Univar

oilS, fats and waxes

Associated Chemicals Ltd Brenntag Ireland Carbon Group Corcoran Chemicals Limited Heterochem Dist Ltd

organic intermediates Arran Chemical Company Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Camida Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd Hovione Ltd IDA Ireland National Chemical Company SK Pharmteco Univar

organometallics Arran Chemical Company Associated Chemicals Ltd Camida Ltd National Chemical Company

reagents Associated Chemicals Ltd Camida Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd IDA Ireland Micro-Bio Ireland Ltd National Chemical Company Source BioScience Water Chromatography Ireland

silanes Arran Chemical Company Associated Chemicals Ltd Brenntag Ireland Camida Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd Univar

solvents A&C Your Global GMP Partner Betco Marketing Ltd Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company Soltec (Ireland) Ltd Teva Pharmaceuticals Ireland Univar Water Chromatography Ireland

surfactants A&C Your Global GMP Partner Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd Langanbach Services Ltd Univar

TREATMENT CHEMICALS Micro-Bio Ireland Ltd

101

GENERAL SUPPLIERS ACTUATORS BS&B Safety Systems Ltd

AGITATORS CPI Technology Ltd Quitmann O’Neill

AIR / ROAD / OCEAN FREIGHT AbsorboPak Hazchem Training Ltd Portakabin Ireland

AIR FILTRATION / MONITORING / INGREDIENTS A1 cbiss CMS Chemstore Engineering Ltd

AIR RESPIRATORS A1 cbiss

ALUMINIUM PRODUCTS Quitmann O’Neill

ANALYSIS SERVICES Almac Sciences Ltd Charles River Microbial Solutions Corcoran Products Ltd Eurofins Biopharma Product Testing IDA Ireland Particular Sciences Ltd P.J. Bonner & Company Reading Scientific Services Ltd

ANALYTICAL EQUIPMENT Eurolec Instrumentation Ltd Fisher Scientific Ireland Ltd LABPLAN Particular Sciences Ltd P.J. Bonner & Company Scientific Instruments Ireland

ASSOCIATIONS GS1 Ireland

AUTOCLAVES Fisher Scientific Ireland Ltd Scientific Instruments Ireland

AUTOMATION Goliath Packaging Systems Ltd LABPLAN O’Flynn Medical Ltd P.J. Bonner & Company Portakabin Ireland ProSys Containment and Sampling Technology Weber Packaging Solutions Ltd

BAGGING SYSTEMS Goliath Packaging Systems Ltd

102

BAG IN BOX Goliath Packaging Systems Ltd Soltec (Ireland) Ltd

BALANCES Fisher Scientific Ireland Ltd P.J. Bonner & Company Scientific Instruments Ireland

BARCODE VERIFICATION Goliath Packaging Systems Ltd GS1 Ireland Holfeld Graphics

BARCODING / LABELLING / TRACEABILITY Corcoran Products Ltd Goliath Packaging Systems Ltd GS1 Ireland Holfeld Graphics Millmount Healthcare Weber Packaging Solutions Ltd

BIOLOGICS MSD Ireland

BIOPHARMACEUTICALS AbsorboPak A&C Your Global GMP Partner Alexion Alkermes Pharma Ireland Limited Almac Sciences Ltd Charles River Microbial Solutions Eurofins Biopharma Product Testing IDA Ireland Janssen Micro-Bio Ireland Ltd MSD Ireland Pharmalex Portakabin Ireland Reading Scientific Services Ltd

BIOTECHNOLOGY Almac Sciences Ltd Charles River Microbial Solutions Eurofins Biopharma Product Testing IDA Ireland Labplan Micro-Bio Ireland Ltd MSD Ireland Particular Sciences Ltd Pharmalex Thornshaw Scientific

BLENDERS Fisher Scientific Ireland Ltd

BLISTERING / DE-BLISTERING Holfeld Graphics

BLOWERS CPI Technology Ltd Flexachem Manufacturing Ltd

BPRV BS&B Safety Systems Ltd

BREATHER VENTS BS&B Safety Systems Ltd Quitmann O’Neill

BURSTING / RUPTURE DISCS BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd

CABINETS Fisher Scientific Ireland Ltd Soltec (Ireland) Ltd Source BioScience Weber Packaging Solutions Ltd

CALIBRATION A1 cbiss Endress & Hauser (Ireland) Ltd Eurolec Instrumentation Ltd Labplan LotusWorks P.J. Bonner & Company Veolia Water Chromatography Ireland

CASE ERECTING / PACKING Goliath Packaging Systems Ltd

CASE SEALING Goliath Packaging Systems Ltd

CENTRIFUGES AQS Environmental Solutions CPI Technology Ltd Fisher Scientific Ireland Ltd Labplan

CHEMICAL CONSULTANTS Corcoran Chemicals Limited Hazchem Training Ltd

CHILLED WATER A&C Your Global GMP Partner Cross Technical Solutions Daikin Europe

CHROMATOGRAPHY Charles River Microbial Solutions Fisher Scientific Ireland Ltd Labplan SK Pharmteco Water Chromatography Ireland

CLEANROOMS Charles River Microbial Solutions Cross Technical Solutions Dawson Rentals Ireland Ltd Fisher Scientific Ireland Ltd Leo Pharma Millmount Healthcare Portakabin Ireland Irish PharmaChem | Industry Buyers Guide 2021

GENERAL SUPPLIERS CLEANING SERVICES / EQUIPMENT AQS Environmental Solutions Portakabin Ireland

CLINICAL RESEARCH ORGANISATION Charles River Microbial Solutions

COLD CHAIN PACKAGING Alexion Cold Move CRS Pharma Solutions Millmount Healthcare Quitmann O’Neill

COMPRESSED AIR / COMPRESSORS Festo Ltd

COMPUTER SYSTEMS Charles River Microbial Solutions Chemishield Premier Validation Weber Packaging Solutions Ltd

CONDENSORS CPI Technology Ltd Cross Technical Solutions Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

CONDITION MONITORING AbsorboPak Charles River Microbial Solutions Flexachem Manufacturing Ltd LotusWorks Q1 Scientific

CONSTRUCTION MANAGEMENT Portakabin Allspace Tandem Project Management Ltd.

CONSULTANCY Accenture Hazchem Training Ltd Reading Scientific Services Ltd Tandem Project Management Ltd

CONVEYORS Goliath Packaging Systems Ltd Weber Packaging Solutions Ltd

COOLING SYSTEMS CPI Technology Ltd Cross Technical Solutions CRS Pharma Solutions Daikin Europe Dawson Rentals Ireland Ltd

DATA ACQUISITION Charles River Microbial Solutions Eurolec Instrumentation Ltd IDA Ireland Labplan P.J. Bonner & Company Weber Packaging Solutions Ltd

DEHUMIDIFIERS Cross Technical Solutions CRS Pharma Solutions

DESIGN Graham Hart (Process Technology) Ltd Nelipak Healthcare Packaging Pharmalex Protech Plastics Quitmann O’Neill Tandem Project Management ltd.

DISPERSERS Fisher Scientific Ireland Ltd

DISTILLATION CPI Technology Ltd Fisher Scientific Ireland Ltd Graham Hart (Process Technology) Ltd Indaver Ireland Labplan Soltec (Ireland) Ltd

DOCUMENTATION SOLUTIONS Charles River Microbial Solutions TWi

DRAINS AQS Environmental Solutions

DRIERS CPI Technology Ltd

CONTINUOUS PROCESSING SK Pharmteco

CONTRACT DEVELOPMENT & MANUFACTURING Hovione SK Pharmteco

CONTRACT DEVELOPMENT & MARKETING Charles River Microbial Solutions Hovione SK Pharmteco

CONTRACT PHARMA SERVICES Alkermes Pharma Ireland Limited Avara Shannon Pharmaceutical Services Charles River Microbial Solutions Eurofins Biopharma Product Testing Hovione McGee Pharma International Pharmalex Reading Scientific Services Ltd SK Pharmteco

CONTROLLED SUBSTANCES SK Pharmteco Irish PharmaChem | Industry Buyers Guide 2021

DRUMS / CONTAINERS AbsorboPak CMS Chemstore Engineering Ltd Complas Packaging Ltd Corcoran Products Ltd Industrial Packaging Ltd Interpac National Chemical Company Protech Plastics Quitmann O’Neill Soltec (Ireland) Ltd

DUST & PARTICULATE MONITORING

A1 cbiss

ECONOMIC DEVELOPMENT AGENCY

IDA Ireland

EDUCATION & TRAINING

Charles River Microbial Solutions CPI Technology Ltd Euraxess GS1 Ireland HRB Clinic Research Facility Leo Pharma Pharmalex Reading Scientific Services Ltd Science Foundation Ireland (SFI) Soltec (Ireland) Ltd Water Chromatography Ireland

EFFLUENT MONITORING / TREATMENT Carbon Group Flexachem Manufacturing Ltd P.J. Bonner & Company Veolia

ELECTRICAL Portakabin Ireland Tandem Project Management ltd.

ELECTRICAL SUPPLY Bord Gais

ENERGETIC CHEMISTRY SK Pharmteco

ENERGY EFFICIENCY / MANAGEMENT Berkley Group Daikin Europe Leo Pharma P.J. Bonner & Company Sustainable Energy Authority of Ireland Veolia

ENGINEERING SERVICES Berkley Group Charles River Microbial Solutions Chemishield Eurolec Instrumentation Ltd Leo Pharma LotusWorks P.J. Bonner & Company Tandem Project Management ltd.

ENVIRONMENTAL CONSULTING Charles River Microbial Solutions CMS Chemstore Engineering Ltd Quitmann O’Neill Veolia

ENVIRONMENTAL MONITORING Charles River Microbial Solutions

ENVIRONMENTAL SERVICES / EQUIPMENT AQS Environmental Solutions Charles River Microbial Solutions CMS Chemstore Engineering Ltd O’Flynn Medical Ltd P.J. Bonner & Company Portakabin Ireland Quitmann O’Neill Soltec (Ireland) Ltd Source BioScience Veolia

EVAPORATORS Cross Technical Solutions Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd Labplan

EXHIBITION DESIGN & DISPLAY Clip Ltd Ireland

EXPLOSION PROOFING CMS Chemstore Engineering Ltd Henley Forklift Group Limited

EXPLOSION PROTECTION / PANELS BS&B Safety Systems Ltd CMS Chemstore Engineering Ltd CPI Technology Ltd Henley Forklift Group Limited

103

GENERAL SUPPLIERS EXTRUDERS BS&B Safety Systems Ltd

FACILITY DESIGN McGee Pharma International Pharmalex

FACILITIES MANAGEMENT AbsorboPak AQS Environmental Solutions Hochtief Facility Management Leo Pharma O’Flynn Medical Ltd Quitmann O’Neill Veolia

FILLING EQUIPMENT Goliath Packaging Systems Ltd Quitmann O’Neill

FILTERS CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd

FILTRATION Associated Chemicals Ltd CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd

FIRE DETECTION / PREVENTION / PROTECTION BS&B Safety Systems Ltd

FLAME ARRESTERS BS&B Safety Systems Ltd

FLEXCO PLATES Holfeld Graphics

FLOW CONTROL CPI Technology Ltd Flexachem Manufacturing Ltd P.J. Bonner & Company

FLUID HANDLING CPI Technology Ltd Idex Pump Technologies (Ireland) Ltd Interpac Labplan ProSys Containment and Sampling Technology Quitmann O’Neill

FUME CUPBOARDS Fisher Scientific Ireland Ltd

FURNACES Fisher Scientific Ireland Ltd Scientific Instruments Ireland

GAS DETECTION A1 cbiss Bord Gais CMS Chemstore Engineering Ltd Fisher Scientific Ireland Ltd

GAS SUPPLY Bord Gais Corcoran Products Ltd Scientific Instruments Ireland

104

GAUGES BS&B Safety Systems Ltd Fisher Scientific Ireland Ltd

GENERATORS Scientific Instruments Ireland

GLASSWARE Associated Chemicals Ltd CPI Technology Ltd Fisher Scientific Ireland Ltd Quitmann O’Neill

GRINDING CPI Technology Ltd Fisher Scientific Ireland Ltd

HAZARDOUS WASTE DISPOSAL INGREDIENTS Chemishield Indaver Ireland Industrial Packaging Ltd Interpac Quitmann O’Neill Soltec (Ireland) Ltd Veolia

HEALTH & SAFETY / FIRST AID Charles River Microbial Solutions Hazchem Training Ltd Tandem Project Management ltd.

INSPECTION EQUIPMENT Holfeld Graphics Lister Machine Tools Ltd O’Flynn Medical Ltd P.J. Bonner & Companyv Weber Packaging Solutions Ltd

INSTRUMENTATION BS&B Safety Systems Ltd Charles River Microbial Solutions Endress & Hauser (Ireland) Ltd Eurolec Instrumentation Ltd Labplan LotusWorks P.J. Bonner & Company Scientific Instruments Ireland

INTERMEDIATES SK Pharmteco

IT Bonner Charles River Microbial Solutions Weber Packaging Solutions Ltd Westbourne Global IT Services

INVESTMENT Goodbody Stockbrokers IDA Ireland

INVESTMENT PROMOTION AGENCY IDA Ireland

HEAT EXCHANGERS BS&B Safety Systems Ltd CPI Technology Ltd Cross Technical Solutions Graham Hart (Process Technology) Ltd Labplan

HEATERS CMS Chemstore Engineering Ltd

HOMOGENISERS CPI Technology Ltd Fisher Scientific Ireland Ltd

HOSES CPI Technology Ltd

HUMIDITY / HUMIDIFIERS AbsorboPak Cross Technical Solutions Dawson Rentals Ireland Ltd Interpac P.J. Bonner & Company Source BioScience

INCINERATION Indaver Ireland Veolia

INCUBATORS Charles River Microbial Solutions Cross Technical Solutions Fisher Scientific Ireland Ltd ProSys Containment and Sampling Technology

INJECTION MOULDING Allstop Europe Ltd Quitmann O’Neill

ISOLATORS ProSys Containment and Sampling Technology

LABELLING CMS Chemstore Engineering Ltd Goliath Packaging Systems Ltd Leo Pharma

LAB IT Westbourne Global IT ServicesS

UPPLIERS LABORATORY EQUIPMENT / SUPPLIERS

Charles River Microbial Solutions Chemishield CMS Chemstore Engineering Ltd Endress & Hauser (Ireland) Ltd Eurolec Instrumentation Ltd Fisher Scientific Ireland Ltd Labplan Leo Pharma Micro-Bio Ireland Ltd O’Flynn Medical Ltd Particular Sciences Ltd P.J. Bonner & Company Portakabin Ireland ProSys Containment and Sampling Technology Scientific Instruments Ireland Solv-Echem Ireland Ltd

LABORATORY SERVICES CMS Chemstore Engineering Ltd Nelipak Healthcare Packaging Reading Scientific Services Ltd Westbourne Global IT Services

LEGAL / FINANCIAL / INSURANCE Goodbody Stockbrokers Irish PharmaChem | Industry Buyers Guide 2021

GENERAL SUPPLIERS LOGISTICS AbsorboPak AQS Environmental Solutions C&G Logistics Group Chemco Ireland Ltd Cold Move Kuehne + Nagel Leo Pharma Portakabin Ireland Quitmann O’Neill Solv-Echem Ireland Ltd Weber Packaging Solutions Ltd

LIFTS & HOISTS A1 cbiss Goliath Packaging Systems Ltd

LIFT TABLES Goliath Packaging Systems Ltd

LIQUID FILLING & CAPPING Goliath Packaging Systems Ltd

MACHINE TOOLS Leo Pharma Lister Machine Tools Ltd Soltec (Ireland) Ltd

MAINTENANCE AQS Environmental Solutions CPI Technology Ltd Cross Technical Solutions Endress & Hauser (Ireland) Ltd Eurolec Instrumentation Ltd Hochtief Facility Management Leo Pharma LotusWorks Particular Sciences Ltd Source BioScience

P.J. Bonner & Company Water Chromatography Ireland Weber Packaging Solutions Ltd

MANUFACTURERS A&C Your Global GMP Partner Abbvie Amneal BS&B Safety Systems Ltd Daikin Europe Endress & Hauser (Ireland) Ltd Eurolec Instrumentation Ltd Hovione IDA Ireland Leo Pharma Micro-Bio Ireland Ltd Novartis Ltd. Portakabin Ireland Ltd Quitmann O’Neill SK Pharmteco Source BioScience

Thornshaw Scientific

MATERIALS HANDLING / FORKLFTS / PALLET TRUCKS AbsorboPak Goliath Packaging Systems Ltd Henley Forklift Group Limited Interpac Leo Pharma Portakabin Ireland Toyota Material Handling Ireland Ltd Weber Packaging Solutions Ltd Irish PharmaChem | Industry Buyers Guide 2021

MECHANICAL ENGINEERING SERVICES Berkley Group CPI Technology Ltd Leo Pharma LotusWorks Portakabin Ireland Tandem Project Management ltd.

Veolia Weber Packaging Solutions Ltd

MECHANICAL & PROCESS ENGINEERING CPI Technology Ltd Leo Pharma LotusWorks P.J. Bonner & Company Tandem Project Management ltd.

Weber Packaging Solutions Ltd

MEDICAL DEVICE MANUFACTURE Abbott B. Braun Medical Charles River Microbial Solutions LotusWorks

MEMBRANE FILTRATION SYSTEMS Microfiltration: Fisher Scientific Ireland Ltd Nanofiltration: Fisher Scientific Ireland Ltd Ultrafiltration: Fisher Scientific Ireland Ltd Reverse osmosis: Fisher Scientific Ireland Ltd

METERS Bord Gais CPI Technology Ltd Fisher Scientific Ireland Ltd

MICRO QC Charles River Microbial Solutions Leo Pharma Reading Scientific Services Ltd

MICROSCOPES Fisher Scientific Ireland Ltd Particular Sciences Ltd

MICROWAVE TECHNOLOGY Scientific Instruments Ireland

MILLING Avara Shannon Pharmaceutical Services CPI Technology Ltd Fisher Scientific Ireland Ltd

MIXERS CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd

NOISE / ODOUR CONTROL AbsorboPak A1 cbiss Associated Chemicals Ltd Flexachem Manufacturing Ltd

OEM MANUFACTURING B. Braun Medical IDA Ireland

PACKAGING / BLENDING UNDER GMP National Chemical Company

PACKAGING / DESIGN Charles Tennant & Co Ltd Complas Packaging Ltd Holfeld Graphics IDA Ireland Industrial Packaging Ltd Interpac Leo Pharma Limerick Packaging Nelipak Healthcare Packaging Protech Plastics Quitmann O’Neill Weber Packaging Solutions Ltd

PACKAGING / MACHINERY AbsorboPak Goliath Packaging Systems Ltd IDA Ireland Interpac Leo Pharma Millmount Healthcare NPP Group Ltd Limerick Packaging Nelipak Healthcare Packaging Quitmann O’Neill Smurfit Kappa Ireland Weber Packaging Solutions Ltd

PALLETS Interpac Leo Pharma Quitmann O’Neill

PALLET INVERTING Goliath Packaging Systems Ltd

PARTICLE SIZING SURFACE AREA Particular Sciences Ltd Reading Scientific Services Ltd

PHARMACEUTICAL FABRICATION Charles River Microbial Solutions IDA Ireland ProSys Containment and Sampling Technology

PHARMACEUTICAL MANUFACTURE Abbvie Leo Pharma LotusWorks

PIPES / CORES Protech Plastics Quitmann O’Neill Smurfit Kappa Ireland

PLASTIC CONTAINERS Measom Freer Interpac Nelipak Healthcare Packaging PrimePac Ltd Protech Plastics Quitmann O’Neill Soltec (Ireland) Ltd

PLASTIC CORES / TUBES Protech Plastics Quitmann O’Neill Smurfit Kappa Ireland

PNEUMATICS Flexachem Manufacturing Ltd

POLLUTION CONTROL Veolia

105

GENERAL SUPPLIERS POWDER HANDLING AQS Environmental Solutions CPI Technology Ltd Goliath Packaging Systems Ltd Industrial Packaging Ltd Interpac ProSys Containment and Sampling Technology Quitmann O’Neill

PRESSURE MEASUREMENT / SWITCHES / VESSELS BS&B Safety Systems Ltd CPI Technology Ltd Eurolec Instrumentation Ltd Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd P.J. Bonner & Company

PRESSURE RELIEF BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd

PRINT PACKAGING Contego Packaging Group Limerick Packaging Protech Plastics Quitmann O’Neill Weber Packaging Solutions Ltd

PROCESS CONTROL A1 cbiss BS&B Safety Systems Ltd Charles River Microbial Solutions O’Flynn Medical Ltd P.J. Bonner & Company Scientific Instruments Ireland

PROCESS DESIGN BS&B Safety Systems Ltd Pharmalex SK Pharmteco

Tandem Project Management ltd.

PROJECT MANAGEMENT Chemishield Leo Pharma Pharmalex P.J. Bonner & Company Reading Scientific Services Ltd Tandem Project Management Ltd

PROTECTIVE CLOTHING / APPARATUS A1 cbiss O’Flynn Medical Ltd ProSys Containment and Sampling Technology

PUMPS CPI Technology Ltd Fisher Scientific Ireland Ltd Idex Pump Technologies (Ireland) Ltd Quitmann O’Neill Water Chromatography Ireland

QUALITY & COMPLIANCE AbsorboPak Charles River Microbial Solutions Chemifloc Ltd Leo Pharma LotusWorks McGee Pharma International Pharmalex ProSys Containment and Sampling Technology Reading Scientific Services Ltd Veolia Weber Packaging Solutions Ltd Westbourne Global IT Services

106

R&D Almac Sciences Ltd Avara Shannon Pharmaceutical Services Charles River Microbial Solutions Chemifloc Ltd Euraxess Ireland Eurofins Biopharma Product Testing IDA Ireland Leo Pharma ProSys Containment and Sampling Technology Protech Plastics Reading Scientific Services Ltd SK Pharmteco Synthesis and Solid State Pharmaceutical Centre TopChem Pharmaceuticals Ltd

REACTORS CPI Technology Ltd Flexachem Manufacturing Ltd

RECRUITMENT Berkley Group Brightwater Chemishield ICDS Recruitment Consultants Leo Pharma Tandem Project Management ltd.

Thornshaw Scientific

REFRIGERATION / FREEZING Cross Technical Solutions CRS Pharma Solutions Daikin Europe Dawson Rentals Ireland Ltd Fisher Scientific Ireland Ltd Langanbach Services Ltd Q1 Scientific Source BioScience

RENEWABLE ENERGY Daikin Europe Sustainable Energy Authority of Ireland Veolia

RESEARCH FUNDING Science Foundation Ireland (SFI)

RESPIRATORY PHARMACEUTICALS Eurofins Biopharma Product Testing Reading Scientific Services Ltd Teva Pharmaceuticals Ireland Thornshaw Scientific

ROBOTICS Charles River Microbial Solutions Goliath Packaging Systems Ltd Labplan Leo Pharma

SANITARY TUBING CPI Technology Ltd Flexachem Manufacturing Ltd

SCADA /DCS / MIS P.J. Bonner & Company ProSys Containment and Sampling Technology

SCRUBBERS Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

SEALS & GASKETS Flexachem Manufacturing Ltd

SIEVING Fisher Scientific Ireland Ltd Particular Sciences Ltd

SLEEVE / STRETCH WRAPPING Goliath Packaging Systems Ltd

SOFTWARE Charles River Microbial Solutions Chemishield CMS Chemstore Engineering Ltd Westbourne Global IT Services

SOLVENT RECOVERY / SERVICES Carbon Group CPI Technology Ltd Soltec (Ireland) Ltd Veolia

STABILITY STORAGE Almac Sciences Ltd Charles River Microbial Solutions CMS Chemstore Engineering Ltd Corcoran Products Ltd Cross Technical Solutions CRS Pharma Solutions Dawson Rentals Ireland Ltd Eurofins Biopharma Product Testing Q1 Scientific Reading Scientific Services Ltd Source BioScience

STABILITY TESTS Particular Sciences Ltd Reading Scientific Services Ltd

STAINLESS STEEL / FITTINGS / PRODUCTS CMS Chemstore Engineering Ltd CPI Technology Ltd Henley Forklift Group Limited Interpac ProSys Containment and Sampling Technology Quitmann O’Neill Weber Packaging Solutions Ltd

STEAM EQUIPMENT BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd

STERILITY TESTING A1 cbiss Charles River Microbial Solutions Reading Scientific Services Ltd Source BioScience

STORAGE / BUNDING CMS Chemstore Engineering Ltd Charles River Microbial Solutions CRS Pharma Solutions Dawson Rentals Ireland Ltd Interpac Quitmann O’Neill

STORAGE OF HAZARDOUS MATERIALS C&G Logistics Group CMS Chemstore Engineering Ltd Corcoran Products Ltd CRS Pharma Solutions Dawson Rentals Ireland Ltd Hazchem Training Ltd Indaver Ireland Leo Pharma Soltec (Ireland) Ltd Veolia Irish PharmaChem | Industry Buyers Guide 2021

GENERAL SUPPLIERS STRAPPING EQUIPMENT AbsorboPak

Goliath Packaging Systems Ltd

SUPPLY CHAIN MANAGEMENT AbsorboPak Alexion C&G Logistics Group Chemco Ireland Ltd Cold Move GS1 Ireland IDA Ireland Kuehne + Nagel KWE (Ireland) Ltd Limerick Packaging McGee Pharma International National Chemical Company Portakabin Ireland Quitmann O’Neill Solv-Echem Ireland Ltd Thornshaw Scientific

TABLETING EQUIPMENT Flexachem Manufacturing Ltd

TANKS Celtic Forwarding Ltd Complas Packaging Ltd Flexachem Manufacturing Ltd Quitmann O’Neill

TEMPERATURE CONTROL Bord Gais CMS Chemstore Engineering Ltd Corcoran Products Ltd Cross Technical Solutions CRS Pharma Solutions Daikin Europe Dawson Rentals Ireland Ltd Eurolec Instrumentation Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd KWE (Ireland) Ltd Labplan LotusWorks P.J. Bonner & Company Q1 Scientific Source BioScience

TESTING SERVICES Almac Sciences Ltd Anecto CPI Technology Ltd Charles River Microbial Solutions Chemifloc Ltd CMS Chemstore Engineering Ltd Eurofins Biopharma Product Testing P.J. Bonner & Company Reading Scientific Services Ltd

THERMAL IMAGING / THERMOGRAPHY Eurolec Instrumentation Ltd P.J. Bonner & Company Reading Scientific Services Ltd

Irish PharmaChem | Industry Buyers Guide 2021

TOOLS Charles River Microbial Solutions

TRAINING Hazchem Training Ltd Reading Scientific Services Ltd

TRANSPORT & LOGISTICS AbsorboPak

AQS Environmental Solutions C&G Logistics Group Celtic Forwarding Ltd Cold Move CRS Pharma Solutions Dachser Ireland Ltd Hazchem Training Ltd Kuehne + Nagel KWE (Ireland) Ltd Leo Pharma Quitmann O’Neill Weber Packaging Solutions Ltd

TRAY HEAT SEALER Nelipak Healthcare Packaging

TUBE SETS / DISPOSABLES Langanbach Services Ltd Quitmann O’Neill

ULTRA SONIC MACHINES Soltec (Ireland) Ltd

VACCINES MSD Ireland

VACUUM SYSTEMS BS&B Safety Systems Ltd CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Goliath Packaging Systems Ltd Particular Sciences Ltd

VALVES BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd

VALIDATION Almac Sciences Ltd Charles River Microbial Solutions Chemishield CRS Pharma Solutions Dawson Rentals Ireland Ltd Eurofins Biopharma Product Testing Leo Pharma LotusWorks McGee Pharma International Pharmalex P.J. Bonner & Company Reading Scientific Services Ltd SK Pharmteco Source BioScience

Tandem Project Management ltd.

VENTILATION Cross Technical Solutions Daikin Europe

VISION SYSTEMS Particular Sciences Ltd Weber Packaging Solutions Ltd

WAREHOUSE MANAGEMENT C&G Logistics Group Celtic Forwarding Ltd CMS Chemstore Engineering Ltd Cold Move Complas Packaging Ltd Henley Forklift Group Limited Leo Pharma Portakabin Ireland Weber Packaging Solutions Ltd

WASHING EQUIPMENT Goliath Packaging Systems Ltd Leo Pharma

WASTE MANAGEMENT / BALERS / RECYCLING AQS Environmental Solutions Indaver Ireland Quitmann O’Neill Soltec (Ireland) Ltd

WATER FOR INJECTION A&C Your Global GMP Partner National Chemical Company

WATER TREATMENT Charles River Microbial Solutions Chemco Ireland Ltd Chemifloc Ltd Flexachem Manufacturing Ltd Industrial Packaging Ltd Portakabin Ireland

WEIGHING Fisher Scientific Ireland Ltd Bonner Weber Packaging Solutions Ltd

WORKWEAR O’Flynn Medical Ltd

WORKWEAR MANAGEMENT DISPENSING MACHINE O’Flynn Medical Ltd

107

COMPANY LISTINGS A

a1-cbiss

A&C 'Your Global GMP Partner'

Address: 5 Valiant Way,

Lairdside Technology Park, Tranmere, Wirral, UK.

Tel: 0044 151 666 8300 Email: sales@a1-cbiss.com Web: a1-cbiss.com Business: Integrators of Flame & Gas Detection Systems.

Contact: Business Development: Tom Rutter

ABBVIE

Address: ABBVIE Sligo – Manorhamilton Road.

Tel: 071 913 6600 Address: ABBVIE Cork - IDA Business &

Technology Park, Carrigtohill,

Co. Cork.

Tel: (021) 488 1400 Business: Pharmaceutical

Address: Grange Business Park, Skule Hill, Fedamore, Co. Limerick

Tel: +353 52 614 8880 Email: euro@acggp.com Web: www.acggp.com/www.acbiobuffer.com Contact: euro@acggp.com Business: A&C is a global GMP manufacturer of excipients, buffers, process

ingredients and a select number

of APIs.

Alkermes Pharma Ireland Limited

Address: Monksland, Athlone,

Co. Westmeath.

Tel: (090) 649 5000 Web: www.alkermes.com Business: Global Biopharmaceutical Company.

Contact: Vice President & Athlone General Manager: Kevin Brady

AQS ENVIRONMENTAL SOLUTIONS

Address: Castletown, Galmoy (via Thurles),

Co. Kilkenny.

Tel: +353 (0)504 57800 Freephone: 1800 500 020 Email: info@aqssolutions.ie Web: www.aqssolutions.ie Business: Provider of drainage, industrial

cleaning, waste management and

processing services.

Contact: Commercial Director:

Stan O’Reilly

arran CHEMICAL COMPANY LTD A Member of the Almac Group

ARRAN CHEMICAL COMPANY Address: Monksland Industrial Estate,

Athlone, Co. Roscommon,

N37 DN24, Ireland.

Tel: +353 906 445700 Email: info@arranchemical.ie Web: www.arranchemical.ie Business: Fine chemical company specialising

in the manufacture of products for

Pharma, Healthcare, Flavour/

Fragrance & other specialised

chemicals & industrial applications.

Contact: Gareth Maguire, Business

Development Manager

PANTONE GREEN 361c PANTONE BLACK CMYK GREEN: c: 78.8 m:11.5 y: 100 k:1.5 CMYK BLACK: K 100% RGB GREEN: r: 52 g: 160 b: 44 RGB BLACK: r: 35 g: 31 b: 32 HEX GREEN: #34A02C HEX BLACK: #231F20 Font: Myriad Pro

AbsorboPak Ltd

Address: 6 Main Street, Howth, Dublin

D13P2C1, Ireland.

Tel: +353 (1) 6978733 Email: info@absorbopak.com Web: www.absorbopak.ie Contact: Sé O'Leary, Sales / Technical Support Business: With our range of desiccants, we

help clients all over the world prevent

moisture damage

Accenture

Address: 1 Grand Canal Square, Dublin 2.

Tel: (01) 646 2000 Email: Info@accenture.com Web: www.accenture.com Business: Professional Services.

Contact: Managing Director, Life Sciences:

Barry Heavey

108

Almac Sciences Ltd.

(formerly BioClin Research Laboratories) Address: IDA Technology & Business Park,

Garrycastle, Athlone, Ireland, N37X061.

Tel: +353 (0)90 646 0200 Fax: +353 (0)90 646 0210 Email: almacanalytical@almacgroup.com Web: www.almacgroup.com Business: Analytical services provider in GMP /

GLP environments across UK, Europe

and US with significant experience in

the analysis of small, large and bio

logic molecules. Our state of the art

labs support drug substance (API),

drug product (finished product)

analytics across all phases of clinical

development and into commercial release.

Contact: Business Development: Chris Merrick

ASSOCIATED CHEMICALS LTD

Address: 16D Euro Business Park,

Little Island, Co. Cork, Ireland.

Tel: +353 21 4351014 Fax: +353 21 4351015 Email: info@acl.ie Web: www.acl.ie Business: Chemical Suppliers.

Contact: Managing Director:

Sylvester Cotter

Irish PharmaChem | Industry Buyers Guide 2021

COMPANY LISTINGS

Avara Shannon Pharmaceutical Services Limited

BonNer

Tel: (01) 450 5050 Fax: (01) 450 5183 Email: contact@bonner.ie Web: www.bonner.ie Business: Instrumentation, Calibration and

Control Solutions including

analysis, maintenance,

temperature mapping and

automation systems.

Instrumentation product sales

from international manufacturers.

Contact: Managing Director: Patrick M Bonner

Service Manager: Roddy Jefferson

Control Solutions: Vernon Smit

Address: Raheen Business Park,

Raheen, Co. Limerick, V94 N4V2 Tel: (061) 484 700 Mobile: (086) 8385556 Email: sales@bsb.ie Web: www.bsbflamearrester.ie www.bsb.ie Business: - Rupture Disks, Safety Heads,

Sensors, Graphite Disks and accessories;

- Custom Engineered Product

solutions for the OEM;

- Explosion Vents, Suppression/

Isolation units;

- Specialty Buckling Pin Relief Valves;

- Flame Arresters, Breather

Valves and PVRV's/Emergency Vents;

- Process Systems for the Oil &

Gas, Chemical & Refining industries.

Contact: Manager: Patrick Murphy

Ireland Direct Sales Manager

B. Braun MEDICAL

C

Address: Shannon Industrial Estate, Shannon,

Address:

Tel: Fax: Email: wjkunz@avara.com Web: www.avara.com Business: US / European based CDMO for API,

Bulk Drug Product, Finished

Product, Packaging and Distribution.

Contact: Mr. Werner Kunz: VP & Site Director

Co. Clare, V14 FX09, Ireland.

00353-61-714114 00353-61-714101

Azelis Ireland Limited Address:

Tel: Fax: Email: Business: Contact:

Unit 23, Sandyford Office Park, Blackthorn Avenue, Sandyford Industrial Estate, Foxrock, Dublin D18 X9X7.

(01) 295 6977 (01) 295 8338 graeme.locke@azelis.ie Chemical Distributor.

Managing Director: Graeme Locke

B

Barentz Ireland Ltd Address: Block S, Grants View, Greenogue Business Park, Rathcoole, Co. Dublin Tel: +353 1 4039518 Fax: +353 1 4039519 Email: pharmaireland@barentz.com Web: www.barentz.com Business: Distributor of excipients, amino acids

and APIs to the Pharmaceutical,

Nutraceutical & Biopharma industries

in Ireland.

Contact: Sales Manager: Storme Delaney

BERKLEY GROUP Address: Dublin: 509 The Capel Building,

Mary’s Abbey, Dublin 7.

Cork:

Mill House, Carrigrohane, Co. Cork.

International Offices: Singapore, London & Dubai.

Tel: (01) 872 4666

(021) 428 9600 Email: sgreenwood@Berkley-group.com Web: www.berkley-group.com Contact: Steve Greenwood Irish PharmaChem | Industry Buyers Guide 2021

BS&B SAFETY SYSTEMS LTD

Instrumentation, Calibration and Control Solutions 35 Western Parkway Business Centre, Ballymount Drive, Ballymount, Dublin 12.

Address: 3 Naas Road Industrial Park, Dublin 12.

Mobile: 086 833 9836 Fax: +353 (0)1 709 1889 Email: robert.bannon@bbraun.com Web: www.bbraun.ie Business: OEM manufacturing.

Contact: Sales Consultant: Robert Bannon

Â

CAMIDA LTD Address: New Quay, Clonmel,

Co. Tipperary, E91 YV66, Ireland.

Tel: +353 52 6125455 rIsh harma hem Fax: +353 52 6125466 Email: info@camida.com Web: www.camida.com Contact: Company Secretary:

Building 1000, Deirdre McGrath

I

P

C

2012

Brenntag Ireland b renntAG ireLAnd

Address: Unit 405, Greenogue Address: Unit 405,

Business Park,

Greenogue Business Rathcoole,

Park, Rathcoole, Dublin 24.

Tel: Dublin 24. +353 (0) 1 401 3500 Fax: +353 (0) 1 401 3599 Tel: (01) 401 3500 Email: dublin.sales@brenntag.ie Fax: (01) 405 3501 Web: www.brenntag.ie Email: dublin.sales@brenntag.ie Business: Chemical Suppliers & Web: www.brenntag.ie Distributors.

Contact: Sales Desk Contact: Evelyn O'Connor: evelyn.o'connor@brenntag.ie

Cole Carroll: colman.carroll@brenntag.ie

briGhtwAter Address:

Tel: Fax:

36 Merrion Square, Dublin 2.

(01) 662 1000 (01) 662 3900

Units 1201& 1202, City Gate, Mahon, Cork.

Tel: (021) 240 9099 Fax: (021) 240 9009 Email: mail@calleng.ie Web: www.calleng.ie Business: Multi-discipline carbon group Address: consulting engineering Ringaskiddy, Co. Cork, P43 R772.

Tel: +353 (0)21 437 8988 and project managment Mobile: +353 (0) 86 2612 485 company.

Fax: +353 (0)21 437 8950 Email: carol.deegan@carbon.ie c AmidA Ltd sales@carbon.ie Address: Tower House, Web: www.carbon.ie Pharma/biopharma Business: New Quay, chemicals.

Area Sales Manager: Contact: Clonmel,

Carol Deegan Co. Tipperary.

Tel: Fax: Email: Web: Contact:

(052) 612 5455 (052) 612 5466 info@camida.com 109 www.camida.com Company Secretary: Deirdre McGrath

Contact:

ceLtic f Address:

Tel:

Fax:

Email: Web: Business: Contact:

COMPANY LISTINGS

Charles River Laboratories Ireland Ltd Address:

Carrentrila, Ballina, Co. Mayo, F26 D786 Ireland

Tel: +353 (0)1 8429300 Email: sales@certificationeurope.com Web: www.certificationeurope.com Business: ISO Management Standards

Certification body for ISO 9001,

14001, 45001, 50001, 27001,

22301 and 2000-1 Contact: Rob Lyons,

Sales and Marketing Manager

Email: askcharlesriver@crl.com Web: criver.com/biologics Business: Biologics Testing Solutions

Charles River Microbial Solutions International Ltd Address:

49, Greenogue Business Park,

Jordanstown Ave, Jordanstown,

Rathcoole, Co. Dublin, D24 NF21, Ireland.

Email: askcharlesriver@crl.com Web: criver.com/microbial Business: Micro QC

Charles Tennant & co Ltd Address: 71 Cookstown Ind Estate,

Belgard Road, Tallaght,

Dublin 24.

Tel: (01) 451 4099 Fax: (01) 451 4702 Email: jgrehan@ctennant.ie Web: www.charlestennant.com Business: Chemical and Packaging supplier.

Contact: Chemical Manager:

Jim Grehan

Chemco Ireland Limited Address:

Tel: Fax: Email:

Unit 2, Stadium Business Park, Ballycoolin, Cappagh, Dublin 11, D11 X205. +353 (0)1 8293600 +353 (0)1 8855029 info@chemco.ie

Web: www.chemco.ie

CERTIFICATION EUROPE Limited

Address:

110

Block 20A, Beckett Way, Park West Business Park, Dublin 12 D12 P8R2

complas packaging ltd Address: Naas Industrial Estate,

Dublin Road, Naas, Co. Kildare.

Tel: (045) 874 088/9 Fax: (045) 874 090 Email: sales@complas.ie Web: www.complas.ie

CORCORAN CHEMICALS LTD

Chemifloc Group: Chemifloc, GI Chemicals, Chemilabs Address:

Address: Tel: Fax: Email:

Web:

Business:

Contact:

17 Parkgate Street, D08 NRP2.

(01) 633 0400 (01) 679 3521 info@corcoran-group.com www.corcoran-group.com Distributors of raw materials for the food, pharmaceutical, polymer & chemical industry.

Sales

Smithstown Ind Est, Shannon, Foynes Port, Limerick.

Tel: 061 708699; 021 4911643 (GI) Fax: +353 61 708653 Email: info@gichemicals.ie; info@chemilabws.ie Web: chemifloc.ie; gichemicals.ie Business: Chemifloc: Water Treatment

Chemicals; GI: Industrial

Chemicals, Chemilabs:

Laboratory Technical Services Contact: Fergal Lawless, Tom Kelly (GI)

Director, GM (GI)

CORCORAN PRODUCTS (IRL) LTD Address:

Tel: Email:

Web:

Business:

Contact:

Unit 12, Northern Cross Business Park, Finglas, D11 DC67.

(01) 864 4422 info@corcoran-group.com www.corcoran-group.com Suppliers of packaging to the food, pharmaceutical and chemical industry.

Derek Lennon

CPI technology ltd

Chemishield Address: Arc Labs, Carriganore, Waterford.

Tel: +353 (0)51 576 025 Email: info@chemishield.com Web: www.chemishield.com Business: Software & Life Sciences Consultancy.

Contact: Commerical Director:

James Steele

CMS Chemstore Engineering Ltd.

Address:

Tel: Email:

Web:

Business:

Contact:

Clondrinagh Industrial Estate, Ennis Road, Limerick, V94 XT27.

(061) 327792 hello@chemstore.ie www.chemstore.ie Solutions provider for the safe storage and management of Hazardous Materials.

Managing Director: Shane O’Carroll

Address: Unit 5 Link Road, Business Park,

Ballincollig, Co. Cork.

Tel: (021) 487 4142 Fax: (021) 487 8764 Email: info@cpitechnology.com Web: www.cpitechnology.com Business: Providers of Process Equipment.

Contact: Managing Director:

Adrian Giltinan

CROSS TECHNICAL SOLUTIONS Address: 9/10 Broomhill Road,

Tallaght, Dublin 24.

Tel: (01) 405 6777 Fax: (01) 413 6932 Email: jmcgrath@crosstechnicalsolutions.ie Web: www.crosstechnicalsolutions.ie Business: Refrigeration.

Contact: Technical Director:

Jonathan McGrath

General Manager:

Jason Keating

Irish PharmaChem | Industry Buyers Guide 2021

COMPANY LISTINGS

Daikin Europe Address:

CRS Pharma Solutions

Address:

Tel: LoCall: Email: Web: Business:

Contact:

Dublin, Belfast, London, Manchester. +353 46 943 5000 1890 929 824 info@crspharmasolutions.ie www.crspharmasolutions.ie GxP compliant pharmaceutical portable temperature controlled storage solutions, chamber temperatures range from -65°C to +60°C. Close control temperature and humidity stores, stability chambers, incubators, Atex cold stores, dual redundant cooling systems with integral back-up generators, blast freezers, freezers for fast freezing of phase change materials (Eutectic plates and gel packs).

Technical Director: Patrick Tyrrell

Unit 1, Orchard Business Centre, Orchard Avenue, Citywest, Dublin 24.

Tel: (01) 642 3430 Email: chillers@daikin.ie Web: www.daikin.ie Business: HVAC manufacturer

Address:

Unit JB Beech Avenue, Newhall, Naas, Co. Kildare

Tel: 045 448810 Fax: 045 448811 Email: aidanmccauley@ dawsongroup.ie Web: www.dawsongroup.ie Business: Temperature Controlled Solutions Contact: Managing Director:

Aidan McCauley

E

ENDRESS+HAUSER (IRELAND) LTD.

Dachser Ireland Ltd

Irish PharmaChem | Industry Buyers Guide 2021

Address: Clogherane, Dungarvan,

Co. Waterford, X35 T628 Ireland.

Tel: +353 (0) 58 48300 Email: EurofinsBPT-IE@eurofins.ie Web: www.eurofins.ie/biopharma-services

Dawson Rentals Ireland Ltd

D

Address: Blackchurch Business Park,

Rathcoole, Co. Dublin, D24 C796.

Tel: +353 1 401 3333 Email: dachser.ireland@dachser.com Web: www.dachser.ie Business: With our comprehensive

European road transport network

of system and charter service,

as well as a homogeneous structure

of branches, subsidiaries and partner

companies, we will support you in

fulfilling your logistics requirements

reliably, cost-effectively and on time.

We transport your groupage, your

full or partial loads and manage your

procurement and distribution, both

Europe-wide and national, to the

highest level.

Eurofins BioPharma Product Testing

Address:

Tel: Email: Web: Business:

Contact:

Exchequer House, Embassy Office Park, Kill, Co. Kildare.

(045) 989 200 info.ie.sc@endress.com www.ie.endress.com Leading supplier of products, services and solutions for industrial process measurement and automation industry.

Sales Manager: Brian O’Connell

EURAXESS IRELAND Address: C/O Irish Universities Association,

48 Merrion Square, Dublin 2.

Tel: (01) 676 4948 Fax: (01) 662 2815 Email: jennifer.cleary@iua.ie Web: www.euraxess.ie Contact: Euraxess Ireland Manager:

Jennifer Cleary

eurolec instrumentation ltd

Address:

Tel: Fax: Email: Web: Business:

Technology House, Cluan Enda, Dundalk, Co. Louth.

(042) 933 3423 (042) 933 1758 info@eurolec-Instruments.com www.eurolec-instruments.com Electronic instrumentation.

F

festo ltd Address:

Tel: Fax: Email: Web:

Business:

Unit 5, Sandyford Park, Sandyford Industrial Estate, Dublin 18.

(01) 295 4955 (01) 295 5680 sales_ie@festo.com/ie www.festo.com/ie Automation company specialising in factory and process automation.

IrIsh P

FISHER SCIENTIFIC f isher scientific IRELAND LTD Address: Suite 4, Plaza 212, Address:

Suite 6, Plaza 212,

Blanchardstown, Blanchardstown

Corporate Park 2, Corporate Park, Ballycoolin, Dublin 15, D15 VY66.

Ballycoolin, (01) 885 5854 Tel: Dublin 15.

Fax: (01) 899 1855 Tel:

(01) 885 5854 Email: fsie.sales@thermofisher.com Fax:

(01) 899 1855 Web: www.ie.fishersci.com Business:

Laboratory supplies, Email: fsie.sales@thermofisher.com

Chemicals, Consumables, Web: www.ie.fishersci.com

Reagents, Equipment & Business: Laboratory

Instruments.

Portfolio Manager: Contact: supplies.

Fitzmauric Contact: GerryMarketing

Manager:

Gerry Fitzmaurice

111

fLexAcheM MAnufActurinG Ltd Address:

Donnybrook

GoLiAt systeM

Address

Tel: Fax: Email: Web: Business

Contact:

GouLd

Address

Tel:

COMPANY LISTINGS

|

flexachem manufacturing ltd

Address:

Tel: Email: Web:

Business:

Contact:

Donnybrook, Commercial Centre, Douglas, Cork T12 X68Y (021) 461 7200 sales@flexachem.com www.flexachem.com Supply of process + mechanical engineering equipment including Pumps, Valves, Process Equipment & Mechanical Seals CommercialManager: Michael Bradley

G

GS1 Ireland GS1 Ireland

Address: Second Floor, The Merrion HETEROCHEM DIST LTD address: Second Floor,

Centre, Nutley Lane, Address: Unit 49, The Merrion Centre, Robertson House,

Donnybrook, Dublin 4.

Baldoyle Industrial Est., Tel: (01) 208 0660 Nutley Lane, 4.

Dublin 13.

Fax: (01) 208 0670 Donnybrook, Dublin Tel: (01) 839 3127 Tel:healthcare@gs1ie.org (01) 208 0660 Email: Email:

info@heterochem.com Fax:www.gs1ie.org/healthcare (01) 208 0670 Web: Web:

www.heterochem.com Business: email: Global Supply Chain

info@gs1ie.org Business: Chemical Distributors

Standards Body.www.gs1ie.org Web:

& Raw Material Specialists.

Contact: Business: Director of Innovation Chain Contact: Globaland Supply Managing Director: Healthcare:

Kim Doran Standards Body.

Siobhain Duggan

kim@heterochem.com Contact: Chairman:

John O’Callaghan Chief Executive Officer: Mike Byrne Helpdesk Manager: Karen Murphy

H

Goliath Packaging Systems Ltd Address: Well Road, Nenagh,

Co. Tipperary, E45YR60 Tel: (067) 37893 Email: info@goliath.ie sales@goliath.ie Web: www.goliath.ie Business: Supply & installation of

End of Line Automation Systems,

Materials Handling Equipment

& Industrial Washing Machinery.

Holfeld Graphics

hazchem training ltd Address:

Tel: Fax: Email: Web:

Business:

Contact:

G10, Maynooth Business Campus, Maynooth, Co. Kildare.

(01) 629 1800 (01) 629 1822 info@hazchem.ie www.hazchem.ie Training and Consultancy Services Manager: Michelle Cleere

Address:

Unit 3, Jamestown Industrial Estate, Kylemore Way, Dublin, D08 PF1C.

Tel: Email: Web: Business:

Contact:

(01) 285 5233 rory@holfeldgraphics.com www.holfeldgraphics.com Manufacturer of Flexo plates for Hapa Blister printers, Agents for Axicon, ISO Barcode Verifiers (GS1 128, GS1 Datamatrix, etc.,) Managing Director: Rory Connaughton

Goodbody Stockbrokers Address: Ballsbridge Park,

Ballsbridge, Dublin 4.

Tel: (01) 667 0400 Fax: (01) 667 0230 Email: goodbody@goodbody.ie Web: www.goodbody.ie Business: Capital Markets,

Investment Management,

Wealth Management.

Graham Hart (Process Technology) Ltd Address: Friars Industrial Estate,

Bradford Road, Idle, Bradford,

BD10 8SW, UK. Tel: (0044) 1274 617021 Fax: (0044) 1274 618614 Email: sales@graham-hart.com Web: www.graham-hart.com Business: Chemical Engineers

Design and

Manufacturers of Heat

Exchangers and Process Plant.

112

Hovione Ltd HENLEY FORKLIFT GROUP LIMITED Address: Henley Industrial Park,

Killeen Road, Dublin 10.

Tel: (01) 620 9200 Fax: (01) 626 5406 Email: pharma@henley.ie Web: www.henley.ie/pharma Business: Forklift and warehousing equipment, sales, service,

hire, parts, driver training,

thorough examinations.

Contact: Director:

Brian O’Connell boconnell@henley.ie

Address:

Tel: Fax: Email: Web:

Contact:

Loughbeg, Ringaskiddy, Co. Cork, Ireland. +353 21 451 2856 +353 21 437 8697 hello@hovione.com www.hovione.com General Manager: Dr. Paul Downing

Irish PharmaChem | Industry Buyers Guide 2021

COMPANY LISTINGS L

I

ICDS Recruitment Consultants Address: Connacht House,

24 Upper Fitzwilliam Street,

Dublin 2.

Tel: +353 1 632 1200 Email: info@icds.ie Web: www.icds.ie Business: Specialist Recruitment

Consultants to the

Pharmaceutical, Life Science,

Chemical, Medical Device, Food and Technology sectors.

ComPany LIstIngs

iIDA rishIRELAND Lift trucks Address: Three Park Place, Address: Clonlara Avenue,

Hatch Street Upper, Baldonnell Business

Dublin 2.

Park, Baldonnell, Tel: (01) 603 4000 Email: idaireland@ida.ie Dublin 22.

Tel: (01) 403 4100 Web: www.idaireland.com Fax: (01) 403 4183 Business: Investment Promotion & Email: info@irishlifttrucks.ie Agency.

Development

Web: Business:

Contact:

www.irishlifttrucks.ie Materials Handling Equipment / Hyster Forklifts / Lancer Sideloaders General Manager: Conal McCourt

iidex rish pump nAtionAL AccreditAtion technologies boArd, the (ireland) ltd Address: Wilton Park House, Address: Bay 145, Shannon Industrial

Wilton Place, Estate, Shannon,

Dublin 2.

Co. Clare, V14 XE40.

Tel: (01) 607 3003 Tel: (061) 471933 Email: vsicsipti@idexcorp.com Fax: (01) 607 3109 Web: www.blagdonpump.com Email: inab@inab.ie www.vikingpump.com Web: www.inab.ie Contact: Customer Services: Business: Provides

Ann O’Gorman

accreditation

of laboratories,

certification &

inspection bodies.

Contact: Information Officer:

Orla Doyle

INDAVER IRELAND

Address: The Highline, 1st Floor,

Bakers Point, Pottery Road,

Dun Laoghaire, Co. Dublin, J AvA cLinicAL A96 KW29. reseArch Ltd Tel: (01) 697Fitzwilliam Buiness 2900 Address: Fax: (01) 633 5464 Centre, 26 Upper Email: info@indaver.ie Web: www.indaver.ie Pembroke St, Hazardous & nonhazardous waste Business: Dublin 2.

disposal and recovery Tel:

ensuring01 637 3903 full compliance.

J

Fax: 01 637 3907 Email: info@javacr.com Irish PharmaChem | Industry Buyers Guide 2021 Web: www.javacr.com Business: Clinical Research Contact: Managing Director:

Ruth Nallen

LABPLAN

interpac Address: 67E Heather Road, Sandyford

Industrial Estate,

Sandyford, Dublin 18.

Tel: (01) 294 0600 Fax: (01) 294 0602 Email: ian@interpac.ie Web:

www.interpac.ie Business: Supplier of packaging to the pharmaceutical, hazardous waste, food and dairy industries.

Contact: Director: Ian Sutton

IrIsh PharmaChem 2012 invest northern ireland Address: Bedford Square, Bedford

Street, Belfast, BT2 7ES. Tel: (048) 9069 8601 Fax: (048) 9043 6536 Email: patricia.oneill@investni.com Web:

www.investni.com J ohnston L oGistics Ltd Business:

Economic development Address: Blackchurch Business agency.

Park, Rathcoole, K Co. Dublin.

Tel: + 353 1 401 3333 Fax: + 353 1 458 8015 Email: info@jol.ie

niallh@jol.ie Web: www.johnstonlogistics.ie Business: Logistics & distribution Kuehne + Nagel IRELAND Address: Unit(Complete Supply D2 Horizon Logistics Park, Harristown, Swords, Co. Dublin,

Chain Management).

K67Business Development Y954.

Contact: Tel: (01) 823 9777 Manager: Email: Seamus.keane@kuehne-nagel.com Web: Niall Hickey www.kuehne-nagel.ie Business: Contact:

K

Logistics & Supply Chain.

Pharma Manager: Seamus Keane Mob: +353 85 8666646

KWE (Ireland) Ltd GDP Wholesale Licence) Holder kwe (ireLAnd Ltd

Dublin Head Office & Temperature Controlled Address: Dublin: Unit 4 Warehouse Facility Horizon Logistics Address: Horizon Logistics Park, Park, New Naul Rd,

Harristown, Swords, Co. Dublin.

(01) 823 9600 Tel: Harristown,

Fax: (01) 836 1111 Swords, Co. Dublin.

Email: kwedub@kwe.com dubsls@kwe.com Cork: Unit 4&5, Web: www.kwe.com South Ring & Warehouse Facility Cork Regional OfficeWest Business Pk, South Ring West Business Park, Address: Tramore Road,

Tramore Road, Cork.

Co. Cork.

Tel: (021) 497 5722 Tel: (01) 823 9600 Fax: (021) 497 5727 Email: (021) 497 5722 kweork@kwe.com Fax: (01) 836 1111

(021) 497 5727 Email: kwedub@ea.kwe.com

kweork@ea.kwe.com Web: www.kwe.com Contact: Sales Manager:

Karl O’Reilly

Address:

Tel: Fax: Email: Web: Business:

Allenwood Enterprise Park, Allenwood, Naas, Co Kildare.

(045) 870 560 (045) 870 811 info@labplan.ie www.labplan.ie Lab supplier of analytical instrumentation, services, technical support.

lennox laboratory supplies ltd

Address:

Tel: Email: Web: Web:

Contact: Business:

Contact:

John F. Kennedy Drive, Naas Road, Dublin D12FP79 (01) 460 7600 padraig.callan@lennox.ie www.labplan.ie www.lennox.ie Padraig Callan, Laboratory supplier Head of Business Development

to pharmaceutical businesses.

Managing Director: Aidan Smyth

LAnGAnbAch services Ltd Address: Unit 4, Cedar Estate, LEO Pharma

Cashel Road, Kimmage, Address: Killarney Road, Dublin 12.

Tel: Bray, Co. Wicklow.

(01) 490 8924 Tel: (01) 276 2510 Email: hr.dublin@leo-pharma.com Web:

www.leo-pharma.com Fax: (01) 276 2472 Business: Pharmaceutical Manufacturing.

Email: sales@langanbach.ie Contact: Angel George, HR Executive ALGIE@leo-pharma.com Web: www.langanbach.ie Business: Supply of laboratory

equipment and

diagnostic tests.

Infection control

products for human and animal health.

Contact: Sales and Marketing LIMERICK PACKAGING Director: Jim Woods

Address: Eastlink Business Park,

Ballysimon Rd., Limerick.

Tel: (061) 400 035 Email: info@lmkpkg.ie Web: www.limerickpackaging.ie Business: Packaging manufacturers, L LAborAtories AncAster Distributors, Designers

and Auditors.

Address: IDA Business Park, Sales Director: Contact: Clogherane,

Mike Boland

Dungarvan,

Co. Waterford.

Tel: (058) 48 300 LISTER MACHINE Fax: TOOLS LTD (058) 42 855 Email: info@lancasterlabs.com Address: PO Box 838,

Bluebell Industrial Estate, Web: www.lancasterlabspharm.com

Dublin 12.

Business: Contract Analytical Tel:

(01) 450 8866 Fax:

(01) 450 9836 Services Email: sales@listermachinetools.com Contact: Business Development Web:

www.listermachinetools.com Sales and service of Machine Business: Director: Tools and related accessories,

Mark Glass consumables and metrology equipment.

Lennox LAborAtory suppLies Ltd Address:

Tel:

John F. Kennedy Drive, Naas Road, Dublin 12.

(01) 455 2201

113

COMPANY LISTINGS

LotusWorks

Address:

Tel:

Email: Web:

Business:

Contact:

Building 3, Finisklin Business Park, Sligo, F91 KAP2.

(071) 916 9783 contactus@lotusworks.com www.lotusworks.com Engineering & Technical Solutions Provider.

Director: Emer Conroy

M

maclachlan & donaldson Address: 47 Merrion Square,

Dublin 2.

Tel: (01) 676 3465 Fax: (01) 661 2083 Email: mail@maclachlan.ie Web:

www.maclachlan.ie Business: Intellectual Property Attorneys.

Contact: Dr. Yvonne McKeown

MSD Ireland Address:

Red Oak North, South County Business Park, Leopardstown, Dublin 18.

Tel: +353 (0)1 299 8700 Email: info@msd.ie Web: www.msd.ie Business: MSD Ireland is one of the

country’s leading healthcare

companies, having first established

here over 50 years ago.

We currently employ

approximately 2,700 employees,

across six sites in Ballydine, Co

Tipperary, Brinny, Co Cork, Carlow,

Dunboyne and Dublin and, in addition, operate substantial

Human Health and Animal Health

businesses. Our Irish sites manufacture approximately half of

MSD’s top twenty products, saving

and enhancing lives in over sixty

countries around the world.

Contact: Mairead McCaul

MSD Ireland (Human Health) LTD

Nelipak Healthcare Packaging Address: Unit 6D, Mervue Business Park,

Mervue, Galway.

Tel: (091) 757 152 Email: info@nelipak.com Web: www.nelipak.com Business: Innovative packaging solutions

and complementary products

and services for the healthcare

market serving the medical and

pharmaceutical sectors.

Contact: Director of Global Marketing:

Sean Egan

npp group ltd Address: Unit 509, Mitchelstown Road,

Northwest Business Park,

Ballycoolin, Blanchardstown,

Dublin 15.

Tel: (01) 880 9299 Email: sales@npp.ie bmcmahon@npp.ie Web:

www.npp.ie Business: Flexible packaging

suppliers & distributors.

O

OBEECO LTD N

Annaville Avenue, Blackrock, Co. Dublin.

Tel: Fax: Email: Web:

Micro-Bio Ireland Ltd

Address: Industrial Estate, Fermoy,

Co. Cork Tel: (025) 31388 Fax: (025) 32458 Email: info@micro-bio.ie Web: www.micro-bio.ie Business: Chemical Manufacturer.

Contact: Director Customer Relations:

Tom Tobin

Address:

OCON CHEMICALS LTD NATIONAL CHEMICAL COMPANY Address: NCC House,

42 Lower Leeson St., Dublin 2,

D02 FX39.

Tel: (01) 613 1400 Fax: (01) 634 0132 Email: sales@ncc.ie Web: www.ncc.ie Business: Supply Chain Partner Life Sciences Industry.

Contact: Product Manager:

Christy Smith

Address: Unit 5, South Cork

Industrial Estate,

Vicars Road, Pouladuff,

Co. Cork.

Tel: (021) 431 8555 Fax: (021) 431 8560 Email: info@oconchemicals.com Web: www.oconchemicals.ie

o’flynn medical ltd Address:

Tel: Fax: Email:

Web:

Business:

Contact:

114

(01) 278 2323 (01) 278 2374 sales@obeeco.ie www.obeeco.ie

The Old Creamery, Tanyard, Millstreet Town, Co. Cork, Ireland.

(029) 21 799 (029) 70 191 info@oflynnmedical.com www.oflynnmedical.com Distributor of Scrubex “Automated Protective Clothing Distributor”.

CEO: Tadhg O’Flynn

Irish PharmaChem | Industry Buyers Guide 2021

COMPANY LISTINGS

P

Q

Portakabin Ireland Address:

particular sciences ltd Address: 2 Birch House,

Rosemount Business Park,

Ballycoolin Road, Finglas,

Dublin D11 T327.

Tel: (01) 820 5395 Fax: (01) 822 8813 Email: sean@particular.ie Web:

www.particular.ie Business: Supply and Service Laboratory Equipment.

Contact: Managing Director:

Sean Quilty

Pharmalex Address:

Suite 2, Stafford House, Strand Road, Portmarnock, Co. Dublin, D13 H525.

Tel: +353 1 846 4742 Email: Victor.cowper@pharmalex.com Web: www.pharmalex.com/ireland Business: An award winning EU and US

Quality, Technical & Compliance

consultancy to the life science industry.

Contact: Client Services Manager:

Victor Cowper

Roseville Business Park, Turvey Avenue, Donabate, Co. Dublin.

Tel: Email: Web: Business:

Contact:

(01) 808 5055 karen.brennan@portabin.com www.portakabin.ie Portakabin is the pioneer of modular construction in Europe, delivering interim and permanent bespoke buildings, of any size and to fulfil almost any application, site and design.

Portakabin has provided award-winning off-site built environments of outstanding quality, with unrivalled on time and on budget performance, for over 50 years.

Marketing Executive: Karen Brennan

PPD, Inc. Address: Building C, Athlone

Business & Technology

Park, Garrycastle, Athlone,

Co. Westmeath.

Tel: (0906) 460 300 Fax: (0906) 460 301 Email: susan.neenan@ppdi.com Web: www.ppdi.com Business: Contract Research Organisation.

pilz ireland

Address:

Tel: Fax: Email: Web:

Business:

Cork Business & Technology Park, Model Farm Road, Co. Cork.

(021) 434 6535 (021) 480 4994 sales@pilz.ie www.pilz.ie Process and machinery safety engineering services and training.

Irish PharmaChem | Industry Buyers Guide 2021

ProSys Containment And Sampling Technology Address: IDA Business Park, Carrigtohill,

Co. Cork, Ireland, T45AP82.

Tel: +353 21 4853900 Fax: +353 21 4853866 Email: Michael.Hennessy@prosysgroup.com Web: www.prosysgroup.com Contact: Head of Global Sales:

Michael Hennessy

Q1 SCIENTIFIC

Address:

Tel: Email: Web: Business: Contact:

87 Westside Business Park, Co. Waterford.

(051) 355977 info@q1scientific.com www.q1scientific.com Stability Storage (ICH/GMP) Louise Grubb, CEO

Quitmann O’Neill Packaging Ltd Address:

Tel: Fax: Email: Web: Business: Contact:

St. Brendan’s Road, Portumna, Co. Galway, H53 HX51.

(090) 9741148 (090) 9741459 sales@quitmannoneill.com www.qonpack.com Packaging Disributor and Stockist.

Managing Director: David O’Neill

R

Reading Scientific Services Limited

Address:

The Reading Science Centre, Whiteknights Campus, Pepper Lane, Reading,

Berkshire, RG6 6LA, UK Tel: +44 (0) 118 918 4076 Email: enquiries@rssl.com Web: www.rssl.com Business: Analytical Testing Laboratory Contact: Commercial Lead Biopharma &

Personalised Medicine:

Gaynor Johnston

S

Science foundation ireland (SFI) Address: Wilton Park House,

Wilton Place, Dublin 2.

Tel: (01) 607 3200 Fax: (01) 607 3201 Email: info@sfi.ie Web: www.sfi.ie Business: Government funding

agency for research.

Contact: Director - Strategy and

Communications: Dr. Ruth Freeman

115

COMPANY LISTINGS

SOLV-ECHEM IRELAND LTD

Scientific Instruments Ireland

Address: Oulart House, Cullagheerva,

Clonsilla, Dublin 15.

Tel: 087 9813310 Email: info@siireland.ie Web: www.siireland.ie Business: Distribution and Service

Support of Sample Preparation

and Analytical Equipment.

Contact: Sales Director:

Aaron Ryder

Address:

Tel: Email: Web: Business:

Contact:

Great Island Industrial Park, Ballincollig, Co. Cork.

(021) 487 7066 tony@solvechem.com www.solvechem.com Chemical distribution, chemicals, solvents, water treatment, warehousing.

Director: Tony Murray

Source BioScience

Address:

Riverstown 5 Complex, Tramore, Republic of Ireland

Tel: Email: Web:

+353 (0) 51 338435 salesireland@sourcebioscience.com www.sourcebioscience.com

SK pharmteco Address: Watery Lane, Swords, Co. Dublin.

Tel: (01) 813 9000 Email: skpharmteco@sk.com Web: www.skpharmteco.com Business: Contract Development

Manufacturing Organisation.

Contact: Brian Fairley, Director Business

Development & Marketing

SMURFIT KAPPA IRELAND Address: Ballymount Road, Walkinstown,

Dublin 12.

Tel: (01) 409 0000 Fax: (01) 456 4506 Email: info@smurfitkappa.ie Web: www.smurfitkappa.ie www.skpackaging.ie Business: Packaging.

SOLTEC (IRELAND) LTD

Address: Zone A, Mullingar Business Park,

Mullingar, Co. Westmeath.

Tel: (044) 933 5133 Fax: (044) 934 5248 Email: info@soltec.ie Web: www.soltec.ie Business: Waste management.

Contact: Managing Director:

Michael Corcoran

116

SSPC, SFI RESEARCH CENTRE FOR PHARMACEUTICALS Address: Bernal Institute,

University of Limerick, Limerick, Ireland.

Web: www.sspc.ie Business: Pharma Research Centre.

Contact: Executive Director,

Dr. Margaret Lawlor

SUSTAINABLE ENERGY AUTHORITY OF IRELAND Address: Glasnevin,

Dublin 9.

Tel: (01) 836 9080 Email: info@sei.ie Web: www.sei.ie Business: Energy advice & information.

T

Tandem Project Management Ltd. Address:

11 Nessan House, Mahon Industrial Estate, Blackrock, Cork. T12 XN4V

Tel: (021) 2038130 Email: info@tandempm.ie Web: www.tandempm.ie Business: Tandem is an innovative project

management and engineering

consultancy delivering

expertise to clients in life sciences

in Ireland, the UK and Europe.

Tandem’s best in class services

include project management

and controls, multi-disciplined

engineering design, construction management and commissioning,

qualification and validation.

Tandem also provide client

representative teams, operational

readiness consultancy and talent solutions.

Contact: Customer Relations Manager:

Linda Nugent 0876897995 linda.nugent@tandempm.ie

teva pharmaceuticals ireland Address: Unit 301,

IDA Industrial Park, Waterford.

Tel: (051) 331 331 Web: www.teva.ie Business: Respiratory

Pharmaceutical R&D

and Manufacture.

Contact: Managing Director:

Andy Crowley

Toyota Material Handling Ireland Ltd Address: Killeen Road,

Dublin 12.

Tel: (01) 419 0200 Web: www.toyota-forklifts.ie Business: Forklift and Warehouse Supplies.

Contact: Noel Foley

Irish PharmaChem | Industry Buyers Guide 2021

COMPANY LISTINGS

V

TWi Address: West Building,

Carrigaline Industrial Park,

Carrigaline, Cork, Ireland.

Tel: +353 (0)21 242 8800 Email: info@technicallywriteit.com Web: www.technicallywriteit.com Business: Technical writing, information

design, and documentation

solutions service provider.

Contact: Emmet Kearney, Business

Development Manager

Veolia Address: Suite 18, Plaza 256,

Tel: Fax: Email: Web: Business:

Contact:

Blanchardstown Corporate Park 2, Blanchardstown, Dublin 15, D15 TR96

+353 (0)1 870 1200 +353 (0)1 870 1201 ie.info@veolia.com www.veolia.ie Energy, Water and Waste Management Solutions.

Business Development Director: Sean Molloy

W

U

Univar Address:

Tel: Email: Business: Contact:

Westbourne IT Global SERVICES

536 Grants Crescent, Greenogue Business Park, Rathcoole, Co. Dublin.

(01) 401 9800 irelandsalesoffice@univarsolutions.com Chemical Distribution Key Account Manager: Carla Byrne

Weber Packaging Solutions Ltd

Address: Kilcannon Industrial

Estate, Old Dublin Road,

Enniscorthy, Co. Wexford.

Tel: (053) 923 3778 Fax: (053) 923 3284 Email: sales@weberireland.com Web: www.webermarking.ie

Address:

Tel: Email: Business: Contact:

Blackpool Retail Park, Blackpool, Co. Cork.

(021) 431 4310 james.symington@westbourneit.com IT Service Provider.

James Symington, Business Development

wRENTECH LTD Address: Eversley,

Church Bay Road, Crosshaven,

Co. Cork.

Tel: (021) 483 2644 Fax: (021) 483 1363 Email: smurray@wrentech.ie Web: www.wrentech.ie

NOTES

Irish PharmaChem | Industry Buyers Guide 2021

117

2021 YEAR PL I r i s h P harm aCh em MON TUES WED

THU

FRI

1

SAT

2

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THU

3

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SUN MON TUES WED

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SAT

4

5

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7

8

9

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11

12

13

14

15

16

1

2

3

4

5

6

7

8

9

10

11

12

13

SU

17

New Year’s Day

January

Public Holiday

14

Saint Valent Day

February 1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

Mother’s Day

March

17

18

19

20

21

Saint Patrick’s Day Public Holiday

1

2

3

4 Easter Sunday

April

5

6

7

8

9

10

11

12

13

14

15

16

17

18

4

5

6

7

8

9

10

11

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13

14

15

16

8

9

10

11

12

13

14

15

16

17

18

19

Easter Monday Public Holiday

1

2

3 Public Holiday

May 1

2

3

4

5

6

7 Public Holiday

June 1

2

3

4

20

Father Day

5

6

7

8

9

10

11

12

13

14

15

16

17

18

2

3

4

5

6

7

8

9

10

11

12

13

14

15

July 1

Public Holiday

August 1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

1

2

3

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1

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14

6

7

8

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18

19

September October November 1

2

3

4

5

December MON TUES WED

118

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FRI

SAT

SUN MON TUES WED

THU

FRI

SAT

SUN MON TUES WED

THU

Irish PharmaChem | Industry Buyers Guide 2021

FRI

SAT

SU

R PLANNER Y e ar P la n n e r 2 0 2 1

HU

4

1

8

5

3

7

5

2

6

4

1

6

HU

FRI

15

SAT

16

SUN

17

MON TUES WED

18

19

20

THU

21

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22

SAT

23

SUN

24

MON TUES WED

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26

27

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28

FRI

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MON TUES

31

January 12

13

14

15

16

17

18

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21

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23

24

25

26

27

28

Saint Valentine’s Day

19

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February 22

23

24

25

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29

30

31

Summer Time Begins

16

17

18

19

20

21

22

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24

25

March 26

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30

April 14

15

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18

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May 18

19

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Father’s

June

Day

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July 13

14

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August 17

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29

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12

13

14

15

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18

19

20

21

22

31 Summer Time Ends

Public Holiday

23

24

25

26

27

28

October 29

30

November 17

18

19

20

21

22

23

24

25 Christmas Day Public Holiday

FRI

SAT

SUN

MON TUES WED

THU

FRI

Irish PharmaChem | Industry Buyers Guide 2021

SAT

26

27

28

29

30

31

Saint Stephen’s Day

December

Public Holiday

SUN

MON TUES WED

THU

FRI

SAT

SUN

MON TUES

119

USEFUL REFERENCES

ACADEMY OF CLINICAL

ELECTRICITY SUPPLY

INSTITUTE OF CHEMISTRY

IRISH PHARMACY UNION

SCIENCE AND LABORATORY

BOARD

OF IRELAND

Tel: (01) 493 6401

MEDICINE

Tel: 1850 372 757

E-mail: info@instituteofchemistry.org

E-mail: info@ipu.ie

Tel: (01) 905 9730

E-mail: esbnetworks@esb.ie

Web: chemistryireland.org

Web: www.ipu.ie

E-mail: mail@acslm.ie

Web: www.esb.ie Intellectual Property Office

IRISH VENTURE CAPITAL

ENTERPRISE IRELAND

of Ireland

ASSOCIATION

Advisory Science Council

Tel: (01) 727 2000

Tel: (056) 772 0111

Tel: (01) 276 4647

Tel: (01) 631 2858

E-mail: client.service@enterprise-ireland.com

E-mail: ipinfo@ipoi.gov.ie

E-mail: secretary@ivca.ie

E-mail: firstname.surname@djei.ie

Web: www.enterprise-ireland.com

Web: www.patentsoffice.ie

Web: www.ivca.ie

Web: www.acslm.ie

Web: www.sciencecouncil.ie ENVIRONMENTAL HEALTH

INTERNATIONAL SOCIETY

MANDATE TRADE UNION

AN BORD PLEANALA

ASSOCIATION OF IRELAND

FOR PHARMACEUTICAL

Tel: (01) 874 6321

Tel: (01) 858 8100

Tel: (01) 276 1211

ENGINERING (ISPE)

E-mail: mandate@mandate.ie

LoCall: 1890 275 175

E-mail: info@ehoa.ie

Tel: +1 (813) 960 2105

Web: www.mandate.ie

E-mail: bord@pleanala.ie

Web: www.ehai.ie

E-mail: ask@ispe.org NATIONAL INSTITUTE

Web: www.ispe.org

Web: www.pleanala.ie ENVIRONMENTAL

FOR TRANSPORT

BIOPHARMACHEM IRELAND

PROTECTION AGENCY

INVEST NORTHERN IRELAND

& LOGISTICS (NITL)

Tel: (01) 605 1500

Tel: (053) 916 0600

Tel: 0044 800 181 4422

Tel: (01) 402 3898

E-mail: info@ibec.ie

LoCall: 1890 335 599

E-mail: dublin@investni.com

E-mail: pamela.obrien@dit.ie

Web: www.biopharmachemireland.ie

E-mail: info@epa.ie

Web: www.investni.com

Web: www.nitl.ie

Web: www.epa.ie IRISH BUSINESS & EMPLOYERS

PARENTERAL DRUG

Tel: (01) 400 4300

HEALTH AND SAFETY

CONFEDERATION (IBEC)

ASSOCIATION (PDA)

E-mail: info@chambers.ie

AUTHORITY

Tel: (01) 605 1500

Tel: +1 (301) 656 5900

Web: www.chambers.ie

Tel: 01 614 7000

E-mail: info@ibec.ie

E-mail: info@pda.org

LoCall: 1890 289 389

Web: www.ibec.ie

Web: www.pda.org

IRISH CLEANROOM SOCIETY

PHARMACEUTICAL

CHAMBERS IRELAND

COMPANIES

E-mail: wcu@hsa.ie

REGISTRATION OFFICE

Web: www.hsa.ie

Tel: 087 958 8045

SOCIETY OF IRELAND

LoCall: 1890 220 226

HEALTH PRODUCTS

E-mail: info@cleanrooms-ireland.ie

Tel: (01) 218 4000

E-mail: cro.info@enterprise.gov.ie

REGULATORY AUTHORITY

Web: www.cleanrooms-ireland.ie

E-mail: info@psi.ie

Web: www.cro.ie

Tel: (01) 676 4971

Tel: (01) 804 5200

Department of the Environment,

Web: www.thepsi.ie

E-mail: info@hpra.ie

IRISH COSMETICS, DETERGENT &

Web: www.hpra.ie

ALLIED PRODUCTS ASSOCIATION

REPAK

Tel: (01) 605 1787

Tel: (01) 467 0190

Climate Action and Communications

HEALTH RESEARCH

E-mail: kevin.maher@ibec.ie

E-mail: info@repak.ie

Tel: 01 678 2000

BOARD

Web: www.icda.ie

Web: www.repak.ie

E-mail: customer.service@decc.gov.ie

Tel: (01) 234 5000

Web: gov.ie/decc

E-mail: hrb@hrb.ie

IRISH EXPORTERS ASSOCIATION

SCIENCE FOUNDATION

Web: www.hrb.ie

Tel: (01) 661 2182

IRELAND

E-mail: contact@irishexporters.ie

Tel: (01) 607 3200

Web: www.irishexporters.ie

E-mail: info@sfi.ie

Department of Enterprise, Trade and Employment

HIGHER EDUCATION

Tel: (01) 631 2121

AUTHORITY

LoCall: 1890 220 222

Tel: (01) 231 7100

IRISH MEDTECH ASSOCIATION

E-mail: info@enterprise.gov.ie

E-mail: info@hea.ie

Tel: (01) 605 1500

UCD SCHOOL OF CHEMICAL

Web: enterprise.gov.ie

Web: www.hea.ie

E-mail: info@irishmedtechassoc.ie

& BIOPROCESS ENGINEERING

Web: www.irishmedtechassoc.ie

Tel: (01) 716 1825

Department of Housing, Local

IDA - INDUSTRIAL

Web: www.sfi.ie

E-mail: chemical.eng@ucd.ie

Government and Heritage

DEVELOPMENT AGENCY

IRISH NATIONAL

Tel: (01) 888 2000

Tel: (01) 603 4000

ACCREDITATION BOARD

LoCall: 1890 20 20 21

E-mail: idaireland@ida.ie

Tel: 1890 289 389

E-mail: qcsofficer@housing.gov.ie

Web: www.idaireland.com

E-mail: info@inab.ie

Web: www.housing.gov.ie

120

Web: www.ucd.ie/chembioeng

Web: www.inab.ie

Irish PharmaChem | Industry Buyers Guide 2021

THE NATIONAL THE NATIONAL THE THENATIONAL NATIONAL AMBULANCE SERVICE AMBULANCE AMBULANCE SERVICE AMBULANCESERVICE SERVICE NAS NAShas hasembarked embarkedon on aa strategic strategicinvestment investment programme programmeto todevelop develop aa modern, quality modern, quality service servicethat thatisissafe, safe,responsive responsive and fit for purpose.

The and fit for purpose. The service service isisimplementing implementingaasignificant significant reform reformagenda agendawhich which mirrors mirrors many of the strategic changes many of the strategic changes underway underwayininambulance ambulance services internationally services internationally as as they they strive for high performance strive for high performance and andefficiency efficiencywhilst whilst coping coping TheThe National Ambulance Service (NAS) is isthe emergency and National Ambulance Service (NAS) thestatutory statutorypre-hospital pre-hospital emergency and with a continuously increasing with a continuously increasing intermediate care provider forfor the state.

InInthe ambulance services intermediate care provider the state. theDublin Dublinarea, area, ambulance servicesare areprovided provided demand on demand onservices. services.

by NAS and Dublin Fire Brigade (DFB). Aero Medical services are provided by the Irish Air

by NAS and Dublin Fire Brigade (DFB). Aero Medical services are provided by the Irish Air Corps andand thethe Irish Coast Guard byby agreement Corps Irish Coast Guard agreementwith witheach eachorganisation. organisation.At Ataalocal locallevel, level, thethe NAS is also supported byby over 275(Mar NAS is also supported over 275(Mar2020) 2020)Community CommunityFirst FirstResponder Responderschemes, schemes, responding to to particular types ofof medical emergencies (i.e. arrest, respiratory responding particular types medical emergencies (i.e.cardiac cardiac arrest, respiratory arrest, arrest, TheThe National Ambulance Service (NAS) is the statutory pre-hospital emergency and intermediate care National Ambulance Service (NAS) is the statutory pre-hospital emergency and intermediate care chest pain, choking and stroke) where it is essential for the patient to receive immediate lifechest pain, choking and stroke) where it is essential for the patient to receive immediate lifeprovider forfor thethe state.

In In thethe Dublin area, ambulance services are provided by NAS and Dublin Fire provider state.

Dublin area, ambulance services are provided by NAS and Dublin Fire saving care whilst anan emergency response saving care whilst emergency responsevehicle vehicleisisenenroute routetotothe thepatient. patient.

Brigade (DFB).

Aero Medical services areare provided Brigade (DFB).

Aero Medical services providedbybythe theIrish IrishAir AirCorps Corpsand andthe theIrish IrishCoast Coast Guard Guard by by In recent years, the NAS has embarked on a strategic investment programme to develop In recent years, NAS has embarked onisaisalso strategic investmentby programme to develop agreement with each organisation.

AtAt a the local level, the over 2020) agreement with each organisation. a local level, theNAS NAS alsosupported supported by over275(Mar 275(Mar 2020) a modern, quality service that is is safe, responsive fitfitfor The service a modern, quality service that responsiveand and for purpose.

The serviceisis Community First Responder schemes, responding tosafe, types of medical emergencies (i.e.

Community First Responder schemes, responding toparticular particular types ofpurpose. medical emergencies (i.e. implementing a significant reform agenda which mirrors many ofofthe strategic changes implementing a significant reform agenda which mirrors many the strategic changes cardiac arrest, respiratory arrest, chest pain, choking cardiac arrest, respiratory arrest, chest pain, chokingand andstroke) stroke)where whereititisisessential essentialfor for the the patient patient underway in ambulance services internationally underway in ambulance services internationallyasasthey theystrive strivefor forhigh highperformance performanceand and to receive immediate lifesaving care whilst an emergency response vehicle is en route to the patient. to receive immediate lifesaving care whilst an emergency response vehicle is en route to the patient. efficiency whilst coping with a continuously efficiency whilst coping with a continuouslyincreasing increasingdemand demandon onservices. services.

CAREERSIN INTHE THENAS NAS CAREERS

PARAMEDIC PARAMEDIC

ADVANCED ADVANCED PARAMEDIC PARAMEDIC

INTERMEDIATE INTERMEDIATE CARE OPERATIVE CARE OPERATIVE

CONTACT DETAILS: National Ambulance Service, Health Service Executive, CONTACT DETAILS: National Ambulance Service, Health Service Executive, Rivers Building, Tallaght, Dublin D24 XNP2 Rivers Building, Tallaght, Dublin 24,24, D24 XNP2 PHONE: 01 463 1624/26 PHONE: 01 463 1624/26 E-MAIL: director.nas@hse.ie E-MAIL: director.nas@hse.ie

www.nationalambulanceservice.ie www.nationalambulanceservice.ie

EMERGENCYCALL CALL EMERGENCY TAKER TAKER

EMERGENCYMEDICAL MEDICAL EMERGENCY DISPATCHER DISPATCHER

For when it matters the most.

T: +353 18239777 | E: Ireland.sales@kuehne-nagel.com | W: www.kuehne-nagel.ie