Irish PharmaChem 2020

The Industry Buyers Guide 2020

BioPharma in Ireland.

Vital for a healthy economy.

The world’s top ten BioPharma companies have operations in Ireland, investing approximately $10 billion in biotech facilities here.

Right place Right time www.idaireland.com

In Association with BioPharmaChem Ireland 168323 IDA Pharmachem A4 Ad.indd 1

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People living with rare and devastating diseases are our inspiration and our Guiding Star.

OUR MISSION IS TO TRANSFORM THEIR LIVES THROUGH THE DEVELOPMENT AND DELIVERY OF INNOVATIVE MEDICINES.

MADDOX LIVING WITH HPP

College Park, Dublin

Monksland, Athlone

is home to over 400 people and:

is home to over 200 people and:

• Bulk Drug Substance Biologics Manufacturing

• Aseptic Drug Product Biologics Manufacturing

• Commercial & Clinical Secondary Packaging

• Commercial Drug Substance Biologics Purification

• QC Global Centre of Excellence

• Clinical Drug Substance Biologics Manufacturing

• Quality Assurance Release & Certification • External CMO Management • Global Supply Chain, Finance, HR and IT Functions

Be Involved, Be Challenged, Be Empowered, Be You... Be More @ Alexion

CONTENTS 2 Sector Overview

70 Water & Waste Water Treatment

2019 saw BioPharmaChem Ireland (BPCI) celebrating its 25th birthday. Matt Moran, Director, BPCI, reflects on a landmark year for the organisation and looks to the companies and healthcare innovations that will shape the sector’s future.

The Chemifloc group specialises in water, waste water treatment and industrial chemicals and laboratory technical services.

72 Outsourced Engineering & Technical Talent

6 BioPharma Ambition 2020

LotusWorks have been successfully helping leading regulated manufacturers in product delivery and facility maintenance for 30 years.

Nessa Fennelly, Senior Executive, BPCI, previews the third BioPharma Ambition Conference, which takes place in Dublin Castle in March 2020.

74 Logistics

10 BPCI Strategy

Logistics is not about moving product from A to B, but about delivering innovative supply chain designs to support businesses, argues Adam O’Sullivan, Kuehne + Nagel Ireland.

‘Ireland – the Global BioPharmaChem Location of Choice’ is the title of BioPharmaChem Ireland’s new five-year strategy.

20 Regulatory Science Ireland

2019 was a busy year in the field of regulatory science, writes Professor Anne Greene, TU Dublin and Board Member of Regulatory Science Ireland.

24 Data Digitalisation The digital thread can successfully link the lab, manufacturing and supply chain in Ireland’s Biopharma sector, explains Barry Heavey, Accenture in Ireland.

26 Blockchain

Enda Dempsey, BPCI, explains exactly what blockchain technology is and how its application could be a massive advantage for the life sciences sector.

2 SECTOR OVERVIEW 50 SSPC

SSPC continues to deliver industry relevant solutions and advancing talent for the pharma sector and was rewarded with two awards at the recent Pharma Industry Awards 2019.

76 Chemicals

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

78 Excipients, APIs and Intermediates

Univar Solutions is a premier global supply chain solutions partner, with proven experience in the primary and secondary pharmaceutical and nutraceutical industries.

52 Occupational Safety and Health Michael Gillen, Senior Executive Responsible for EHS & Responsible Care, BPCI, examines the future of Occupational Safety and Health (OSH) in the Irish biopharmachemical industry.

56 Cell Engineering Technology

80 IT Services

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

Avectas is at the cutting edge of cell engineering technology, with the potential to revolutionise cell therapy for patients via its Solupore non-viral technology.

82 Material Handling

59 Pharmaceutical Manufacturing

Technology Centre

84 Future Challenges

34 Microbiology

37 Cell and Gene Therapies

62 Waste Management

86 Specialist Integrated CDMO

64 Packaging

87 Brenntag Pharma

67 Active Pharmaceutical Ingredients

88 Packaging

32 IDA Ireland

Tommy Fanning, Global Head of Biopharmaceuticals, IDA Ireland, advises on how Ireland can stay at the forefront of the biopharma industry in the coming years.

RSSL has launched a fast, responsive and flexible sterility testing service.

The next wave of biopharma investments will focus on cell and gene therapies, which represent complex challenges to manufacture economically, explains Killian O’Driscoll, Director of Projects, NIBRT.

42 Traceability

The evolution of the regulatory landscape is driving harmonised identification and traceability standards in healthcare. GS1 is at the forefront of this movement.

44 Regulation

Dr Lorraine Nolan, Chief Executive, HPRA, examines the innovations that will drive the medical/ biopharmachem sector and explains how our healthcare regulator has to remain agile to ensure the system and approach to regulation meets current and future needs.

47 Pharmaceuticals and the

Environment

The Eco-Pharmaco-Stewardship aims to protect both the patients and the planet, writes Sini Eskola, EFPIA.

Christy Smith, Product Manager, NCC Pharma Services, takes a closer look at the potential challenges and opportunities that exist and lie ahead for the pharmaceutical industry.

The PMTC has proved its worth to the industry, as evidenced by its second funding award from Enterprise Ireland.

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

Indaver are helping to use less fossil feedstocks and limiting their environmental impact through safe and sustainable waste management.

Delivering ‘On Time, Everytime’ is the secret behind the continued success of Limerick Packaging.

Brenntag Pharma offers a comprehensive range of products for the formulation of pharmaceuticals and the chemical synthesis of APIs. Goliath Packaging Systems Ltd sources, supplies, installs and after-sales services a comprehensive range of end-of-line packaging, materials handling and industrial washing equipment.

SK pharmteco is a new name with more than 75 years’ experience.

68 Documentation Solutions

TWi is a leading technical writing and information design service provider, offering high-quality, flexible, and scalable documentation solutions.

69 Instrumentation

Bonner are uniquely positioned to offer site wide solutions across traditional pharmaceutical, biopharma and chemical facilities nationwide.

Irish PharmaChem is published by: Tara Publishing Ltd 14 Upper Fitzwilliam Street, Dublin 2.

Tel: 00 353 (0)1 678 5165 Email: kathleenbelton@tarapublications.ie Web: www.irishpharmachem.com

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Managing Director: Patrick Aylward Editorial and Marketing Director: Kathleen Belton Editor: John Walshe Irish PharmaChem | Industry Buyers Guide 2020

Henley has been supplying a modern comprehensive range of material handling equipment through its nationwide sales network for over 40 years.

90 Barcoding

Holfeld’s Axicon 15000 series offers a fresh approach to barcoding.

91 Process Automation

Endress+Hauser have launched an e-commerce platform to streamline industrial procurement processes.

LISTINGS SECTION 93 94 100 110 112

Chemical Suppliers General Suppliers Company Listings Year Planner Useful References

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Sector Overview

2019 saw BioPharmaChem Ireland (BPCI) celebrating its 25th birthday.

Matt Moran, Director, BPCI, reflects on a landmark year for the organisation and looks to the companies and healthcare innovations that will shape the sector’s future.

Bright future for Biopharmachem

d– Irelan lobal hem G e th harmaC BioP tion of Locaice Cho the y for ateg em A Str armaCh h g BioP facturin d u Man r in Irelan Secto 023 -2 2019

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In 2019, BPCI launched Phase 5 of its industry strategy, ‘Ireland - the Global BioPharmaChem location of choice’, outlining the major priorities for the sector going forward.

Irish PharmaChem | Industry Buyers Guide 2020

Sector Overview 2019 had been a very busy year for BioPharmaChem Ireland (BPCI). Readers of the PharmaChem Buyers Guide will have seen the special publication to mark 25 years in existence for BPCI – the industry and the team at BPCI are very proud of this achievement. These are 25 years that have seen enormous change within the sector and continued growth and diversification to the point where it is now exporting products worth over €73 billion and employing over 30,000. Ireland remains a true global centre of biopharma and chemical manufacture, supply and development.

New BPCI strategy launched In 2019, BPCI launched Phase 5 of its industry strategy, ‘Ireland - the Global BioPharmaChem location of choice’. This clearly outlines the major priorities for the sector going forward.

1. Retention of competitive taxation

regime including corporation tax – the 12.5% rate and R&D Tax Credits;

2. Attraction of the right kind of talent to the sector;

3. To be a leader in innovation and new

technologies within the sector; 4. The need for the right kind of infrastructure, including one supportive

of Advanced Therapeutics, Clinical

Research and Regulatory Science;

5. Support for the continued growth of the sector, including the research community

and locally based companies.

This strategy was presented to Minister for Business, Enterprise and Innovation, Heather Humphries TD, in May of 2019. In September of 2019, BPCI launched the strategy in the USA at a dinner in Boston during Biotech Week there. The dinner was co-hosted with the IDA in Boston and NIBRT. The dinner was attended by mainly US based executives who were able to discuss this strategy and to be made aware of Ireland’s ambitions in biopharma. The event was a great success and continued to reinforce the very strong connections between Ireland and the US in this sector.

One interesting outcome of the discussion was the need to prioritise cell and gene therapy; this has been included in the BPCI Strategy.

The value of industry showing a combined front with Government through the IDA and research via NIBRT again proved effective and remains a core component of Ireland’s offering as an ongoing location for investment in this sector.

In September, BPCI led an industry delegation to Brussels in order to meet newly elected MEPs and to meet with Commission officials.

BPCI were joined by colleagues from The Irish Pharmaceutical and Healthcare Association (IPHA). Included in the delegation were such companies as Eli Lilly, Pfizer, Innopharma, and MSD. BPCI met with the newly appointed Irish Ambassador to the European Union, Maeve Collins, and her colleagues from the Permanent Irish PharmaChem | Industry Buyers Guide 2020

EU Commissioner Phil Hogan; BPCI Director Matt Moran; and BPCI Senior Executive Nessa Fennelly; pictured in Brussels for the formal launch of the new BPCI Strategy in the EU. Representation in Brussels.

Commissioner Phil Hogan formally launched the BPCI Strategy in the EU for BPCI at a reception, where BPCI were joined by colleagues and Brussels based officials.

Further value growth expected The sector finds itself in a position to grow further in value terms, with a number of large

biotech drug substance plants due to come on stream soon, including Bristol Myers Squibb, Alexion and Mallinckrodt in Dublin and Takeda Biologics in Dunboyne, Co. Meath.

Meanwhile, the construction of a new biotech plant in Dublin by MSD continues, adding to the investment at their vaccines facility in Carlow, which will create an additional 300 jobs there, as well as the ongoing investment at their biotech plant in Brinny, Cork.

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Sector Overview In Dundalk, Chinese manufacturer Wu-Xi announced that they will invest a further €200 million at their site, adding a vaccines facility to the biotech drug substance plant under construction. They plan to employ 600 at that site, with a total capital investment of €500 million. Meanwhile, Allergan in Westport, Co. Mayo, continue to invest in their extensive campus there.

Biomarin continue to expand their operation in Cork and recently announced the opening of their headquarters for EMEA in Dublin; Biomarin now employ over 500 people in Ireland, specialising in rare disease therapeutics.

Janssen announced the opening of an extension to their biotech plant in Ringaskiddy, Cork. This expansion doubles the size of that plant, the total investment of €300 million adding 200 new jobs.

Just across the bay from that site, Portuguese contract manufacturer, Hovione celebrated 60 years in existence, while Servier in Arklow celebrated 30 years in this country in December.

Nevertheless, the competitive environment remains challenging for the sector here and we were reminded of this with Novartis at Ringaskiddy announcing plans to reduce and cease production in Cork. This emphasised the need for Government to remain very much focused on the needs of this important sector.

Novartis remains a state-of-the-art chemical synthesis facility dedicated to excellence in all regards. Not far from Novartis, GSK announced the sale of its Cork facility to US based contract manufacturer, Thermofisher.

BioPharma Ambition 2020 BPCI will partner with IPHA and NIBRT to host the third BioPharma Ambition conference in Dublin Castle, on March 3 and 4, 2020. The usual glittering array of international speakers have been lined up and we hope that this follows on from the success of BioPharma Ambition 2016 and 2018. As well as keynotes, there will

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be three specialist panels: ● Connected Health ● Factory 4.0 - The New Manufacturing Sites ● Future Fitting BioPharma for Best Societal Impact The conference will include a workshop on Next Generation Biologics and one on Taxation, hosted by one of the conference’s strategic sponsors, PWC. BPCI is keen to support the development of indigenous companies in the sector too; lightning presentations by local companies Avectas and Inflazome will take place at BioPharma Ambition, while Innopharma, another indigenous company, is a patron of the event.

Availability of talent The availability of talent remains a challenge for the sector. In many ways, the industry is a

victim of its own success in this regard, with new investments placing increased demands on existing skills bases.

In order the help address this, BPCI launched its own Laboratory Apprenticeship Programme at Tallaght Institute of Technology in 2018. This is now entering its second year and is proving a great success – offering a new non-traditional route into the sector – a vocational route.

A second programme has just been launched in Waterford Institute of Technology. Feedback from the participants and companies alike has been uniformly positive.

Global Solutions Group established BPCI recently established a Global Solutions Group which brings together the Global Shared or Strategic Services operations that are being established by biopharma companies here in Ireland. Well established names such as Pfizer, Eli Lilly, Novartis and Bristol Myers Squibb are joined by newer entrants such as Horizon Pharma and Jazz Pharma to consider an ever more sophisticated offering in the centralisation of global services into Ireland – ranging from traditional financial services through regulatory services and services that support direct patient interaction.

The Novartis Global Service Centre in Dublin recently announced a collaboration with Microsoft Research Lab in the area of artificial intelligence. They plan to start with tackling personalised therapies for macular degeneration, cell and gene therapy and drug design.

As we face into a world which becomes increasingly uncertain, driven by unforeseen events such as Brexit and escalating trade disputes, you can be sure that BPCI and its member companies remain focused and ready for the challenges ahead.

Irish PharmaChem | Industry Buyers Guide 2020

As proud members, Sanofi wish continued success to BioPharmaChem Ireland and our industry counterparts across Ireland The team at our biopharmaceutical and medical device campus in Waterford are honoured to serve patients around the world and to be part of a thriving sector providing exciting career opportunities for skilled graduates and experienced professionals.

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Ireland having significant operations from all of the top 10 pharma companies in the world is a tremendous national achievement. Wherever we play on the team, we can all be proud of the work we do at locations across the country every day.

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BioPharma Ambition 2020

Highlighting our b Nessa Fennelly, Senior Executive, BioPharmaChem Ireland, previews the third BioPharma Ambition Conference, which takes place in Dublin Castle in March 2020.

Dr Lorraine Nolan, Chief Executive, Health Products Regulatory Authority, will speak at BioPharma Ambition 2020.

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On March 3 and 4, 2020, at The Printworks in Dublin Castle, BioPharma Ambition will mark the impact of biopharmaceutical innovators, showcasing the economic and social value they create for Ireland. The event is a stage to celebrate the discovery, development, manufacture and delivery of innovative medicines and technologies for improving human health.

BioPharma Ambition is led by the biopharmaceutical industry’s representative bodies, BioPharmaChem Ireland (BPCI) and the Irish Pharmaceutical Healthcare Association (IPHA), and the National Institute for Bioprocessing Research and Training (NIBRT).

BPCI is the biopharma, pharma and chemical sector organisation of Ibec. BPCI influences, supports and represents the sector in realising its ambition by bringing together all relevant stakeholders in the State, namely the industry, the government, the regulator, the research community and the public at large, to effectively communicate the unique attractiveness of

Ireland as a leading location for the supply and development of pharmaceutical products.

The IPHA is the representative organisation for the international research-based pharmaceutical industry in Ireland. IPHA members discover and develop innovative medicines for treating or curing medical conditions and diseases, improving patients’ quality of life and their life expectancy.

NIBRT is a world-class institute that provides training and research solutions for the bioprocessing industry. NIBRT supports the bioprocessing industry by providing a unique learning experience for trainees in an environment that replicates the most modern industrial bioprocessing facility. In parallel, NIBRT undertakes leading edge research in key areas of bioprocessing in collaboration with industry.

Recent investment of over €3 billion from leading, global biotech companies has affirmed Ireland as a preferred location for the development and manufacture of Irish PharmaChem | Industry Buyers Guide 2020

BioPharma Ambition 2020

r bio-ambition biologics. 55,000 people are employed directly and indirectly in the biopharma, pharma and chemical sectors in Ireland, with pharmaceutical exports accounting for over 60% of total Irish exports.

Representing our multinational and indigenous members, our vision is that Ireland will enhance its reputation as a recognised centre of excellence for innovation and development in pharmaceutical, biopharmaceutical and chemical supply, thereby becoming the location of choice for the launch of new products.

Bigger than ever before BioPharma Ambition was previously held in 2016 and 2018 at the same venue. Then, we drew more than 800 delegates from across the island of Ireland and from around the world experts in industry, policy, research, academia, clinical care, entrepreneurship and finance.

This year, we will bring even more global influencers to Dublin for a larger-scale live production. The event will strengthen our networks, research collaborations, reputation and investment proposition, as we look to the future of innovation in biopharmaceutical research and manufacturing.

The event sponsor is PwC. The Global Pharmaceuticals and Life Sciences Industry Group at PwC is dedicated to delivering Irish PharmaChem | Industry Buyers Guide 2020

Sean Hemingway, SVP, Head of Strategy & Business Excellence, Takeda, will be one of the speakers at BioPharma Ambition in March 2020. effective solutions to the complex business challenges facing pharmaceuticals and life sciences companies. A global leader in serving the pharmaceuticals and life sciences industry, PwC has extensive experience working with companies on industry-specific strategic, operational, and financial issues. Their expertise includes assurance, tax and advisory services, as well as specialised capabilities in regulatory

James Greenwood, President & CEO, Biotechnology Innovation Organisation (BIO), one of the speakers at BioPharma Ambition 2020. compliance, risk management, performance improvement and transaction support. With over 6,500 pharmaceutical and life sciences specialists in Ireland and around the world dedicated to the provision of professional services to pharmaceutical and life science clients, PwC has the breadth of knowledge and experience to provide quality services to clients facing the most complex of challenges.

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BioPharma Ambition 2020 Pharma patrons for the event include: Alexion Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialisation of lifechanging therapies.

Astellas Astellas Pharma is one of the world’s top 20 pharmaceutical companies, employing 16,000 people globally.

A young and forward-thinking company, Astellas is dedicated to improving the lives of people around the world through providing innovative and reliable pharmaceutical products. Astellas’ key strengths lie in the therapy areas of Transplantation, Urology and Oncology.

BMS Bristol-Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. BMS is focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immune-science and fibrosis.

Eli Lilly Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. Eli Lilly was

founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today they remain true to that mission in all their work.

Innopharma Group Innopharma are a group of companies who work together to bring the future of manufacturing forward.

Janssen Janssen in Ireland employ over 800 dedicated individuals across their commercial and manufacturing sites in Dublin and Cork, who are inspired to help find new and better ways to prevent, intercept, treat and cure some of the most complex medical challenges of our time.

Mallinckrodt Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies.

MSD MSD Ireland is one of the country’s leading healthcare companies, having first established here over 50 years ago. MSD currently employ approximately 2,300 employees, across five sites in Ballydine, Co. Tipperary; Brinny, Co. Cork; Carlow

A globally networked player BioPharma Ambition aims to position Ireland as a globally networked player in biopharmaceutical innovation. The event, outward-facing and future-orientated, will help to build our reputation as a consequential investor, as a responsible innovator and as a global connector. It will enable the seeding of a new set of perceptions about the value of innovation and our industry’s role in improving Ireland’s society and economy. Our dedication to the application of science for new therapies and cures is exciting.

Mining new frontiers BioPharma Ambition 2020 will capture that excitement. The event will mine new frontiers in presentation, content, contributors and communications. The programme with encompass a blend of workshops, keynotes, thematic presentations and moderated discussions. All of these will explore the themes shaping our industry, including public-private partnerships, next-generation therapies, Factory 4.0 and connected health.

Among the keynote speakers are Professor Ian Greer, President and Vice-Chancellor, Queen’s University Belfast, and James C. Greenwood, President and CEO of the Biotechnology Innovation Organisation, and former US

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and Dublin and, in addition, operate substantial Human Health and Animal Health businesses.l

Novartis Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, Novartis use innovative science and digital technologies to create transformative treatments in areas of great medical need

Sanofi Sanofi is dedicated to supporting people through their health challenges. Sanofi is a global biopharmaceutical company focused on human health, who prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. They stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

Takeda Takeda Pharmaceutical Company Limited, a global, values-based, R&D-driven biopharmaceutical leader committed to bringing better health and a brighter future to patients by translating science into life-changing medicines, has been established in Ireland since 1997. Across Ireland, Takeda has commercial operations, corporate services and three manufacturing facilities in Bray, Dunboyne and Grange Castle.

Congressman. The Taoiseach, Leo Varadkar TD, has been invited to open the event.

NIBRT and PwC will hold special workshops on March 3 covering Manufacturing (NIBRT) and Tax (PwC). The Government will host invited guests at a dinner at Farmleigh House in Dublin, while the conference dinner will take place at the Mansion House.

Confirmed speakers include the following:  Professor Ian Greer - President and Vice- Chancellor, Queen’s University Belfast;  Karin Shanahan, SVP - Global Biologics & Sterile Operations, MSD;  Dr Lorraine Nolan - Chief Executive, Health Products Regulatory Authority;  Dr Ian Jones - Founder and CEO, InnopharmaGroup;  James Greenwood - President & CEO, Biotechnology Innovation Organisation (BIO);  Sean Gallagher - Executive Director, Global Technical Operations / Product and Process Lifecycle Management, Alexion;  Alan Shefflin - Director Automation and IT, Bristol-Myers Squibb;  Ruth Beadle - Head of Vials Liquid/Lyo & Biologics Technology Group, Sanofi;  Sean Hemingway - SVP, Head of Strategy & Business Excellence, Takeda.

Irish PharmaChem | Industry Buyers Guide 2020

An All – Island Event 3–4 March, The Printworks, Dublin Castle

Globally Networked Innovation Be part of Ireland’s premier thought-leadership event for biopharmaceutical innovators. This is a stage to celebrate the discovery, development, manufacture and delivery of innovative medicines and technologies for improving human health.

With a wide-ranging agenda, we will explore the therapies of the future and the role of data and technology in new medicines’ development. We will debate topics such as the convergence of biopharmaceuticals and medical technology, policy and regulatory drivers.

Book your place

www.biopharmaambition.com

Professor Ian Greer, President and Vice-Chancellor, Queen’s University Belfast

Dr Lorraine Nolan, Chief Executive, Health Products Regulatory Authority

James C. Greenwood, President and CEO, Biotechnology Innovation Organisation

Jim O’Donoghue, President, S3 Connected Health

Ian Winburn, Global Medical Lead, Haemophilia, Endocrine and IEM, Rare Diseases, Pfizer

Karin Shanahan, SVP, Global Biologics and Sterile Operations, MSD

Ruth Beadle, Head of Vials Liquid/Lyo and Biologics Technology Group, Sanofi

Sean Hemingway, SVP, Head of Strategy and Business Excellence, Takeda

Presented by

BioPharma_Ambition2020-OnePager_v7.indd 1

Event sponsors

Agency partners

18/12/2019 11:05

BPCI Strategy

BPCI Launches New Five-Year Strategy ‘Ireland – the Global BioPharmaChem Location of Choice’ is the title of BioPharmaChem Ireland’s new five-year strategy.

Ireland – the Global BioPharmaChem Location of Choice A Strategy for the BioPharmaChem Manufacturing Sector in Ireland 2019-2023

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Irish PharmaChem | Industry Buyers Guide 2020

BPCI Strategy

BioPharmaChem Ireland (BPCI) launched its new five-year strategy on May 29, 2019, ‘Ireland – the Global BioPharmaChem Location of Choice’.

“Ireland’s continued success in biopharmaceutical manufacturing is a fitting testament to the innovative companies that are based here and to the commitment of our

talented people,” noted Minister for Business, Enterprise and Innovation, Heather Humphreys TD, at the launch. “In launching this new strategy, BioPharmaChem Ireland has built on those strengths and set out a clear vision for the future development of the industry over the next number of years. As Minister, I am very aware of the importance of this sector to

our economy and I look forward to working together to maintain and grow Ireland’s position as a global leader in biopharma manufacturing.”

Also speaking at the launch, BPCI Director, Matt Moran, said: “The phenomenal growth of the sector in Ireland is no accident – it has been achieved by world class companies who

Pictured at the launch of BPCI’s new five-year strategy, ‘Ireland – the Global BioPharmaChem Location of Choice’, are (l-r): Minister for Business, Enterprise and Innovation, Heather Humphreys TD; Matt Moran, Director, BPCI; BPCI Chair Patricia Quane, VP and General Manager, Astellas Ireland; and Nessa Fennelly, BPCI.

Irish PharmaChem | Industry Buyers Guide 2020

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BPCI Strategy continually focus on innovation and through delivering new and improved products to the market.

“We have always tried to stay at the cutting edge, including a campaign to encourage Government to focus on biotechnology in the mid-1990s,” he continued. “This has paid dividends and over the last decade alone, in excess of €10 billion has been invested by the industry in bio-manufacturing operations in Ireland. Looking forward, we need to focus on the next phase of development, including the digitisation of manufacturing and advanced therapeutics.”

BPCI Chair Patricia Quane, VP and General Manager, Astellas Ireland, added: “The strategy is designed to bring the industry to its next phase of innovation. We are proud of our international reputation, with all of the top 10 global BioPharma companies operating in this country.”

In a Foreword to the new strategy, Martin Shanahan, CEO, IDA Ireland, wrote that the new strategy allows for “the continued growth and development of the sector in Ireland”.

He highlighted the culture of collaboration between companies that at other times are competitors: “This collaboration is looking at the bigger picture of how certain initiatives will bring benefits to all and allow all companies in the biopharma sector to continue to grow in our country.”

The CEO reaffirmed IDA Ireland’s continued support for the future growth of the sector in Ireland: “I believe that Ireland has a strong future in life sciences and will be a leading player in manufacturing excellence and process development work for many generations to come. To this end, I commend Biopharmachem Ireland on their new strategy and in ensuring that we have all the building blocks in place for the continued success of both the current large group of companies and

for future investments.”

BPCI Director, Matt Moran stressed the need for Ireland to keep pace with change: “Advanced Therapeutics are coming to the fore but manufacturing these in a cost effective and reliable way remains a challenge to be addressed,” he noted. “The role of data and digitisation of manufacturing and healthcare presents challenges and opportunities. How pharmaceuticals and chemicals are being manufactured continues to evolve and develop. We need to ensure that the pipeline of talent, so critical for the ongoing development

of our companies, is strong and vibrant.”

Industrial Policy Ireland has a competitive rate of corporation tax, R&D tax credits and supports. The sector is high value added and a significant contributor to corporation tax receipts. It has a high growth rate of between 6.5% and 9.6%. Competition for Biopharma FDI is ramping up globally with several EU and ROW countries investing in “NIBRT-like” models. Ireland needs to replicate the vision and foresight that resulted in the creation of NIBRT and similarly position the

‘Ireland – the Global BioPharmaChem Location of Choice’ has five strategic themes:

Industrial Policy

Talent

12.5% Corporation Tax;

Attracting global talent;

25% R&D Tax Credit;

Industry-ready graduates;

Capital Allowance for Advanced Manufacturing.

Apprenticeships.

Innovation

Infrastructure

CLUSTERS

Make Ireland a global leader in ATMP (cell and gene) characterisation, manufacturing and supply;

Investment in Advanced Therapeutics Research Infrastructure;

Design a national framework for the “Cluster”;

Allocation of funding for Regulatory Science Ireland;

Alignment of academia with cluster industry needs;

Support and development of Clinical Research Development Ireland.

Encourage the development of support services.

Enhanced data analytics of manufacturing, supply chain and the patient; Biopharma 4.0.

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Irish PharmaChem | Industry Buyers Guide 2020

The image depicted contains models and is being used for illustrative purposes only. Ja nssen Global Services, LLC. © JGS 2018

The image depicted contains models and is being used for illustrative purposes only. Ja nssen Global Services, LLC. © JGS 2018

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Our Big promise isFearless to deliver bold So that one day, the world’s most daunting diseases will be found only in and meaningful medical innovations sen.com. to create the pages of history books. Learn more at www.jans

a future where disease is a thing of the past.

Learn more at www.janssen.com/ireland/

Irish PharmaChem | Industry Buyers Guide 2020

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BPCI Strategy technologies and data science are critical areas of focus. Therefore, it is critical that industry works with academia to develop programmes to prepare students for these high-tech manufacturing jobs.

In order to diversify the talent pool and attract people from other sectors, BPCI member companies looked at developing a vocational route into the sector (echoing the German and Swiss models) which resulted in the launch of two laboratory apprenticeship programmes in 2018. We expect to see the development of further apprenticeships over the coming years in line with industry needs.

Innovation

country for the next wave of investment and innovation.

Ireland’s corporation tax rate and R&D tax credits policy, coupled with the tax treaty network and IP offering, presents a very competitive and compelling landscape for companies. The Irish statutory regime is agile, with a choice of three financial reporting options – International Financial Reporting Standards (IFRS), Irish Generally Accepted Accounting Principles (GAAP) and US GAAP (in certain circumstances).

The sector has invested €10 billion in Irish facilities since 2009. Biopharma exports from Ireland in 2018 totalled in excess of €73 billion.

The sector is a high value-added sector and a large contributor to corporation tax receipts.

International developments determine that Ireland needs to continually strengthen its competitive advantage for investment and remain the location of choice for manufacturing and innovation by retaining and maintaining a competitive taxation environment.

R&D is a critical component of our industry.

Companies are increasing in-house R&D expenditure (in addition to staff numbers involved) and partnering with the Irish research system. The R&D tax credit plays a vital role in corporate decision making to undertake additional RD&I activity in Ireland. The sector invested €1.8 billion in manufacturing process development R&D in 2017. It is vital that it is retained.

We are entering a new era of advanced biopharmaceutical manufacturing. In order to futureproof investment, accelerated capital allowances for several areas of advanced manufacturing (including computerised/ computer aided machinery and robotic

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machines) should be introduced by Government. Ireland is the second largest net exporter of medicinal and pharmaceutical products from the EU, accounting for almost 30% of Ireland’s total extra-EU trade, the highest amongst EU countries (Source: Eurostat, 2017).

Talent Ireland has a highly skilled workforce. The sector employs 30,000 people directly, 60% of whom hold a third level qualification. Over 25% of all PhD graduates employed in Irish industry work in our sector.

Ireland ranks in 21st place in the IMD ‘World Talent Rankings’ of 63 countries in three main categories, namely: appeal, readiness and investment & development. While Ireland comes in the top five for the prioritisation of attracting and retaining talent, in addition to worker motivation in companies, it scores 38th place for cost of living as an incentive for professionals.

Biologics manufacturing in Ireland will require many additional employees over the next five years. Government needs to prioritise the future attraction of talent to this sector.

A highly regulated sector such as biopharma depends on having the right level of employee in terms of qualification, aptitude and experience. Ireland continues to excel in this regard; however, BPCI believes in the need to continually invest in our talent pool. BPCI works closely with IDA, Skillnets and NIBRT to ensure the robustness of the talent pipeline. As the digitisation of the sector evolves, opportunities are emerging in entirely new skill sets such as information technology and software development.

Advanced manufacturing

Therapeutic modalities are becoming increasingly diverse, encompassing cell and gene therapies, antibody-drug conjugates, regenerative and genomic based precision medicines and RNA therapies.

Data analytics is core to manufacturing excellence, quality and customisation. Irish manufacturing sites are globally recognised as manufacturing process/ product development specialists. Ireland, with the correct supports, is well positioned to be at the cutting edge of this multi-faceted ground breaking innovation.

We need to make Ireland a global leader in ATMP (cell and gene) characterisation, manufacturing and supply. BPCI is encouraged to see the commitment in the Government’s “Future Jobs” initiative to embracing innovation and technological change. The industry has moved from the blockbuster into the speciality drugs era. We need to know and understand the disease and the patient. Drugs will be more expensive; however, they will potentially provide a cure, thereby enabling people to return to work. Half of the top 20 drugs in 2018 were injectable and we are also seeing strong growth in the orphan drug space. Treatments are coming on-stream and patients are well informed; indeed, the development of CAR-T and other new technologies are not just a treatment but a cure.

However, there are new manufacturing challenges requiring scalable technology. With the correct supports from government, Ireland is ideally positioned to take on this challenge and position itself for the next wave of biopharmaceutical innovation and investment.

We need to harness the potential of data; gathering and analysing it for outcomes-based measurement and personalised healthcare.

The sector needs to deal effectively with the level of data it generates. Machine learning and artificial intelligence can be deployed to improve healthcare delivery and patient outcomes. With the large concentration of life science and technology companies in Ireland, there is a unique opportunity to collaborate on new technological approaches to drug Irish PharmaChem | Industry Buyers Guide 2020

A LOCAL FOOTPRINT WITH A GLOBAL REACH Recordati is a European specialty pharmaceutical group dedicated to partnering, discovering and developing innovative, value-added products that improve the quality of life and help people to enjoy longer, healthier and more productive lives.

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Irish PharmaChem | Industry Buyers Guide 2020

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BPCI Strategy development and patient care. This should be an area of focus for the 2020 Future Jobs review.

Biopharma 4.0 (echoing Industry 4.0) heralds the onset of digitisation and emergence of disruptive technologies. Companies need to understand and implement concepts and technologies around AI, continuous manufacturing, data analytics and 3D printing.

With this will come the need for requisite skills, in addition to regulation that is more science and risk based.

The Biopharma Ambition 2018 Conference report stated “Industry 4.0 and the changing global healthcare landscape brings a raft of new challenges for the biopharmaceutical industry; integration of emerging technologies, digitisation, regulatory hurdles, access, pricing and reimbursement and R&D productivity and costs. What this will mean in the short, medium and long-term for the sector is already the subject of intense discussion. The industry is taking care to diversify and collaborate.”

Infrastructure BPCI has identified three areas, which will position Ireland for the next wave of biopharma investment. We urgently need Government funding for “ATMPs” – Advanced Therapy Medicinal Products. Governments globally are making significant investments in this space and Ireland similarly needs to invest in order to compete and stay ahead of the game.

Regulatory Science Ireland will enable Ireland to operate at the forefront of global regulatory development, which is hugely challenging and presents an exciting opportunity for us. Clinical Research Development Ireland is a unique opportunity to create an innovative force for the development of clinical and translational research in Ireland.

Currently, Ireland is lacking in infrastructure to support the development of cell and gene therapy manufacture, which is needed to meet future challenges and opportunities.

The “Disruptive Technologies Innovation Fund” administered by the Department of Business, Enterprise and Innovation, is the appropriate funding mechanism to address this deficit.

The €10 billion investment in Ireland by the sector over the past decade, in addition to its €1.8 billion investment in manufacturing process development R&D in 2017, more than demonstrates its commitment to Ireland. Inhouse R&D expenditure and the number of employees involved in R&D has been steadily rising. Companies are partnering with the research system on biopharma projects. We need a commitment from Government to fund infrastructure, which will serve to place Ireland at the forefront of advanced therapeutics manufacturing development.

The sector is highly regulated and Ireland has a strong global reputation for excellence

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Irish PharmaChem | Industry Buyers Guide 2020

At Bristol-Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

Irish PharmaChem | Industry Buyers Guide 2020

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BPCI Strategy in manufacturing and regulatory compliance.

Regulatory Science Ireland is committed to the development of an integrated Irish response to the global Regulatory Science effort by establishing an environment through which relevant research, training and communication creates a cohort of Irish-based Regulatory Science experts, and further strengthens the value proposition of Ireland as an attractive location for healthcare products. Regulators need to be on board with what the industry wants to do. It is important to make GMP risk based, as the old GMP is killing innovation.

Regulation is getting in the way.

“Approvals are coming faster and faster. FDA want clinical trials to be faster. They want an automated aseptic filling process,” said Gert Moelgaard, Novo Nordisk, at IPSE Dublin, 2019.

Regulations must be modernised to become more science and risk based. Global regulators need to support novel manufacturing processes. The regulatory process drives the cost of development and time to market.

Increased global regulatory stringency may affect innovation activity.

Clinical Research Development Ireland can create an innovative force for the development of clinical and translational research in Ireland, which would be recognised, both nationally and internationally, as a model of organisational

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excellence, focused on advancing evidencebased patient care and network coordination.

We need to set an ambitious target for clinical trials. The number of trials carried out in Ireland is declining (from 114 in 2007 to 96 in 2017). Clinical trials enhance Ireland’s innovation value proposition and in turn its attractiveness for future investment in manufacturing.

Clusters A Cluster is when the business model is characterised by a dynamic ecosystem involving multinationals in different sectors generating local SMEs and partnering with the indigenous sector, along with higher education, health and research institutions.

Achieving the full potential of the Biopharma cluster will create an ecosystem to sustain and evolve the sector, according to BPCI. Ireland has an impressive mix of large multinationals, high growth SMEs and start-ups. Enterprise Ireland supports over 100 Irish owned companies specialising in drug discovery, development and delivery, in addition to API, veterinary and human finished products manufacturing, as well as pharma service, regulation, engineering, construction and clinical trial management.

The Irish life sciences manufacturing sector

has grown exponentially in recent years, with major investments from large multinationals.

In parallel, indigenous Irish companies have developed to support the cluster of multinationals.

Barry Heavey, Managing Director of Life Sciences at Accenture Ireland, described the Irish pharma cluster as being “in an enviable position as a world leader in pharma manufacturing.

Strategic Government investments (such as the Science Foundation Ireland pharmaceutical research centre SSPC and the IDA Ireland-funded National Institute for Bioprocessing Research and Training) and successful indigenous companies (such as ESP and APC) bode well for the sector here. Ireland is well positioned to be a leader in the industry 4.0 space in life sciences.”

A national framework to identify the strengths of the existing organically developed clusters and replicate them on a co-ordinated countrywide basis would greatly enhance the evolution of the sector, according to BPCI. We have seen great success in the development of innovative Irish companies to support the ever changing multinational environment, in addition to the alignment of academia with industry needs. A focus on this very important and productive area is timely.

Irish PharmaChem | Industry Buyers Guide 2020

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09/07/2019 18:08

Regulatory Science Ireland

The continued evolution of regulatory science 20

Irish PharmaChem | Industry Buyers Guide 2020

Regulatory Science Ireland

Rick Friedman, Deputy Director, Science and Regulatory Policy, CDER, FDA, is pictured in TU Dublin on April 4, 2019, at the symposium, which brought together thought-leaders in the field of QRM and KM.

Regulatory Science Ireland (RSI) was established in 2014 to provide an Ireland response to global initiatives in the area of Regulatory Science, a term which was described by the US FDA as “the science of developing new tools, standards and approaches to assess the safety, quality and performance of drug products” (1). The EU proposed a similar definition as “a range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision making throughout the lifecycle of a medicine” (2).

The creation of Regulatory Science Ireland brought together interested parties from the private and public sectors, including involved academics, with the support of the HPRA. The founders considered this particularly timely in light of the importance of innovative pharmaceutical and medical device industries to the Irish economy and the national benefits that would accrue by the retention and expansion of the footprint of such companies.

The evolution of regulatory science

2019 was a busy year in the field of regulatory science, writes Professor Anne Greene, TU Dublin and Board Member of Regulatory Science Ireland.

Irish PharmaChem | Industry Buyers Guide 2020

Regulatory science has evolved since the concept was first put forward in 2010 by the FDA for the purpose of advancing science for public health.

Indeed, as the next generation of medicinal products is developed and presents personalised therapies based on cell and gene technologies, the greater complexity of these therapies presents challenges in terms of defining precise mechanisms of action, biological activity, scale-up, manufacturing and quality assurance. Therefore, the sciences concerned with regulation need to move forward in parallel. In addition, challenges around drug supply, globalisation and quality issues resulting in drug shortage underscore the critical importance of modernising and advancing regulatory science to match the advances in basic and applied science and technology.

RSI is a network of interested parties from academia, the pharmaceutical industry, the medical devices industry, and various governmental agencies. Its ambition is to be the umbrella organisation, providing relevant research, training and communication that facilitate the Irish contribution to an effective response to the increasing complexity of health products and their associated regulatory systems, that creates a cohort of Irish-based regulatory science exerts – not regulatory affairs experts, but regulatory science experts, who further strengthen Ireland’s attractiveness as a location for people in this particular sector.

A busy year 2019 was a busy year for regulatory science with the publication by EMA for public consultation of their draft strategy for ‘Regulatory Science towards 2025’ (3). RSI was one of 150 individuals /organisations who submitted comments to the draft stragtegy.

The five key goals of the strategy are currently

defined as:  Catalysing the integration of science and technology in medicine development;  Driving collaborative evidence generation to improve the scientific quality of evaluations;  Advancing patient-centred access to medicines in partnership with healthcare systems;  Addressing emerging health threats;  Enabling and leveraging research and innovation in regulatory science.

The strategy seeks to offer informed guidance on modern medicines development, facilitate the optimisation of regulatory science and critically assess the benefits and risks of innovative therapies and diagnostics based on new technologies.

In addition, TOPRA (The Organisation for Professionals in Regulatory Affairs) (4), held its annual conference in October in Dublin, and aimed to put “Europe at the forefront of global healthcare regulation by driving innovation through convergent approaches in medicines, devices and veterinary regulatory affairs”. To coincide with the conference, the September 2019 issue of TOPRA’s journal focused on Ireland’s regulatory framework: ‘How this modestly sized country is leading the way in regulatory affairs globally’. RSI contributed an article to this edition, entitled ‘Regulatory Science Ireland and the regulatory dilemma for future innovative therapeutics’ (5).

RSI symposia Focusing on regulatory science in the commercial phase of the pharmaceutical product lifecycle, RSI, together with TU Dublin (formally DIT) and HPRA, ran two symposia. The first of these, entitled ‘An Audience with International Regulators’, was held

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Regulatory Science Ireland

Panel Discussion: An audience with Regulators, Academia and Industy, TU Dublin April 2019. Pictured are (l-r): Luke Kiernan, Innopharma; Paige Kane, MSD; Marty Lipa, MSD; Rick Freidman, FDA; Hal Baseman, Valcource; John Lynch, HPRA; Martine Nolan, Kiadis Pharma; and Kevin O’Donnell, HPRA.

About the Author Anne Greene leads the Pharmaceutical Regulatory Science Team (PRST), in TU Dublin (formerly DIT), where she also lectures, and is Director of the several MSc. and BSc. pharmaceutical programmes. Prior to embarking on an academic career, Anne worked at a senior level for several years in the pharmaceutical sector, in Validation and Technical Management roles. Anne has a PhD in Synthetic Organic Chemistry from University College Dublin, and is currently Secretary of the Irish Chapter of PDA. Anne is also on the Board of Directors of Regulatory Science Ireland (RSI), leading the Education & Training development group.

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in DIT in October 2018, on the 10-year anniversary of ICH Q10 ‘Pharmaceutical Quality System’. ICH Q10 describes a model for an effective quality management system for the pharmaceutical industry which advocates the use of Knowledge Management (KM) and Quality Risk Management (QRM) as enablers to achieve its three key objectives of:  Achieving Product Realisation;  Establishing and Maintaining a State of Control;  Facilitating Continual Improvement.

The Q10 model proposes that QRM and KM would provide the means for science-based and risk-based decisions related to product quality.

While many publications on both topics have been produced in the last decade, they are usually treated as separate enablers. RSI’s vision for these symposia and research work was to explore how QRM and KM work together to enhance decisionmaking with respect to pharmaceutical product quality.

The second symposium, held in TU Dublin on April 4, 2019, continued with this theme, bringing together regulatory, academic and industry thought-leaders in the field of QRM and KM, who contributed to a stimulating discussion on the topic. The proceedings from both symposia are published in two open access monographs available to download from the DIT academic press (6,7).

References 1. Advancing Regulatory Science at FDA, A strategic plan (August 2011) 2. European Medicines Agency’s contribution to science, medicines and health, A road map to 2015 (December 2010) 3. https://www.ema.europa.eu/en/ about-us/how-we-work/regulatoryscience-2025 (accessed November 14, 2019) 4. https://www.topra.org/TOPRA/ TOPRA_Member/Symposium_2019/ TOPRA_Annual_Symposium.aspx (accessed November 14, 2019) 5. Hallinan F. et al, Regulatory Rapporteur. Vol 16, No 9, September 2019 6. Greene A et al, An Audience with International Regulatory in the Manufacture of Medicine: QRM and KM, https://arrow.dit.ie/ditpress/9/ 7. Greene A. et al, An audience with Regulators, Academia and Industry: The role of QRM and KM in the realisation of medicine for patients in the 21st century https://arrow.dit.ie/ditpress/10/

Irish PharmaChem | Industry Buyers Guide 2020

Data Digitalisation The laboratory is the location where drugs are discovered, where manufacturing processes are developed and where quality control tests are performed to allow product release.

The digital thread can successfully link the lab, manufacturing and supply chain in Ireland’s Biopharma sector, explains Barry Heavey, Managing Director, Life Sciences, Accenture in Ireland.

In 2019, Accenture Life Sciences practice published an analysis of strategic change in the biopharma industry, entitled New Science: Biopharma’s New Growth Engine.

The research identified three clear trends of compressive disruption in the industry: ● 33% decline in future value as a percentage of enterprise value from 2015-2018; ● 51% decline in the amount of time a treatment retained market leadership position; ● 50% decline in three-year average pipeline replenishment ratio.

However, despite these headwinds, our results identified a category of companies who are thriving amid disruption. There is a common thread between these outliers: they are companies that combine investment in great science with investment in digital and data.

Enhanced use of data through digitalisation Against this backdrop, Accenture is increasingly focused on the laboratory, where the generation, curation, analysis and utilisation of data can be enhanced and accelerated through digitalisation. We have invested in the creation of a global speciality practice called Accenture Scientific Informatics Services (ASIS).

Our ambition is to bring deep expertise in laboratory operational excellence and laboratory information management systems together with Accenture’s expertise in digital tools (such as artificial intelligence) to help drive laboratory transformation for our clients.

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Unlocking the power of the digital thread Accen ture Life

Patie nt

Why is this important to our clients? The laboratory is the location where drugs are discovered, where manufacturing processes are developed and where quality control tests are performed to allow product release. In the case of some of the most exciting precision medicines, such as cell and gene therapies, the laboratory is the manufacturing site for the product.

Efficient data capture and analysis In an industry where R&D cycles are getting shorter and products and processes more

c o m p l e x , the efficient capture and analysis of data in the laboratory is key. Without this, R&D productivity can drop and product release times can get dramatically extended.

R&D laboratories and QC laboratories

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New Science: Biopharma’s New Growth Engine: an analysis of strategic change in the biopharma industry

by Accenture Life Sciences.

See: accenture.com/NewScience

Irish PharmaChem | Industry Buyers Guide 2020

Data Digitalisation

“It is not enough to think about the ‘factory of the future’ which is often cited in commentary about the fourth industrial revolution. Equally important is the laboratory-of-thefuture and the enablement of the ‘digital thread’; an ability to unlock the data and knowledge silos in large and complex organisations.”

must efficiently transfer knowledge on products, processes and test methods between global teams, while ensuring data security and integrity.

QC laboratories are a key nexus within the supply chain and digital transformation of quality control will be vital if the industry is to increase efficiency in supply chain, while maintaining the highest quality standards and protecting patients.

Enabling the digital thread It is not enough to think about the ‘factory of the future’ which is often cited in commentary about the fourth industrial revolution. Equally important is the laboratory-of-the-future and the enablement of the ‘digital thread’; an ability to unlock the data and knowledge silos in large and complex organisations. With the increasing pace of scientific and technological development, companies must create stronger bidirectional links between R&D and operations and they must drive better links between supply chain, manufacturing and quality.

Enhancing these links will help companies

Irish PharmaChem | Industry Buyers Guide 2020

About the Author Barry Heavey is Managing Director of Life Sciences, Accenture in Ireland. He leads Accenture Ireland’s efforts in supporting multinational pharmaceutical and medical device companies transform their operations in Ireland and globally. Prior to working with Accenture in Ireland, he has worked in a variety of roles in government, start-ups and multinationals focused on manufacturing, R&D and business development.

ensure that they can better utilise the enormous amounts of data they can access to rapidly surface useful insights in areas such as product and process development, tech transfer, operational excellence and continuous improvement.

Accenture is continuing to invest in enhancing our ability to support clients in their R&D and QC laboratory digitalisation journey through our global ASIS practice. This, coupled with our recent acquisition of Enterprise System Partners (ESP) in Ireland, will enhance the digital thread linking global labs, manufacturing and supply chain teams.

Ireland is a key hub in the global biopharmaceutical industry supply network and many companies are undertaking process development manufacturing and release testing of exciting new precision medicines here today.

QC laboratories are a key nexus within the supply chain.

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Blockchain

Blockchain A silent revolution?

Enda Dempsey, BioPharmaChem Ireland, explains exactly what blockchain technology is and how its application could be a massive advantage for the life sciences sector.

Enda Dempsey, Executive, BioPharmaChem Ireland.

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Bitcoin, the most famous example of blockchain technology.

Over the last number of years, blockchain has been trumpeted as a panacea to almost every imaginable data management issue by citing its core strengths - decentralisation, transparency, immutability and anonymity. This has led to a digital goldrush, with the most famous example undoubtedly being Bitcoin, a virtual currency that is still hovering on the precipice of being a trusted commodity, in part due to its unstable valuation and numerous dubious if not outright fraudulent competitors e.g. OneCoin.

As a result, there is widespread scepticism and misinformation about the technology which has hampered its roll-out to more mainstream industries. However, the fundamental architecture of blockchain is still sound, which is why most of the world’s largest corporations are exploring different options for integrating it into their own operations or products e.g. Tencent are using it for invoicing passengers on public transport; Siemens partnered with LO3 to manage micro-electric generation; and the Royal Bank of Canada are using it to automate credit scores. In short, there are numerous, diverse applications to the technology. Therefore, the question remains, why is it not more frequently seen in the life science sector and specifically the pharma industry?

The reality is that the technology is being widely

used or at least being trialled. Oftentimes, its impact is felt by improving existing systems or in assisting in B2B relations rather than B2C. In fact, outside of the cryptocurrencies, there are not too many examples of a forthright blockchain product on the market. So, what is blockchain, how is it disruptive, what examples are there in the life science sector and what does the future hold for it?

What is Blockchain?

Blockchain is a technology, a generic way of processing information as opposed to being an application which leverages off its strengths.

It is a digital spreadsheet, that is incorruptible, interoperable across any computerised system and it can be programmed to record virtually anything of value, not just financial data.

It works by adding “blocks” of encrypted information to these digital ledgers in series. Each new block is validated by the adjacent ones to ensure they are both authentic and unique, among other factors. Once the block has been confirmed, it is propagated across all the computers using the blockchain which typically run into the millions.

This decentralisation is markedly different to cloud storage which would be comprised of just a few servers at discrete locations.

A simple example would be two people Irish PharmaChem | Industry Buyers Guide 2020

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Irish PharmaChem | Industry Buyers Guide 2020

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Blockchain

Blockchain is a digital spreadsheet that is incorruptible, interoperable across any computerised system and it can be programmed to record virtually anything of value, not just financial data. wishing to transfer money from one account to another. Normally a bank would act as the emissary and would validate the accounts of both parties so the transaction can be completed. But with blockchain, this is done automatically by using the intelligent protocols as described above.

There are three types of blockchains, public (e.g.

Bitcoin), Private (e.g. American Express Credit Card) or a consortium (e.g. IBM Hyperledger) which chiefly vary, depending on levels of access and transparency. For B2B operations such as inventory management, patient records, clinical trial data etc, the consortium approach would be much more applicable. There is an inherently strong encryption mechanism built into the fabric of the blockchain technology too.

In essence, each previous block in the chain is related to each other through “hashes� so if an attempt is made to change any detail, it will cause a ripple affecting the entire chain. This results in the change being rejected, ensuring the integrity of the blockchain is protected.

How is it disruptive to the life science sector?

Data Integrity is a crucial component for determining the quality and safety of a medicine has been maintained throughout its entire lifecycle.

This is especially true as the new manufacturing wave, Factory 4.0, sweeps over the biopharma

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industry. The level of equipment sophistication and digital connectivity has skyrocketed, along with the generation of GxP information, creating even more complex audit trails.

For manufacturing sites, at least the information is contained in one area, but this is not true for supply chains that span the globe with tens to hundreds of partners being involved along the way. This creates huge risks, allowing potential errors to creep in over time so rigorous processes and CAPAs are required, which is one reason why the biopharmachem industry tentatively approaches new technologies.

Fortunately, the most valuable feature for any blockchain-based application is the ability to trust, or more commonly referred to in the biopharmachem industry, validate the data. The distributed ledgers only allow data to be added to them with no deletions. Being decentralised means that every partner can access/update the file as required and the inputted values can be tightly controlled. Therefore, it is possible to create a selfverifiable system with strict parameters that can be used by the relevant parties only.

What examples are there in the life science industry?

Less than half of the biopharmachem manufacturing industry has embraced electronic batch records, although most have adopted some

paperless solutions, despite massive improvements in broadband and computer power since the turn of the century.

This reluctance within the industry is primarily due to its highly regulated nature, massive costs for upgrading bespoke equipment and the criticality of its products. Therefore, rolling out a sweeping new technology that could potentially interfere with the core business would normally happen at a glacial pace.

However, blockchain differs by working behind the scenes of applications, increasing their functionality, similar to how cloud computing replaced local hard drives without affecting the dayto-day work. As a result, there has been significant interest from major life science companies to get involved early.

Serialisation in the USA The US has enacted the Drug Supply Chain Security Act (DSCSA) which specifies that all US manufacturers must implement serialisation or barcoding of drugs at a package level and that these serial numbers must be used to verify the authenticity of the returned drugs. Unlike in the EU, the US have opted for a decentralised system and it is up to the industry to find a solution. SAP partnered with Merck, Sharp & Dohme and other industry collaborators to develop successful proofIrish PharmaChem | Industry Buyers Guide 2020

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Irish PharmaChem | Industry Buyers Guide 2020

Blockchain of-concept (POC) that allowed the real-time tracking of the products, along with other required information.

The POC App was added to a mobile barcode scanner, causing minimum disruption to normal operations.

SAP have also developed another consortium with Chronicled’s MediLedger. Their key aim is to ensure interoperability between different organisations, specifically those that do not use SAP as their ERP system. Included in this group are the top three wholesalers for the US, AmerisourceBergen, McKesson and Cardinal Health, who account for more than 94% of all the traded pharma products, along with a major 4PL, Tracelink.

Compliance in the Supply Chain The pharma supply chain is probably the most amenable division within the industry for an innovative disruptive technology, despite being specifically regulated by Good Distribution Practice.

This is mainly due to the sheer number of hand-offs a product will go through from the manufacturing site to the patient.

The cold chain is particularly vulnerable, so realtime data loggers that provide actionable information are frequently deployed. As a result, there has been an explosion of companies looking for ways to simplify the network and reduce the risks, such as Wipro, Ambrosus and LTI. One example where a blockchain-backed technology can help is a temperature breach. A notification is sent to the shipping provider, who will have access to the relevant SOP on the same blockchain solution (usually an application on a tablet device) and they can then make the required adjustments. An entire validated audit trail will be generated that can be reviewed by the Marketing Authorisation Holder and the regulator. Furthermore, smart contracts can be deployed, so there would be immediate reduction from the invoice amount due to the logistics company.

While pharma and shipping companies are already performing this activity, it is fragmented and not interoperable among all the different stakeholders.

Managing clinical trials information Managing clinical trial data for new medicines has

become significantly more challenging as 90% fail and those that succeed cost on average €2.3 billion to finally bring to market. This has been exacerbated by the advent of GDPR, which has unambiguously delineated how personal/identifiable information can be handled, and a trend towards bespoke medical treatments, but mostly it due to poor data management.

However, the last year has seen the announcement of two big collaborations to develop a universal clinical trials ledger, which should eliminate some of the common issues; IBM are working with Boehringer Ingelheim and Pfizer and Biogen have established a Clinical Supply Blockchain Working Group (CSBWG).

Other independent start-ups are looking to develop their blockchain ledger, although it remains to be seen if they get sufficient traction to become market leaders.

What does the future hold for this technology?

Currently blockchain is most closely linked with cryptocurrencies, which is a huge underestimation of its potential to change our industry. Its key strengths and potential uses seem a perfect match for a maximum quality-driven industry. This boundless potential has generated an equally boundless buzz but there are reasons to be concerned.

Not all blockchains can communicate with each other, just like Mac OS and Windows used to stubbornly refuse to recognise each other’s files, unless they are built from the same platform.

This is one reason why the aforementioned large consortiums are working together to build one universal frame which everybody can use.

Also, a 2018 survey found that 40% of pharma companies are not experimenting with blockchain at all, the overriding reason being that they just don’t understand it.

In the end, blockchain will probably be widespread, but felt subtly in our daily life as new applications are developed and old ones updated with extra features.

Similar to when our computer operating systems changed from 32 bit to 64 bit, this is a silent revolution, but one the only IT experts really appreciated.

Barcode scanners with digital apps – this is to signify that blockchain can be installed as an app to existing devices, a point I was keen to get across.

Irish PharmaChem | Industry Buyers Guide 2020

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IDA Ireland An artist’s impression of the new MSD plant in Carlow.

Keeping Ireland front and centre in Biopharma

Tommy Fanning, Global Head of Biopharmaceuticals, IDA Ireland, examines Ireland’s success in biopharmaceuticals, and advises on where future growth is going to come for the sector and how Ireland can stay at the forefront of this industry in the coming years.

Ireland has done well with a very strong biopharmaceutical sector which is now 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.

In the last decade, we have seen the rise of biologics, with significant capital investment resulting in 20 manufacturing plants. The effect this has on the Irish economy cannot be understated through the value of exports, purchases of both equipment and services, alongside the salaries of those highly skilled employees at plants all over the country.

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

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investments in Limerick, Carlow and elsewhere.

These can in many cases be the backbone of those regional economies. It is easier though at this juncture to consider Ireland, which is smaller than some US states, as one cluster within the global medicines landscape.

Why Ireland has succeeded so far 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 the expansion projects from companies that invested initially in new biologics operations six, seven or even 10 years ago. This shows the confidence companies have in Ireland. Much of this, in the IDA’s opinion, is down to two key elements: skills and our regulatory environment.

Taking skills first, we 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 launching of NIBRT (National Institute for Bioprocessing Research and Training) in 2007 and then the physical building in 2011, we realised 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 but also collaborates on research specifically related to industry problems. Skills are the key currency in future success for global biopharma companies and Ireland can lead.

Strong regulatory environment The 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).

Irish PharmaChem | Industry Buyers Guide 2020

IDA Ireland WuXi’s plant in Dundalk, the first biologics CDMO in Ireland.

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 as well from the companies based in Ireland that they get clear direction from our regulator, as well as receiving tough audits of manufacturing sites, keeping all companies vigilant. What is most important, though, is that a culture of professionalism has developed across all the companies in Ireland, with employees in each company understanding that their actions effect every company and not just themselves. With Brexit, this has seen an increased understanding of the regulatory needs of our country and the readiness to make sure Irish patients also get the medicines they require.

This has all been very positive for Ireland, but we are now at an inflection point on a number of fronts. Among these is biologics becoming a mature sector, API becoming a tried and tested manufacturing process, and the 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, 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 site investments in terms of new equipment, technology platforms and manufacturing processes. We in IDA Ireland continue to work with our clients on an ongoing basis to support training needs and process R&D across the country.

Maturity in biologics 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: Takeda in Dunboyne, WuXi in Dundalk, MSD in Swords to name just three. 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 where for the major companies at least, there is now sufficient manufacturing capacity in place.

With the continued growth of the CDMO model, though, it will be interesting to see what is next. We are already seeing this trend in small molecule, with SK acquiring the BMS API plant in Dublin and Thermo Fisher acquiring the GSK API facility in Cork.

In this context, though, the first biologics Irish PharmaChem | Industry Buyers Guide 2020

CDMO in Ireland will be WuXi. We believe there is space for more, as many global CDMOs already have relationships with our clients elsewhere on the globe.

Cell and gene therapies The big topic, though, is cell and gene therapies or ATMPs (Advanced Therapeutic Medicinal Products). 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.

Gilead acquired Kite for US$11.9 billion and Celgene acquired Juno for US$9 billion.

Currently, Roche is in the process of concluding

the acquisition of Spark for US$4.3 billion.

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 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 1000+ potential products in clinical trials and it is now that those 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 has been the REMEDI research team in Galway who 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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Microbiology Reading Scientific Services Ltd has expanded its microbiology capabilities with the launch of a fast, responsive and flexible sterility testing service for pharmaceutical and medical device companies.

RSSL launches sterility testing service

Following the opening of its state-of-theart microbiology laboratory earlier this year, Reading Scientific Services Ltd (RSSL) has launched a sterility testing service in response to sustained client demand and market growth. The move enables the leading contract research organisation (CRO) to further enhance the scope of its biopharmaceutical services and increase testing capacity.

“Over the last five years, our pharmaceutical analytical services have experienced tremendous growth, so entering the sterility market is a strategically sound step,” explains Reginald Fernandes, microbiology laboratory manager at RSSL. “It builds on our already diverse range of services which, together with our reputation for quality and scientific excellence, is a compelling combination, particularly for clients who are keen to work with one trusted laboratory.

“Not only that, in addition to a standard 21-day timeframe for this service, we are also offering clients an expedited 16-day and 14-day, which we believe to be one of the quickest available on the market today.”

an open invitation to visit our new facilities and discuss how our full-service microbiology offering can help to achieve individual safety goals,” adds Fernandes.

RSSL’s new sterility testing service is part of its comprehensive range of critical assessment services for manufacturers of sterile products. This complete biopharmaceutical testing package also includes microscopy to reduce the risks of particulate contamination, as well as endotoxin to analyse potential pyrogen contamination.

RSSL’s sterility testing service enables the Readingbased company to further enhance the scope of its biopharmaceutical services and increase testing capacity.

Two sterility test methods RSSL’s new service encompasses two sterility test methods; membrane filtration for aqueous, alcohol, solvent and oil-based products, as well as direct inoculation for non-solubles. Both are used to determine the presence or absence of contaminating micro-organisms in terminally sterilised or aseptic filtered drug products, in accordance with Ph. Eur, JP and USP regulations.

Its introduction has been facilitated by further investment in a purpose-designed sterility testing suite, featuring a Grade D clean room installed by Connect2Clean rooms with Grade A Bioquell isolators.

The new laboratory is expected to be fully operational from February 2020.

Full service microbiology offering “To mark the launch, we are pleased to offer an exclusive cost-saving offer to every client who engages our sterility test services in the first 12 months. We would also like to extend

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For more information, visit www. rssl.com, telephone +44 (0)118 918 4076 or email enquiries@rssl.com.

Irish PharmaChem | Industry Buyers Guide 2020

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Cell and Gene Therapies

Winning the next wave of investment Ireland is a recognised global centre of excellence for biopharma manufacturing. The last 10 years have seen tremendous success in attracting foreign direct investment (FDI) associated with multi-national companies establishing their biopharmaceutical manufacturing operations in Ireland. In this period, capital investments of approximately €10 billion have been made and the number of biopharmaceutical manufacturing sites has grown from three in 2003 to 22 in 2019.

Over 30,000 employees are directly employed in the sector, contributing more than €40 billion in exports. 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.

While this national strategy has clearly been successful, the sector is evolving rapidly and we must again take proactive measures to ensure our position. The majority of current activity relates to the production of recombinant therapeutic proteins such as monoclonal antibodies. Recently, there has been a global surge in interest and investment in cell and gene therapies (also Irish PharmaChem | Industry Buyers Guide 2020

Ireland had established a hard-won reputation as a centre of excellence in biopharma manufacturing. However, the next wave of biopharma investments will focus on cell and gene therapies, which represent complex challenges to manufacture economically. How can Ireland win this next wave of manufacturing investment? asks Killian O’Driscoll, Director of Projects, NIBRT. sometimes referred to as ATMPs - Advanced Therapy Medicinal Products). This interest is supported by: • The large number of clinical trials (1,028 globally in 2018 with a target enrolment of 59,000 patients); • The increase in venture capital investment ($13 billion globally); • The increase in capital investment in new facilities and the number of partnerships and acquisitions in ATMPs (1).

Current status Cell and gene therapies (CGT) encompass a range of diverse, life-changing and life-saving therapeutic modalities based on using cells and genes to address some of the most grievous

human illnesses. While recombinant protein technology has revolutionised medicine since the mid-1980s, CGTs have progressed at a more modest pace over the same period of time. Partly, that is related to the complexity of these new modalities but also to some negative outcomes in clinical trials in the early 2000s.

Recently, however, we have seen an increase in approvals of cell and gene therapies and some very promising, in some cases striking, clinical outcomes in a number of trials. For example, Novartis was the first to launch a CAR-T therapy (which is combination of cell and gene therapy), called Kymriah, in 2017. This one-time treatment for B-cell acute lymphoblastic leukaemia has shown an 83% remission rate after three months in patients that do not respond to standard treatments. However, 49% of the patients suffered

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Cell and Gene Therapies

strong cytokine release syndrome, a side effect that has been responsible for several deaths in clinical trials run by Novartis’ competitors.

This has created huge interest in these approaches both in terms of new trials and commercial activity. It is estimated that there are >900 start-up companies in this space and many of the large pharma/biopharma MNCs are now actively entering the arena - via acquisition mainly.

Currently, there are over: • 900 regenerative medicine companies worldwide, including gene therapy, cell therapy and tissue engineering therapeutic developers; • 484 are based in North America; • 241 in Europe and Israel; • 142 in Asia (2).

The commercial value of CGTs is forecasted to be very substantial over the coming years.

Interestingly, the majority of this growth will come from outside of the top 20 Biopharma companies, thus leading to potential FDI opportunities from newer US mid-size biotechs.

In Europe since 2009, 10 cell and gene products have been authorised; four have been withdrawn, such as Glybera (4). As of end 2018, there were over 1,028 clinical trials ongoing or completed worldwide and this number is rising rapidly (5). In January 2019, the US Food and Drug Administration stated that it expects to see more than 200 applications per year by 2020 requesting permission to begin cell and gene therapy trials.

The agency already has more than 800 such applications on file and plans to hire some 50 clinical reviewers to handle the surge (6).

Specifically, recent commercial activity in the CGT space includes: • 2017 saw the landmark FDA approvals of the first two chimeric antigen receptor (CAR) T-cell therapies; • 2018 saw Celgene paying $9 billion to acquire leading CAR-T company, Juno Therapeutics; • May 2018, Novartis acquired gene therapy developer AveXis for $8.7 billion • In December 2018, Moderna had the largest ever biotech IPO valued in excess of $600m based on its mRNA therapeutics; • January 2019, BMS announced a bid to acquire Celgene for $74 billion; • February 2019, Roche offer $4.3 billion for Spark Therapeutics; • March 2019, Cellectis announces plans to build 82,000 square feet CAR-T facility in North Carolina and 14,000 square feet facility in France; • In March 2019, Thermo agree to buy Brammer Bio a viral vector CDMO, in a $1.7 billion cash deal; • In April 2019, Regeneron announce an $800m investment in Alnylam, who in August 2018 received the first-ever FDA Approval of an RNAi Therapeutic.

Manufacturing challenges CGT manufacturing technology is still at a very early stage of development, equivalent perhaps to the Irish PharmaChem | Industry Buyers Guide 2020

manual roller-bottle technology of the 1980s for early clinical manufacturing of the first approved products from recombinant CHO cells (i.e., rtPA and EPO). As with mAbs and other recombinant proteins, the manufacturing technology around CGTs must and will improve in order to meet market demand and to ensure affordability. Each modality has its own unique challenges but some are relevant to all. Furthermore, there is no universally accepted way of generating either gene or cell therapies – therefore, each company is developing their own manufacturing capability, often with limited in-house expertise, which is time- and resource-consuming.

Gene therapy The technology currently employed to manufacture viral vectors is adequate for small patient populations (rare diseases) or to generate enough GMP material for clinical trials but significant improvements still need to be made to improve yield for more common indications. Dose can vary greatly also, depending on the indication, with ocular treatments typically requiring 1,011 AAV particles per eye for example, but blood factor replacement or muscular dystrophy could require 1,013-1,014 particles per kg.

Furthermore, viral vectors (both AAV and LV) are produced by transfecting a human cell line growing in culture, typically adherent culture – which is difficult to scale – with three or four plasmids carrying the various genes required to generate the virus, as well as the therapeutic gene.

These plasmids must initially be made in bacterial cells and purified to GMP standards. The resulting viral particles must be harvested, purified and tested for purity and potency and formulated for delivery.

At each of these steps, there are challenges to solve and opportunities to improve the associated technologies. For example: • generating high-yielding suspension culture cell lines; • generating chemically-defined media formulations for cell culture; • finding alternatives to large-scale transient transfections (for example creating stable, inducible cell lines akin to a mAb-producing CHO cell); • reducing the incidence of ‘empty’ viral particles (where the therapeutic gene has not been packaged within the virus – a particular problem with AAV); • finding novel separation technologies to purify correctly packaged virions from empty capsids; • ensuring absence of replication-competent virus; • new analytical techniques to monitor critical quality attributes of the viral product and improving stability after formulation.

This is by no means an exhaustive list but illustrates some of the hurdles that must be overcome to ensure gene therapies are a commercial as well as a therapeutic success.

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Cell and Gene Therapies

The single use training facility at NIBRT

Scott Gottlieb, M.D., former FDA Commissioner commented that, ‘In contrast to traditional drug review, where 80% of the review is focused on the clinical portion of that process, and maybe 20% is focused on the product issues, I’d say that this general principal is almost completely inverted when it comes to cell and gene therapy. The initial clinical efficacy is often established early, and sometimes in small series of patients. The more challenging questions relate to product manufacturing and quality…’ (8).

Finally, it is also worth noting that there is currently a global lack of clinical-grade

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manufacturing capacity available, which creates a bottleneck both for small companies and academia trying to generate material for early stage trials and larger entities anticipating market authorisation for more advanced leads (9).

Cell and gene-modified cell therapies The challenges related to manufacturing cells as therapies are very much dependent on whether the treatment in autologous or allogeneic.

Autologous treatments, such as CAR-T cells, by their very nature cannot be scaled-up (apart from production of the viral vector), as each individual

treatment is essentially a unique batch produced from and for a single patient. Therefore, the technical solution to delivering this type of therapy to large patient cohorts depends on scale-out, i.e. multiple small production units. In addition, the individual nature of the treatment means that ‘raw materials’ – the patient’s blood cells – are inherently and dramatically variable, creating significant debate as to how QC can be applied.

Also, the process of harvesting a patient’s T cells, activating and expanding them, transducing with lentivirus, harvesting, formulating and re-infusing, must be achieved in a compressed timeframe – typically 10-15 days – which limits the opportunity

Irish PharmaChem | Industry Buyers Guide 2020

Cell and Gene Therapies

to perform extensive product quality/ safety or other traditional lot release assays.

Allogeneic products are more amenable to scale-up, at least for part of the manufacturing process, after which they can be stored, but once thawed, they may also have a very limited timeframe within which they need to be administered. This last step must, therefore, either be achieved near to the patient, which requires local specialist infrastructure and skilled operators, or more centrally, which requires a reliable, fast and efficient logistics network. Finally, this creates challenges around data handling, including supply chain management, product tracking, complex data privacy laws (such as GDPR) and an increased trend towards linking remuneration structures to patient outcome.

The opportunity for Ireland Building on its pharmaceutical manufacturing legacy from the 1950s onwards, Ireland was able to successfully compete for FDI investment in biologics manufacturing, winning over €10 billion of investment from 2008-2018. Government’s strategic investment in NIBRT in 2005 to provide biologics manufacturing training and research was especially helpful in winning and sustaining this investment. For Ireland to capitalise on the opportunity presented by CGT, NIBRT established the Cell and Gene Therapy Manufacturing Forum in December 2018, with stakeholders from industry, academia and Government. This Forum produced a White Paper in May 2019 which defined a series of actions that are now being implemented to ensure Ireland can take

References 1:http://alliancerm.org/wp- content/ uploads/2019/03/ARM_AR2018_Web_FINAL. pdf 2. Data from Alliance for Regenerative Medicine 2018 3. Evaluatepharma World Preview 2018, May 2018 4. https://labiotech.eu/features/atmp-cell-genetherapy-ema 5.http://alliancerm.org/wp- content/ uploads/2019/03/ARM_AR2018_Web_FINAL. pdf 6.https://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm629493.htm 7. Evaluate Pharma World Preview 2018, May 2018 8. https://www.fda.gov/NewsEvents/Speeches/ ucm608445.htm 9.https://www.genengnews.com/insights/ scaling-up-cell-therapy-manufacturing/

advantage of this opportunity, including: • Workforce development: a commitment to ensuring small and large companies can source appropriately trained advanced manufacturing staff; • Research excellence: ensuring availability of scientific and engineering expertise within the national research system; • Infrastructure: providing the necessary capabilities to support investment or development (testbeds, incubators).

Ireland has many of the components to build a CGT industry, including the Remedi Centre in NUI Galway, who have a long history in this area.

It was encouraging to see Takeda opening a facility in Grange Castle that will produce Alofisel - an allogeneic cell therapy approved for treating complications associated with Crohn’s disease.

However, this is a highly competitive space and other jurisdictions are investing heavily to attract and support this industry. The UK has invested in a Cell and Gene Therapy Catapult in Stevenage, which provides facilities to scale-up production. 30% of Europe’s 400+ SMEs active in cell and gene therapies are based in the UK, and the UK have stated that the CGT Catapult will help build a £10 billion industry. It is worth noting that this facility took approximately four years from conception to active operation.

NIBRT looks forward to working with BPCI and all other stakeholders to ensure Ireland continues its impressive track record of success in biopharma manufacturing by winning the next wave of cell and gene therapy investment.

Note:.

This article is based on the White Paper, The case for supporting Cell and Gene Therapy Manufacturing in Ireland written by Professor Niall Barron, NIBRT.

Irish PharmaChem | Industry Buyers Guide 2020

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Traceability Investment & Development

Traceability from manufacturer to patient The evolution of the regulatory landscape is driving harmonised identification and traceability standards in healthcare. Industry is working with GS1 to achieve regulatory compliance for the identification of pharmaceuticals and medical devices and most recently the development of an identification standard for investigational products in clinical trials.

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Irish PharmaChem | Industry Buyers Guide 2020

Traceability

Healthcare systems around the globe are facing challenges that affect the entire supply chain.

The sector is concerned primarily with two main issues: patient safety and greater supply chain efficiency and accuracy. The facility to identify things uniquely and accurately is essential, be it a medication, an item of clinical equipment or even a patient.

Children’s University Hospital have been using the 2D barcodes applied at goods receiving to manage batch traceability for infant feeds within the hospital. Additional benefits of time saving, improved patient safety and improved stock management are also being realised. This is an excellent example of electronic traceability and it has prompted further traceability initiatives within the hospital.

Going beyond regulation

The regulatory landscape continues to evolve globally, and regulations in the EU, the US and elsewhere are having a major direct impact on the healthcare supply chain.

The Falsified Medicines Directive (FMD) took effect on February 9, 2019, for all EU member states. The directive, which seeks to establish a more secure supply chain for the distribution of prescribed medicines, requires the serialisation of patient packs to include a 2D barcode on all patient packs, which are then scanned at the point of dispensing for verification purposes.

Added to this, the legislation requires tamper evident labelling to enable the authentication of medicines prior to being dispensed to patients. In Ireland the ‘use and learn’ period will end on a phased basis starting from January 31, 2020.

FMD also presents an opportunity to leverage the value of regulatory compliance, particularly given the investment involved. As all prescription packs now have a 2D barcode, this barcode can be used to track products internally in the hospital or healthcare provider for the purposes of batch traceability, inventory management, scanning to the patient and more.

This legislation, along with the regulation for Unique Identification of Medical Devices, is driving a harmonised standard for identification in healthcare, and industry is working with GS1 to achieve compliance.

Laying the foundations for greater patient safety Hospitals are using GS1 standards when implementing traceability solutions to ensure the reliability of data and to optimise processes. This in turn reduces preventable errors, enhances Electronic Health Record management, supports outcome-based medicine and comparative effectiveness, and provides transparency for better clinical and supply chain management.

The Scan4Safety programme in the UK introduced barcode scanning in the theatre, with technology to scan products, patients, staff, locations, assets and more. This has had a significant impact on patient safety improvements and cost and process efficiencies.

Many sites in Ireland are now following suit, implementing their own programmes.

In Ireland, the benefits of using 2D barcodes to track and trace Haemophilia medication, surgical instruments and endoscopes are well recognised. Most recently, CHI at Temple Street Irish PharmaChem | Industry Buyers Guide 2020

GS1 traceabilty standards help to: ●

Improve patient safety;

Lower costs through increased efficiency;

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Reduce medication errors;

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Enable supply chain visibility;

Facilitate effective product recalls;

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Track pharmaceutical products/ medical devices;

Reduce introduction of falsified products

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Enhance inventory management;

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Link critical product data to the patient record;

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Support regulatory compliance;

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Optimise order, invoice, sales reporting and chargeback/ rebate processes.

Opportunities for Clinical Trial Supply Processes The opportunity for clinical trial sites is no different than for pharmaceutical companies and hospitals.

Barcodes are commonly used throughout clinical

Example of a product with a GS1 DataMatrix barcode (01) 09501101530003 (10) AB-123 (21) 000124pc123 (7240) PR0044

– Global Trade Item Number – Batch Number – Serial Number – Protocol Number

530003 501101 (01) 09 23 B-1 (10) A 24pc123 01 (21) 00 0044 PR ) (7240

trial supply processes. However, in the majority of cases they are designed by individual companies for their own internal use. They are inconsistent in the format and structure of the data encoded, and not useful to anyone apart from the organisation that originally printed the barcode. What this means is that the next stakeholder who scans the barcode is unable to use the information contained, which may lead to site-specific identifiers being applied at every point in the supply chain. This leads to manual paper-based processes, inefficient double-checking and potentially to errors when over-labelling and re-identifying.

In May 2019, following a nine-month collaboration with 37 clinical trial organisations from around the world, GS1 released an open application standard to support the management of clinical trials. This standard, developed by industry for industry, considers the many complexities and needs of clinical trial administration, such as the need for anonymity in the identification of products used in blind clinical trials.

The ‘GS1 Application Standard for the Identification of Investigational Products in Clinical Trials’ defines the rules, roles, and responsibilities for the allocation of GS1 identification keys and the barcoding of investigational products, primarily from the time of kit assembly to use and, if necessary, destruction. It is intended for use by all parties involved in clinical trial processes, including manufacturers, sponsors, packaging sites, distributors/3PLs, clinical trial sites, regulators, and patients.

The advantages of using a standardised approach to labelling investigational products includes; accuracy, efficiency, process familiarity, and safety.

Most importantly, adopting the GS1 Standard adds an element of trust at all levels of the supply chain – a trust that ultimately extends to the patients themselves.

Support Do you understand how to correctly implement GS1 identification numbers on your production lines? Are you aware of the specifications for creating and printing barcode labels?

GS1 licences the most widely used system of supply chain standards, serving more than two million public and private sector organisations worldwide.

GS1 experts are on hand to provide you with the help needed. They offer company-specific tailored courses on-site or you can choose to participate in one of their online webinars to learn about implementing GS1 identification standards such as GTINs and barcodes.

For more information please contact: Siobhain Duggan, Director of Innovation and Healthcare, GS1 Ireland. Tel: (01) 2080660. Email: healthcare@gs1ie.org Web: www.gs1ie.org/healthcare

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Regulation& Development Investment

Why agility matters in innovation and regulation Dr Lorraine Nolan, Chief Executive, Health Products Regulatory Authority, examines the innovations that will drive the medical/biopharmachem sector, including advanced therapy medical products and the evolution of the connected health era, and explains how our healthcare regulator has to remain agile to ensure the system and approach to regulation meets current and future needs.

BPCI’s BioPharma Ambition conferences, focusing on excellence in innovation and development in pharmaceutical, biopharmaceutical and chemical manufacture and supply, present a unique opportunity to showcase a sector in Ireland which continues to excel. These conferences continue to demonstrate not only an impressive evolution for BPCI but also for the sector as a whole.

The messaging reflects BPCI’s and its member’s acute awareness that past performance does not guarantee future success without sustained future investment in development and manufacture of medicines in Ireland. The HPRA, as the regulator, values the focus BPCI places on continually monitoring and acting on the many aspects of the changing environment.

The importance of agility It is clear that it has never been more necessary for manufacturers to be agile and adaptable, ready to compete for investment in new and next generation manufacturing technologies.

In parallel, for regulators, agility is essential to ensure the system and approach to regulation

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meets current and future needs.

It could be said that it is an unsurmountable challenge to regulate a sector which is at the forefront of technological innovation, particularly with respect to the biopharmaceutical manufacturing sector, where facilities are state of the art and feature cutting edge technology.

To me, this is not so much about the challenge but about the incredible opportunity it has afforded our organisation to contribute to patient health protection across the globe, where the medicines produced in Ireland are consumed globally, and provide critical, lifesaving and life altering treatment options to patients.

Achieving optimum regulation The HPRA has had to adapt and engage to ensure preparedness to achieve optimum regulation for the sector. This includes how we function and interact, our expertise requirements and ensuring that our regulatory and policy approaches remain fit for purpose in light of evolving needs. Part of our response includes working to enhance mechanisms for collaboration and harmonisation

with other regulators across the globe.

Innovators set the direction and the pace for the evolution of regulatory processes. Innovators bring forward the scientific development in products, technology and processes. To regulate effectively, we require innovators, whether working in industry or non-commercial settings, to engage with us earlier and earlier in their development pipeline.

The HPRA has always supported innovation but since the establishment of the HPRA’s Innovation Office in 2016, we have increased our outreach and offering. Much of this is built on engagement with our stakeholders at an early stage to sense and analyse needs. This is reinforced at European level through the EU innovation network, the European Medicines Agency’s (EMA) Innovation Task Force and indeed the EMA’s ‘Regulatory Science to 2025’ strategy, which plans to advance EMA’s engagement with regulatory science over the next five to 10 years.

Inevitably, working on a network basis provides access to a wider pool of expertise. This offers huge future potential, particularly with the development of centres of excellence and pools Irish PharmaChem | Industry Buyers Guide 2020

Regulation

Dr Lorraine Nolan, Chief Executive, Health Products Regulatory Authority.

of experts across the European network. All of this dialogue and engagement is vital to inform the future of regulation.

Advanced therapy medicinal products Looking towards future developments, there is no doubt that the next generation focus will be in the areas of advanced therapy medicinal products, specifically in the area of gene therapies, genome editing, and cellular regenerative medicines, which have incredible life-saving, life-altering potential.

It is already apparent that we will see a drive toward personalised medicines, driven through use of biomarkers to identify populations. We will also see harnessing of technology and process development, and greater use of new manufacturing technologies such as 3D printing to produce medicines and therapies tailor-made for the individual.

We live in the fourth industrial revolution, where

our access to data and technology has never been greater. This too is shaping regulatory thinking in terms of how we make benefit/risk assessments for medicines and other health products now and in the future. Harnessing the capabilities of realworld evidence and its use in regulatory decisionmaking is very much at the heart of evolving regulatory science.

The connected health era The next decade will see continued breakthroughs in technology that will directly impact the nature of patient care, bringing it more and more towards a home setting, particularly in light of aging populations. This will be enabled through connected health and reliance on medical smart devices and wearable technologies. This approach will support the generation of data and evidence on clinical outcomes and impact.

The connected health era will prevail as

populations age and care providers and payers require more evidence around clinical outcomes and impact. We expect to see smart sensors applied to more devices and increased levels of virtual care and remote monitoring.

Some key opportunities will present in the convergence between pharma, biopharma, medtech and technology. This certainly will bring us to explore how we can evolve our approach to regulation of medicines to include agile, adaptive and flexible approaches. I see this as an exciting time for the sector and a time where open conversations will lead us to a new and improved ways of operating.

Our success will be underpinned by engagement, among regulators, with industry and with all our stakeholders. As ever, our ultimate goal is to achieve the best outcomes for patients through collaboration, shared knowledge and robust regulation.

“To regulate effectively, we require innovators, whether working in industry or non-commercial settings, to engage with us earlier and earlier in their development pipeline.�

Irish PharmaChem | Industry Buyers Guide 2020

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Pharmaceuticals and the Environment

Managing the environmental impact of pharmaceuticals pharmaceutical industry.

The Eco-Pharmaco-Stewardship (EPS) aims to protect both the patients and the planet, The project, which ended in 2019, has used all writes Sini Eskola, Director, Team Leader, Regulatory, Drug development and Manufacturing, available scientific knowledge to develop tools European Federation of Pharmaceutical Industries and Associations (EFPIA).

Pharmaceutical innovation has delivered treatments that allow people to live longer, healthier and more active lives, particularly in recent decades. Since the 1980s, we have seen death rates from HIV fall by over 80%; since the 1990s, deaths from cancer have fallen by 20%; and recent pharmaceutical innovation means 90% of people living with Hepatitis C can be cured through a 12-week course of medicines.

One of the unintended but inevitable results of delivering these life-changing medicines to patients is that our products can find their way into the environment. The major source of pharmaceuticals entering into the environment (ca. 90%) is via patient excretion following use of a medicine that is taken to prevent, cure or alleviate a medical condition. A comparatively smaller contribution to PIE stems from emissions from industry (ca. 2%) during the manufacture of pharmaceuticals and from the incorrect disposal of unused or expired medicines (ca. 8%).

A balanced approach The issue of pharmaceuticals in the environment requires, however, a balanced and multistakeholder approach to be well managed. In contrast to many other substances/chemicals found in the environment, medicines play an important role in human health. The public health benefits of pharmaceuticals are undeniable.

This aspect should always be the priority when assessing the benefits and risks (including the environmental impact) of pharmaceuticals.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) recognises the concerns raised by stakeholders regarding the presence of pharmaceuticals in the environment (PIE) and we are committed to playing our role in addressing them.

Given the complex nature of this challenge, EFPIA decided to team-up with the selfmedication industry (AESGP), and generic and biosimilar manufacturers (Medicines for Europe) Irish PharmaChem | Industry Buyers Guide 2020

already a half a decade ago in order to minimise the impact of the industry’s activities on the environment, whilst remaining mindful of patient needs and ensuring access to medicines.

Pharmaceuticals in the Environment taskforce With this aim in mind, our inter-association Pharmaceuticals in the Environment “Taskforce” (IAI PIETF) has proactively developed the Eco-Pharmaco-Stewardship (EPS) concept, a proposal that strives to protect patient access to medicines, while appropriately considering environmental aspects. It considers the entire lifecycle of the medicine and addresses the roles and responsibilities of all parties involved, including public services, the pharmaceutical industry, environmental experts, doctors, pharmacists, and patients.

This life-cycle approach focuses on areas where we believe we can most effectively reduce the potential environmental risks that might result from industry’s activities: Pillar 1 – IMI iPIE project: the identification of the potential environmental risks of existing and new active pharmaceutical ingredients (API) through intelligent and targeted assessment strategies.

The European pharmaceutical industry has initiated a project under the Innovative Medicines Initiative (IMI), a joint undertaking between the European Commission (EC), academia and the

and assays which will prioritise and identify the pivotal areas in which more data would strengthen the understanding of a potential risk for medicinal products in use today. This will enable the most efficient and effective use of resources. It is anticipated that the output may also be applied to screen new Active Pharmaceutical Ingredients in development to target environmental testing needs.

In addition, the journey continues; in 2020, the industry is again driving the public-private partnership project in collaboration with multiple other stakeholders. The premier project will kick off sometime in spring and will focus on the four main aspects to bring more knowledge and tools for the management of PIE: 1) Co-designing of a decision tree and guidance for environmental assessment of pharmaceuticals; 2) Exposure and effects tools; 3) API information and assessment system; 4) Management, communication and dissemination of the information and delivered results.

Pillar 2 – Manufacturing effluents management: the compilation of best industry practices, enabling manufacturers to minimise risks to the environment.

For the most part, the processes used to manufacture medicinal products are largely similar, wherever in the world they may be used.

It therefore follows that potential losses into the environment from manufacturing facilities should also be equally controllable. However, this assumes that a good understanding of the risk to the environment and the knowledge required to limit losses are uniformly available.

In an effort across the industry, experts from several major manufacturers have shared experiences and developed a “maturity ladder” and associated guidance, in order to enable an enhanced understanding of the existing methods and the potential need for specific methodologies relative to the potential environmental risk posed

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by APIs and/or manufactured medicinal products.

Manufacturing companies were encouraged to exchange practices in further developing their level of effluent control systems. Furthermore, building on the earlier described work, the European pharmaceutical industry is working on the proposal for self-regulation to achieve a transparent and robust way of managing the manufacturing effluents from their own production sites and those from third party manufacturers.

Pillar 3 – extended ERA: the refinement of the existing environmental risk assessment (ERA) process for medicinal products to ensure that they remain up-to-date and relevant.

An important cornerstone of EPS is a refined Environmental Risk Assessment (ERA) process, extending beyond marketing authorisation.

The ERA of a medicinal product is currently performed by companies either as part of a new marketing authorisation or when an increase in the environmental exposure is expected, e.g. with the approval of a new indication or the inclusion of a new patient population.

ERA must be performed to evaluate potential risks of medicines to the environment and ensure adequate precautions are taken where specific risks are identified.

The extended ERA (eERA) includes provisions to adjust exposure predictions as usage figures become available to better reflect reality, including all products with the same API, and reconsider the effects profile, as relevant and reliable laboratory findings and/or observations in the field linked to an adverse outcome become available.

Other opportunities to minimise environmental impact The need for diligence does not end with the EPS pillars; there are many other opportunities to minimise losses to the environment along the lifecycle of a medicinal product, such as increasing transparency and access of the environmental data, and educating the public on the correct use and disposal of unused and expired medicines.

In order to promote the latter, a collaborative campaign focusing on the correct disposal of Irish PharmaChem | Industry Buyers Guide 2020

unused and expired medicines was initiated by the industry in 2015 (www.medsdisposal.eu).

Open collaboration EFPIA believes in open collaboration and constructive dialogue with stakeholders and policymakers, taking into account environmental and public health aspects, as well as their policy ramifications.

As our scientific understanding improves, we will find new ways of detecting the trace amounts of pharmaceuticals in the environment and understanding their impact. We are striving to improve our processes and develop new ways of creating treatments that not only save lives, but that are also mindful of the environment.

We remain committed to continuing to address environmental concerns through the Eco-Pharmaco-Stewardship initiative, whilst responding to patient needs and ensuring access to medicines, the paramount objective of our industry.

49

SSPC Investment & Development

SSPC

named research centre of the year SSPC continues to deliver industry relevant solutions and advancing talent for the pharma sector and was rewarded with two awards at the recent Pharma Industry Awards 2019, writes Louise O’Neill, Marketing & Communications Manager, SSPC. SSPC, the Science Foundation Ireland (SFI) research centre for pharmaceuticals, is a hub of Irish research expertise, developing innovative technologies to address key challenges facing the pharmaceutical and bio pharmaceutical industry.

The aim of SSPC is to deliver industry relevant technical solutions, which result in job growth and retention within this sector in Ireland and grow the skills base of qualified scientists and engineers.

The research carried out by SSPC crosses the pharmaceutical production chain from molecule to medicine, with the objective of

gaining a better understanding of mechanisms, controlling processes, and predicting outcomes for the efficient and environmentally sustainable production of safe medicines.

Specific areas of expertise include catalysis for organic synthesis, flow chemistry, theranostics, informed formulation for poorly soluble drugs, crystallisation, solid form selection, continuous manufacturing, peptide/protein production routes and characterisation, novel reactor technology, process, molecular and mathematical modelling.

Last year was particularly significant for SSPC as the Centre secured the outcome of their Phase II SFI Research Centre renewal application with a total value of €61m. This phase will fund 68 investigators, who will collectively support over 100 PhD students and over 80 Post-doctoral researcher years. SSPC, hosted by the University of Limerick (UL) in partnership with eight Higher Education Institutes, will continue and grow from (2019-2025), with an expanded research programme, flexible business model and greater focus on single-industry partner targeted projects.

Funding Success Over the past 12 months, SSPC accumulated an additional €7.5m in funding revenue. Some worthy highlights from this funding include a prestigious EU funding Innovative Training Networks (ITN) award (€276,000) with Janssen, Beerse and TU Dortmund, Germany, titled LongActNow. SSPC/ Trinity College Dublin (TCD) won funding of €3.5m under the EPSRC-SFI Centres for Doctoral Training (CDT) Partnership programme, engaging with two of the world’s leading Schools of Pharmacy in the UK, at the University of Nottingham and University College London, in a new CDT in Transformative Pharmaceutical Technologies.

SSPC/UL was awarded a €1.8m H2020 Cofund application titled Process this project aims to train researchers and develop engineering solutions for the pharmaceutical process industry, covering several thematic areas including process modelling and integrated process control, process analytical technologies (PAT) and smart data management, to promote processing agility and flexibility within an Industry 4.0 framework. With

50

Irish PharmaChem | Industry Buyers Guide 2020

SSPC Last year was particularly significant for SSPC as the Centre secured the outcome of their Phase II SFI Research Centre renewal application with a total value of €61m.

SSPC Co Director Professor Michael Zaworotko is pictured being formally admitted to the Royal Irish Academy. innovation central to the industry lifespan and success, facilitating knowledge sharing is critical in measuring collaboration and its successes.

Talent Development SSPC is producing an industrially relevant and ready workforce for the pharmaceutical and biopharmaceutical industry. SSPC has developed an existing international profile due to the quality of the research outputs and its people; 70% of SSPC graduates now work in the pharmaceutical sector globally, for example, Vertex, US; Bayer, US; Polpharma, Poland; Sanofi, France; Ardena, Belgium; Leo Pharma, UK; Marinomed, Germany; and Rg Pharmaceuticals, US. SSPC produces PhD graduates and post-doctoral researchers with specific disciplinary expertise, coupled with a broad understanding of cognate disciplines across pharmaceutical science and manufacturing. SSPC is the only research centre in Ireland to offer an industry placement to their PhD students. This programme’s emphasis has been to train the next generation of highly skilled industryrelevant researchers to spearhead a new phase in the evolution of Ireland’s pharmaceutical sector.

regulatory professionals. SSPC engaged with Skillnet, Springboard, BioPharmaChem Ireland (BPCI) and industry to ensure the programme was both fit for purpose and accessibility. 90% of participants would or already have recommended the course to a colleague. Feedback indicated the course was “excellent” and students “would highly recommend to anyone with an interest in gaining a solid background in the regulatory area, commercial or clinical, or those working in regulatory who would like to broaden their existing knowledge.”

Niamh Lawlor Turner, Industry Course Director, added, “I think that the phenomenal interest in the course is as a consequence of the feedback that the course has received from previous attendees; we have not needed to invest in a marketing campaign. The quality of the course is as a result of the very experienced lecturers, who were chosen for their diverse expertise in all aspects of pharmaceutical regulation (Chemistry Manufacturing and Controls (CMC), preclinical, clinical and post marketing). This, coupled to the fact that our competencies come from different areas of the pharmaceutical industry, i.e. companies (innovative and generic), EU

regulatory authorities, the European Commission, as well as from the professional body TOPRA (The Organisation for Professionals in Regulatory Affairs), means that our delegates get a very broad yet thorough grounding in the area of Regulatory Science.”

Flexible Business Model A new business model has now come into effect at SSPC. Feedback from industry formed the basis of the model, providing opportunity for direct engagement through targeted single or multiple industry partner projects or broader engagement through a bespoke industry membership model.

Targeted projects, by their nature, offer increased opportunity to generate measurable intellectual property and will be an important aspect of the Centre into the future.

SSPC is led by the UL at the Bernal Institute, in partnership with University College Cork, National University of Galway, Trinity College Dublin, Dublin City University, University College Dublin, Waterford IT, Maynooth University and Royal College of Surgeons Ireland.

For further information, visit www.sspc.ie.

Delivering Results SSPC has been acknowledged for excellent research and advancing talent by receiving two awards at the recent Pharma Industry Awards 2019, winning Pharma Research Centre of the Year and the Pharma Education and Training Award.

Speaking on their win, Denise Croker, SSPC Executive Director, said, “SSPC has had a strong year recording exceptional businesses and growth. We are delighted to win such an award that recognises the contribution the Centre is making through its collaborations in Ireland and abroad. Engagement with the pharmaceutical sector and building R&D excellence has been one of the hallmark achievements of SSPC.” SSPC/UL’s Specialist Diploma in Regulatory Affairs won the Pharma Education and Training Award. This is a jointly developed course, making a significant contribution to the pharmaceutical sector in Ireland through the provision of skilled Irish PharmaChem | Industry Buyers Guide 2020

SSPC members are pictured receiving an award for Pharma Research Centre of the Year at the Pharma Industry Awards 2019.

51

Occupational Safety and Health

Psychosocial risks require additional attention, particularly in terms of determining situations and employment practices that effect work-related stress and mental health outcomes.

Putting OSH at the heart of your business Jobs exist today that were unheard of 10 years ago and jobs will exist in 10 years’ time that are unheard of today. Workplaces are constantly changing; there are new forms of employment, types of businesses and cultural norms which affect the structure of workforce/labour market.

In the biopharmachem sector, technologies that are now commonplace – such as single use technology – were in their infancy 10 years ago and the same will happen again in the next 10 years.

This article will look at how biopharmachem companies can make OSH the heart of their business in a sustainable and proactive way.

It examines how the International Labour Organisation’s (ILO) Safety and Health at the Heart of the Future of Work report can be adapted to the circumstances of the Irish workplace and address the obligations of Irish employers to ensure the future wellbeing for everybody in the sector.

Historical context and an Irish perspective The late 1980s saw a flurry of OSH activity in Europe, culminating in the publication of the European Framework Directive on Safety and Health at Work (Directive 89/391 EEC). Adopted in 1989, this was a substantial milestone in improving safety and health at work across the European Union. It guarantees the minimum safety and health requirements, while Member

52

Michael Gillen, Senior Executive Responsible for EHS & Responsible Care, BPCI, examines the future of Occupational Safety and Health (OSH) in the Irish biopharmachemical industry.

assessment affords the necessary controls to work safely in more hazardous environments, such as those encountered in our industry.

Anticipation of new OSH risks Michael Gillen, Senior Executive Responsible for EHS & Responsible Care, BPCI

States are allowed to maintain or establish more stringent measures. The key principles contained within this directive are:  Protection of safety and health;  Assessment and prevention/elimination and

of risks and accident factors;

 Balanced consultation, participation and training of workers and their representatives.

Indeed, it is this concept of ‘risk assessment’ that has been at the cornerstone of improvements in all areas of OSH in the intervening years. Risk

Anticipating risks is a crucial first step to effectively managing them and building a preventative OSH culture in an ever-changing world. In recent years, foresight processes have emerged, particularly in Europe, led by EU-OSHA, which aim to identify and prioritise research and innovation to deal with the type of changes highlighted in this article. These include practices such as forecasting, technology assessments and future studies, which enable the identification of potential work-related safety and health risks and the development of effective preventative actions.

In 2015, the European Commission published an ex-post evaluation of the EU OSH acquis.

The results of this review confirmed that the Irish PharmaChem | Industry Buyers Guide 2020

Safer, more efficient care starts with a simple scan Achieving patient safety and efficiency through the adoption and implementation of GS1 standards to enable seamless track and trace from manufacturer to the patient bedside.

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Occupational Safety and Health existing legislation is generally effective and fit-forpurpose, while pointing to the need of reviewing, where appropriate, objectives, priorities and working methods to adapt the EU legislative and policy framework to changing patterns of work, and new and emerging risks. Below, we examine two risks that require careful consideration.

We need to understand the dynamics of antecedents of stress, including unhealthy work stressors.

Psychosocial risks Psychosocial risks require additional attention, particularly in terms of determining situations and employment practices that effect workrelated stress and mental health outcomes. The Ibec publication, ‘An employer’s guide to mental health in the workplace’, found that a positive and proactive approach to the promotion of mental wellbeing will reap benefits in terms of reduced absenteeism and greater productivity.

Many people with mental health problems require minimal support, while others need more substantial support, and this may vary over time for the individual. Line managers and colleagues are key to promoting a culture that is positive towards mental health and supporting individuals with mental health problems in the workplace. Working in a supportive team that cares about the wellbeing of its members can make a huge difference to the working environment for everyone.

Further considerations and research are required on issues such as:  How to integrate psychosocial risks in risk assessments as part of OSH management systems in order to develop targeted prevention and hazard management strategies, interventions and evaluations;  How to develop a psychosocial safety climate and better manage mental health at the workplace;  Understanding the dynamics of antecedents of stress (unhealthy work stressors) and the antecedents of well-being (including demand-resource models and issues related to the individual), organisation and the environment;  The correlation between psychosocial risks at work and their effect on the physical health of workers;  The correlation of excessive working hours and sedentary work with physical health effects on workers.

Ibec’s KeepWell mark is an example of how employers are embracing evidence-based accreditation in workplace wellbeing. KeepWell provides a clear path, outlining and guiding companies on how to improve workplace health and safety while maintaining a sense of wellbeing.

The programme helps boost productivity among the workforce, along with reducing employee absenteeism and turnover.

OSH have a clear spill-over on people’s health and wellbeing in general, and on that of society as a whole. If work is recognised as a social determinant of health and wellbeing, then there is a need for greater attention to the connections between OSH and public health. This link has implications for the interconnected infrastructures that govern health care, environmental health, and social welfare and social protection. Healthy Ireland is a government-led initiative aimed at improving the health and wellbeing of everyone living in Ireland.

It is articulated through four central goals:  Increase the proportion of people who are healthy at all stages of life;  Reduce health inequalities;  Protect the public from threats to health and well being;  Create an environment where every individual and sector of society can play their part in achieving a healthy Ireland.

There is a strong bridge among various mechanisms, e.g. occupational health services and public/private health service, to support the health of workers.

There is an increased recognition of the links between the worker wellbeing and the cause/ prevention of psychosocial disorders and noncommunicable diseases, such as hypertension, cardiovascular disease, gastrointestinal disorders,

The link to public health A major consideration for employers is the blurring of boundaries between occupational and public work, which will negatively impact upon employee wellbeing. The effects and outcomes of

52 54

Ibec’s KeepWell mark is an example of how employers are embracing evidence-based accreditation in workplace wellbeing.

diabetes and other leading causes of mortality.

This may call for expanded protection through public health approaches and services and more research on the combination of procedures governing occupational and environmental health, considering, for example, aspirations for a better quality of life that are closely joined with other activities relating to the protection of the human environment.

The evolution of the worker lifecycle For most workers, the norm is no longer to work for a single employer. Instead, a worker’s lifecycle encompasses many employers and potentially several jobs and careers of various forms. The lifecycle of a worker also spans from education to training, to work, to managing various responsibilities, to social protection and to retirement. Lifelong learning is increasingly part of the worker lifecycle. Therefore, the safety and health of an individual as a human being as well as a worker is crucial to public health and OSH, as it is a constant factor in all forms of work.

The shifting boundaries between work and domestic life also have important implications for protections of workers that may be offered by public health approaches and services. Where work occurs beyond the traditional confines of the workplace, public health may face additional challenges in protecting the health and wellbeing of workers.

The employment relationship is increasingly fragmented - often in terms of limited-term contractual agreements or other non-standard forms of employment - and workers face many different working conditions and working arrangements.

Many of the improvements made in relation to OSH in Ireland over the past 40 years have gone hand-in-hand with social and economic development more generally. This development coincided with the emergence of the biopharmachem industry as being a key sector in Ireland’s story. We now know that strategies to achieve social and economic development go far beyond those related to OSH; nevertheless, OSH should be properly integrated into wider development approaches to provide for a future of work that benefits all.

Irish PharmaChem | Industry Buyers Guide 2020

Engineering Cells Fit Engineering Cells Fit For Immunotherapy For Immunotherapy Engineering Cells Fit For Immunotherapy

Avectas is a cell engineering business, developing a disruptive non-viral delivery technology Avectas for theisdevelopment of next generation cell and gene therapies. a cell engineering business, developing a disruptive non-viral delivery

technology for the next generation cell and gene therapies. is gentle onofcells and delivers advanced molecules Our technology SoluporeÂŽ, development is gentletools on cells delivers Our technology Solupore such as mRNA, proteins and geneÂŽ,editing toand a range ofadvanced primarymolecules cell types such as mRNA, proteins gene editing tools to a range primaryapplications. cell types ncluding T cells and NK cells forand immuno-oncology and geneofediting Avectas isTacells cell and engineering developing a disruptive delivery including NK cellsbusiness, for immuno-oncology and gene non-viral editing applications. technology for the development of next generation cell and gene therapies.

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Our technology SoluporeÂŽ, is gentle on cells and delivers advanced molecules such as mRNA, proteins and gene editing tools to a range of primary cell types including T cells and NK cells for immuno-oncology and gene editing applications.

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Avectas believes that in a cGMP manufacturing setting, SoluporeÂŽ will deliver efficacy, safety and reduced cost of goods, while decreasing the time required to deliver modified cells to patients.

Irish PharmaChem | Industry Buyers Guide 2020

Cell Engineering Technology Avectas is a cell engineering technology business, enabling the manufacture of cell therapies. The Avectas Solupore® non-viral technology delivers advanced molecules such as mRNA, DNA, proteins and gene editing tools to a range of cell types, including primary human T cells for immunotherapy applications.

Immunotherapy is a type of biological therapy that has the potential to revolutionise cancer treatment by helping a patient’s own immune system to better target cancer cells. Increased understanding of the role of the immune system in cancer has led to the development of new approaches to harness and enhance the body’s natural defence system.

One such approach is ex vivo immune cell therapy, where live cells, taken from either a patient or a healthy donor, are transferred into a patient to treat disease. Before being administered to patients, the immune cells can be engineered to possess more functionality, including disease targeting, potency, and safety. This form of cellmediated immunity can eliminate cancer cells and enable durable remissions.

CAR T immunotherapy CAR T is a type of immunotherapy in which T cells are taken from a patient’s blood and are modified or ‘engineered’ in the laboratory to attack cancer cells. The gene for a special receptor - Chimeric Antigen Receptor (CAR) - that binds to a certain protein on the patient’s cancer cells is delivered into the patient’s T cells.

Large numbers of the CAR T cells are grown in the laboratory and infused back into the patient.

Viral vectors have successfully been used to engineer the first CAR T products for patients with certain haematological malignancies.

Novartis AG’s Kymriah (tisagenlecleucel) and Gilead’s Yescarta (axicabtagene ciloleucel) have provided exciting clinical efficacy for these first-generation breakthrough therapies, with significant numbers of patients experiencing either a complete or partial response.

Non-viral technology The next challenges for the field include improving patient response rates, reducing manufacturing costs, targeting solid tumours and developing off-the-shelf CAR T products.

While viral vectors are currently leading within the field of cell engineering issues with long lead times, high costs, manufacturing bottlenecks, packaging constraints and immunogenicity have encouraged cell therapy manufacturers to seek alternative non-viral technologies.

Currently, the leading non-viral delivery technology is electroporation, which involves subjecting cells to an electrical pulse that transiently increases the permeability of the cell membrane, allowing certain cargoes to enter the cell. However, electroporation is harsh on cells and has been found to reduce functionality of cells. In autologous settings, the cells isolated from patients are already in a weak state from previous rounds of conventional therapies, so it is a challenge for cell therapy developers to maintain their phenotypes and their fitness, while Irish PharmaChem | Industry Buyers Guide 2020

CAR T is a type of immunotherapy in which T cells are taken from a patient’s blood and are modified or ‘engineered’ in the laboratory so they can attack cancer cells more effectively. performing extensive genetic manipulations on the cells. Thersfore alternative delivery technologies are required.

Solupore® Avectas is currently focused on the scale-up, validation and commercialisation of its non-viral delivery technology. The company’s technology, Solupore®, comprises a proprietary formulation and fluidic device to transiently permeabilise cell membranes, which allow for efficient take-up of a broad range of cargoes, including large proteins nucleic acids and combinations of cargoes.

Solupore® can be applied either to adherent cells or to cells growing in suspension. The protocol has been integrated with back-end electronics and automation from the start to ensure smooth integration into manufacturing processes.

Uniquely, compared with other non-viral technologies such as electroporation, cells engineered with Solupore® retain high levels of viability and functionality. The Avectas team has presented data at the leading cell and gene therapy conferences, including Phacilitate and ASGCT. The company is positioning the

technology for the next wave of cell therapies, including CAR T and CAR NK therapies, which will be more heavily engineered than the firstgeneration therapies that are currently available on the market.

Worldwide collaboration The Irish-based company, a 2012 spinout from Maynooth University, is already working with leading therapeutic developers and research institutes in the US, UK and Europe. Whilst receiving guidance from an international scientific advisory board, which includes Professor Mark Lowdell, Director of Cellular Therapy at University College London; Professor Evren Alici, Leader of the Cell and Gene Therapy Group at the Karolinska Institute; Professor Karl Peggs, Head of Stem Cell Transplantation and Immunotherapy at University College London; and Professor Bruce Levine, of the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, a coinventor of Kymriah.

Avectas believes that in a cGMP manufacturing setting, Solupore® will deliver efficacy, safety and cost-of-goods benefits, while cutting down on the time required to deliver modified cells to patients.

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• Site survey & system recommendation choice for ou guidelines. We provide a • Supply, installation & commissioning complete solution of Mechanical • Project management maintaining, • Energy Saving Packages equipment fr Equipment, Fire Rated Insulation • Monitoring Systems and a wealth of application knowledge to ourPRODUCTS & SERVICES clients. • Plant service and maintenance cabinets and PRODUCTS & SERVICES • Site survey & system recommendation Cross Technical Solut • Site survey & system recommendation Unit 26, Cookstown Industri PRODUCTS & SERVICES • Supply, installation & commissioning Cross Te • Supply, installation & commissioning With a vast knowledge of the refrigeration industry and the Cookstown, Tallaght, D • Site survey & system recommendation Unit 26, Cooks • Project management Co. Dublin • Project management • we Supply, installation & commissioning Cookstow • Energy Saving Packages Pharmaceutical sector in particular, are the first choice for Tel (+353) 01 4 • Energy Saving Packages • Project management • Monitoring Systems Fax (+353) 01 our large client base when• itMonitoring Systems comes• to servicing, maintaining, Energy Saving Packages • Plant service and maintenance sales@crosstechnicalsolT • Plant service and maintenance F • equipment Monitoring Systems and replacing all types refrigeration from large www.crosstechnicalsol sales@cros • Plant service and maintenance

Suppliers of a wide range of raw materials /blending services to the pharmaceutical and medical device industries 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

www.cros

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Pharmaceutical Manufacturing Technology Centre The PMTC provides an introduction platform, giving SMEs a place at the table so that they can directly engage in technical discussions with multi-nationals.

PMTC

proves its worth Since its inception in 2013, the Pharmaceutical Manufacturing Technology Centre (PMTC) has established itself as a sector-leader in delivering industry informed, strategically-relevant research focused on developing advanced technology solutions for all stages of pharmaceutical manufacturing.

Growing from strength to strength, the centre was recently awarded a second funding grant from Enterprise Ireland to support the next five years of research and innovation projects.

The decision by Enterprise Ireland to re-fund the PMTC was based on a number of factors, namely the PMTC’s track-record of attracting new industry membership, clear projected economic value to Ireland, evidenced by improved process efficiencies and innovation, and its alignment

The Pharmaceutical Manufacturing Technology Centre has proved its worth to the industry, as evidenced by its second funding award from Enterprise Ireland, writes PMTC Director, Sarah Hayes. with Enterprise Ireland’s strategic goals to support Ireland’s manufacturing excellence.

PMTC and the Irish manufacturing landscape Industry is at the heart of delivering manufacturing competitiveness. The Irish pharmaceutical industry directly employs over 28,000 people, with almost the same number employed indirectly through the sector. Medicines count for more than 60% of all exports from the country, with the level of exports having increased three-

fold in the past two decades, making Ireland the largest net exporter of pharmaceuticals in the EU. While Ireland has positioned itself as a sector leader, there is still much to be done to fully demonstrate the economic returns to Ireland Inc. The Irish operations of big pharma are increasingly aware of the need to improve their value proposition and efficiency and are looking to research, development and innovation to support this strategy. Despite its economic and societal importance, the pharmaceutical sector is facing significant societal, scientific and economic challenges globally, which have the

The PMTC is projected to add significant value over the coming years.

Irish PharmaChem | Industry Buyers Guide 2020

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Pharmaceutical Manufacturing Technology Centre potential to impact its future sustainability. As a result of these challenges, pharmaceutical manufacturers need to respond to these changes by developing and implementing new and more efficient production techniques.

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

The PMTC sits at the interface of industry and academia and supports the pharmaceutical manufacturing industry and its supply chain to solve problems. To date, the research developed by the PMTC has helped deliver a range of outputs that are starting to help companies, both large and small, deliver benefits to the company and, therefore, to Ireland.

The PMTC differentiates itself by focusing on industry-informed research, where programmes are driven by real market needs defined by industry.

With this in mind, the PMTC is led by an Industry Steering Committee with an active research programme championed by its industry members. Companies seek out collaboration with the PMTC to create projects and to execute world-class research in advanced technology solutions to address contemporary manufacturing challenges. 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. Cleaning - including containment,

changeover, and validation; 2. Process control and optimisation; 3. Applied data utilisation/analytics;

A key objective for the PMTC in Phase 2 will be enhanced emphasis on broadening its SME membership and will 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.

The PMTC provides an introduction platform, giving the SMEs a place at the table 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. While the PMTC team is relatively small, with a current staff of less than 10, this allows the Centre to be agile in approach.

The Centre will, by design, respond to the needs of the industry members and will acquire additional competencies and team members in line with defined projects and the growth path of the Centre as it evolves.

Where we will lead

the PMTC also facilitates company/company collaborations, many of which provide SMEs access to an MNC customer base.

The PMTC further recognises that collaboration requires meaningful engagement. To this end, 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.

Knowledge sharing across the PMTC community 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. In line with the ongoing capital investment programme, the demand for highlyskilled talent is on the rise. In response, the PMTC Sarah Hayes, PMTC Director, and Professor Gavin Walker, pictured at the PMTC Knowledge Day 2019.

The impact of the PMTC The PMTC currently partners with 38 industry members. The benefits of the Centre are multi-faceted and include access to the direct outputs from the research programme. Not only do member companies have access to competencies and a suite of world-class facilities, but they also retain preferential right of first sight of the research output.

Collaboration is central to the ethos of the PMTC, and processes are in place to translate the outputs of the research to realise impact in companies for licensing or further funding mechanisms to be exploited.

Fostering collaboration is not limited to the PMTC and individual industry partners; rather, by working together towards mutual benefit,

About the PMTC The Pharmaceutical Manufacturing Centre (PMTC) is one of 10 world-leading technology centres funded through the Technology Centre Programme. The framework is a joint initiative between Enterprise Ireland and IDA Ireland and unites highly-skilled researchers and institutions of excellence with industry to deliver cutting-edge and strategically-relevant R&D projects. For more information about PMTC and its mission, visit www.pmtc.ie.

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Irish PharmaChem | Industry Buyers Guide 2020

A NEW NAME BACKED A NEW NAME BACKED BY 75+ YEARS OF BY 75+ YEARS OF EXPERTISE EXPERTISE Comprising of SK biotek Korea, AMPAC Fine Chemicals and SK biotek Ireland combined toofenable the provision of the Fine highest quality services to ourIreland customers.

Comprising SK biotek Korea, AMPAC Chemicals and SK biotek

combined to enable the provision of the highest quality services to our customers.

• Sites across the globe •• 1000m3 of global capacity Sites across the globe •• 31000m3 R&D Centres of global capacity •• 13 Analytical Service R&D Centers •• Energetic Chemistry 1 Analytical Service Center •• Continuous Flow Process Energetic Chemistry •• High PotencyFlow Process Continuous •• Controlled Substances High Potency •• Particle Engineering Controlled Substances • Particle Engineering

COME VISIT US

5 – 7 November 2019 | Frankfurt, Germany

USA | Ireland | Korea www.skbiotek.com | ampacfinechemicals.com USA | Ireland | Korea skbiotekmarketing@sk.com | afcbusdev@apfc.com www.skbiotek.com | ampacfinechemicals.com skbiotekmarketing@sk.com | afcbusdev@apfc.com

HALL 10.1 STAND A30

Waste Management

Your partner in safe and sustainable waste management Indaver help convert waste to energy at their Meath plant.

As an international waste management company offering sustainable, cost-efficient and tailored solutions to large-scale industry, Indaver takes its responsibility seriously to contribute to a clean and safe planet. In doing so, we focus on using less primary and fossil feedstocks and on recovering, reusing and recycling materials efficiently. Thanks to our 30 years of expertise and wide range of in-house facilities and processing possibilities with third parties, we offer a solution for each type of waste. Through improved recycling and maximum recovery of energy and valuable components from waste, Indaver is leading the field in sustainable waste management.

Over the years, Indaver has 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. In our Meath plant, the first Waste to Energy installation ever in Ireland, 235,000 tonnes of waste per annum is converted into renewable energy, thus providing a sustainable alternative to fossil fuels.

Energy recovery The energy we recover through thermal treatment of waste goes to a combination of steam heating networks (e.g. ECLUSE in the port of Antwerp) and electricity grids (e.g. Meath). It is supplied to users as steam, heating and electricity. This approach has a lot of advantages. We are avoiding and reducing CO2 emissions and reducing dependency on limited fossil fuels. We are replacing them with renewable energy sources, such as green gas

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Indaver are helping to use less fossil feedstocks and limiting their environmental impact through safe and sustainable waste management, writes Dr Ruth Appelbe, Industrial Waste Services Manager, Indaver Ireland.

Dr Ruth Appelbe, Industrial Waste Services Manager, Indaver Ireland. from composting VGF waste.

Materials recovery We have to be sure that the products made from recovered raw materials have the same quality as products from primary raw materials and that they are equally safe. That is why we focus on the molecular level when looking at material recovery. Our high-tech installations break down hazardous industrial/ pharmaceutical waste to its basic building blocks. Our expertise and innovation proved to be key in this matter. As true ‘Molecule Managers’, we developed new chemical recycling techniques and invested in finetuning proven technologies. New high-quality products are then made from these building blocks. This way, we recover as many valuable high-quality materials as possible from the waste we treat.

Keeping the food and materials safe We protect the environment, the food and materials chains from contamination because

our specialised processing installations not only recover energy but fully destroy the hazardous substances and residues in the waste as well. Any contaminants we can’t destroy are treated and/or stored away securely. That is our ‘Safe Sink’ guarantee. This prevents hazardous particles from causing any damage in the materials/food chain, now or in the future.

Minimise our environmental impact Our ambition is to further reduce the environmental impact of our own activities.

That is why we use water and energy sparingly in our own processes. We are always looking for ways to reduce raw materials usage and we substitute new materials with recovered materials where possible. We limit our ecological footprint when transporting waste by choosing lean, local and intermodal logistics. Our activities meet the strictest environmental standards. We monitor our performances closely to have a minimal impact on the air, water and soil.

Irish PharmaChem | Industry Buyers Guide 2020

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

The circular economy. Together we make it happen. www.indaver.ie

adv A4_IERL_20191002.indd 1

3/10/19 10:20

Packaging

The world today is in disarray; whether it is the United States you look at, or the UK and Brexit, or China and Hong Kong, or Climate Change protests, uncertainty reigns supreme.

This uncertainty has permeated all aspects of society, from politics to business.

Amid all the chaos, there is reassurance for Irish business owners in the constant that is Limerick Packaging with their 100% sustainable products made from a material with the second lowest carbon footprint, delivered “On Time, Everytime”. The people at Limerick Packaging make corrugated cardboard boxes using paper and claim that they can make a box using 230g of paper that will protect and carry a product to the ends of the earth and can easily resist a load of 500kgs or half a tonne. That’s quite a claim, as is their further assertion that when printed to the standard that they achieve on a daily basis, that box will increase sales for their clients because of brand recognition and its visibility on-shelf.

Another huge string to Limerick Packaging’s bow is the way they deal with their customers.

“We love orders,” explains Limerick Packaging’s Sales Director, Mike Boland. But simply taking an order is only the beginning of the customer relationship. Once an order is produced, Limerick Packaging don’t simply deliver it in one bulk and forget about it. Limerick Packaging will store that order and deliver daily or weekly

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A constant in a world of uncertainty Delivering ‘On Time, Everytime’ is the secret behind the continued success of Limerick Packaging, who sometimes understand their clients’ packaging needs even better than the clients themselves. as the customer requires. In this way, the customer does not require warehousing, does not have capital tied up in stock and only pays for their packaging as they use the products.

“We have very many clients today who have converted their warehouses into production halls,” explains Boland. “They only have the packaging on-site that they need right away, instead of having a warehouse full of packaging they don’t need. In this way, the capital that

would have been tied up in packaging stock is being used to grow their businesses.”

High quality print In walking through the magnificent facilities at Limerick Packaging one cannot help but be struck by the cleanliness and organistaion of the facilities. All stock is bar-coded, as are all locations, so ease of location and FIFO (first in, first out) is made simple.

Irish PharmaChem | Industry Buyers Guide 2020

Packaging Another thing to catch the observer’s eye is the sheer volume of medical/pharmaceutical packaging and food and drinks packaging that Limerick Packaging supplies. Managing Director, Connie Ryan explains that the company excels at very high quality print and in recent years has become exceptionally good at Shelf-Ready Packs or Retail-Ready Packs.

The medical/pharma sector has always been an important one to the Limerick company, and they count a host of blue chip Irish pharma companies among their client base. Along with their standard range of Corrugated Boxes in regular slotted case form and die-cut format, Limerick Packaging’s extensive product range includes Retail Ready Packs (SRP/RRP) in either Litho print, Pre-Print Flexo or high quality Post-Print Flexo. They also supply industrial polythene bags, sheets and pallet hoods, pallet edgeguards, high quality post-printed boxes, pallet-wrap, strapping, strapping accessories, tapes and a full range of protective foams.

Understanding their clients’ business The appeal of Limerick Packaging to the pharmaceutical sector goes beyond mere product range, however, as Connie Ryan explains: “We were also always very good at manufacturing medical/pharmaceutical packaging, but what completely sets us apart from our competition is we take the time and effort to understand our customers’ business.

Because of this, we know our customer’s requirements intimately and will alert our clients to the need to place new orders, sometimes before they know themselves.”

So what is it that makes Limerick Packaging the fastest growing packaging company in Ireland? “We have completely underestimated

Irish PharmaChem | Industry Buyers Guide 2020

the power of delivering ‘On Time, Everytime’,” notes Ryan. “We are also extremely grateful to all the customers that gave us business 18 years ago when we started. Imagine, most of those customers are still with us today and have grown with us. Every day, we add new customers, eager to avail of our unique and now famous stock & serve system and our aim is that these will also still be with us long into the future.”

Growing client portfolio When Limerick Packaging began operating back in 2002, entrepreneurs Connie Ryan

and Mike Boland wished for a client list of 60 customers. Today, that list is 400-strong and growing all the time “Wouldn’t it be great to look back in another 18 years and find we are retaining all our customers purely on our pin-point accurate service,” notes Ryan. “As Mike Boland tells all of our customers, “We will work hard so you don’t have to; we will make your working life easy’.”

That simple promise continues to serve them well, and the future looks extremely bright for this progressive, customer-centric company.

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ADVERTORIAL

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As channel partners for leading manufacturers of laboratory solutions we offer services to a wide range of industries including the Food, Pharmaceutical, Chemical,

Environmental and Research sectors in Ireland & Northern Ireland. We work with a team of dedicated service engineers to support all our distributors systems.

CEM, design and develop laboratory instrumentation and scientific methods used by major companies, prestigious research institutes, and universities around the world. CEM create unique solutions for compositional analysis of food and chemical samples, acid digestion for elemental analysis, and chemical synthesis of peptides and small molecules.

Magnetic Resonance offers a range of benchtop Nuclear Magnetic Resonance (NMR) instruments to a wide range of industries. X-Pulse is a high resolution, broadband benchtop NMR spectrometer. Our MQC+ benchtop analysers measure oil, water, fluorine and solid fat in a variety of samples and are typically used for quality assurance and quality control in the food, agriculture, polymers and chemicals industries. MQR is a low resolution, high performance TD-NMR research system designed for applications based on relaxation and/or diffusion measurements and our GeoSpec rock core analysers are used for sample testing in the oil exploration field.

Parker, the global leader in gas generation technologies offer Hydrogen (Lab & Industrial), Nitrogen, LCMS Nitrogen, Zero air and CO2 Free air Gas generators for many diverse applications within many different laboratories.

A&D’s core technology of analogue and digital conversion enables us to understand and utilise information within the environment. With this competency, we provide balances using precision measurement and controlling technology.

The wide range of features available in the Prestige Medical Classic range offers multiple benefits for users. Options include: 9 or 12 litre capacity; 121, 126 or 134°C sterilising temperatures; different internal furniture options; and models with a printer connection – flexible, practical, portable and value for money.

http://siireland.ie info@siireland.ie Scientific Instruments Ireland (Sii), Phone: +353 (086) – 8258346 (Michael Crean) Oulart House, Phone: +353 (087) – 9813310 (Aaron Ryder) Cullaghreeva, Phone: +353 (086) – 8331056 (Jenny Egan) Clonsilla, Phone: +353 (087) - 6154386 (Sarah Flynn) Dublin 15

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Irish PharmaChem | Industry Buyers Guide 2020 1

Active Pharmaceutical Ingredients

SK pharmteco:

a partnership for success SK pharmteco is a new name with more than 75 years’ experience.

SK pharmteco is the single market-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 them to provide the highestquality services to customers.

SK pharmteco is a wholly owned subsidiary of the South Korean conglomerate SK, a global leader in energy, chemicals and information technology; it is the cornerstone of SK holdings’ growth strategy.

As part of SK, SK pharmteco enjoys worldclass, state-of-the-art facilities and technology, with increased capabilities across energetic chemistry, continuous flow process, controlled substances, particle engineering, high potency - with world-class potent handling capability (down to low nanogram per cubic metre levels).

They have multiple cGMP manufacturing and development sites, with over 1020 m³ of capacity between six sites, including the USA, Korea and Ireland.

Their scientists and engineers are leaders in continuous manufacturing methodologies (tubular and fixed bed reactions and CSTRs), having successfully developed processes from low kilograms through to tens of tonnes.

Simulated Moving Bed technology SK is a world leader of Simulated Moving Bed technology (SMB) and offers this powerful technology from lab, through pilot to large commercial scale. They have a proven track record in successfully developing processes involving highly energetic chemistry and now offer supply capability for controlled substances from their DEA-approved facilities in Virginia and California.

In addition to providing analytical development and validation for all of the products that they manufacture in their global network, SK pharmteco also provide this same service for other customers as a stand-alone business at their analytical services facility in California “As leaders in operational excellence and continuous improvement and boasting exceptional technical capabilities, the global presence of our highly skilled and experienced team offers total support, from development Irish PharmaChem | Industry Buyers Guide 2020

through to commercial production, including seamless project transfer and management, plus flexibility in R&D and manufacturing,” explains Bill Dubay, Global Head of R&D, SK pharmteco All their plants have been approved by global regulatory agencies including the FDA, EMEA, PDMA and Korean MFDS.

Commercial and clinical API production SK pharmteco specialise in the commercial and clinical production of APIs, Advanced Intermediates, Highly Potent APIs, Controlled Substances, Registered Starting Materials and Key Building Blocks. Their offering includes process research and development, analytical method development, scale-up and optimisation, validation and stability.

They offer PAI and full regulatory support as well as complete confidentiality. “We also have a strong record of environment, health and safety performance,” Bill Dubay notes. “With a strong technology toolbox and over 1020 m³ of global capacity, spread across three continents, we have the capability and capacity to support all your API and Intermediate needs across the full lifecycle.

“We have been producing many of the world’s most recognised drugs for over 75 years. As an SK customer, you will have our commitment to work with you and your product as if it were our own.”

SK pharmteco enjoys world-class, state-ofthe-art facilities and technology, including continuous flow process.

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DOCUMENTATION SOLUTIONS 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 bio/pharma and medical device companies.

Your Challenges:

• 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;

• 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 skills and strategies.

The Results

Partner with TWi

“TWi is partnering with us on an extensive global project to simplify internal process documentation and make it easily accessible through an online playbook,” explains Len James, Director of Process Improvement, Janssen Biologics Europe.

“The writing team quickly got up to speed on the complex subject matter of drug development and offered a fresh, objective perspective. TWi is greatly enhancing the usability of our content.”

With TWi’s help, your documentation becomes a valuable business asset.

For more information, see www.technicallywriteit.com.

• Creating user-friendly product information

• High-quality CAPAs and reduced human errors; • Standardised and user-friendly SOPs, BMRs

• Achieving resource efficiencies, while

• Enhanced documentation quality,

documents and user manuals;

maintaining quality and ensuring regulatory compliance;

• Developing the skills of your team.

TWi’s Solutions

• Information design and technical communication expertise;

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“TWi created a top-quality operator manual, for our new bench-top DNA library prep workflow, BD-CLiC. We needed TWi’s assistance in adhering to the detailed style and content guidelines stipulated by the larger Becton Dickenson (BD) group. TWi simplified things by sourcing and managing a translation partner, so we didn’t have to engage with a second vendor,” said John Malone, BD-Gencell, Ireland.

and IFUs;

consistency, and usability;

• Greater operational efficiency, saving time and resources.

Irish PharmaChem | Industry Buyers Guide 2020

Instrumentation

A new approach to site instrumentation

calibration, both predictive and preventative maintenance, procurement & supply, temperature mapping & control Solutions.

Calibration services

The programme provides an all-round view and and monitoring, and the activity trends within encompassing package for the site. Calibration Bonner are uniquely positioned to offer site services remain a core component of the your plant. wide solutions across traditional pharmaceutical, biopharma and chemical facilities nationwide, The Bonner team then examines the collected programme, providing the site with an assurance due to their expertise in instrumentation and data in detail, reviewing plant timetables, unmatched in industry of the correct completion automation for measurement and control. compiling a full instrument list and analysing of calibrations, showing accurate tolerances and Working across an entire site, looking after every instrument individually, including criticality, results, plus providing documentation that is up instrumentation from all manufacturers, supply calibration and maintenance frequency and to within hours for quality teams. The complete of products and complete project delivery of specified tolerances. They compile all findings programme enables facilities to preserve the advanced control solutions, they can provide a into a detailed report and develop a customised integrity of the plant, meet quality and safety solution to suit any plant. implementation plan. The plan is put into action directives and deliver long-term cost reductions.

Bonner_PharmaChem_90x130_9.pdf 18/10/2018 with a range of services,1including regular analysis,17:14 For more information, see https://bonner.ie/.

Instrumentation programme A key component is a newly developed advanced programme, which works within the wider Quality & Engineering Management Systems, helping clients minimise risk, enhance efficiencies and improve outputs.

The scope of the programme is tailored to Bonner_PharmaChem_90x130_9.pdf meet precise needs, beginning with an initial review session and undertaking a thorough information-gathering exercise. This involves a complete assessment of your current instrumentation, processes and schedules that are currently in place for calibration, maintenance

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We’ve been setting the standards for calibration in Ireland for over 40 years.

Bonner’s comprehensive Instrumentation Programme delivers unrivalled quality, safety and value, making us the partner of choice for quality assurance managers across the country.

When it has to be calibrated, it has to be Bonner.

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Irish PharmaChem | Industry Buyers Guide 2020

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Water & Waste Water Treatment

The Chemifloc group of companies specialises in water, waste water treatment and industrial chemicals and laboratory technical services.

The H²O Files The Chemifloc group is a wholly Irish owned group of companies specialising in water and waste water treatment chemicals (Chemifloc Ltd), Industrial Chemicals (GI Chemicals) and laboratory technical services (Chemilab Water Services).

The Chemifloc group facilitates the delivery of drinking water to homes and businesses throughout the island of Ireland, provides the basis for environmental protection by treatment of municipal wastewater and meets both the in-process and waste treatment requirements of Irish industry. Their Chemilab Water Services technical team facilitates continuous optimisation of current practices within the industry, as well as engaging with their customers on forward looking research projects.

Chemifloc Ltd specialises in the manufacture and supply of the full suite of products required during the water treatment process: ● Coagulation/Flocculation: Aluminium Sulphate, Polyaluminium Chloride, Ferric Aluminium Sulphate, Ferric Sulphate, Ferric Chloride, Sulphuric Acid (PH) control, Polyelectrolytes, Powder Activated Carbon; ● Disinfection: Sodium Chlorite & Hypochlorite; ● pH Correction: Sodium Hydroxide, Lime.

Chemifloc Ltd also specialises in the manufacture and supply of the full suite of products required during the waste water treatment process: ● Coagulation/Flocculation: Ferric Sulphate, Ferric Chloride; ● Odour and Septicity control: Ferric Nitrate, Sodium Nitrate, Calcium Nitrate.

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In addition, Chemifloc Ltd offers a variety of general chemicals such as Urea solution for SCR-diesel vehicles (Chemblue), iron based added micro-nutrients for combating sludge bulking problem (bulk floc), Antifoam, Salts etc.

Tailoring Solutions to Your Requirements Chemifloc Ltd has a large manufacturing and storage facility in Shannon, Co. Clare, and has the capability to tailor and develop solutions to meet specific customer requirements. In order to facilitate prompt delivery, they have the largest fleet of bulk chemical tankers and ADR drivers in Ireland, complemented by a fleet of rigid trucks to facilitate intermediate bulk and small pack size deliveries.

They have recently invested approximately €10m in bulk storage facilities in Shannon Foynes Port at a critical time in Ireland.

Security of supply is an essential assurance for their customers in these uncertain times for trade, particularly given the uncertainty created by Brexit.

GI Chemicals DAC GI Chemicals DAC is a subsidiary of Chemifloc and focuses on the supply of industrial chemicals in bulk tanker format in Ireland,

with storage tanks in Cork, Foynes and New Ross.

GI Chemicals DAC supplies Hydrochloric Acid, Sulphuric Acid and a range of concentrations of both Sodium Hydroxide and Potassium Hydroxide. The company has ISO 9001:2015 certification and has received FECC Accreditation to Responsible Care.

Investing in New Laboratory The Chemifloc group has recently invested in a new technical laboratory at their facility in Shannon, Co. Clare, called Chemilab Water Services. Primarily, this facility will provide coagulation study (jar testing) facilities to optimise the treatment process in the production of drinking water. This facility will help water treatment undertakers, including local authorities and private industry, to determine the best form of treatment using inorganic coagulants and flocculants to produce the highest quality water.

Irish PharmaChem | Industry Buyers Guide 2020

The Chemifloc Group Irelands largest indigenous manufacturer supplier and distributor of Water treatment and Industrial bulk Chemicals GI CHEMICALS DAC a newly formed subsidiary within the Chemifloc group formerly traded as Gouldings Industrial Chemical.

ISO 9001.2015 and IBEC certified the Group has operations located in Shannon, Foynes, Cork and New Ross

Supplying to Industry the following: • Caustic soda Solutions • Sulphuric Acid solutions • Hydrochloric acid solutions • Caustic Potash solutions • All bulk formats catered for all industry sectors Contact us at:

info@gichemicals.ie

Supplying to Industry the following: • Flocculent and Coagulant aids for water and waste treatment processes • Odour and Septicity control chemicals • Disinfection chemicals • PH correction chemicals • CHEMLABS Laboratory Analytical services for water systems Contact us at:

info@chemifloc.ie

Chemifloc Group Smithstown Industrial Estate, Shannon, Co. Clare, V14 VY67 Phone: +353-61-708699 Website: www.chemifloc.ie www.gichemicals.ie

Outsourced Engineering & Technical Talent

Let LotusWorks work for you…

LotusWorks have been successfully helping leading regulated manufacturers in product delivery and facility maintenance for 30 years.

Specialists in regulatory facility commissioning, calibration, operations and maintenance, LotusWorks has been supporting world leading manufacturers who require technical and engineering talent to supplement their teams long-term or for projects in the pharmaceutical/ biotechnology and medical device sectors across Europe & North America for 30 years.

Today, more than ever, manufacturers must guarantee they have complete visibility throughout their supply chain for their own compliance and must also guarantee the compliance of their suppliers. There is substantial focus on implementing procedures that keep a steady stream of new products in the pipeline to ensure manufacturing success.

Impeccable track record LotusWorks has become a supplier of choice within regulated manufacturing industries as the company has an impeccable track record in supporting clients’ compliance procedures and safety cultures. LotusWorks supplements the client engineering teams, sometimes in new build

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/retrofits with their commissioning expertise, but the company is best known for its ability to provide long-term value-adding expertise to the client’s sustaining operations and maintenance functions within regulated industries. LotusWorks offered calibration solutions initially but has evolved its service offering to include facility commissioning and facility operation and maintenance in the past two decades.

“Our clients need assurance and peace of mind that their valuable instruments and equipment is functioning correctly and is being maintained and monitored to support aggressive manufacturing targets,” explains James Casey, Operations Director, LotusWorks. “We’ve the right expertise to guarantee the upkeep of facility equipment and we have substantial knowledge about the high level of compliance and stringent quality procedures in place within these regulated facilities. It’s our efficiency and professionalism that is driving our client satisfaction and our ability to monitor and report robustly on the status of all their equipment and instrumentation.”

Continuous improvement is better than delayed perfection In the past three years, LotusWorks is most proud of its investment in the development and implementation of a Continuous Improvement Programme. The programme ensures clients experience the best of value-added improvement from the LotusWorks team, who are based longterm at their facilities, executing work scopes for the client.

During the past three years, LotusWorks has successfully saved clients over €3 million through ideas for process change, waste elimination and quality enhancements. The programme is incentivised, resulting in highly motivated and engaged LotusWorks teams, focused on valueadding activity and on driving improvements.

The promise to manufacturing clients is to deliver teams who can achieve measurable results and operational excellence, while consistently meeting agreed regulatory compliance goals and safety requirements, delivering scheduled reporting and engaging in continuous improvement activity for the clients.

Substantial growth LotusWorks is experiencing substantial growth as it continues to seek out partnerships in large regulated manufacturing environments. The value proposition is clear and appealing to organisations who require additional expertise in an outsourced capacity. Partnering with LotusWorks delivers peace of mind that technical and engineering work scope is completed to the highest standards by experienced, competent teams, who are operationally flexible. Employing 465 people, LotusWorks is a strong, safety conscious organisation, with teams who follow procedures, support compliance and most importantly, are incentivised to go above and beyond. LotusWorks’ clients are primarily in the pharmaceutical, biotechnology and medical devices sector in Europe & North America.

For more information, see www.lotusworks.com.

Irish PharmaChem | Industry Buyers Guide 2020

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Specialists in Calibration, Commissioning, Operations & Maintenance, and Contract Staffing, LotusWorks is 30 years supporting world leading manufacturers who require technical and engineering talent to supplement their teams on a long term or project basis in the Pharma/Biotechnology and Medical Device sectors across Europe & North America.

Tailoring and delivering the “best fit” expert technical and engineering teams to clients, allows you to focus on your core activity. LotusWorks focus on the delivery of consistent technical expertise to enhance clients’ operational performance.

Collaborating with you onsite, the LotusWorks team will integrate quickly, to deliver expert service, on time and cost effectively.

LOGISTICS

Kuehne + Nagel pledge their commitment to the Pharma Industry Logistics is not about moving product from A to B, but about delivering innovative supply chain designs to support businesses, argues Adam O’Sullivan, Director of Pharmaceutical and Healthcare for Kuehne + Nagel Ireland.

By investing in logistic solutions for the pharmaceutical and healthcare industry, Kuehne + Nagel aim to alleviate the pressures of supply chain management so that customers can focus on the quality of their product for patients.

The ongoing trend in the pharma and healthcare industry towards stricter regulations on patient safety, as well as strong market competition, calls upon innovative logistics solutions. With now 200 GxP certified operations, KN PharmaChain offers our customers integrated, technology-enabled and reliable end-to-end logistics solutions, covering the highest quality requirements across the globe.

GxP compliance We have over 2,000 people in our global care team who are trained, GxP compliant professionals across our network that monitor and deliver consignments according to the strict and precise requirements pertaining to the industry. This means that every single touchpoint is only managed by a person who is an expert in GxP compliance. Moreover, we have this standard across all three transport modes - air, road and sea - in strategically located IATA CIEV certified stations.

Indeed, Kuehne + Nagel were the first company in the logistics industry to be given IATA certification for its entire pharma air network. The KN PharmaChain network provides multimodal GxP compliant door-todoor shipping on a global scale. This enhances visibility and traceability of the deliveries, as well as intensive and proactive risk management and integrated warehousing services.

We also continue to invest locally for pharma companies with a newly built bespoke facility in Dublin, which has been HPRA certified for temperature-controlled requirements, while

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we have recently upgraded our facilities in Cork to the same standards. This year, we also added a further 100,000 square feet facility in Dublin that was purpose-built for a new healthcare client, further demonstrating our commitment to long-term partnership and support for the pharmaceutical industry in general.

Analysing risks for Irish pharma Moreover, we have a dedicated team in Kuehne + Nagel Ireland, who analyse the risks when transporting goods in advance of the goods moving. The team can then offset those risks with the use of technology. In simple terms, the team analyse routes and modes of transport in order to be able to advise pharma companies of the best possible routing for their product. The best possible route will be guided by the customer’s overall strategy to minimise the risk of temperature deviation, for example. It is part of our strategy to provide highly specialised industry-specific solutions reflecting our customers’ needs.

In today’s strict regulatory environment, there is certainly no shortage of regulations that pertain directly to the pharmaceutical industry.

Quality is of utmost importance at Kuehne + Nagel and we have integrated high standards of quality into the heart of our business. Locally, in Kuehne + Nagel Ireland, we go beyond the industry standards of quality. We actively invite our customers to perform their own audits at our premises, allowing them to inspect our quality standards and procedures first hand, while we continue to invest in our facilities.

Adam O’Sullivan, Director of Pharmaceutical and Healthcare for Kuehne + Nagel.

For more information, contact: Adam O’Sullivan, Director Pharma + Healthcare, Kuehne + Nagel Ireland.

Email: adam.osullivan@kuehne-nagel.com.

Tel: (01) 8239777.

Irish PharmaChem | Industry Buyers Guide 2020

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

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

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 pharmaceutical, water treatment, electronics, brewing and dairy 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 Chlor-alkali 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, Director of Customer Relations. “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 customer satisfaction and a more secure future for all employees.

New Product Development New Product Development is an important part of this process. Indeed, Micro-Bio was asked by

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Fermoy-based Micro-Bio Ireland Ltd is the only Chlor-alkali manufacturer in Ireland and also pioneered the commercial use of Membrane Cell Technology. a large biopharma company to manufacture a grade of Sodium Hydroxide that would suit their stringent requirements.

“Through our high level of knowledge and our excellent level of customer service, this was a task that we embraced wholeheartedly,” explains Denis O’Brien, Technical Director.

“For the last number of years, we have been producing and supplying this grade of Sodium Hydroxide. In fact, we are now the sole supplier to a number of the large biopharma companies here on the island.”

Tom Tobin adds: “We see this as a product that will lead us into several overseas markets and currently, we are in talks with a number of companies outside of Ireland.”

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/EP grade 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 0.2micron filtration in a clean-room to ensure the purity Irish PharmaChem | Industry Buyers Guide 2020

Chemicals Product range

of the solutions is maintained. Dedicated bulk tankers (Nitrogen blanketed) are filled from the dedicated dilution tanks through 0.2micron 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 Fermoy area.

If you would like more information, please contact any of the following: Peter McNamara, Managing Director Tom Tobin, Director Customer Relations 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.

Irish PharmaChem | Industry Buyers Guide 2020

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Excipients, APIs and Intermediates

Univar Solutions: serving the needs of the pharmaceutical industry

Univar Solutions is a premier global supply chain solutions partner, with proven experience in the primary and secondary pharmaceutical and nutraceutical industries.

Univar Solutions’ portfolio includes products along the medicinal production chain, where they offer a broad portfolio of excipients, solvents, reactants, active pharmaceutical ingredients (API), and intermediates. In this, they work with customers in the human and veterinary markets.

Univar Solutions understand their customers have unique needs, requiring custom solutions. Their team of dedicated pharmaceutical specialists, experts in technical, regulatory, and quality, has the flexibility to develop solutions to your manufacturing challenges, improving total costs of operation while providing a secure source of supply.

Range of services Univar Solutions’ range of services includes:  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.

Comprehensive product portfolio Their comprehensive product portfolio supports the range of primary and secondary pharmaceutical manufacturing:  APIs

 Acids

 Alkalis

 Binders

 Buffers

 Coatings

 Disintegrants  Emulsifiers  Fillers

 Flavours

 Humectants  Lubricants  Solvents

 Surfactants

 Sweeteners  Thickeners

For more information, call (01) 4019800 or email irelandsalesoffice@univar.com.

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Irish PharmaChem | Industry Buyers Guide 2020

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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.

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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 2020

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

Material Handling Mitsubishi Electric Generation: keen to go green.

Henley: Raising Standards Since 1973 In 2019, Henley continued its success in delivering both standard and specialist machines to the pharma and life sciences industries. During the year, Henley’s deliveries included Sichelschmidt pedestrian stackers with telescopic forks to meet a Zone 1 / Zone 21 requirement, Ulma Inox trucks to meet cleanroom applications, along with counterbalanced and warehouse equipment protected, where necessary, to operate in hazardous environments. Pedestrian machines were required in all sectors of the life sciences industry.

Henley represents some of the world’s leading forklift manufacturers, including Mitsubishi, UniCarriers, Konecranes, Combilift, Aisle-Master, Sichelschmidt and Ulma Inox. With this comprehensive range of quality equipment, Henley can offer positive solutions to customers, meeting their specific requirements with the correct machine.

local service on a nationwide basis. With strategically located service centres and some home-based engineers, Henley can respond to customers in a very short space of time. “This local service results in strong local relationships where we have a clear understanding of our customers’ needs and priorities,” explains Brian O’Connell, Director, Henley.

Nationwide rental fleet Short term rental machines are available from all Henley service centres throughout the country. Henley continues to expand its rental fleet, offering the widest range of modern equipment.

“With one of the most modern hire fleets in the country, we take every step to ensure

Henley has been supplying a modern comprehensive range of material handling equipment through its nationwide sales network for over 40 years. that our trucks are maintained to the highest standards,” O’Connell stresses. “With dedicated hire centres in Dublin, Cork, Galway, Limerick, Waterford, Donegal and Belfast, we are never far away from you.”

For more information, visit www.henley.ie or email pharma@henley.ie.

Nationwide service network Today, Henley manages and maintains large fleets of machines for its customers, whose trucks are located throughout the country.

Customers benefit from Henley’s fleet management service, where truck utilisation, cost control and safety for operators and trucks are a priority. Regular reporting is an integral part of Henley’s management service.

Henley’s core strength is its ability to provide

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Ulma Inox trucks hygienically designed for clean room environments.

Irish PharmaChem | Industry Buyers Guide 2020

Future Challenges

How secure is your raw material supply chain?

Some would argue that the pharmaceutical industry is a bit more resilient to market fluctuations than other industries. Though there may be some truth in this, I believe that it is important to be prepared for the worst-case scenario. With that in mind, I have assembled a list of potential challenges that face the pharma industry, along with solutions.

This is not a complete list but rather a selection that I think the industry should consider.

Future and current Pharma challenges and solutions REACH: If a chemical is not REACH registered and your company requires more than one tonne, then it may be necessary to go through the process of REACH registration. It can be complicated, costly and resource intensive.

Challenges include identifying suitable manufacturers (this can be particularly difficult outside of the EU), as well as the expense, expertise and time required to go through the registration process.

Solution: Regardless if your organisation has inhouse REACH expertise or not, registration can be very laborious and utilising an outsourcing partner that has expertise and resources could be worth considering.

Brexit: Ireland has been traditionally grouped with the UK when it comes to sales channels for supply and distribution. With Brexit, establishing new transport routes for sourcing raw materials to avoid potential UK tariffs and delivery setbacks may be necessary. In addition, will UK sales offices be able to deal

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Christy Smith, Product Manager, NCC Pharma Services, takes a closer look at the potential challenges and opportunities that exist and lie ahead for the pharmaceutical industry. effectively with EU regulations when exporting to Ireland?

Solution: If you haven’t already done so, then re-examine all existing sourcing channels, establishing which partners can provide the most reliable and competitive routes as soon as possible.

Governmental enforcement of regulations: In Jiangsu province, China, local government stated that in 2019 they planned to shut down 579 chemical firms, as well as nine chemical industrial parks. This was as a result of a series of accidents within the region. Shutdowns similar to this could lead to shortages in key raw materials, resulting in higher prices and longer lead times.

Solution: Ensure you have a contingency plan, partner with a supplier who has second sourcing options.

Sustainability concerns: Increasingly complex regulations are making it difficult to use chemicals that traditionally would be the most cost-effective solution. Often, these chemicals are not the most environmentally sound or safe to handle; therefore, alternative solutions will be required in the foreseeable future to maintain supply chain integrity.

Solution: Sustainability within pharma will more than likely become a very important factor in the near future. Therefore, researching

and sourcing alternatives sooner rather than later should be high on most organisations’ agendas.

Supply Chain Complexity: Managing change control issues when using multiple suppliers can be not only cumbersome, it can also be incredibly resource intensive and challenging to keep track of. In addition, compliance and regulatory challenges can occur when using manufacturers outside of the EU. Solution: Simplify your sourcing channels and partner with a supplier that has inhouse research capabilities as to conduct manufacturer due diligence, assessments and verification. In addition, this supplier should also have internal compliance, sourcing and logistics expertise.

Taking steps To ensure that you’re not vulnerable to some of the future challenges listed above, it’s important that your company partners with an experienced sourcing supplier. 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, contact: (01) 6131400 or email hello@ncc.ie.

Irish PharmaChem | Industry Buyers Guide 2020

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

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Irish PharmaChem | Industry Buyers Guide 2020

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

ireland pharma advert half page.inddBuyers 1 Irish PharmaChem | Industry Guide 2020

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.

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Packaging Goliath works with a number of internationally known specialist packaging equipment suppliers.

Goliath:

part of the equation With experience gained through many years of successful project delivery for discerning blue-chip customers throughout Ireland, the expertise of its international partners / suppliers and the skills of its factory trained staff, Goliath Packaging Systems is perfectly positioned to meet the demands of its customer base in the Irish PharmaChem sector.

In business since 2007, Goliath 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 GSK, West Pharma, Norbrook Labs & Jazz Pharma, amongst others.

Extensive 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 manipulators)  Pallet Elevating Systems  Palletising Systems (Gantry, Articulated Arm & Layer)  Stretch Wrapping  Strapping Systems (Case & Pallet)

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 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.

Goliath serves the following segments of the Irish PharmaChem sector;  Pharmaceutical  BioTech  Chemical  Healthcare  Medical Devices  Contract Packing 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

Understanding your needs Goliath understands the specific needs of the PharmaChem sector. From liquid filling, shrink wrapping / banding, case-packing,

Goliath Packaging Systems Ltd sources, supplies, installs and after-sales services a comprehensive range of endof-line packaging, materials handling and industrial washing equipment to the Irish PharmaChem sector.

Goliath Packaging Systems: meeting the demands of the Irish PharmaChem sector

labelling / coding, palletising, pallet inverting & high speed washing, 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.

To discuss your particular packaging equipment needs, please contact: George O’Leary, Goliath Packaging Systems Ltd, Well Road, Nenagh, Co. Tipperary. Tel: (067) 37893.

Fax: (067) 34794. Mobile: (087) 1222816.

E-mail: info@goliath.ie / service@goliath.ie.

Web: www.goliath.ie.

Irish PharmaChem | Industry Buyers Guide 2020

Barcoding

Holfeld’s Axicon 15000: A Fresh approach to Barcoding

15500 series 1D/2D barcode verifier ISO/IEC compliant

The Falsification of Medicines Directive and Unique Device Identification for healthcare products require global standards for labelling. The traceability data needs to be encoded into one dimensional and two dimensional bar codes. 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 (AI).

The Axicon 15000 series verifiers take a fresh approach. A verifier ‘Plugin’ can be chosen to check against a particular application specification table in the GS1 General Specifications. 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 print

quality of the code is verified to ISO/ IEC 15415 for 2D bar codes or to ISO/IEC 15416 for linear bar codes.

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 free of charge from the Axicon website (www.axicon.com) 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

Free licence software Data content checking USB Powered 2 year warranty The software can be updated free of charge from the Axicon website (www.axicon.com).

www.holfeldgraphics.com

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Irish PharmaChem | Industry Buyers Guide 2020

Process automation

Endress+Hauser launch e-commerce platform E-commerce presents many difficulties for industrial suppliers, distributors, and consumers.

Some of these challenges include identifying/ confirming product details, obtaining answers to product-related questions, and finding postsale technical support.

Endress+Hauser are committed to developing an online shopping experience that’s tailored to the needs of industrial buyers. With that goal in mind, they recently announced the debut of e-commerce on Endress.com, a platform designed to streamline industrial procurement processes.

gain complete access to all past and present online and offline transactions.

This makes it possible to check the status of ongoing quotes, track delivery orders, access delivery notes and invoices, and re-order previously purchased items. All relevant documentation can also be exported into several file formats for the company’s records.

www.ie.endress.com was designed to streamline industrial procurement processes.

Intuitive platform

Advanced search options

By creating an intuitive platform with maximum functionality and usability, Endress+Hauser hope to improve online and offline shopping experiences and provide maximum benefit for all of their clients. “With Endress.com, we’re confident that we can make order fulfilment a seamless process for any industrial company,” explains Alison Kenny, Marketing Manager, Endress+Hauser.

Industrial equipment is usually available in several different variations, each of which is subject to strict specifications. The website’s advanced search, purchase, and configuration options help users to quickly identify the correct component for their given application, eliminating the guesswork that often comes with industrial procurement.

By simply logging in to their account, users

The extensive inventory can also be filtered

New possibilities, new experiences

PERSONAL+ DIGITAL

based on criteria such as product area, measurement principle, and product type. To further simplify the decision-making process, two or more devices can be put together for a side-by-side comparison of features and specifications. For more information on Endress+Hauser’s new e-commerce offering, visit www.ie.endress.com.

Products. Services. Solutions. Find yours.

• Buy your devices online with easy access to technical information • Order your spare parts via our Operations app • Search for products using a serial number or order code • Get access to product recommendations • View your transactions (past and present) all in one place

Get started now! www.ie.endress.com

Complete e-commerce functionality now on Endress.com Irish PharmaChem | Industry Buyers Guide 2020 half page ad.indd 1

Endress+Hauser Ireland Ltd Tel: 045 989 200 info.ie.sc@endress.com

22/10/2019 15:57:30

91

GOOD MORNING, EUROPE. DACHSER European Logistics

Enjoy achieving your goals – every day of the week. With one of the strongest European transport networks for fast and flexible deliveries to all destinations between Scandinavia and North Africa, the Urals and the Atlantic. We can improve your logistics.

Reliably. Efficiently. Daily.

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www.dachser.ie

Stockist & Distributors of: •

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Vendor managed inventory.

Next day delivery service.

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DRUMS (PLASTIC, STEEL & FIBRE) PLASTIC JERRYCANS IBCS PET BOTTLES & JARS FOOD GRADE BUCKETS & JARS

• FIBCS

ISO 9001: 2015

CHEMICAL SUPPLIERS Acids & alkalis AQS Environmental Solutions Associated Chemicals Ltd Azelis 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

Leo Pharma Micro-Bio Ireland Ltd SK Pharmteco

biochemicals Alexion Arran Chemical Company Associated Chemicals Ltd 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

chiral compounds Arran Chemical Company Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Camida Ltd Fisher Scientific Ireland Ltd Hovione Ltd National Chemical Company

excipients A&C Your Global GMP Partner Associated Chemicals Ltd Azelis Brenntag Ireland Camida Ltd

Irish PharmaChem | Industry Buyers Guide 2020

Chemco Ireland Ltd Corcoran Chemicals Limited Heterochem Dist Ltd Leo Pharma Micro-Bio Ireland Ltd National Chemical Company Univar

fine chemicals A&C Your Global GMP Partner Arran Chemical Company Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Azelis 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

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

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 Hovione Ltd IDA Ireland National Chemical Company 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 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 Langanbach Services Ltd Univar

TREATMENT CHEMICALS Micro-Bio Ireland Ltd

93

GENERAL SUPPLIERS ACTUATORS BS&B Safety Systems Ltd

AGITATORS CPI Technology Ltd Quitmann O’Neill

AIR / ROAD / OCEAN FREIGHT 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 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

94

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 A&C Your Global GMP Partner Alexion Alkermes Pharma Ireland Limited Almac Sciences Ltd IDA Ireland LotusWorks Micro-Bio Ireland Ltd Pharmalex Portakabin Ireland Reading Scientific Services Ltd

BIOTECHNOLOGY Almac Sciences Ltd IDA Ireland Labplan LotusWorks 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 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 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

CLEANING SERVICES / EQUIPMENT AQS Environmental Solutions Portakabin Ireland Irish PharmaChem | Industry Buyers Guide 2020

GENERAL SUPPLIERS 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 Charles River Microbial Solutions Flexachem Manufacturing Ltd P.J. Bonner & Company Q1 Scientific

CONSTRUCTION MANAGEMENT Portakabin Allspace

CONSULTANCY Accenture Hazchem Training Ltd Reading Scientific Services Ltd

CONTINUOUS PROCESSING SK Pharmteco

CONTRACT DEVELOPMENT & MANUFACTURING Hovione SK Pharmteco

CONTRACT DEVELOPMENT & MARKETING Charles River Microbial Solutions Hovione

CONTRACT PHARMA SERVICES Alkermes Pharma Ireland Limited Avara Shannon Pharmaceutical Services Charles River Microbial Solutions Eurofins Biopharma Product Testing Hovione Kuehne + Nagel McGee Pharma International Pharmalex Reading Scientific Services Ltd SK Pharmteco

CONTROLLED SUBSTANCES SK Pharmteco

CONVEYORS Goliath Packaging Systems Ltd Weber Packaging Solutions Ltd

COOLING SYSTEMS CPI Technology Ltd Cross Technical Solutions Irish PharmaChem | Industry Buyers Guide 2020

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’NeillDIS

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

DRUMS / CONTAINERS 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

ELECTRICAL SUPPLY Bord Gais

ENERGETIC CHEMISTRY SK Pharmteco

ENERGY EFFICIENCY / MANAGEMENT Berkley Group Daikin Europe Leo Pharma 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

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 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

95

GENERAL SUPPLIERS EXTRUDERS BS&B Safety Systems Ltd

FACILITY DESIGN McGee Pharma International Pharmalex

FACILITIES MANAGEMENT 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

GAUGES BS&B Safety Systems Ltd Fisher Scientific Ireland Ltd

96

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

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 Cross Technical Solutions Dawson Rentals Ireland Ltd Interpac P. J. Bonner & Company

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

INSPECTION EQUIPMENT Holfeld Graphics Lister Machine Tools Ltd O’Flynn Medical Ltd P.J. Bonner & Company Weber Packaging Solutions Ltd

INSTRUMENTATION BS&B Safety Systems Ltd Charles River Microbial Solutions Endress & Hauser (Ireland) Ltd Eurolec Instrumentation Ltd Labplan P.J. Bonner & Company Scientific Instruments Ireland

INTERMEDIATES SK Pharmteco

IT Charles River Microbial Solutions Weber Packaging Solutions Ltd Westbourne Global IT Services

INVESTMENT Goodbody Stockbrokers IDA Ireland

INVESTMENT PROMOTION AGENCY IDA Ireland

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

LOGISTICS 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 Irish PharmaChem | Industry Buyers Guide 2020

GENERAL SUPPLIERS 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 Particular Sciences Ltd P. J. Bonner & Company Water Chromatography Ireland Weber Packaging Solutions Ltd

MANUFACTURERS A&C Your Global GMP Partner Abbvie BS&B Safety Systems Ltd Daikin Europe Endress & Hauser (Ireland) Ltd Eurolec Instrumentation Ltd Hovione IDA Ireland Leo Pharma Micro-Bio Ireland Ltd Portakabin Ireland Ltd Quitmann O’Neill SK Pharmteco Thornshaw Scientific

MATERIALS HANDLING / FORKLFTS / PALLET TRUCKS Goliath Packaging Systems Ltd Henley Forklift Group Limited Interpac Leo Pharma Portakabin Ireland Toyota Material Handling Ireland Ltd Weber Packaging Solutions Ltd

MECHANICAL ENGINEERING SERVICES Berkley Group CPI Technology Ltd Leo Pharma Portakabin Ireland Veolia Weber Packaging Solutions Ltd

MECHANICAL & PROCESS ENGINEERING CPI Technology Ltd Leo Pharma P. J. Bonner & Company Weber Packaging Solutions Ltd

MEDICAL DEVICE MANUFACTURE B. Braun Medical Charles River Microbial Solutions LotusWorks Irish PharmaChem | Industry Buyers Guide 2020

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 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 IDA Ireland Industrial Packaging Ltd Interpac Leo Pharma Limerick Packaging Nelipak Healthcare Packaging Protech Plastics Quitmann O’Neill Weber Packaging Solutions Ltd

PACKAGING / MACHINERY 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

PHARMACEUTICALS MSD Ireland

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

POWDER HANDLING AQS Environmental Solutions CPI Technology Ltd Goliath Packaging Systems Ltd Industrial Packaging Ltd Interpac P.J. Bonner & Company 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

97

GENERAL SUPPLIERS 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

PROJECT MANAGEMENT Chemishield Leo Pharma Pharmalex P.J. Bonner & Company Reading Scientific Services 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 Charles River Microbial Solutions Chemifloc Ltd Leo Pharma McGee Pharma International Pharmalex ProSys Containment and Sampling Technology Reading Scientific Services Ltd Veolia Weber Packaging Solutions Ltd Westbourne Global IT Services

R&D Almac Sciences Ltd Avara Shannon Pharmaceutical Services Charles River Microbial Solutions Chemifloc Ltd Euraxess Ireland IDA Ireland Leo Pharma MSD Ireland 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

98

Chemishield ICDS Recruitment Consultants Leo Pharma 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

RENEWABLE ENERGY Daikin Europe Sustainable Energy Authority of Ireland Veolia

RESEARCH FUNDING Science Foundation Ireland (SFI)

RESPIRATORY PHARMACEUTICALS 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 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

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

STORAGE / BUNDING CMS Chemstore Engineering Ltd 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 Leo Pharma Soltec (Ireland) Ltd Veolia

STRAPPING EQUPMENT Goliath Packaging Systems Ltd

SUPPLY CHAIN MANAGEMENT Alexion C&G Logistics Group Chemco Ireland Ltd Cold Move GS1 Ireland IDA Ireland 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 Irish PharmaChem | Industry Buyers Guide 2020

GENERAL SUPPLIERS 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 P.J. Bonner & Company Q1 Scientific

TESTING SERVICES Almac Sciences Ltd Anecto CPI Technology Ltd Chemifloc Ltd CMS Chemstore Engineering Ltd Nelipak Healthcare Packaging P. J. Bonner & Company Reading Scientific Services Ltd

THERMAL IMAGING / THERMOGRAPHY Eurolec Instrumentation Ltd P. J. Bonner & Company Reading Scientific Services Ltd

TOOLS Charles River Microbial Solutions

TRAINING

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 Leo Pharma McGee Pharma International Pharmalex P. J. Bonner & Company Reading Scientific Services 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 Kuehne + Nagel 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 P.J. Bonner & Company Weber Packaging Solutions Ltd

WORKWEAR O’Flynn Medical Ltd

WORKWEAR MANAGEMENT DISPENSING MACHINE O’Flynn Medical Ltd

Hazchem Training Ltd Reading Scientific Services Ltd

TRANSPORT & LOGISTICS 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 Irish PharmaChem | Industry Buyers Guide 2020

99

COMPANY LISTINGS A

a1-cbiss

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

A&C Your Global GMP Partner

Address:

Questum, Ballingarrane, Cahir Road, Clonmel, Co. Tipperary, E91 V239.

Tel: +353 52 614 8880 Fax: +353 52 614 8880 Email: euro@acggp.com Web: www.acggp.com/www.acbiobuffer.com Contact: Sales & Marketing Director:

Gearoid O’Rourke Business: A&C is a global GMP manufacturer of

excipients, buffers, process ingredients and a select number of

APIs. Services offered include:

 GMP custom raw materials development

 GMP custom raw materials manufacturing

 GMP custom packaging and repacking

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

Almac Sciences Ltd.

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

100

(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 both small and

large molecules. Our state-of-the-art

labs support drug substance (API)

and drug product (finished product)

analytics across all phases of clinical

development and into commercial release.

Contact: Business Development: Deepthi Kolli

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 2020

COMPANY LISTINGS C

Avara Shannon Pharmaceutical Services Limited

Address: Shannon Industrial Estate, Shannon,

Co. Clare, V14 FX09, Ireland.

00353-61-714114 00353-61-714101

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

Â

B. Braun MEDICAL 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

CAMIDA LTD

I

Address: New Quay, Clonmel,

Co. Tipperary, E91 YV66, Ireland.

Tel: +353 52 6125455 Fax: +353 52 6125466 rIsh harma hem Email: info@camida.com Web: www.camida.com Contact: Company Secretary:

Deirdre McGrath

P

C

2012

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

Brenntag Ireland b renntAG ireLAnd

Address: Unit 405, Greenogue Address: Unit 405, Business Park, Rathcoole,

Greenogue Business

Dublin 24.

Park, Rathcoole, Tel: +353 (0) 1 401 3500 Fax: Dublin 24. +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.

O'Connor: Contact: Evelyn Contact: Sales Desk evelyn.o'connor@brenntag.ie

Cole Carroll: colman.carroll@brenntag.ie

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

BonNer Instrumentation, Calibration and Control Solutions Address:

35 Western Parkway Business Centre, Ballymount Drive, Ballymount, Dublin 12.

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 Irish PharmaChem | Industry Buyers Guide 2020

briGhtwAter

Address: 36 Merrion Square,

Dublin 2.

Tel: (01) 662 1000 BS&B SAFETY SYSTEMS LTD Fax: (01) 662 3900 Address: Raheen Business Park, Email: e.moloney@brightwater.ie

Raheen, Co. Limerick, V94 N4V2 Web: www.brightwater.ie Tel: (061) 484 700 Mobile: (086) 8385556 Contact: Eileen Moloney

Email: sales@bsb.ie Web:

www.bsbflamearrester.ie bs&b sAfety systems Ltd www.bsb.ie Address: Raheen Business Park, - Rupture Disks, Safety Heads, Business: Raheen,

Sensors, Graphite Disks and Co. Limerick. accessories; Tel: (061) 484 700

- Custom Engineered Product solutions for the OEM;

Emergency Delivery: - Explosion Vents, Suppression/

086 241 0615

Isolation units;

Direct Line:

- Specialty Buckling Pin Relief Valves; 086 838 5556 Fax: (061) 352 240

- Flame Arresters, Breather

Valves and PVRV's/Emergency Email: sales@bsb.ie Vents; Web: www.bsb.ie

Systems for the Oil & Business: - Process Pressure relief devices.

Gas, Chemical & Refining Contact: Sales Manager: industries.

Contact: Patrick Murphy Manager: Patrick Murphy

Ireland Direct Sales Manager

C cALLAGhAn enGineerinG Address:

Dublin: Wentworth House, 19/20 Hogan Place,

Building 1000, Units 1201& 1202, City Gate, Mahon, Cork.

Tel: (021) 240 9099 Fax: (021) 240 9009 Email: mail@calleng.ie carbon group Web: www.calleng.ie Address: Ringaskiddy, Co. Cork, P43 R772.

Tel: +353 (0)21 437 8988 Business: Multi-discipline +353 (0) 86 2612 485 Mobile: consulting engineering Fax: +353 (0)21 437 8950 and project managment Email: carol.deegan@carbon.ie company. sales@carbon.ie Web: www.carbon.ie

Business: Ltd Pharma/biopharma chemicals. c AmidA

Contact: Area Sales Manager: Address: Tower House,

Carol Deegan

New Quay,

Clonmel,

Co. Tipperary.

Tel: (052) 612 5455 Fax: (052) 612 5466 Email: info@camida.com Web: www.camida.com Contact: Company Secretary: Charles River Microbial Solutions Deirdre McGrath International

Ltd

Address:

49, Greenogue Business Park,

Jordanstown Ave, Jordanstown,

Rathcoole, Co. Dublin, D24 NF21, Ireland.

Email:

askcharlesriver@crl.com

c Arbon Group criver.com/microbial Web:

Business: Micro QC Address: Factory Cross,

Ringaskiddy,

Co. Cork.

Tel: +353 (0)21 437 8988 Mobile: 086 2612 485 Charles Tennant & co Ltd Fax: Address: 71 +353 (0)21 437 8950 Cookstown Ind Estate, Email: carol.deegan@carbon.ie

Belgard Road, Tallaght, sales@carbon.ie

Dublin 24.

Tel: (01) 451 4099 Web: www.carbon.ie Fax: (01) 451 4702 Business: Pharmachemicals.

Email:

jgrehan@ctennant.ie Contact: Area Sales Manager: Web: www.charlestennant.com Carol Deegan Business: Chemical and Packaging supplier. c AtALent phArmA soLutions Contact: Chemical Manager: Address: Unit 26,

Jim Grehan

Cherry Orchard Industrial Estate, 101

Dublin 10.

Tel: (01) 620 0600 Fax: (01) 626 2815 Email: diarmuid.wilson@catalent.com

Contact:

ceLtic f Address:

Tel:

Fax:

Email: Web: Business: Contact:

c + G Lo Address:

Tel: Fax: Email: Web: Contact:

COMPANY LISTINGS

CPI technology ltd

Chemco Ireland Limited Address: Unit 2, Stadium Business Park,

Ballycoolin, Cappagh, Dublin 11,

D11 X205.

Tel: +353 (0)1 8293600 Fax: +353 (0)1 8855029 Email: info@chemco.ie Web: www.chemco.ie

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

complas packaging ltd

Chemifloc Group: Chemifloc, GI Chemicals, Chemilabs Address:

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

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 CHEMICALS LTD Address: Tel: Fax: Email:

Web:

Business:

Contact:

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@ctsolutions.ie Web:

www.crosstechnicalsolutions.ie Business: Refrigeration.

Technical Director: Contact:

Jonathan McGrath

General Manager:

Jason Keating

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

CRS Pharma Solutions

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

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

Address:

Tel: LoCall: Email: Web: Business:

Contact:

102

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

Irish PharmaChem | Industry Buyers Guide 2020

COMPANY LISTINGS

D

E

F

festo ltd

Dachser Ireland Ltd

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.

ENDRESS+HAUSER (IRELAND) LTD.

Address:

Tel: Email: Web: Business:

Contact:

Exchequer House, Embassy Office Park, Kill, Co. Kildare.

(045) 989 200 info@ie.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

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

Dawson Rentals Ireland Ltd

Address:

Eurofins BioPharma Product Testing Address: Clogherane, Dungarvan,

Co. Waterford, X35 T628 Ireland.

Tel: +353 (0) 58 48300 Email: pharma@eurofins.com Web:

www.Eurofins.com/Biopharma

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

Irish PharmaChem | Industry Buyers Guide 2020

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.

FISHER SCIENTIFIC f isher scientific IRELAND LTD Address: Suite 4, Plaza 212, Address:

Daikin Europe Address:

Address:

Tel: Fax: Email: Web:

Business:

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.

Commercial Product Manager: Contact: supplies.

Fitzmaurice Contact: GerryMarketing

Manager: flexachem Gerry Fitzmaurice

manufacturing ltd Address:

Donnybrook, Commercial f LexAcheM

Centre, Douglas, Co. Cork.

M AnufActurinG Ltd Tel: (021) 461 7200 / (021) 4617209 Address:

Fax: Email:

Web:

Tel:

Business: Fax:

Contact:

Email: Web: G Business:

Contact:

(021) Donnybrook 489 1297 sales@flexachem.com Commercial Centre, tim.quigley@flexachem.com Douglas, Co. Cork. www.flexachem.com (021) 461 7200 Manufacturer/ Distributor.

(021) 489 1297 Operations Manager: Tim Quigley sales@flexachem.com

www.flexachem.com Manufacturer/ Distributor.

Commercial Director: Agnes Mullins

g

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.

GOLIATH PACKAGING SYSTEMS LTD Address: Well Road, Nenagh, Co. Tipperary.

Tel: (067) 37893 Fax: (067) 34794 Email: info@goliath.ie G LAnbiA estAtes Web: www.goliath.ie Business: SupplyGlanbia House, & installation of Address:

End ofRing Road, Line Automation Systems,

Materials Handling Equipment

Co. Kilkenny. & Industrial Washing Machinery.

Tel: +353 (0) 87 256 4339 Email: gmullally@glanbia.com Web: www.kilmeadenfields.com 103 Business: Property Business

Unit of Glanbia PLC. Contact: CEO: Ger Mullally

IrIsh P

GoLiAt systeM

Address:

Tel: Fax: Email: Web: Business

Contact:

GouLd

Address:

Tel: Fax: Email: Web: Business

GrAhAM (proce

Address:

Tel: Fax: Email: Web: Contact:

Gs1 ir

Address:

COMPANY LISTINGS

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.

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

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.

HETEROCHEM DIST LTD GS1 Ireland

Address: Second Floor, The Merrion

Centre, Nutley Lane,

Donnybrook, Dublin 4.

Tel: (01) 208 0660 Fax: (01) 208 0670 Email: healthcare@gs1ie.org Web: www.gs1ie.org/healthcare Business: Global Supply Chain

Standards Body.

Contact: Director of Innovation and Healthcare:

Siobhain Duggan

Address:

Tel: Email:

Web:

Business:

Contact:

Unit 49, Robertson House, Baldoyle Industrial Est., Dublin 13.

(01) 839 3127 info@heterochem.com www.heterochem.com Chemical Distributors & Raw Material Specialists.

Managing Director: Kim Doran kim@heterochem.com

IDA IRELAND Address: Three Park Place,

Hatch Street Upper,

Dublin 2.

Tel: (01) 603 4000 Email: idaireland@ida.ie Web: www.idaireland.com Business: Investment Promotion &

Development Agency.

H

Holfeld Graphics

Address:

hazchem training ltd Address:

Tel: Fax: Email: Web:

Business: Contact:

104

G10, Maynooth Business Campus, Maynooth, Co. Kildare.

(01) 629 1800 (01) 629 1822 info@hazchem.ie www.hazchem.ie Training.

Manager: Michelle Cleere

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

idex pump technologies (ireland) ltd Address: Bay 145, Shannon Industrial

Estate, Shannon,

Co. Clare, V14 XE40.

Tel: (061) 471933 Email: vsicsipti@idexcorp.com Web: www.blagdonpump.com www.vikingpump.com Contact: Customer Services:

Ann O’Gorman

Irish PharmaChem | Industry Buyers Guide 2020

Contact:

Forklifts / Lancer Sideloaders General Manager: Conal McCourt

irish nAtionAL AccreditAtion boArd, the Address: Wilton Park House,

Wilton Place,

Dublin 2.

Tel: (01) 607 3003 Fax: (01) 607 3109 Email: inab@inab.ie Web: www.inab.ie Business: Provides

accreditation

of laboratories, INDAVER IRELAND Address: The Highline, certification & 1st Floor,

inspection bodies.

Bakers Point, Pottery Road,

Dun Laoghaire, Co. Dublin, Contact: Information Officer:

A96 W5T3 Orla Doyle

Tel: (01) 697 2900 Fax: (01) 633 5464 Email: info@indaver.ie Web: www.indaver.ie J AvA c LinicAL eseArch waste Ltd Business: Hazardous &r nonhazardous Address:

disposalFitzwilliam Buiness and recovery

ensuringCentre, 26 Upper full compliance.

J

Pembroke St,

Dublin 2.

Tel: 01 637 3903 Fax: 01 637 3907 Email: info@javacr.com Web: interpac www.javacr.com Business: Clinical Research Address: 67E Heather Road, Sandyford Contact: Managing Director:

Industrial Estate,

Ruth Nallen Sandyford, Dublin 18.

Tel: (01) 294 0600 Fax: (01) 294 0602 ian@interpac.ie Email:

Web: www.interpac.ie Business: Supplier of packaging to the pharmaceutical, hazardous waste, food and dairy industries.

Contact: Director: Ian Sutton

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 52,63 Company Listings 2012.indd 7 Business: Economic development agency.

niallh@jol.ie Web: www.johnstonlogistics.ie Business: Logistics & distribution

(Complete Supply

Chain Management).

Contact: Business Development Manager:

Niall Hickey

K

Tel: Fax: Email: Web: Business:

(01) 276 2510 (01) 276 2472 sales@langanbach.ie www.langanbach.ie Supply of laboratory equipment and diagnostic tests.

Infection control products for human and animal health.

Sales and Marketing Director: Jim Woods

COMPANY LISTINGS

Contact:

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, Address:

South Ring West Business Park,

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 L

kweork@ea.kwe.com Web: LABPLAN www.kwe.com Contact: Sales Manager: Address: Allenwood Enterprise Park,

Karl O’Reilly Allenwood, Naas, Co Kildare.

Tel:

(045) 870 560 Fax:

(045) 870 811

info@labplan.ie Email: Web:

www.labplan.ie Business: Lab supplier of analytical LAbpLAn

instrumentation, services, Address: Allenwood Business

technical support.

L

Park, Allenwood,

Naas, Co. Kildare. lennox laboratory Tel: (045) 870 560 supplies ltd Fax: (045) 870 811 Address: John F. Kennedy Drive, Email: info@labplan.ie

Naas Road, Dublin 12.

582201 Tel: (01) 455 Fax: (01) 450 7906 sales@lennox.ie Email: greg@lennox.ie Web:

www.lennox.ie Business: Laboratory suppliers.

K

LAncAster LAborAtories

Address: IDA Business Park, LIMERICK PACKAGING Address: Clogherane,

Eastlink Business Park, Dungarvan,

Ballysimon Rd., Limerick.

Tel: Co. Waterford.

(061) 400 035 Email: info@lmkpkg.ie Tel: (058) 48 300 Web: www.limerickpackaging.ie Fax: (058) 42 855 Business: Packaging manufacturers, Email: info@lancasterlabs.com

Distributors, Designers Web: www.lancasterlabspharm.com

and Auditors.

Business: Contract Analytical Contact: Sales Director:

Mike Boland Services Contact: Business Development

Director: LISTER MACHINE

Mark Glass

TOOLS LTD

Address:

PO Box 838, Lennox LAborAtory Bluebell Industrial Estate, suppLies Ltd Dublin 12.

Address: John F. Kennedy Tel:

(01) 450 8866 Fax: Drive, Naas Road,

(01) 450 9836 Email: Dublin 12. sales@listermachinetools.com Tel: (01) 455 2201 Web:

www.listermachinetools.com Business: Sales and service of Machine Fax: (01) 450 7906

Tools and related accessories, Email: sales@lennox.ie

consumables and metrology greg@lennox.ie equipment.

Web: www.lennox.ie Business: Laboratory suppliers.

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 30/05/2012 Solutions Provider.

Director: Emer Conroy

M

Kuehne + Nagel IRELAND Address:

Tel: Email: Web: Business: Contact:

Unit D2 Horizon Logistics Park, Harristown, Swords, Co. Dublin, K67 Y954.

01 823 9777 Alison.moore@kuehne-nagel.com www.kuehne-nagel.ie Logistics & Supply Chain.

Marketing & Communications Manager: Alison Moore Mob: +353 86 4104241

Irish PharmaChem | Industry Buyers Guide 2020

LEO Pharma

Address:

Cashel Road, Kimmage, Dublin 12.

Tel: (01) 490 8924 Email: hr.dublin@leo-pharma.com Web:

www.leo-pharma.com Business: Pharmaceutical Manufacturing.

Contact: Angel George, HR Executive ALGIE@leo-pharma.com

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

105

16:57

COMPANY LISTINGS

N

O

OBEECO LTD Address:

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

MSD Ireland Address:

106

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

Oak North Rd, 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. MSD employs

approximately 2,300 people in

Ireland across four sites in

Ballydine, Co Tipperary, Brinny, Co

Cork, Carlow and Dublin and, in

addition, operate substantial

Human Health and Animal Health

businesses. Significantly, our Irish

sites manufacture approximately

half of MSD’s top 20 products,

saving and enhancing lives in

over sixty countries around the world.

Contact: Ger Brennan

MSD Ireland (Human Health) LTD

Annaville Avenue, Blackrock, Co. Dublin.

Tel: Fax: Email: Web:

(01) 278 2323 (01) 278 2374 sales@obeeco.ie www.obeeco.ie

OCON CHEMICALS LTD 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:

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

The Old Creamery, Tanyard, Millstreet Town, Co. Cork, Ireland.

Tel: Fax: Email:

Web:

Business:

Contact:

(029) 21 799 (029) 70 191 info@oflynnmedical.com www.oflynnmedical.com Distributor of Scrubex “Automated Protective Clothing Distributor”.

CEO: Tadhg O’Flynn

P

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.

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 Irish PharmaChem | Industry Buyers Guide 2020

COMPANY LISTINGS

Q

Pharmalex Address:

Suite 2, Stafford House, Strand Road, Portmarnock, Co. Dublin, D13 H525.

Tel: +353 1 846 4742 Victor.cowper@pharmalex.com Email: 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

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.

Portakabin Ireland Address:

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.

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

Irish PharmaChem | Industry Buyers Guide 2020

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) 974 1148 (090) 974 1459 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: Business Development Manager:

Dale Hirst

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

107

COMPANY LISTINGS

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

SOLV-ECHEM IRELAND LTD

T

Address:

Tel: Email: Web: Business:

Contact:

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

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

SK pharmteco Address: Watery Lane, Swords, Co. Dublin.

Tel: (01) 813 9000 Email: Ireland@sk.com Web: www.skbiotek.ie Business: Contract Development

Manufacturing Organisation.

Contact: Brian Fairley, Director Business

Development & Marketing

Address: 1 Orchard Place,

Nottingham Business Park, Nottingham,

NG8 6PX,

United Kingdom.

Tel: +44 (0) 115 855 2528 Web: www.sourcebioscience.com

teva pharmaceuticals ireland

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

TWi 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.

SSPC, SFI RESEARCH CENTRE FOR PHARMACEUTICALS

Address: Bernal Institute,

University of Limerick, Limerick, Ireland.

Tel: +353 (0)61 233754 Web: www.sspc.ie Business: Pharma Research Centre.

Contact: Executive Director, Dr Denise Croker

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

U

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

108

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.

Univar Address:

Tel: Email: Business: Contact:

536 Grants Crescent, Greenogue Business Park, Rathcoole, Co. Dublin.

(01) 401 9800 irelandsalesoffice@univarsolutions.com Chemical Distribution Key Account Manager: Carla Byrne

Irish PharmaChem | Industry Buyers Guide 2020

COMPANY LISTINGS

V

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

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

Westbourne IT Global SERVICES Address: Blackpool Retail Park, Blackpool,

Co. Cork.

Tel: (021) 431 4310 Email: james.symington@westbourneit.com Business: IT Service Provider.

Contact: 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

www.irishpharmachem.com NOTES

Irish PharmaChem | Industry Buyers Guide 2020

109

2020 YEAR P 2020 YEAR P I r i s h P harm aCh em MON TUESWED WEDTHU THU FRIFRI SAT SAT SUN SUNMON MON TUESWED WEDTHU THU FRIFRI SAT SAT SUN SUNMON MON TUESWED WEDTHU THU FRIFRI MON TUES TUES TUES

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SAT SAT

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1010 1111 1212 1313 1414 1515 1616 1717

1818

1 1

2 2

3 3

4 4

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7 7

1515

New New Year’sYear’s Day Day

January January

Public Public Holiday Holiday

8 8

9 9

1010 1111 1212 1313 1414 SaintSaint Valentine’s Valentine’s Day Day

February February 1 1

2 2

3 3

4 4

5 5

5 5

6 6

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8 8

9 9

6 6

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8 8

9 9

1010 1111 1212 1313

1414

1010 1111 1212 1313 1414 1515 1616 1717

1818

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2 2

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GoodGood Friday Friday

April April

Easter Easter Easter Easter Sunday Monday Monday Sunday Public Public Holiday Holiday

1 1

2 2

3 3

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4 4

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8 8

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1010 1111 1212 1313 1414 1515

1616

9 9

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2020

Public Public Holiday Holiday

2 2

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8 8

Public Public Holiday Holiday

F

June June

D

1 1

2 2

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1010 1111 1212 1313 1414 1515 1616 1717

1818

3 3

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7 7

1010 1111 1212 1313 1414

1515

July July 8 8

9 9

Public Public Holiday Holiday

August August 1 1

2 2

3 3

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9 9

1010 1111 1212 1313 1414 1515 1616 1717 1818

1919

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1717

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1010 1111 1212 1313

1414

6 6

7 7

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9 9

1010 1111 1212 1313 1414 1515 1616 1717 1818

1919

September September October October 8 8

9 9

November November 1 1

2 2

3 3

4 4

5 5

December December MON TUESWED WEDTHU THU FRIFRI SAT SAT SUN SUNMON MON TUESWED WEDTHU THU FRIFRI SAT SAT SUN SUNMON MON TUESWED WEDTHU THU FRIFRI MON TUES TUES TUES

118_119 2020 Year Planner 2p.indd 118

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SAT SAT

118_11

PLANNER RR PLANNER Y e ar P la n n e r 2 0 2 0

U FRIFRI

1717

1414

SAT SUN SUNMON MONTUES TUESWED WEDTHU THU FRIFRI SAT SAT SUN SUNMON MONTUES TUESWED WEDTHU THU FRIFRI SAT SAT SUN SUNMON MONTUES TUES SAT

1818 1919 2020 2121 2222 2323 2424 2525 2626 2727 2828 2929 3030 3131

January January 1515 1616 1717 1818 1919 2020 2121 2222 2323 2424 2525 2626 2727 2828 2929

aintSaint Valentine’s alentine’s Day Day

1313

1717

1515

1919

1717

1414

1818

1616

1313

1818

U FRIFRI

0 12:19

February February 1414 1515 1616 1717 1818 1919 2020 2121 2222 2323 2424 2525 2626 2727 2828 2929 3030 3131 SaintSaint Patrick’s Patrick’s Day Day

Mother’s Mother’s Day Day

Summer Summer Begins TimeTime Begins

March March

Public Public Holiday Holiday

1818 1919 2020 2121 2222 2323 2424 2525 2626 2727 2828 2929 3030

April April 1616 1717 1818 1919 2020 2121 2222 2323 2424 2525 2626 2727 2828 2929 3030 3131

May May 2020 2121 2222 2323 2424 2525 2626 2727 2828 2929 3030 Father’s Father’s

June June

Day Day

1818 1919 2020 2121 2222 2323 2424 2525 2626 2727 2828 2929 3030 3131

July July 1515 1616 1717 1818 1919 2020 2121 2222 2323 2424 2525 2626 2727 2828 2929 3030 3131

August August 1919 2020 2121 2222 2323 2424 2525 2626 2727 2828 2929 3030

September September 1717 1818 1919 2020 2121 2222 2323 2424 2525 2626 2727 2828 2929 3030 3131 SummerPublic Public Summer Holiday TimeTime EndsEnds Holiday

Halloween Halloween

October October

1414 1515 1616 1717 1818 1919 2020 2121 2222 2323 2424 2525 2626 2727 2828 2929 3030

November November 1919 2020 2121 2222 2323 2424 2525 2626 2727 2828 2929 3030 3131 Christmas Christmas SaintSaint Stephen’s Day Day Stephen’s Public Day Day Public

December December

Holiday Public Public Holiday Holiday Holiday

SAT SUN SUNMON MONTUES TUESWED WEDTHU THU FRIFRI SAT SAT SUN SUNMON MONTUES TUESWED WEDTHU THU FRIFRI SAT SAT SUN SUNMON MONTUES TUES SAT

118_119 2020 Year Planner 2p.indd 119

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USEFUL REFERENCES ACADEMY OF CLINICAL SCIENCE AND LABORATORY

ELECTRICITY SUPPLY

INSTITUTE OF CHEMISTRY

IRISH PATENTS OFFICE

BOARD

OF IRELAND

Tel: (056) 772 0111

MEDICINE

Tel: 1850 372 757

E-mail: info@instituteofchemistry.org

E-mail: patlib@patentsoffice.ie

Tel: (01) 905 9730

E-mail: esbnetworks@esb.ie

Web: www.instituteofchemistry.org

Web: www.patentsoffice.ie

E-mail: mail@acslm.ie

Web: www.esb.ie INTERNATIONAL SOCIETY

IRISH PHARMACY UNION

ENTERPRISE IRELAND

FOR PHARMACEUTICAL

Tel: (01) 493 6401

Tel: (01) 727 2000

ENGINERING (ISPE)

E-mail: info@ipu.ie

E-mail: client.service@enterprise-ireland.com

Tel: +1 (813) 960 2105

Web: www.ipu.ie

Web: www.enterprise-ireland.com

E-mail: ask@ispe.org

Web: www.acslm.ie ADVISORY COUNCIL FOR SCIENCE, TECHNOLOGY & INNOVATION Tel: (01) 631 2858 E-mail: firstname.surname@djei.ie Web: www.sciencecouncil.ie AN BORD PLEANALA Tel: (01) 858 8100 LoCall: 1890 275 175 E-mail: bord@pleanala.ie

IRISH VENTURE CAPITAL

Web: www.ispe.org

ASSOCIATION

ENVIRONMENTAL HEALTH ASSOCIATION OF IRELAND

INVEST NORTHERN IRELAND

Tel: (01) 276 4647

Tel: (01) 276 1211

Tel: 0044 800 181 4422

E-mail: secretary@ivca.ie

E-mail: info@ehoa.ie

E-mail: dublin@investni.com

Web: www.ivca.ie

Web: www.ehai.ie

Web: www.investni.com MANDATE TRADE UNION

ENVIRONMENTAL

IRISH BUSINESS &

Tel: (01) 874 6321

PROTECTION AGENCY

EMPLOYERS

E-mail: mandate@mandate.ie

Tel: (053) 916 0600

CONFEDERATION (IBEC)

Web: www.mandate.ie

LoCall: 1890 335 599

Tel: (01) 605 1500

E-mail: info@ibec.ie

E-mail: info@epa.ie

E-mail: info@ibec.ie

Web: www.biopharmachemireland.ie

Web: www.epa.ie

Web: www.ibec.ie

CHAMBERS IRELAND

HEALTH AND SAFETY

IRISH CLEANROOM

Tel: (01) 400 4300

AUTHORITY

SOCIETY

E-mail: info@chambers.ie

Tel: 01 614 7000

Tel: 087 958 8045

Web: www.chambers.ie

LoCall: 1890 289 389

E-mail: info@cleanrooms-ireland.ie

E-mail: wcu@hsa.ie

Web: www.cleanrooms-ireland.ie

Web: www.pleanala.ie BIOPHARMACHEM IRELAND Tel: (01) 605 1500

COMPANIES REGISTRATION OFFICE Tel: (01) 804 5200 LoCall: 1890 220 226 E-mail: info@cro.ie

Web: www.hsa.ie

Web: www.cro.ie

NATIONAL INSTITUTE FOR TRANSPORT & LOGISTICS (NITL) Tel: (01) 402 3000 E-mail: nitl@dit.ie Web: www.nitl.ie PARENTERAL DRUG ASSOCIATION (PDA) Tel: +1 (301) 656 5900 E-mail: info@pda.org

IRISH COSMETICS, HEALTH PRODUCTS

DETERGENT & ALLIED

REGULATORY AUTHORITY

PRODUCTS ASSOCIATION

Tel: (01) 676 4971

Tel: (01) 605 1671

PHARMACEUTICAL

E-mail: info@hpra.ie

E-mail: siobhan.dean@ibec.ie

SOCIETY OF IRELAND

Web: www.hpra.ie

Web: www.icda.ie

Tel: (01) 218 4000 E-mail: info@psi.ie

HEALTH RESEARCH

IRISH EXPORTERS

Web: www.thepsi.ie

BOARD

ASSOCIATION

Tel: (01) 234 5000

Tel: (01) 661 2182

E-mail: hrb@hrb.ie

E-mail: iea@irishexporters.ie

Web: www.hrb.ie

Web: www.irishexporters.ie

HIGHER EDUCATION

IRISH MEDTECH

AUTHORITY

ASSOCIATION

Tel: (01) 231 7100

Tel: (01) 605 1500

E-mail: info@hea.ie

E-mail: info@irishmedtechassoc.ie

Web: www.hea.ie

Web: www.irishmedtechassoc.ie

& LOCAL GOVERNMENT

IDA - INDUSTRIAL

IRISH NATIONAL

Tel: (01) 888 2000

DEVELOPMENT AGENCY

ACCREDITATION BOARD

LoCall: 1890 20 20 21

Tel: (01) 603 4000

Tel: 1890 289 389

Tel: (01) 716 1825

E-mail: qcsofficer@housing.gov.ie

E-mail: idaireland@ida.ie

E-mail: info@inab.ie

E-mail: chemical.eng@ucd.ie

Web: www.housing.gov.ie

Web: www.idaireland.com

Web: www.inab.ie

Web: www.ucd.ie/chembioeng

Web: www.pda.org

DEPARTMENT OF COMMUNICATIONS, CLIMATE ACTION AND ENVIRONMENT Tel: 01 678 2000 E-mail: customer.service@dccae.gov.ie Web: www.dccae.gov.ie DEPT. OF Business, ENTERPRISE & INNOVATION Tel: (01) 631 2121 LoCall: 1890 220 222 E-mail: info@dbei.gov.ie Web: www.dbei.gov.ie

REPAK Tel: (01) 467 0190 E-mail: info@repak.ie Web: www.repak.ie SCIENCE FOUNDATION IRELAND Tel: (01) 607 3200 E-mail: info@sfi.ie Web: www.sfi.ie

DEPT. OF HOUSING, PLANNING

112

UCD SCHOOL OF CHEMICAL & BIOPROCESS ENGINEERING

Irish PharmaChem | Industry Buyers Guide 2020

On Time, Everytime!

Packaging Manufacturers, Distributors & Packaging Consultants • Corrugated Boxes (RSC, Die Cut, Sheets, Pads, Divs, Etc) • Protective Foam Packs (EPS, EPE, EPP, EPU) • Industrial Polyethylene Bags, Sleeves & Sheets

• Pallet Edgeguards • Litho Printed Cartons & Litho Laminated Outers • High Quality Post Printed Corrugated Boxes

T: + 353 61 400035 F: + 353 61 400036 E: info@lmkpkg.ie • Shelf-Ready/Retail-Ready Packs.

• Pallet Wrap / Strapping Strapping Accessories / Tapes / Labels

Limerick ad.indd 1 Food Cover.indd 1

T: + 353 61 400035

21/12/2010 11:58

E: info@lmkpkg.ie

11/01/2012 15:56

W: www.limerickpackaging.ie

For when it matters the most.

T: +353 18239777 | E: Ireland.sales@kuehne-nagel.com | W: www.kuehne-nagel.ie