Irish PharmaChem 2017 by Retail News

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CONTENTS

2 0 1 2

30 Serialisation

16 BioPharma Ambition Conference 3 Minister’s Foreword

30 Serialisation

Government support for the pharma and chemical sector remains strong, writes Mary Mitchell O’Connor TD, Minister for Jobs, Enterprise and Innovation.

4 Sector Overview BioPharmaChem Ireland is the new name for the Ibec association, chosen to better fit the changing face of the sector in Ireland, writes Matt Moran, Director.

8 Science Foundation Ireland Science Foundation Ireland invests in research that generates knowledge, produces cutting-edge technologies and develops industry, enterprise and employment in the fields of science, technology, engineering and mathematics in Ireland.

12 Investment & Development There is a bright future for biopharmaceuticals in Ireland, writes Tommy Fanning, Head of Biopharmaceuticals & Food at IDA Ireland.

16 BioPharma Ambition Conference The inaugural BioPharma Ambition Conference was hosted by the Irish Pharmaceutical Healthcare Association and BioPharmaChem Ireland, together with NIBRT.

20 NIBRT The biologics sector has seen more than €10 billion of investment in the last 10 years, with more investment and jobs likely in the coming years.

24 Health & Safety Majella Cosgrave, Senior Inspector, Chemicals & Prevention Division, HSA, on the impact of the REACH Directive on the Irish pharmachem sector.

26 Medicine Shortages

53 Medtech

Serialisation and the Falsified Medicines Directive (FMD) for Europe is nearly here. There is less time than you think to prepare, warns Siobhain Duggan, GS1 Ireland.

32 Marketing Authorisation Holders Ann McGee, MD of McGee Pharma International, outlines the legal obligations of the Marketing Authorisation (MA) Holder and how these translate on a daily basis.

36 Pharmaceutical Manufacturing and Technology Centre The last 12 months have seen the Pharmaceutical Manufacturing Technology Centre continue to capitalise on its earlier successes.

Regulatory Science Ireland is conducting a research project to enhance understanding of biosimilar medicines and encourage best practice in their use.

Interpac are proud to announce the launch of Multitank, the first reusable watertight container that doesn’t need a liner or a bag, to the Irish market.

58 Rigid Plastics OnePlastics has opened an industry-leading packaging plant at its Protech site in Little Island, Cork.

60 Material Handling Toyota Material Handling Ireland brings to the market the full range of Toyota and BT products, offering the customer a one stop shop for all material handling needs.

62 Specialised Chemicals Camida has been sourcing and supplying specialised chemicals for the life science, industrial and ingredient sectors for 28 years, over which time it has developed into one of the most customerfocused and flexible companies in the industry.

43 Research & Development The Synthesis and Solid State Pharmaceutical Centre (SSPC) has won the Pharma Research Centre of the Year Award for the third year in a row.

44 Biotech Start-Ups

64 Industrial Cleaning Unrivalled expertise and a determination to innovate define AQS Environmental Solutions’ cleaning and waste management services for chemicals and pharma clients.

There has never been a better time to back a young, lean biotechnology start-up, writes Steven O’Connell of RebelBio.

47 Education & Skills Development Ireland’s biopharmachem industry could generate up to 8,000 new jobs if we successfully nurture our talent pool.

Eurofins Lancaster Laboratories’ major expansion plans in Ireland enhance global biopharmaceutical services and create new jobs.

Irish PharmaChem is published by: Tara Publishing Ltd 14 Upper Fitzwilliam Street, Dublin 2. Tel: 00 353 (0)1 678 5165 Fax: 00 353 (0)1 6477127 Email: kathleenbelton@tarapublications.ie Web: www.irishpharmachem.com

Irish PharmaChem | Industry Buyers Guide 2017

56 Packaging Solutions

39 Regulatory Science Ireland

50 Laboratories

Enda Dempsey of BioPharmaChem Ireland examines the causes of medicine shortages and, more importantly, strategies to minimise them.

Sinead Keogh, Ibec Director of Medtech and Engineering, explains how Ireland is innovating for future healthcare and economic growth with medtech.

LISTINGS SECTION Chemical Suppliers

General Suppliers

Company Listings

2017 Year Planner

Useful References

Managing Director: Patrick Aylward Editorial and Marketing Director: Kathleen Belton Editor: John Walshe

Advertising Sales: Brian Clark Design: Tony Hunt Production: Ciara Conway Printed by: WG Baird

Minister’s Foreword

Supporting Your Success Government support for the pharma and chemical sector remains strong, writes Mary Mitchell O’Connor TD, Minister for Jobs, Enterprise and Innovation.

property solutions through the provision of advanced buildings as part of its €150m Regional Property Programme. The successful completion and almost immediate occupancy of the first advance facilities shows the extent of demand for these tailor-made and sector-specific property solutions and their importance to sustaining the inward flow of investments from overseas. The continued high levels of foreign direct investment in Ireland by pharmaceutical/ chemical and other companies reflects Ireland’s stellar international reputation for producing high value, high quality products. Our first-class workforce deserves most of the credit for earning our country that hard-won reputation. That is why we are committed to providing ongoing education and training opportunities in order to maintain this pipeline of skilled and talented people.

As Minister for Jobs, Enterprise and Innovation, I am very pleased to provide the foreword for the 2017 PharmaChem Yearbook and Directory. Ireland’s economy has weathered the storm of the global financial crisis and is now performing strongly and growing steadily. The pharmaceutical/chemical sector has been one of the star performers in our export-led economic recovery and we want to see it continue to grow further. The sector is already contributing significantly. In the last two years, pharmaceutical/chemical companies have committed over €4 billion in Mary Mitchell O’Connor TD, Minister for capital to projects in Ireland, creating over 3,000 Jobs, Enterprise and Innovation. new high-value jobs. This figure doesn’t include indirect jobs created as a result of these investments in supporting The Value of NIBRT industries such as construction. The work of the National Institute for Bioprocess Research and Training The vibrancy of the sector is clearly reflected in just a few headline (NIBRT) has been critical in this context and it’s no surprise that many statistics: pharmaceutical/chemical companies locating in Ireland cite it as a key Medical and pharmaceutical products worth €30.17 billion were determinant in their choice of a location for investment. NIBRT is an exported in 2015, which accounted for 27% of our goods exports in invaluable resource for the sector and epitomises the collaborative spirit 2015; that is so vital to it. I was, therefore, especially delighted to see NIBRT Chemical products accounted for €13.9 billion or 12.5% of exports in receive recognition for its innovative work at the Irish Pharma Awards in 2015; October 2016, where it received awards for Pharma Education & Training Ireland is the world’s largest net exporter of pharmaceuticals; and for Partnership Alliance of the Year. Ireland is the 8th largest producer of pharmaceuticals in the world; We operate in a difficult global marketplace and international Nine of the top 10 pharmaceutical companies have operations in competition is fiercer than ever for investment in this sector. Ireland, Ireland; though, continues to win new and significant investments versus our 17 of the top 25 medical technology companies have a presence in competitor locations. We are proud of that record and we intend to Ireland. continue to compete hard for further investment in the future to make sure that Ireland remains an attractive destination for pharmaceutical/ These facts illustrate that Ireland has remained at the forefront of the chemical companies. pharmaceutical/chemical sector and is a flagship location for many of the larger industry members. There is also a strong regional spread to I wish PharmChem Ireland every success in 2017 and into the future. I investments by companies, which is very much in keeping with IDA look forward to hearing of new developments and breakthroughs in the Ireland’s overall strategy to secure more projects and employment for field, as we continue to work together over the time ahead. regional areas.

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Regional Development Regional development is, in fact, a priority of mine as well as of IDA Ireland. The IDA is working hard to ensure the availability of suitable

Irish PharmaChem | Industry Buyers Guide 2017

Mary Mitchell O’Connor TD Minister for Jobs, Enterprise and Innovation

Sector Overview BioPharmaChem Ireland is the new name for the Ibec association, chosen to better fit the changing face of the sector in Ireland, writes Matt Moran, Director, BioPharmaChem Ireland.

BioPharmaChem Ireland:

The Dawn of a New Era PharmaChemical Ireland is no more: the industry association revealed a brand new name, BioPharmaChem Ireland, on the occasion of the publication of phase four of its industry strategy, ‘Molecules Make a Difference’, at the The Drug, Chemical and Associated Technologies (DCAT) meeting in New York City in March 2016. BioPharmaChem Ireland (BPCI) is the name agreed by the membership to better fit the changing face of the sector in Ireland, where the level of investment in biotech or large molecule manufacture is increasingly rapidly at the moment, as I outlined in my piece last year. If anything, since I wrote that, the stream of investment has in fact increased, with Shire and GE Healthcare both announcing biotech investments adding to the others and bringing total capital invested to over €4 billion.

DCAT Meeting BPCI were joined by Barry Heavey of IDA Ireland and Dominic Carolan of NIBRT at the DCAT meeting. Both the IDA and NIBRT made compelling presentations at this event, which was titled ‘Inside Ireland’. In fact, Ireland is the only country so far to present at this prestigious event, which is attended by the majority of leaders from within the US based

pharmaceutical and chemical sectors, making it the ideal occasion to profile the sector here in Ireland. A largely US-based audience were updated on the latest BPCI strategy and were able to interact with BPCI, IDA and NIBRT, resulting in them receiving a comprehensive overview on the state of play in Ireland. A lively and interesting panel discussion followed: we were very fortunate to be joined by Paul Duffy of Pfizer, David Keenan and Tyson Popp of Mallinkrodt and Morgan Norris of GE Healthcare, the whole event being very ably chaired by BPCI Chair, Seamus Fives of Pfizer. ‘Molecules Make a Difference’ clearly outlines the six primary priorities for the sector for the next phase of its development:

Competitiveness Ensuring that Ireland maintains a competitive environment that supports further growth of the sector, with a particular emphasis on innovation, operational excellence and that it retains a competitive rate of corporation tax.

Talent Ireland’s talent pool remains a key competitive advantage: it is important that industry, Government and the academic community Irish PharmaChem | Industry Buyers Guide 2017

Sector Overview work together to ensure that this pool stays nourished. This is especially relevant in light of the enormous opportunity for employment generated by the recent wave of capital investment, particularly in the biotech sector.

Innovation and Manufacturing Excellence Ireland has a significant life sciences cluster, with a proven record in operational excellence, compliance and supply chain security, in addition to a green image. The correct manufacturing environment is critical; hence, it is vital that we keep up to date with the latest manufacturing technology, moving from batch to continuous, utilising skid technology, prioritising innovation in both process development and manufacturing technology.

Academic Collaboration A key advantage of the Irish business environment is the productive collaboration between industry, academia and Government agencies. All these stakeholders should continue to work together to consolidate Ireland’s position as a leading knowledge based economy and as a primary location for research and development. Industry links and networks should continue to develop and be enhanced.

Skills Demand for skills in Ireland remains very strong and therefore, continuity of investment in education is critical to building a future stream of highly skilled employees. It is important to nurture talent through the promotion of investment in science and technology at all stages in the academic lifecycle. The Expert Group on Future Skills Needs (EGFSN) have published an excellent report outlining what needs to be done to ensure that Ireland stays at the forefront of talent development for this sector. BPCI have published their own ‘Action Plan for Skills for Life Sciences’ and are currently engaged in implementing these through their skills forum.

Pictured are (l-r): Tyson Popp, Vice President & Chief Procurement Officer at Mallinckrodt Pharmaceuticals; Matt Moran, Director, BioPharmaChem Ireland; Seamus Fives, Site Leader at Pfizer Pharmaceutical and Chair of BioPharmaChem Ireland; David Keenan, Vice President Global External Supply and Managing Director Mallinckrodt Pharmaceuticals Ireland; Barry Heavey, Head of Life Sciences, Engineering & Industrial Tech, IDA Ireland; Dominic Carolan, CEO, NIBRT; Morgan Norris, GM, BioProcessing Upstream Products at GE Healthcare; and Paul Reid, MD, Pfizer Healthcare Ireland.

Authority (HSA), including REACH, the EU package for chemicals. The strategy document contains a range of case studies that exemplify how the industry has been developing since the publication of phase one of their strategy in 2010. Case studies by IDA Ireland, a range of Irish based manufacturers, the Synthesis and Solid State Pharmaceutical Centre (SSPC) and The Pharmachem Skillnet address thematic areas of competitiveness, innovation, academic

collaboration, manufacturing excellence and skills. These areas provide a very solid foundation for a predicted continued growth in the sector, a sector that has recovered very well since the patent cliff experienced just a short few years ago, a sector that now exports products to the value of €64 billion, well over half of all the goods that leave this country’s shores. Of course, one of the primary drivers for the continued success of the sector in this country

Compliance Ireland’s pharmaceutical sector has an extraordinarily good track record in terms of compliance with statutory and quality based regulations. The US Food and Drug Administration (FDA), The Health Products Regulatory Authority (HPRA) and customer audits consistently rate Irish manufacturers’ good manufacturing compliance (GMP) as world class. This presents the sector here with a real competitive advantage, especially in a world of ever more complex and scattered supply chains, which inevitably lead to quality and compliance problems for the industry. Also, the sector exceeds the requirements laid down by both The Environmental Protection Agency (EPA) and The Health and Safety Irish PharmaChem | Industry Buyers Guide 2017

Sector Overview

Pictured are (l-r): Barry Heavey, Head of Life Sciences, Engineering & Industrial Tech, IDA Ireland; Dominic Carolan, CEO, NIBRT; Matt Moran, Director, BioPharmaChem Ireland; and Seamus Fives, Site Leader at Pfizer Pharmaceutical and Chair of BioPharmaChem Ireland.

is the talent of the people who work in and support the sector. The ability of Irish nationals to succeed at the very upper echelons of major biopharmaceutical and chemical companies is evidence of this. Global leaders such as Julie O’Neill of Alexion, Paul Duffy of Pfizer, David Keenan of Mallinckrodt, Greg Timmons of Takeda and Liam Murphy of Henkel are profiled in the report. They cover the entire span of the sector, from biotech through traditional small molecule pharmaceutical supply, right the way through to pure chemical production, spanning regions from the USA through Continental Europe, all the way to Japan. There is little doubt that the sector in Ireland has entered a new and exciting phase

of development, much of this driven by the significant investment in biotech drug substance manufacture by existing and new companies. This part of the sector is often referred to as large molecule manufacture. Nevertheless, Ireland remains an important centre for small molecule or chemical manufacture and continues to be an important location for the manufacture of finished drug products. Increasingly, we are seeing convergence of technologies, whether that be with medical technology or indeed data management of other forms of information technology, such as telematics. In my view, molecules – all molecules, small medium or large – and how they are managed will continue to make a difference to all aspects of society and how we live in and interact with the world around us. I would like to acknowledge Nessa Fennelly, Senior Executive at BPCI, who was responsible for bringing together and publishing this report.

BioPharma Ambition Before I sign off, let me reference BioPharma Ambition, which I know will feature elsewhere in the Guide. It was a truly remarkable experience and represented the coming together of ourselves at BPCI, our partners at The Irish Pharmaceutical and Healthcare Association (IPHA) and at The National Centre for Bioprocessing Research and Training (NIBRT). This event, spread across five locations and one week, profiled the allisland biopharmaceutical sector in the most positive light. Addressed by three Government Ministers, Mary Mitchell O’Connor TD and Simon Harris TD from the Republic and Simon Hamilton MLA from Northern Ireland, this international event addressed many of the key issues facing the sector, from bench to bedside, both here in Ireland and in the rest of the world. We were proud to be part of it.

Conclusion To conclude then, I think it is very true to say that the sector here is indeed entering a new era of development. I believe that it has never been more robust than before and I feel that the sector here is well set to meet the challenges presented by a post Brexit/ Trump Presidency world. Though global companies are coming under some criticism at the moment, there can be no doubt that the one thing that sets apart the sector here is substance, substance based on people, on innovation, on quality, on meeting the needs of the patient and the customer and on 100% reliability. This type of substance can and will sustain well into the future.

Irish PharmaChem | Industry Buyers Guide 2017

At Roche we focus on developing medicines and diagnostics that will help patients live longer, better lives.

For further information please contact Roche Ireland Limited Clarecastle Co. Clare Tel: (065) 686 7200

Science Foundation Ireland

Furthering Irish Research Potential Ireland is building a reputation as a world leader in scientific research capability, continuously climbing international rankings to be 10th in global rankings for overall quality of scientific research, while achieving rankings of first in nanoscience, second in animal and dairy, third in immunology, chemistry, materials sciences and agricultural sciences, and fourth in mathematics. Currently, Ireland is ranked 7th in the world by the Global Innovation Index 2016. Ireland is committed to funding excellent and impactful research. Over 4,040 people work on Science Foundation Ireland supported research projects. Science Foundation Ireland place a key focus on collaborations, supporting over 1,220 collaborations with industry: 711 with multinational companies and 437 with SMEs. Science Foundation Ireland research teams

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are engaged in 2,081 international collaborations across 62 countries.

The Science Foundation Ireland Strategy: Agenda 2020 Agenda 2020, Science Foundation Irelandâ&#x20AC;&#x2122;s ambitious seven-year strategic plan, lays out four key goals, the strategies for achieving them, and the performance indicators which are used to measure progress. Science Foundation Irelandâ&#x20AC;&#x2122;s four goals are: 1. To be the best science funding agency in the world at creating impact from excellent research and demonstrating clear value for money invested; 2. To be the exemplar in building partnerships that fund excellent science and drive it out into the market and society; 3. To have the most engaged and scientifically informed public;

Irish PharmaChem | Industry Buyers Guide 2017 2016

Science Foundation Ireland

Science Foundation Ireland invests in research that generates knowledge, produces cuttingedge technologies and develops industry, enterprise and employment in the fields of science, technology, engineering and mathematics in Ireland. 4. To represent the ideal modern public service organisation, staffed in a lean and flexible manner, with efficient and effective management. The Agenda 2020 publication outlines the reasoning behind these objectives, the actions designed to achieve them and the KPIs which measure progress. A progress audit and annual plan are published annually. Commenting on Science Foundation Ireland’s plans for 2017, Professor Mark Ferguson said: “Science Foundation Ireland will support the academic and commercial research community to build Ireland as a global leader in research and innovation through a number of ambitious initiatives. We will fund excellent individual researchers, maintain and develop worldleading research centres of scale and impact, attract talent and foster greater international collaboration. Our activities will continue to fuel excellence and impact, relevant to Ireland,

Irish PharmaChem | Industry Buyers Guide 2017 2016

through supporting outstanding research teams and partnerships. Through our innovative education and public engagement programmes, we will create an inclusive dialogue where everyone in Ireland can engage with progress in science, technology, engineering and maths.”

Science Foundation Ireland’s 2017 development plans aim to:

• Build the number of SFI Research Centres of scale and excellence; • Expand the research community by

attracting and recruiting world leading ➧ Overleaf

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Science Foundation Ireland

talent through programmes including the SFI Research Professor Programme and the SFI Future Research Leaders Programme; Foster links between academia and industry promoting innovation though the SFI Research Centres, SFI Partnership Programme and the SFI Industrial Fellowship Programme; Engage and encourage the people of Ireland to explore and discover the world of science, technology, engineering and maths through the SFI Discover Programme Call and events including Science Week, with a particular focus on highlighting STEM careers; Continue to grow and expand international links through partnerships and collaborations with organisations in the United States, China, the United Kingdom and across Europe; Catalyse research teams in Ireland to lead and win major awards from the competitive European funding programme Horizon 2020; Encourage and support individual members of the research community from early stages of their careers through programmes such as the SFI Starting Investigator Research Grant (SIRG) to leading Investigators. Furthermore, with the aim of delivering on its Innovation 2020 commitments, Science Foundation Ireland will seek the necessary funding to develop new programmes which will be important to maintaining Ireland’s international competitiveness and positioning the country as a global research and innovation leader. In 2017, Science Foundation Ireland intends to design and pilot the following new programmes: A large-scale PhD programme; Ireland’s first Challenge-based funding programme for STEM; A new collaborative programme with the UK with a view to further strengthening

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links and exploiting opportunities arising from Brexit.

Science Foundation Ireland Research Centres Science Foundation Ireland has established 12 world-leading SFI Research Centres that focus on strategically important areas of research for Ireland. Each SFI Research Centre spans several Higher Education Institutions and collaborates with multiple industry partners. Science Foundation Ireland has committed to invest over €355m in the 12 Research Centres, with a further €190m from industry collaborators. The SFI Research Centres have over 300 industry partners and have produced 14 spin-out companies to date. The SFI Research Centres which have a strong focus on pharma-related investments include: The Alimentary Pharmabiotic Centre (APC) Microbiome Institute, led by Prof. Fergus Shanahan, with co-investigators in UCC, Teagasc Moorepark Food Research Centre, Mercy University Hospital, Cork University Hospital and Cork Institute of Technology, investigates the close links between diet, the microbiota and health status. The Centre aims to provide the necessary scientific basis for the selection of healthpromoting bacteria and food constituents for incorporation into ‘functional foods’ for improved health, and which can support the development of novel bioactives to treat intestinal and infectious diseases. The research undertaken by the APC will address important societal issues, such as disease prevention, improved cognition and healthy ageing, and is supported by food, biotechnology, pharmaceutical and diagnostic industries. INFANT, Irish Centre for Fetal and Neonatal Translational Research, is led by Prof. Louise Kenny and Prof. Geraldine Boylan at UCC, with

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co-investigators based in the Royal College of Surgeons (RCSI) and Tyndall National Institute at UCC. INFANT is an international leader in the development of innovative technologies in perinatal healthcare, improving treatment and care for pregnant mothers and newborn babies. The INFANT team are a diverse group of doctors and scientists, supported by strong industry partners, international collaborators and business and regulatory advisors. The Research Centre’s collaborations have resulted in the development of screening and diagnostic tests and novel methods of monitoring pregnancy and newborns. Acting as a hub for innovation, research in INFANT spans three of the major priority areas outlined in the Research Prioritisation Report: diagnostics, medical devices and connected health. These areas are associated with large global markets that have a strong Irish base. Centre for Research in Medical Devices (CÚRAM), led by Prof. Abhay Pandit aims to develop implantable ‘smart’ medical devices for chronic ailments, including cardiovascular, musculoskeletal, neural, and respiratory diseases. Strong clinical collaborations with industry partners and hospital groups enable the rapid translation of these devices to clinical settings. The multidisciplinary centre brings together experts in biomaterials and drug delivery, tissue engineering and regenerative medicine, glycoscience and device design. The Synthesis & Solid State Pharmaceutical Centre (SSPC) is led by Prof. B.K. Hodnett. The overarching aim of the SSPC Centre will be to better understand mechanisms, control processes and predict outcomes for the efficient and environmentally sustainable production of safe medicines. This will be achieved by utilising a ‘molecule-to-medicine’ approach that encompasses chemical synthesis, crystal engineering, and drug production and manufacture. SSPC research projects fall under one of three main themes: 1. New Frontiers in Pharmaceutical Synthesis:

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Science Foundation Ireland Partnership with Pfizer Continues to Thrive THERE are three new research projects under the Science Foundation Ireland-Pfizer Biotherapeutics Innovation Award Programme. The Programme provides academic researchers with an opportunity to translate scientific discoveries into new medicines. In addition to funding, researchers have the unique opportunity to work with the Pfizer Global Biotherapeutics Technology (GBT) group, and Pfizer’s R&D innovation engine, the Center for Therapeutic Innovation. Research projects under the Science Foundation Ireland-Pfizer Biotherapeutics Innovation Award Programme have focused on developing potential new therapies for medical conditions, including chronic itch, treatment resistant breast Pictured at the award programme announcement are Dr Paul Duffy, Vice President, cancer, haemophilia, fibrosis, psoriasis, Crohn’s disease and enhancing the Biopharmaceutical Operations and External Supply, Pfizer; Prof. Mark Ferguson, body’s natural anti-tumour response. Director General, Science Foundation Ireland and Chief Scientific Adviser to the Irish Government; and Dr Leonie Young, Royal College of Surgeons Ireland.

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Irish PharmaChem | Industry Buyers Guide 2017 2016

Science Foundation Ireland

efficient synthetic routes and processes for molecules that are precursors to potential pharmaceutically relevant materials; 2. Crystal Growth and Design: studying the physical characteristics of crystalline materials and their interactions to understand how to utilise them most effectively as active pharmaceutical ingredients; 3. Drug Product Formulation and Manufacture: using science- and engineering-based knowledge to optimise solid state pharmaceutics and produce new and improved drug formulations.

Key Programmes of Interest to Industry Science Foundation Ireland supports the development of strategic partnerships to deliver ground breaking scientific research for the competitive advancement of Ireland. Science Foundation Ireland has different funding levels and programmes that suit industry informed research and academic industry interactions at a number of levels:

Science Foundation Ireland Industry Fellowships: The Industry Fellowships Programme facilitates the placement of researchers in industry or academia to stimulate excellence through knowledge transfer and training. Fellowships enable access for researchers to new technology pathways and standards, facilitating training in the use of specialist research infrastructure. Fellowships can be awarded to academic researchers wishing to spend time in industry worldwide or to individuals from industry anywhere in the world (including Ireland) wishing to spend time in an eligible Irish research body. Funding of up to â&#x201A;Ź120,000 direct costs per fellowship is available.

Science Foundation Ireland Partnerships: The Partnerships Scheme provides a flexible mechanism by which key partners, including companies, funding agencies, charities, philanthropic organisations or research bodies, can partner with the goal of co-funding outstanding research opportunities in Ireland. The scheme provides an opportunity for industry to engage with world class academic researchers and have access to infrastructure and intellectual property, using a shared risk funding model in which Science Foundation Ireland matches the investment made by industry.

Irish PharmaChem | Industry Buyers Guide 2017 2016

A key feature of the Partnerships Scheme is the recognition that collaboration with industry must be responsive and flexible. For this reason, the scheme employs adaptive partnership models that have been developed to meet industry partner needs or specific industry challenges. For example, through the Competitive Partnership Programme, Science Foundation Ireland partners directly with industry to launch a competitive call for proposals to address key research priorities or challenges and identify academic partners of interest to the company. The Strategic Partnership Programme supports more targeted collaborations between industry and academic research groups (i.e. a company has identified a specific academic group with which it wishes to collaborate prior to application) through a non-competitive, fast track, international peerreview process.

Science Foundation Ireland Research Centres: These are world-leading, large-scale research centres with a major economic impact for Ireland. They consolidate research activities across higher education institutes to create a critical mass of internationally leading researchers in strategic areas which will lay the foundation for effective and productive academic and industrial partnerships. Science Foundation Ireland Research Centres can receive â&#x201A;Ź1-5m a year in direct costs. Science Foundation Ireland funds up to 70% of the overall research centre budget. A minimum of 30% of the budget must be secured from industry partners, at least one-third of which must be cash. New industry partners are always welcome to join Science Foundation Ireland Research Centres and are encouraged to contact centres of interest directly.

Science Foundation Ireland Research Centre Spokes: The Science Foundation Ireland Spokes Programme provides additional funding opportunities for companies to engage in collaborative research projects of scale with Science Foundation Ireland Research Centres. The Programme includes both a competitive Fixed Deadline and a non-competitive Rolling Call: applications can be submitted to the Rolling Call at any time. For more information about Science Foundation Ireland supported research and details of upcoming calls, go to www.sfi.ie.

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Investment & Development

Bright BioFuture for Ireland There is a bright future for Biopharmaceuticals in Ireland, writes Tommy Fanning, Head of Biopharmaceuticals & Food at IDA Ireland, who outlines key actions which support our future focus in the biopharma sector. The Biopharmaceutical industry is of critical importance to Ireland. The sector today employs over 27,500 people directly across 80 companies with a total of 124 sites. Exports of Medical Pharmaceutical and Medical Products accounted for 27%, €30.17 billion, of Ireland’s goods exports in 2015, which is a significant component of Irish economic activity. The IDA Biopharmaceutical team partners with biopharma companies globally to enable both existing and new investors to successfully establish international activities in Ireland. We want to see continued new investment from our existing base of investors, which includes most of the ‘Big Pharma’ players, and to work with new companies developing next generation products for global markets. This may all sound straightforward but anyone who has worked in a biopharma company knows nothing happens in straight lines, at regular intervals with everything under control… The type of projects that international biopharmaceutical companies have established in Ireland can be broken down into three main areas: ● Pharmaceutical Manufacturing (Small Molecule) - Drug substance ( also known as Active Pharmaceutical Ingredients, API); - Drug Product (also known as tabletting or formulation). ● Biologics Manufacturing (Large Molecule) - Drug Substance (also known as bulk bio); - Drug Product (also known as sterile fill finish);

also have international operations in Ireland. We don’t just want to win the investments for today but also work with our clients to make sure we are supporting the development of future manufacturing and services platforms.

Key Actions There are a number of key actions which support our future focus in the biopharma sector.

Tommy Fanning, Head of Biopharmaceuticals & Food at IDA Ireland. ● Services Centres

- This includes internal SSCs(Finance, HR, IT), a number of global CROs (Contract Research Organisations), global supply chain management operations, and more recently, biopharma-specific com mercial and medical services activities, such as regulatory affairs, pharmacovigilance, pharmacoeconomics, medical writing, sales and marketing support, digital platform development and clinical trials management. Ireland has been at the forefront of life sciences manufacturing for some time now, both for biopharmaceuticals and for medical devices. We are now beginning to see the convergence of these two sectors and the involvement of the large tech companies, who

1. 2. 3.

Transformation of existing small molecule sites in Ireland. While there may be limited new investment in this area, existing companies will have new products and projects. We will want to work with our clients to make sure the Irish sites are true centres of excellence and the go-to locations for new products being developed. Win new investment in the large molecule area, with increased emphasis on new manufacturing technologies and the developing areas in next generation therapeutics (combination products, gene & cell therapies). Develop and win new investment in biopharma specific services, which will support the international growth of our companies. This would also include developing our CRO community in Ireland. We truly believe that Ireland has the skills and the infrastructure, along with some key companies already growing in this area, to create a cluster of

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Investment & Development

talent and a template for consolidating these types of activities. 4. Work closely with our clients to see more business to business collaboration with indigenous and technology companies and our academic research community. The achievement of these objectives will require: ● A continued investment by companies in R&D activities and capability, with continuing support for key strategic projects and target locations from IDA; ● A focus on next generation manufacturing platforms, industry 4.0 and continuous manufacturing initiatives; ● A coordinated strategy across all stake holders to increase skills availability: - Biotech manufacturing skills; - Clinical development skills; - Commercial skills. ● Financial support for the building out of the ecosystem for clinical activity post Brexit: - Clinical trial activity; - Clinical trial management; - Commercial services innovation (Accenture/Novartis). ● A strong partnership approach to growing the sector in collaboration with: Biopharmachem Ireland, NIBRT, EI and SFI, alongside other departments within IDA, in particular the Medical Technologies department. ● Support for B2B collaboration around drug delivery devices, future convergence opportunities and combination drug therapies. The challenge today for existing operations is to transform their production processes to compete in the increasingly high value, hightech segments of the market. This applies to both small and large molecule companies, with developments in continuous manufacturing, single-use systems, analytics, industry 4.0 and changes in the potency of products requiring a smaller quantity of drug substance, in addition to the small size of patient populations for certain orphan drugs.

Recent Success and Regional Clusters The last three years have seen a strong resurgence in the Irish life sciences sector and 2015 was another strong year. Major projects have been announced from companies such as Alexion, Amneal and Regeneron, with over $4 billion in capital committed, over 3,000 new high value direct jobs, with a large number of additional indirect jobs in construction and other services. In 2016, we have seen significant announcements of projects from Shire for the Mid-East region with 400 jobs and Opko for

the South-East with over 200 jobs. There is a strong regional dispersal, with locations such as Westport, Galway, Limerick, Cashel, Waterford and Athlone.

Brexit For our clients, there will be the potential new regulatory regime in the UK and with it the move of the European Medicines Agency (EMA) out of the UK. Ireland has announced publicly that it will bid for this and IDA will be a key member of the working group, led by our Department of Health. The bigger immediate concerns, though, are the currency fluctuations and volatility around the price of both raw materials and the sale of products in the UK. However, there may be an opportunity as well around the level of future European commercial activity looking for a HQ location. Ireland is already seeing an influx of this in other sectors such as tech and digital media and there is no reason why this could not be the case in the life sciences sector as well.

Skills Ireland has been very successful in terms of winning highly capital intensive new investments from global biopharma companies but for this to continue will require a highly skilled workforce alongside the development of new talent for the sector. In August 2016, the Department of Jobs, Enterprise & Innovation (Expert Group on Future Skills) published a report outlining the skills building blocks over the next five years to make sure that Ireland can continue to be the location of choice for biopharma manufacturing and process development. Ireland has already proved itself in terms of its exemplary regulatory track record across the sector and now has an opportunity to further that with the new biologic products that our clients will be commercialising in the future.

Conclusion With a stellar cluster of companies in Ireland and significant return to the state in salaries, local supply contracts, deep talent development and taxes, the biopharma sector fits hand-inglove with the Government’s objective to be a knowledge and high value led economy. There are many challenges ahead for the sector but also opportunities. Through collaboration across industry and all stakeholders, the sector can continue to grow both in scale and significance for the delivery of life-saving medicinal products for a global patient population. Irish PharmaChem | Industry Buyers Guide 2017

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BioPharma Ambition Conference

Ireland Showcases its ambition

Prof. Luke O’Neill, Chair of Biochemistry, Trinity College Dublin, speaking at the BioPharma Ambition Plenary Session.

The inaugural BioPharma Ambition Conference took place on September 21 and 22, hosted by the Irish Pharmaceutical Healthcare Association and BioPharmaChem Ireland, together with the National Institute for Bioprocessing Research and Training (NIBRT). Bringing together international policy leaders, renowned researchers and senior industry personnel, the BioPharma Ambition Conference highlighted Ireland’s booming biopharma industry and its ambitions for the health and well-being of populations. It also inspired and showcased innovation in discovery, development, manufacturing and healthcare solutions. Establishing Ireland as a biopharmaceutical centre of excellence was at the heart of this year’s event, providing a platform to call for specific investment in both Ireland and Northern Ireland. There was a large focus on sustaining talent, growing competitiveness, providing greater support for clinical trials, IT and key specialists and ultimately, ensuring that Ireland and Northern Ireland have the capability to drive innovation and bring medicines to patients quickly. BioPharma Ambition provided a variety of case studies of various transformations taking place within the industry, including the introduction of new technologies, new research avenues and new types of collaborations. The central themes featured at the conference were the future of manufacturing, pioneering discovery, and driving innovation. The agenda provided a platform for debate and discussion, and pointed to how Ireland will be central to the sector’s future. Ireland is well-placed to enable the biopharma

industry to deliver therapeutic solutions for patients globally. We have excellent training and research for bioprocessing staff provided by the National Institute for Bioprocessing Research and Training (NIBRT), which allows biopharma to locate and grow here. We have high-quality regulatory science and oversight, with the wellrespected Health Products Regulatory Agency. We have the human capacity and skills base and we are investing in education. The policy environment for business is good, including a transparent corporation tax regime that facilitates substantive business activity, as seen in bioprocessing. Furthermore, we continue to emphasise Ireland’s strategic, fully embedded membership of the European Union, including the Euro Zone and EU single market, while we continue to foster fantastic links internationally, in the US, North America and Asia.

Unprecedented Change The biopharmaceutical industry is currently being challenged from multiple directions and faces unprecedented change. Such challenges include the burdens of chronic disease, the digitisation of health and rapid pace of technological change and scientific advancement, the introduction of biosimilars, the increasing demand for value, new pricing and reimbursement models, and the clear

requirement to collaborate across stakeholders and institutional boundaries. These issues are set to have ramifications across every part of the sector. In recent years companies have been looking beyond traditional boundaries and are renewing their commitment to innovation in all respects as the key to their future. Acceptance that the blockbuster model has shifted to a ‘niche-buster’ model has injected renewed energy into R&D, alongside technological uptake across the value chain and a greater emphasis on collaboration. BioPharma Ambition exemplified how the industry was prepared to take on new challenges across the spectrum. Speakers confirmed that it was an exciting, albeit challenging time for the biopharma industry, with plenty of opportunity. There is the potential to add 8,000 jobs over the next three years in Ireland, while Northern Ireland has the potential to double its biopharma footprint by generating revenues of £1.6 billion per annum by 2020. In this environment of opportunity, the industry will evolve by turning to innovation and technology to address the main challenges. “There will still be blockbuster products, and as an industry we are obsessed with a product,” said Graham Symcox, Managing Director at Pharmacentaur AG. “But what the patient wants is a solution. This is a move away from a product to a healthcare outcome, and that brings a whole new complexity to biopharma and manufacturing.” One significant challenge for the industry has been, and will continue to be, finding solutions Irish PharmaChem | Industry Buyers Guide 2017

BioPharma Ambition Conference around value and pricing with Government and payors. According to Sir Andrew Dillon, Chief Executive of the UK’s National Institute for Health and Care Excellence (NICE), the industry had a responsibility to consider the cost implications of the new drugs being developed. “The industry needs to recognise the stress it brings to health systems with its value proposition,” he said. “Closer working is a really good way of making sure there is the best possible alignment between the industry’s ambition and the health system’s ambition of the adoption of new technology.”

The Future of Manufacturing Ireland’s biopharma heritage has been built on the strength of its biopharma manufacturing expertise. The success of NIBRT in research and training for bioprocessing is considered a landmark example. The readiness to uptake new technologies, particularly in manufacturing, is an especially attractive asset and, according to a survey run by Pharmacentaur, this is a significant reason for companies to consider further investment in the country. However, much is changing in the global manufacturing environment, conference delegates were told. Firstly, there are a number of technological developments, including continuous manufacturing; big data statistical analysis of bioprocesses; next-generation DNAbased approaches for contamination control; and mini-bioreactors. Secondly, there are a number of unique challenges affecting biopharma manufacturing, including globalisation and the cost associated with multiple manufacturing sites; the need to reduce drug substance costs; supply versus cost issues; the convergence of modalities and technologies; the integration and regulation of new technology; the continued need to train people in bioprocessing; new manufacturing infrastructure, especially in emerging markets; and the complexity associated with strategic

Prof. Charles Cooney, Massachusetts Institute of Technology. manufacturing decisions. In addition, attention increasingly focuses on streamlining manufacturing and improving efficiency, and ensuring that complex biologic pipelines can be delivered, particularly in regards to the major advances around biosimilars, precision medicine and advanced manufacturing. Consensus at the conference was that the uptake of technology in manufacturing can help this, although there were concerns around regulation. In the USA, regulators are directly addressing this issue through the Office of Pharmaceutical Quality (OPQ), which was established to help drive and foster innovation and quality in the industry. According to Dr Michael Kopcha, Director of the OPQ at the US Food and Drug Administration (FDA), two thirds of drug shortages are a result of quality issues. The OPQ aimed to prevent drug shortages by focusing on more efficient and emerging manufacturing technologies, he said, which would lead to more robust manufacturing,

less failures and more consistent clinical performance. “We need to understand the advances in technology to help us in regulation and help forward innovation. We want to be seen as encouraging emerging technology,” Kopcha said. There are numerous examples where the OPQ is spearheading success, such as the approval of cystic fibrosis drug Orkambi, which marked the first New Drug Application approval by the FDA for a continuous drug product manufacturing process. A number of speakers presented case studies, with continuous manufacturing a particularly strong theme, including Dr Humphrey Moynihan, Research Advisor at Eli Lilly and Co., and Professor Kieran Hodnett, from the Solid State Pharmaceutical Centre (SSPC), funded by Science Foundation Ireland (SFI), who discussed the impact of collaboration between the small molecule industry and academia, with a particular area of opportunity on continuous manufacturing.

The Challenge of Biosimilars

Dominic Carolan, CEO, NIBRT; Killian O’Driscoll, Director of Projects, NIBRT; Matt Moran, Director, BioPharmaChem Ireland; pictured in NIBRT at day one of BioPharma Ambition. Irish PharmaChem | Industry Buyers Guide 2017

The presence of biosimilars, meanwhile, promises to present a unique challenge for companies from a manufacturing, regulatory and uptake point of view. According to Nigel Darby, Advisor at GE Healthcare Life Sciences, one of the event sponsors, biosimilars would fragment the marketplace. In psoriasis, for example, there are currently as many as six antibodies approved to treat the disease but there are around 10 biosimilars in development, plus new antibodies in the pipeline. Thus, by 2020 there could be 20 different antibodies on the market as treatment options for psoriasis, Darby said, adding that in the coming years, each originator product could expect five to 10 biosimilar competitors. With such interest in biosimilars, it makes sense that Ireland take advantage of the opportunity this provides. Already, the Irish Government

BioPharma Ambition Conference has explored this, with the Department of Health currently assessing the area with a plan to develop a policy that supports biosimilar use in Ireland. Meanwhile, the Health Service Executive’s Medicines Management Programme has already supported the development of biosimilars and “the Government is looking to create the right market conditions that will enable the biosimilar industry to grow”, Minister of Health Simon Harris TD, told conference delegates.

Scientific Advances Today’s research landscape has changed dramatically as new scientific advances and technologies transform the space. Notably, this includes: synthetic biology and developments in genomics, gene editing, proteomics, metabolomics; nanotechnology; automation and robotics; novel drug delivery strategies; and

advanced diagnostics, analytics and sensors. In addition, alternative therapeutic modalities are on the cusp of emerging; notably cell therapy, gene therapy, regenerative medicine, and electroceuticals. Meanwhile, bioinformatics, big data and developments in the digital world are further transforming research and the healthcare space. These advances provide new and exciting research avenues, which Ireland is embracing, positioning the country as a hotbed of innovation. Examples of leading-edge research in Ireland were presented by speakers from several Irish universities and institutes, including the National University of Ireland Galway, University College Cork, Dublin City University, University College Dublin, UCD Conway Institute, and Trinity College Dublin. At the National University of Ireland Galway’s Regenerative Medicine Institute, for instance, human stem cells are being transplanted

Dr Áine Carroll, National Director for Clinical Strategy and Programmes Division, HSE, speaking at the BioPharma Ambition MIT Health Hackathon

to injured organs to stimulate tissue repair. Significant early phase trial results had led to a Phase II trial, which will look at stem cell impact on mild to moderate osteoarthritis. Professor Frank Barry, Professor of Cellular Therapy at the Institute, said that if the trial is successful, this could be the first disease-modifying agent developed for osteoarthritis, and could pave the way for treating other joints and discovering new drugs. At the University College Cork’s APC Microbiome Institute, researchers are mining data from gut bacteria to develop pharmabiotics to promote health and treat disease. A range of projects are being explored, from faecal transplants and antibiotic discovery to the brain-gut link and the possible role of probiotics. Meanwhile, Systems Biology Ireland, based at University College Dublin, is using omic technologies and computational biology to model cancer networks to describe and analyse biological processes and develop new therapeutic approaches to cancer. Conference delegates were also introduced to the pioneering cell-based research at Dublin City University, presented with examples of the various research groups at the Conway Institute, and shown how connected health technology was being used in research at Trinity College. Professor Luke O’Neill, Chair of Biochemistry at Trinity College Dublin, spoke of the advances in immune system research, which have been boosted by the success of several immunooncology drugs. According to O’Neill, $12 billion had been invested in the area between 1999 and 2015, as researchers asked whether the immune system could be harnessed to cure all diseases. The interest led O’Neill to set up the university spin-out, Opsona Therapeutics, to focus on innate immunity research and to specifically explore toll-like receptors and inflammasome signalling earlier in the immune pathway.

Precision Medicine

Pictured are: Dr Gerard Fox, Senior Director and Head, Calico Collaboration at Abbvie; Dr Bernadette Doyle, Vice President, Global Technical and NPI, Global Manufacturing and Supply at GlaxoSmithKline; Dr Mike Thien, SVP, Global Technology and Commercialisation at MSD; Professor Charles Cooney, FT Haslam Professor of Chemical Engineering at Massachusetts Institute of Technology; and Chairman of the session, Johnathon Marshall, PwC.

The pioneering research taking place in Ireland will contribute to new and innovative drugs that will not only change the way diseases are treated in the future but will also forward precision medicine and address unmet patient medical needs. “It’s clear that the types of products we make in the future won’t be the types of products we make now,” noted Dr Mike Thien, SVP, Global Technology and Commercialisation at MSD. Although he believes small molecule and monoclonal antibody drugs will still be manufactured, more emphasis would be on personalised medicines and providing more value to patients and healthcare systems: “We will have to think about what we’re making and how we deliver it, and make sure the patient will derive the full benefit from the therapy.” There was significant time given to the development of personalised or precision medicine, where information from our genetic code, proteome, lifestyle, environment and other health data is used to tailor more effective drugs Irish PharmaChem | Industry Buyers Guide 2017

BioPharma Ambition Conference for sub populations, and ultimately the individual. “The more we understand diseases, the more we follow the science, the more we see the need for personalised medicines,” said Dr Damian Page, Group Scientific Director for Personalised Healthcare and Molecular Information at Roche. The more comprehensive the genomic information, he said, the more likely the move to a one patient, one tumour profile. Currently, one of the most prominent research areas in precision medicine is the identification of biomarkers to predict disease, divide patients into subgroups and determine drug response. Advances in this area are seen, for example, where, in 2015, more than half of all non-small cell lung cancer cases were known to be driven by genomic alterations, whereas, in 2004, genomic alterations were known to contribute to only a third. Biomarkers are becoming of “fundamental importance”, noted Dr Damian O’Connell, Senior Vice President, Drug Discovery, Global Head of Clinical Sciences at Bayer Pharma, particularly when drugs without a biomarker were found to have a third less chance of success. Alongside precision medicine is the increasingly broader focus on health solutions that go beyond just medicine. Dr Leisha Daly, Country Director at Janssen and President of the Irish Pharmaceutical Healthcare Association (IPHA), stated that nonmedicine treatments such as smartphone apps could be prescribed and technology could increasingly be used to complement medicines through patient support programmes, such as homecare services and real-world data collection via remote monitoring. Collaboration is key to future innovation, with Dr Gerard Fox, Senior Director and Head, Calico Collaboration at Abbvie, explaining how some of the best ideas resulted from the totally unexpected interactions between different technologies. He gave the example of Calico, the Google setup that is researching the biology of ageing in which Abbvie has also invested. In many cases, disruptive technologies have been applied to healthcare, highlighting the convergence of life sciences, physical sciences and engineering. According to Professor Charles Cooney, FT Haslam Professor of Chemical Engineering at Massachusetts Institute of Technology, the introduction of such technologies presents challenges and requires forethought on how these technologies can be integrated and used in the future. The area of collaboration extends to patients. It’s only through working with patient groups that the industry will be best placed to understand diseases and the disease experience, said Dr Anthony Coyle, SVP/CSO Centres for Therapeutic Innovation at Pfizer. Big data can play its part in the medicines of the future in the form of electronic health records and biobanks, to help uncover unexpected disease associations and to inform individual health Irish PharmaChem | Industry Buyers Guide 2017

Dr Leisha Daly Presidant of the Irish Pharmaceutical Healthcare Association and Country Director for Janssen Pharmaceuticals, is pictured with Minister for Jobs Enterprise and Innovation, Mary Mitchell O’Conner TD and Seamus Fives, Chairman of BioPharmaChem Ireland and site lead in Pfizer Cork.

requirements, noted Dr Garret Fitzgerald, Director at the Institute for Translational Medicine and Therapeutics, University of Pennsylvania. In the UK, this is evident in initiatives like the Biobank and 100,000 Genome project.

The Future for Ireland Consensus among many conference speakers was that Ireland is ideally placed to host the future biopharma industry because of its established biopharma ecosystem and infrastructure. This comes down to the strength of its various institutions, such as NIBRT, SFI, the NovaUCD startup incubator, the Conway Institute and the Belfast Biobank. There are numerous reasons Ireland was seen as a good place to invest, according to Seamus Fives, Site Leader at Pfizer Pharmaceuticals and Chairman of BioPharmaChem Ireland, including regulatory compliance, manufacturing performance, talent, skills training, can-do attitude, tax advantages and the climate of collaboration between Government, academia, agencies and companies themselves. The three Government Ministers from Ireland and Northern Ireland who spoke at the BioPharma Ambition Conference emphasised the unique contribution the biopharmaceutical industry has made to the economy. Mary Mitchell O’Connor TD, Minister of Jobs, Enterprise and Innovation, stressed that the Governmetn is “interested in working with the industry to make sure Ireland is world leading in innovation investment and to make sure the right conditions are in place to ensure continued investment and employment.” Simon Hamilton MLA, Minister for the Economy in the Northern Ireland Executive, echoed this, saying the biopharma industry was a “priority sector” for Northern Ireland and the 20% growth in turnover and employment over the past three years served to “underline the importance of the industry to our future economic growth”. Health Minister, Simon Harris TD, stressed that

he planned to address the Brexit scenario by submitting a bid to bring the European Medicines Agency (EMA) to Ireland. There are, however, areas that require investment to further bolster Ireland’s attractiveness, including the importance in maintaining high levels of training for the future workforce.

Clinical Trials There was also much interest in establishing a stronger clinical trials landscape in Ireland, which has already been identified as an area for growth. Improvements in clinical trial activity were seen, with the HPRA approving the commencement of 108 clinical trials in 2015, compared with 80 in 2014, while a number of clinical trial hubs had been set up, for example Mercy Hospital and University College Cork. There had also been the recent announcement of the Wellcome-Health Research Board Irish Clinical Academic Training Programme to advance clinical research capability among doctors in Ireland. The development of electronic health records would be another step to furthering this ambition, said Tom Lillie, Vice President and Head of European Clinical Development at MSD. Seamus Fives predicted more trials would be done in Ireland in the future, which would further bolster the country’s attractiveness. BioPharma Ambition showcased the ambition of the industry, heralding Ireland as a leader in innovation, manufacturing and partnerships. The conference provided a platform to highlight Ireland’s competitiveness, support for innovation and collaboration. It demonstrated the central role patients play in the new healthcare environment and the dedication of the industry to deliver innovation for patients. “BioPharma Ambition is the beginning, not the end,” noted Dr Leisha Daly. “It reaffirms our commitment to providing innovation from bench to bedside.”

NIBRT

NIBRT Oversees Strong BioPharma Growth 2016 continued to be another strong year for the biopharma sector in Ireland, with a number of new investments announced, including significant projects from GE, Shire and Grifols. In an exciting development in September 2016 GE announced a €150m investment in a new biopharmaceutical manufacturing campus at Loughbeg, Ringaskiddy, Co. Cork. GE BioPark Cork will feature Europe’s first KUBio, prefabricated, off-the-shelf bio-manufacturing facilities, owned and run by GE customers, and will serve as focal point for further investment in next-generation biopharmaceutical manufacturing in Ireland. The BioPark is expected to be home to more than 500 new jobs when fully operational; 400 with biopharma companies and a further 100 employed directly by GE. The GE-managed campus will include four fullyequipped KUBio factories owned by independent biopharma companies manufacturing proprietary medicines, with GE running centralised shared utilities and site services. GE’s KUBio enables pharmaceutical companies to quickly deploy new biologics manufacturing capacity and bring medicines to market faster. According to GE, KUBios increase manufacturing flexibility and “are between 25 and 50 percent more costeffective to build than comparable traditional facilities. Carbon dioxide emissions can be reduced by 75 percent and water and energy use by approximately 80 percent. Build time can be shortened to 18 months from the usual three

Killian O’Driscoll, Projects Director, National Institute for Bioprocessing Research (NIBRT).

The biologics sector has seen more than €10 billion of investment in the last 10 years, with more investment and jobs likely in the coming years, writes, Killian O’Driscoll, Projects Director, National Institute for Bioprocessing Research (NIBRT). years”. The construction phase in Ringaskiddy is expected to begin by mid-2017 and create up to 800 construction jobs.

In April 2016 Shire announced that it plans to expand its global biotechnology manufacturing capacity over the next four years by investing

Pictured at the GE-NIBRT announcement in September 2016 are Barry Heavey, Head of Life Sciences, Engineering & Industrial Tech at IDA Ireland; David Radspinner, Global Business Leader - GE BioParks at GE Healthcare, Minister Mary Mitchell O’Connor TD, Minister of Jobs, Enterprise and Innovation; Dominic Carolan, CEO of NIBRT; and Martin Shanahan, CEO of IDA Ireland. Irish PharmaChem | Industry Buyers Guide 2017

NIBRT

US$400m in Piercetown, Co. Meath, to meet the rapidly growing demand for its for rare disease treatments. A new, state-of-the-art biologics manufacturing campus will be constructed, leading to the creation of approximately 400 permanent jobs on a 120-acre site. The facility will employ flexible production strategies, enabling Shire to supply both clinical and commercial scale products. The roles at Shire’s new campus will consist of highly skilled, full time jobs in the areas of R&D, operations, technical staff, engineering and construction. The site is expected to be operational by mid-2019. In March 2016 Grifols announced an additional $85m investment in its biologics plant at Grangecastle, Co. Dublin. Grifols said it was bringing forward plans for the construction of a purification plant for the protein albumin to cater for rising demand. Construction will begin towards the end of this year, with the plant expected to be operation-ready in early 2020. These announcements complement the recent investments from BMS, Alexion, Lilly, Regeneron, Sanofi Genzyme, West Pharma, BioMarin and others, which have seen the biologics sector accounting for over €10 billion of investment in the last 10 years, creating 6,000 new jobs and significant secondary employment in construction and other services.

for biopharma manufacturing. In this context, NIBRT was delighted to work with a broad range of stakeholders from industry, Government and academia to develop a new report by the Expert Group on Future Skills Needs (EFGSN) on the Future Skills Needs of the Biopharma Industry in Ireland. The objective of the study is to review the supply of, and demand for, skills for the biopharma industry in Ireland up to 2020. The report, which was published in August 2016, highlights the important contribution to the Irish economy in terms of employment and manufacturing exports from the biopharma sector. There is an ongoing need to ensure that we anticipate the changing skills requirements of the sector and ensure that there is a close alignment between industry’s needs and the skills being

taught in the education and training system. The report highlighted that 8,400 new biopharma jobs will arise in the period up to 2020. These will be a diverse range of roles requiring specific scientific, engineering and technical skills across National Framework of Qualifications (NFQ) levels 6-10. As well as technical skills, soft skills such as communications, team-working, problem solving and environmental health and safety are essential. The Expert Group produced a set of recommendations which serve as an Action Plan for addressing the skills needs of the sector up to 2020. NIBRT is pleased to be working with BioPharmaChemical Ireland and other stakeholders in the successful implementation of these recommendations.

Pictured at the launch of Biopharma Ambition are Matt Moran, Director, BioPharmaChem Ireland; NIBRT CEO, Dominic Carolan; Minister of Jobs, Enterprise & Innovation Mary Mitchell O’Connor TD; and Leisha Daly, Country Director, Janssen.

8,400 New Biopharma Jobs by 2020 The availability of people with the right skills and talent to work in biopharma will be critical to the continued growth of the industry and for Ireland to maintain its position as a key hub

Pictured at the launch of the Expert Group on Future Skills Needs of the Biopharma Industry in Ireland are, (front row, l-r): Matt Moran, Director BioPharmaChem Ireland Mary Mitchell O’Connor TD, Minister of Jobs, Enterprise & Innovation; Una Halligan, Chairperson, Expert Group on Future Skills Needs; John Halligan TD, Minister for Training, Skills & Innovation; and Killian O’Driscoll, Director of Products, NIBRT; (back row, l-r): Barry Heavey, Head of Life Science, Engineering & Industrial Technology at IDA Ireland; Gerry Hamill, Executive Director, DPS; Tommy Fanning, Head of Biopharmaceuticals & Food at IDA Ireland; Louise Prendergast, HR Director, Biologics Ireland.

Irish PharmaChem | Industry Buyers Guide 2017

Biopharma Ambition In association with BioPharmaChem Ireland (BPCI) and the Irish Pharmaceutical Healthcare Association (IPHA), NIBRT organised the inaugural Biopharma Ambition conference on September 21 and 22, 2016. The conference brought together senior international leaders from organisations such as AbbVie, GSK, Amgen, Lilly, BMS, Sanofi Genzyme, Mallinckrodt, BioMarin, FDA, MIT, MSD, Pfizer, Bayer, Janssen, and Roche. Ministers Mary Mitchell O’Connor TD and Simon Harris TD addressed over 300 delegates in attendance. The plenary session featured world leading industry experts from the pharmaceutical industry, which is worth over €30 billion in exports and has the potential to add 8,000 jobs over the next three years in Ireland and has the potential to double its size in Northern Ireland by generating revenues of £1.6 billion per annum by 2020. In order to meet this ambition and realise the future full potential of the industry across the island of Ireland, North and South, the BioPharma Ambition Conference called for: • An emphasis on talent: invest in education and create a sustainable basis to fund excellence in STEM education, particularly at university level in Northern Ireland and Ireland; • Growth in competitiveness: focus on the fundamentals of a competitive

NIBRT

business environment to facilitate the long-term investment decisions made for bioprocessing; • Growth in health innovation: ensure health services are capable of evaluating and bringing innovative medicines to patients quickly, by promoting more clinical trials and greater investment in IT and key specialists.

The winning team from 3R are pictured with Matt Moran, Director, BioPharmaChemical Ireland, at the MIT Hacking Medicine event.

Robust Growth NIBRT continued to show strong growth across all lines of business in 2016 and in supporting the robust growth of the biopharmaceutical industry in Ireland. Some key highlights include: The appointment of Professor Michael Butler as Chief Scientific Officer (CSO). Prof. Butler is an acknowledged global leader in mammalian cell culture bioprocessesing. His distinguished research career has seen key advances in animal cell technology, glycosylation, and development of mammalian cell culture bioprocesses for scaleup and industrial production. He is the author of seven books, and over 100 peer-reviewed scientific articles, with a strong record of leading industryacademic collaborations. Working with a broad consortium of academic and industry partners, NIBRT was pleased to be asked to submit a full proposal for the Bio-Logic Research Centre to Science Foundation Ireland. Involving the collaboration of six Irish universities, three national institutes and 27 biopharma-related companies, the Bio-Logic vision is the development of key areas of bioprocess intensification that will enhance the global development of biopharmaceutical production and enable rapid, efficient and controlled generation of next generation biotherapeutics. NIBRT had its busiest year to date and trained over 4,000 people in 2016 delivering in excess of 18,000 days of training to a broad range of clients based in Ireland and internationally. To further develop biopharma manufacturing

Attendees at the Careers in BMS event at NIBRT, November 2016.

skills and expertise in Ireland, NIBRT and GE also announced the creation of a NIBRT-GE Single-use Centre of Excellence at NIBRT’s Dublin facility. This is expected to train up to 1,500 bioprocessing professionals annually on next-generation biologic manufacturing technologies and to support the new GE BioPark Cork’s manufacturing facilities. NIBRT also announced a scientific collaboration with Thermo Fisher Scientific which focuses on the development of analytical solutions for the characterisation of complex biopharmaceuticals. This collaboration will provide valuable insights to improve the technology, simplify analysis, generate informative characterisation data and understanding of complex biotherapeutic

molecules. In recognition of these achievements, NIBRT was delighted to be awarded the Pharma Education & Training Award and the Partnership Alliance of the Year (for our partnership with BMS) at the Irish Pharma Awards in October 2016. In addition, NIBRT Principal Investigator Dr Jonathan Bones was listed on Medicine Maker’s 2016 Power List, while NIBRT was shortlisted for Bioprocess International Collaboration of the Year Award.

Future Trends: Product and Process Diversification Ireland has seen a very successful period in attracting biopharma investment and has now established one of the largest concentrations of biopharma manufacturing capacity globally. The majority of this investment is focused on mammalian cell production of monoclonal antibodies but there is now increasing diversification in the product pipeline, with advances in innovative biotherapeutics such as cell therapy, gene therapy, combination products, precision medicines etc. In parallel, the nature of biopharma manufacturing processes are constantly evolving, with novel technologies such as continuous bioprocessing, process intensification, single use systems, novel bioanalytics etc. To maintain and build on Ireland’s success requires a constant effort from all stakeholders to further develop our value proposition, and NIBRT is delighted to play a key role in preparing the talented workforce and driving biopharma manufacturing research for the exciting opportunties ahead.

Irish PharmaChem | Industry Buyers Guide 2017

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Health & Safety

Irish Pharmachem REACHes for the Stars Majella Cosgrave, Senior Inspector, Chemicals & Prevention Division, HSA, writes on the impact of the REACH Directive on the Irish pharmachem sector.

Majella Cosgrave, Senior Inspector, Chemicals & Prevention Division, HSA.

It is widely acknowledged that chemicals bring about benefits upon which modern society is entirely dependent and they make a vital contribution to the economy in terms of trade and employment. In Ireland, the biopharmachem sector is a major driver of Irish export, with 2015 exports reaching €64 billion. Ireland was the world’s 7th largest exporter of medicinal and pharmaceutical products in 2014, with five out of the top 12 selling drugs produced in Ireland. However, as the former Vice President of the European Commission, Margaret Wallstrom, once said, “chemicals are both a blessing and a curse”. While we benefit from having chemicals in our lives, we must remember to treat them with respect to ensure that any harmful effect they may have on human health or the

environment is minimised. Sound chemical management across the entire lifecycle of a chemical is essential to ensure both man and the environment are safe from harm. In addition to general workplace health and safety legislation, there is a large amount of legislation relating to chemicals specifically. This legislation applies to all Irish workplaces and includes the Chemicals Agents Regulation, COMAH, Biocidal Products Regulation, Classification, Labelling and Packaging Regulation and REACH. While all of these pieces of legislation may have overlapping elements and all must be complied with, for the Irish pharmachem sector, the one with the greatest impact is probably the REACH Regulation (hereafter referred to as REACH), and it is the main focus of this article.

REACH was created to protect all of us and our environment from the hazardous effects of chemicals. It was also designed to enhance the competitiveness and innovation of European industry and promote alternatives to the testing of chemicals on animals. The REACH Regulation has been in force for almost 10 years now and with this in mind, it is probably a good time to take a look at how it is working in the pharmachem industry in Ireland and the implications it is having for the sector.

Regstration While there are many elements of REACH that Irish pharmchem companies must comply with, it is probably fair to say that it is the registration and authorisation elements that are having the most impact within the sector. Irish PharmaChem | Industry Buyers Guide 2017

Health & Safety Registration requires companies to register any substance they import at greater than one tonne per annum, unless the substance meets the exemption criteria. No registration effectively means no access to the market for that substance, so it is vital that companies ensure they register their substances. The majority of substances are to be registered on a phased basis (so called ‘phase-in’ substances). The first registration deadline, for high tonnage and certain hazardous substances, was in 2010; another deadline followed in 2013 and the final deadline for substances manufactured or imported in tonnages between 1 and 100 tonnes per annum is May 31, 2018. All companies are urged to check if this final deadline applies to them and to ensure they are now preparing to register. As the final deadline is for low tonnage substances, it is more likely that smaller companies will be affected. Registration may prove a bigger challenge for those smaller companies and so they are urged to begin their preparations now and seek help where needed. While it is difficult to fully gauge the exact compliance rate with registration requirements amongst all Irish chemical companies, it is expected that the pharmachem sector in particular understands the requirements and implications of the registration element of REACH.

‘SVHC’) and included in Annex XIV of REACH (the authorisation list) needs an authorisation to be in place for its continued use beyond a certain date. Any company using a substance subject to authorisation must apply (to the European Commission) for, and be granted, an authorisation to ensure the continued use of the substance. For the Irish pharmachem sector, there are a number of substances that are known to be critical within the industry, some key aprotic solvents and Triton X, which have been identified as SVHCs and thus are candidates for authorisation. The authorisation process can be a difficult and costly one, but of most significance for the pharmachem sector, it appears to introduce an element of uncertainty about the future use and availability of these key substances in Europe. However, from the Competent Authority’s point of view, the HSA is keen to dispel the myth that authorisation is a ban. Authorisation is not a ban on the use of a substance in Europe: it is a licensing system. If a company can demonstrate in their authorisation application that the risks from the use of the substance are appropriately managed or that the benefits of the use of the substance outweigh the risks, then there should be no reason that the authorisation would not be granted to the company for the continued use of the substance. Hopefully,

as time goes on and more authorisations are granted, confidence will grow in the system and companies will feel more comfortable with applying for their authorisations.

HSA Chemicals Helpdesk For companies in need of assistance, or with questions on any aspects of REACH, they are reminded to contact the Chemicals Helpdesk at the HSA, by emailing chemicals@hsa.ie or by calling 1890 289 389 and to sign up to the Helpdesk’s e-bulletin to ensure they keep up to date with all developments in the world of chemicals legislation. Overall, thanks to REACH, we now hopefully have more information on the hazards and risks of chemicals, about exposure to them and how to control them. We should continue to see improved communication within supply chains, from suppliers down to all users. And most importantly, we should have more control over the substances for which we are most concerned about and as the years continue, we should see many of these SVHCs gradually replaced by safer, less hazardous alternatives.

Authorisation Authorisation appears to be a far more worrying element for the Irish pharmachem sector. This is a licensing system of sorts, whereby any substance that is identified as a substance of very high concern (so called

Irish PharmaChem | Industry Buyers Guide 2017

Medicine Shortages

Managing Medicine Supply Around the World Enda Dempsey of BioPharmaChem Ireland examines the causes of medicine shortages and, more importantly, strategies to minimise them in the future.

Irish PharmaChem | Industry Buyers Guide 2017

Medicine Shortages One of the greatest challenges facing the healthcare industry today is managing the supply of critical medication. The European Association of Hospital Pharmacies commissioned a pan-European survey in 2014 and found that 66% of hospitals had experienced medicine shortages on a daily or weekly basis. Antimicrobial agents and oncology products were among the most frequently affected. These shortages have been linked to poorer clinical outcomes for patients due to delays in treatment, medication errors and using alternatives which may have sub-optimal performance or cause severe adverse effects. To combat this issue, the Heads of Medicines Agencies (HMA) and European Medicine Agency (EMA) have set up a dedicated medicine shortage taskforce which will liaise directly with the national competent authorities. They will develop new initiatives and refine existing measures to better manage the shortfall in medicinal products. Medicine shortages are caused by multiple, interlinking factors which can make it exceptionally difficult to predict and solve. For simplicity, they have been broken down into two broad categories and will be discussed in some detail; Supply Chain Dependent and Supply Chain Independent.

Supply Chain Dependent Lean Manufacturing/Just-in-Time Minimising stock levels is both a strength and flaw of lean manufacturing. Managing stock records is normally handled by the

Enterprise Resource Planning (ERP) system, which would be integrated throughout the company. However, the pharmaceutical industry relies heavily on independent Contract Manufacturing Organisations (CMO) that are not always connected to their customer. Therefore, product may be available but the delivery times are disrupted, which has knockon effects for the entire product life-cycle.

Unexpected Events While uncommon and very difficult to legislate for, natural disasters affecting individual sites or the general supply chain can result in significant disruption to the industry. Political upheaval and wars are also important influencers, particularly when the majority of the starting materials come from Asian markets.

Shortage of Quality Raw Material Despite the fact that the pharmaceutical industry is the biggest consumer of fine chemicals, holding two thirds of the market, they are mostly produced in Asia but often not to Good Manufacturing Practice (GMP) standards. Also, some raw materials have a single point of origin but are sold through several different companies. Therefore, companies may falsely believe they are dual-sourcing. Combined, this can cause bottle-necks in the supply chain.

Parallel Trading This refers to the arbitraging of genuine pharmaceutical products between countries in the European Economic Area after they have been sold by the Marketing Authorisation Holder (MAH). Parallel traders do need to ensure the packaging matches the final country and meets all current regulations, including generating new serial codes for the Falsified Medicine Directive (FMD). This can lead to shortages in markets where health products are cheaper, as they are bought up and sold elsewhere. Additionally, pharmaceutical companies see their profit margins reduced due to a disproportionate shift of their sales to the countries with the lowest prices. Therefore,

both manufacturers and distributors adjust the delivery of stock to match national prescription demands, which can lead to shortfalls in the case of mis-matched predictions.

Counterfeited Drugs According to the European Union Intellectual Property Office (EUIPO), fake medicines have a significant presence in the EU supply chain, accounting for 4.4% of the total sales. This can directly affect the stock levels in wholesalers and legitimate medical outlets.

Supply Chain Independent Economically Unviable Companies have a limited manufacturing capacity and will discontinue older, less profitable products which have been affected by the patent cliff, healthcare reform and new regulatory compliance. The Food and Drug Administration (FDA) claimed the discontinuation of products was responsible for 14% of drugs shortages in the US in 2012. This also included companies that ceased trading or changed business interests.

Fluctuating Demand for Products Sudden spikes in demand for medicinal product can leave gaps, as manufacturers are not always able to keep pace with the changes in markets. These surges can be caused for a variety of reasons, some already mentioned but typically, demand can drastically increase if a rival product experiences issues in production. The main limiting factor to increasing supply is the long lead-in times and complex production processes which typically require months of preparation. Unstable markets also feed into products becoming economically unviable.

Delay in Regulatory Approval Certification of new medicines and production facilities are typically lengthy and expensive processes. Delays can be caused by the MAH making errors in their submission or slow turnaround times from the health authorities after an inspection.

Pricing and Reimbursement Small markets have restricted purchasing power and are not capable of accessing all the authorised medicines. Ireland, for example, has on average only 75% of all licenced medicines available.

Quality Issues Deviation in product quality accounts for almost 65% of all medicine shortages in the EU. Depending on the quality defect, this can affect the entire manufacturing process and require product recalls, which in turn deplete the stocks in medical outlets. Currently, Irish PharmaChem | Industry Buyers Guide 2017

Medicine Shortages Ireland is still experiencing delays in supply of the Bacillus Calmette-Guérin (BCG) vaccine (anti-tuberculosis) 18 months after the sole manufacturer for Europe in the Netherlands discovered a problem validating the capping of their vials. A recent report commissioned by the Health Products Research Authority (HPRA) found that they investigated 3,999 cases over a five-year period and the top three reasons for recalls were contamination, using unlicensed products and inaccurate labelling.

Strategies to Managing the Shortage The diverse set of factors influencing delivering medical products to the patient means there is no silver bullet but external stakeholders, such as national governments, health authorities and medical outlets, can work together to remediate this challenge. Legislation for parallel trading is currently being reviewed across a number of European Member States. In Spain, Royal Decrees in 2012 and 2015 were passed, preventing the export of licenced medical products without prior consent of their health authority, with severe penalties for any infractions. Similar regulations are currently being reviewed by the HPRA. Counterfeited medicines are being tackled through the Falsified Medicines Directive. There are many distinct improvements, the most significant of which will be the inclusion of a randomised serial code on all prescription medicines (with some exceptions) that will be generated by the manufacturers or parallel traders. This code will scanned at various points throughout the product life-cycle before finally being validated and dispensed to the patient at an approved location (e.g. a licenced pharmacy), ensuring the integrity of the supply chain. Early warning of supply disruption is considered the most effective method to

alleviate shortages and 21 of the 28 EU member states, plus the US, have mandatory notification requirements. The revised Annex 16 in the EU GMP guide came into force in April 2016 and the Qualified Person (QP) is now required to map the entire supply chain. This should include Active Pharmaceutical Ingredients (API), high and medium risk excipients, intermediates, bulk and finished product transportation, storage and distribution facilities and activities. Companies have carried out failure mode and effects analysis (FEMA) risk assessments on the maps to satisfy auditors that their supply chain is secure. However, not all CMOs or intermediate suppliers are willing to provide the necessary information to complete the map as they have multiple customers and/or privacy concerns. When combined, these strategies are designed to give greater transparency over the global supply network of the pharmaceutical companies so that supply disruptions can be better predicted.

Balancing Patient Safety with Access to New Treatments National health authorities are keenly aware of the need to balance patient safety and provide access to the latest treatments. Therefore, they are willing to work directly with companies who provide medically necessary drugs by: expediting inspections and reviews of submissions; fast tracking life-saving medicines; providing assistance remediating non- compliance issues; providing work-arounds for defects where possible. A particular example of a work-around cited by the FDA was permitting the use of an essential injectable drug which was found to contain particulate matter. Filtering the drug before use was considered safe until the

• • • •

company was GMP compliant again. Incentives may be necessary to encourage companies to manufacture important but low profit medicines. This could take the form of tax credits to mitigate the costs, if the market cannot support the products. Sterile products are at particular risk due to the high cost of manufacture but the relatively low return, despite being critically important. The FDA is now looking at using four base Quality Metrics, with an additional two subject to industry feedback. They will be used to determine the frequency of inspections in lieu of the two-year rule but are also designed to be key indicators of potential medicine shortages. To date, one pilot study has been completed, while the second is currently ongoing. The biggest challenge for this initiative is harmonisation of the metrics across the industry, as sites tend to be silo’ed and not all the information required to calculate the metrics can be obtained or is comparable.

Conclusion Medicine shortages are a common issue that affect all economies and are caused by multiple interlinking factors. However, with greater communication and engagement from the MAHs, national governments, regulators and other key stakeholders, the negative affects on patient health can be mitigated.

Irish PharmaChem | Industry Buyers Guide 2017

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Serialisation The facility to identify things uniquely and accurately is essential, be it a medication, an item of clinical equipment or even a patient.

Are You Ready for Serialisation? 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. The regulatory landscape continues to evolve globally. New regulations in the EU, the US and elsewhere will have a major direct impact on the healthcare supply chain. Did you know that between June 9-16, 2015, in just one week, a record 20.7 million fake and illicit medicines, with an estimated value of $81m, were seized, including blood pressure medication, erectile dysfunction pills, cancer medication and nutritional supplements. This was part of Operation Pangea, an international week of action tackling the online sale of counterfeit and illicit medicines and highlighting the dangers of buying medicines online. Coordinated by Interpol, the annual operation brings together customs, health regulators, national police and the private sector from countries around the world.

Ensuring Regulatory Compliance Product serialisation, compliance with EU, FDA and other international drug pedigree requirements and establishing anticounterfeiting solutions are key priorities for the pharmaceutical industry. The EU Falsified Medicines Directive (FMD), which seeks to establish a more secure supply chain for the

Serialisation and the Falsified Medicines Directive (FMD) for Europe is nearly here. There is less time than you think to prepare, warns Siobhain Duggan, Director of Innovation and Healthcare, GS1 Ireland. distribution of prescribed medicines, will require the serialisation of patient packs to include a 2D barcode on all patient packs which are to be scanned at the point of dispensing for verification purposes. The legislation also requires tamper evident labelling to enable the authentication of medicines prior to being dispensed to patients. The European Federation of Pharmaceutical Industry Associations (EFPIA) has developed and successfully piloted an authentication solution based on GS1 automatic identification and data capture standards, together with the use of a standards-based federated database, which ensures that a retail pharmacy can check the authenticity of a medicine before dispensing to a patient. In January 2012, GS1 and EFPIA issued a joint vision statement for achieving the EU regulatory requirements. The introduction of the European Falsified Medicines Directive means all manufacturers of prescription medicines will be expected to print a 2D datamatrix barcode with serialisation data on medicine packs and these packs then need to be verified at the point of dispense. This requires significant changes for pharmaceutical manufacturers and will require IT development changes in hospitals and community pharmacies. The final Delegated Acts for the European

Falsified Medicines Directive were published in February 2016. The new legislation is expected to take effect three years after publication of the delegated acts for countries without preexisting measures, and six years for countries with pre-existing measures. In the Irish context, this means that all prescription medicines sold in Ireland will need to be fully EU-FMD compliant by February 9, 2019.

A Framework for Validating Pharmaceuticals The EU medicine authentication system will consist of: ● A Unique identifier (UI), a 2D barcode (ISO compliant) containing four mandatory elements: product code, serialisation number, batch number and expiry date. The national reimbursement number can be included (optional), if requested by the Member State; ● Verification of the safety features: systematic verification of the safety features at the dispensing point, supplemented by risk-based verification by wholesale distributors. Note, the choice of the most appropriate anti-tampering device will be left to the manufacturer; ● Establishment, management and Irish PharmaChem | Industry Buyers Guide 2017

Serialisation

accessibility of the repository system for the Unique Identifier (UI) by stakeholders. A repository has been established by the European Stakeholder Model (ESM) and is managed by the European Medicines Verification Organisation (EMVO). Manufacturers will upload information relating to the medicines packs being shipped to Europe. Each member country is expected to establish an NMVO (National Medicines Verification Organisation) to oversee the implementation of the national repository, which should be interoperable and interconnected with the other repositories.

There is Less Time Than You Think – Act Now Implementation of the Falsified Medicines Directive requires many different disciplines. Developing solutions will be a team effort, with manufacturers assembling consortia of specialists in coding, imaging, data management and handling. Be warned: this will take time and manufacturers are finding there is less time than they think. Based on experience, it can take six months to select vendor partners, anything up to a year to set up and test the pilot packaging line, and a further year to then upgrade other lines, each of which will differ slightly from the pilot. So

team selection needs to start now!

Unique Device Identification Regulations In addition to the FMD legislation, the proposed European and existing US FDA Unique Device Identification (UDI) regulations are to the fore in the medical device arena and companies need to transform disparate medical identification methods into a standardised UDI system. Both pharmaceutical and medical device manufacturers are leveraging GS1 standards and the support of GS1 experts to prepare for these new requirements and ensure regulatory compliance. Get involved! Go to www.GS1ie. org/Healthcare

Why GS1 Standards? Use of GS1 standards enables traceability and promotes a safe and secure supply chain by providing greater visibility, accuracy and efficiency for the benefit of all parties. Preventing medical errors, enabling traceability and recall and combating counterfeiting are key concerns facing the sector, and GS1 standards are helping to solve these issues. References: 1. The EU FMD Whitepaper – Domino Printing (Sep 2012) 2. http://www.interpol.int/Crime-areas/Pharmaceutical-crime/ Operations/Operation-Pangea 3. GS1 Healthcare and EFPIA shared vision for product identification in the context of the EU FMD: http://www.efpia.eu/uploads/ Modules/Documents/efpia-gs1-shared-vision-090312_2.pdf

The Benefits of adopting GS1 standards in Healthcare

• • • • • • • • • • •

Improving patient safety; Lowering costs through increased efficiency; Reducing medication errors; Enabling supply chain visibility; Facilitating effective product recalls; Tracking pharmaceutical products/medical devices; Reducing introduction of counterfeit products; Enhancing inventory management; Linking critical product data to the patient record; Supporting regulatory compliance; Optimising order, invoice, sales reporting, and chargeback/rebate processes.

About GS1

GS1 is an international, neutral, not-for-profit organisation with operations in 112 countries around the world, including Ireland. The GS1 system of standards is the most widely-used system of supply chain standards, serving more than 2m organisations, both public and private sector, worldwide. In addition to the traditional sectors of grocery, food service and DIY, membership in Ireland also includes the Health Service Executive (HSE), with over 40 hospitals and many suppliers of healthcare products. GS1 is recognised by organisations such as the International Organisation for Standardisation (ISO), and the European Committee for Standardisation (CEN). For more information please contact: Siobhain Duggan Director of Innovation and Healthcare Email: siobhain.duggan@gs1ie.org Twitter: @sioduggan_GS1 Web: www.gs1ie.org/Healthcare Tel: 353 1 208 0660 Irish PharmaChem | Industry Buyers Guide 2017

Product serialisation, compliance with EU, FDA and other international drug pedigree requirements and establishing anti-counterfeiting solutions are key priorities for the pharmaceutical industry.

Marketing Authorisation Holders

The Legal Obligations of the MAH

Ann McGee, MD of McGee Pharma International, outlines the legal obligations of the Marketing Authorisation (MA) Holder and how these translate on a daily basis. The process of reviewing and assessing the dossier to support your medicinal product in view of its marketing has been finalised and you have been granted the Marketing Authorisation (MA). But what does this mean in terms of your responsibilities? How up to date are you with your legal obligations as MA Holder? In this article, we outline the legal obligations of the MA Holder and how these translate

What are your legal obligations as a MAH?

on a daily basis. As you read this article, why not test your knowledge and score yourself on: 1. Awareness of your obligations. 2. Compliance with these obligations. If you would like an independent review of your MAH compliance or if you are interested in conducting a gap analysis of your current MAH activities, our team of consultants can help.

Ethical Clinical Design It is ultimately your responsibility as the MAH to ensure that the medicinal product is designed and developed ethically, taking into account the requirements of Good Manufacturing Practices.

Oversight of Manufacturing from API to release to market ● Ensuring the security and GMP

compliance of the entire manufacturing supply chain is an important responsibility of the MAH; ● Ensuring compliance with GDP, including

prevention of falsified medicines entering the supply chain; ● Ensuring appropriate and continued

availability of medicinal products for human use.

Identification of the RP/QP

The legal obligations of the MAH.

A Qualified Person or Responsible Person, as appropriate, must be identified by the MAH. The RP is responsible for safeguarding product users against potential hazards arising from poor distribution practices. The Qualified Person is ultimately responsible for ensuring that each Irish PharmaChem | Industry Buyers Guide 2017

Marketing Authorisation Holders

Have I full control of labelling and packaging? Are patients at risk?

individual batch has been manufactured in accordance with the MA.

Control of labelling and packaging The MA Holder must ensure that there is control of labelling and packaging throughout the product lifecycle, as both labelling and packaging play an essential part in the safe and effective use of the medicine by patient and healthcare professional. A key risk is compliance of labelling with MA in each market, for example: ● Managing labelling changes across multiple markets ● Ensuring ongoing knowledge management between Regulatory Affairs and manufacturing sites

Supply and distribution to the customer As the MAH, you are responsible for the secure, controlled and compliant pharmaceutical supply chain, from raw material supplies to shipments of

products to customers. GDP must be covered by the MAH’s quality system.

Complaints/Recalls & Quality Defects All complaints and quality defects should be investigated by the MAH, manufacturer or wholesaler, as appropriate, regardless of their nature. A quality defect should be reported if it could result in ‘a recall or abnormal restriction on supply’. If this is the case, the decision on recall or other market action will be made in conjunction with the Health Authority.

Control of responsible marketing and promotion ● Ensuring control of marketing and

promotional activities and compliance with advertising regulations and local codes of practice. ● Non-compliant advertising activities may affect the safe prescribing and use of medicines and, ultimately, these activities can present risks to patients.

Continuity of supply Ensuring the security and GMP & GDP compliance of the manufacturing supply chain is an important responsibility of the Marketing Authorisation Holder, to guarantee appropriate and continued availability of medicinal products for human use to meet the needs of patients, in accordance with

Article 81 of Directive 2001/83 and The Notification of Marketing Status of Human Medicines, AUT-G0021-3 guide issued by the HPRA. EU legislation requires mandatory prenotification by MAHs of potential disruption or disruption of supply in the case of permanent or temporary cessations and in the case of any defect that could lead to an abnormal restriction in supply.

Pharmacovigilance & provision of medical information The MAH is required to comply with European Directive 2010/84/EU governing Pharmacovigilance. There is an obligation on all applicants for marketing authorisations to submit a risk management plan, and to implement the plan as a condition of any marketing authorisation granted. There is a requirement to establish a Pharmacovigilance System Master File and a responsibility on the MAH to audit their pharmacovigilance system at intervals. In addition, there is a requirement to report suspected adverse reactions, not only from the authorised use of a product at normal doses, but also from medication errors and misuse of the product. Adverse events may be collected within Individual Case Safety Reports or as Signals within Periodic Safety Update Reports collated by the Marketing Authorisation Holder’s pharmacovigilance department and forwarded to the regulators.

Take account of technical and scientific progress The MAH must ensure ongoing compliance with the terms of the MA, taking into account relevant technical and scientific progress.

Quality Systems for the MAH When the MAH office is separate from the manufacturing site and other regulated business functions, it is important to understand how much reliance the manufacturing site places on the responsibilities and activities of the MAH office. It is important to ensure that systems are in place to confirm this reliance is well founded. Technical agreements are not sufficient! The quality systems that are required to ensure that batches of medicinal products comply with their MA are becoming o our Where d fo staff increasingly complex In l Medica roduct as a result of: p ir e h ? get t 1. Globalised supply ion from t a m r info chains; 2. Increased use of outsourcing; 3. Site rationalisations; 4. Company mergers. Identify your risks and manage them accordingly. How have you scored? Do the various elements of your PQS link with one another to ensure compliance across your activities? Remember, ultimately, all activities may be delegated but responsibility is retained by the MAH.

Irish PharmaChem | Industry Buyers Guide 2017

Waste Management Indaver’s Total Waste Management service is designed to meet the needs of large international industrial companies, primarily from the pharmaceutical and chemical sectors. Indaver manages all waste streams generated on the customer’s site in accordance with the EU waste hierarchy. Regular reviews ensure waste management services are optimised in a cycle of continuous improvement. ISO accredited for over 10 years, Indaver provides full compliance with Irish, UK, EU environmental and health & safety legislation and all relevant ADR and IMDG transport legislation.

Sustainable Waste Solutions from Indaver

An Extensive Network of Facilities in Europe Indaver, a leading European waste management company, has been established in Ireland since 1977. Their core business is running specialised facilities and managing intelligent waste management systems, focusing on sustainable material and energy management. With over 30 years’ experience, Indaver has the expertise to provide sustainable, cost effective and tailored total waste management solutions to offer customers the lowest total cost of ownership. Indaver’s European network of hazardous waste processing facilities and strong data management systems ensures the flexibility to meet customers’ needs and the ability

Indaver’s Solvent Recovery Facility in their Hazardous Waste Transfer Station in Dublin Port. to provide full traceability from the point of collection to final disposal. Customers also have secure access to their own online reports.

Developing Waste Infrastructure in Ireland Indaver’s facilities in Ireland include the EPA licensed Dublin Port Hazardous Waste Facility, incorporating a transfer station, a laboratory and a state-of-the-art solvent recovery facility. Indaver has constructed Ireland’s first wasteto-energy facility in Duleek, Co. Meath. The

€140m facility has been operating since August 2011, and is helping Ireland meet its EU and national objectives by diverting waste away from landfill and up the waste hierarchy to recovery. In addition, Indaver is now treating suitable hazardous waste in Meath. This brings to 235,000 tonnes the amount of waste turned into energy for the equivalent of more than 20,000 homes. Indaver is committed to providing Irish industry with secure, costeffective and sustainable waste solutions.

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Pharmaceutical Manufacturing and Technology Centre

PMTC continues to shine The last 12 months have seen the Pharmaceutical Manufacturing Technology Centre continue to capitalise on its earlier successes

Dr Adeyinka Aina, Innovation Fellow PMTC, is pictured (left) with Dr Charles Gordon of Britest, during the Britest members’ day event in October 2016.

Although only entering its third year in existence, the Pharmaceutical Manufacturing Technology Centre (PMTC) has quickly developed a reputation as a reliable provider of advanced technology solutions to contemporary manufacturing issues. The Centre’s research, spanning six discrete themes, seeks to provide workable solutions to some of the most pressing problems facing the pharmaceutical industry. Their highly-qualified research teams, based in partner institutions across the country, have developed a range of

innovative and very promising technologies in the last year. These include a novel microbial apparatus for quantitative determination of bacterial contamination, a QbD approach for continuous processing in production processes, soft sensor modelling tools for critical processes, including freeze drying, and PAT methods for at line analysis and real time release.

Cleaning Validation and Verification The Centre’s Executive Director/CEO, Dr Chris Edlin drew particular attention to the successes surrounding the cleaning validation and verification research. This research focuses on developing a methodology based on real process understanding to support optimisation and design of more efficient cleaning/changeover processes, an activity being carried out in collaboration with Britest Ltd.; developing mathematical models to fully understand the physical processes involved; and PAT approaches to verify and validate plant cleaning. Dr Edlin noted that PMTC’s activities in plant cleaning have now begun to make immediate and demonstrable impacts in pharmaceutical facilities across Ireland. For example, he described how at one Irish facility, initial applications of the methodology have resulted in a 40% reduction in solvent usage in gross cleaning, which is expected to lead to a 33% reduction in overall cleaning/changeover cycle times. In a second facility, the impact has been a 10% reduction in the time spent cleaning, reducing the number of site cleaning shifts from eight to seven per annum. Dr Adeyinka Aina, Innovation Fellow at PMTC, explained that the regulatory compliance and scientifically-based cleaning methodology is generating extremely high levels of interest across the industry. He has found that industry partners are very excited about the possibility of a reliable methodology with the potential to create a significant reduction in cleaning times and attendant costs. Dr Aina is now looking forward to the methodology implementation phase, which is on track to take place both in Ireland and the UK in the near future.

Cleaning Validation and Verification Future Directions? When asked about the possible future directions for the protocol being developed, Dr Aina explained that he sees it steadily evolving to have wider applications that span beyond the pharmaceutical sphere, including fine chemicals and the food industry. He hopes that the cleaning validation document will become a multiindustry gold standard in the area of cleaning validation and verification.

Collaboration: a Key Driver of Success Dr Edlin is a strong proponent of crosscollaboration between technology and research

Irish PharmaChem | Industry Buyers Guide 2017

Pharmaceutical Manufacturing and Technology Centre

Pictured at the PMTC Knowledge Day are (l-r): Marco Marques, Pfizer; Carlos Escobar Rodriguez, Johnson and Johnson; Dr Mary Shire, Vice President Research; Joe Haugh, Zenith Technologies; Dr Chris Edlin, Centre Director PMTC; and Professor Gavin Walker, Bernal Chair. Photo: Alan Place Photography

centres. His experience has shown that outputs from these endeavours can help to create a landscape in which pharmaceutical companies can better thrive and expand. To put this vision into action, he has become actively involved in a number of collaborative ventures that are in line the with Centre’s overall mission. For example, PMTC worked closely with research teams at both NIBRT and SSPC to produce and launch a brochure detailing pharmaceutical and biopharmaceutical research capability in Ireland (www.therapeutics. ie). The three research centres are working together as part of a very successful (bio)Pharma working group. This group has several aims, including showcasing the Irish biopharmaceutical industry abroad, the highlighting of Irish RPO capability and the increase of funding opportunities for the (bio)Pharma sector in future EU work programmes. The group recently travelled to Brussels to connect with members of DG GROW and EU Commissioners, including Sean Kelly MEP. PMTC looks forward to continuing to work with (bio) Pharma Ireland to promote awareness of the need for innovation in pharmaceutical manufacturing processes.

PMTC Knowledge Day 2016 The second annual PMTC Knowledge Day was Irish PharmaChem | Industry Buyers Guide 2017

a definite highlight of 2016. “This annual event brings together academic groups, industry and government agencies to showcase state-of-theart applied research into contemporary industry problems,” Dr Edlin explained. “It was extremely pleasing to welcome established partners plus a growing cohort of new companies interested in collaboration.” Careful consideration had been given to choosing the theme of the event. Reflecting current industry concerns about the speed of change in processes, the focus finally decided on was: ‘The future of pharmaceutical manufacturing – using advanced technology solutions to address contemporary issues’. PMTC were pleased to have the CEO of Zenith Technologies, Joe Haugh, address attendees on the topic of delivering MES, automation and process control excellence. Other notable speakers included Carlos Escobar Rodriguez from Johnson & Johnson Product Supply and Marco Marques of Pfizer. A dynamic event schedule, including industry presentations and vendor lightning sessions, was created for attendees. The agenda for the day was carefully designed to allow for multiple opportunities for networking and peer-to-peer learning throughout the day. Looking towards 2017 and beyond, Dr Edlin predicts that “the environment in which the

pharmaceutical sector operates will continue to present significant challenges to the industry; these include, for example, the ongoing impact of the patent cliff on sectoral revenue streams and increased pressure on cost competitiveness.” In order to respond to these issues, he highlights the need for companies to be able to rapidly respond to problems relating to their processes and procedures. “In light of these challenges, I consider that membership of the PMTC, which is dedicated to solving sectoral problems, will become an important tool to help companies survive in a volatile marketplace,” he said. Finally, it is evident that the pharmaceutical industry creates a significant number of high quality jobs in Ireland; its sectoral outcomes playing a key role in the economic health of the country. PMTC’s research contributes positively to the sectoral landscape by creating a world class centre of excellence for the resolution of pharmaceutical manufacturing issues. “We in PMTC will continue to work to both attract and retain companies that provide valuable employment opportunities for thousands of workers,” confirms Dr Edlin. “This will be a measurable output of our vision of making Ireland a global hub of pharmaceutical process innovation.”

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Regulatory Science Ireland

Understanding Biosimilars... Regulatory Science Ireland is conducting a research project to enhance understanding of biosimilar medicines and encourage best practice in the use of these medicines, writes Joan Oâ&#x20AC;&#x2122;Callaghan, Research Scientist, RSI.

Regulatory Science Ireland (RSI) is a voluntary network of interested parties from academia, the Health Products Regulatory Authority (HPRA), pharmaceutical and medical device industries and government agencies. RSI is conducting a research project, the objective of which is to enhance understanding of biosimilar medicines amongst stakeholders and encourage best practice in the use of these medicines. Regulatory Science Ireland (RSI) is an integrated Irish response to global regulatory science initiatives. The group is composed of interested parties from the HPRA, academia, pharmaceutical industry, medical devices industry and government agencies (see Figure 1). RSI is contributing to the regulatory science effort by conducting research, provision of educational materials and organisation of regulatory symposia. Efforts such as these will help to improve regulatory understanding among all stakeholders and will ultimately be of real benefit to patients.

Why is RSI focusing on biological and biosimilar medicines? Biosimilars are biological medicinal products, which contain a version of the active substance of an already authorised original biological medicinal product (reference medicinal product). During the regulatory approval process, the biosimilar must demonstrate similarity to its reference product in terms of quality, Irish PharmaChem | Industry Buyers Guide 2017

safety and efficacy. This is achieved through a series of comparability studies conducted at the quality, preclinical and clinical levels. The biosimilar approval process is based on extensive characterisation and comparison of the structural and functional characteristics of the reference and biosimilar products, using state-of-the-art analytical tools. The clinical data provided to confirm biosimilarity is tailored to each product on a case by case basis and can be abbreviated in comparison to evidence that would be included in the marketing authorisation dossier of an original biological medicine. The biosimilar medicine may also be licensed in therapeutic indications for which no specific clinical trials have been conducted. This is commonly referred to as indication extrapolation and is only approved by regulators after comprehensive scientific justification, which includes consideration of the mechanism of action in each indication. A regulatory emphasis on the evidence from the quality and preclinical comparability exercises may be an unusual concept for clinicians, who are more accustomed to evidence from clinical studies. A key output from the RSI biosimilar project is to identify and implement mechanisms to increase the understanding of how these medicines are regulated and used amongst healthcare professionals, patients and healthcare providers.

HPRA Guide to Biosimilar Medicines Prior to commencement of the RSI biosimilar project, the HPRA was already engaged in activities to facilitate knowledge transfer concerning biosimilar medicines to stakeholders. In 2015, the HPRA published a guide to biosimilar medicines. This guide is targeted primarily at healthcare professionals but is also relevant to patients, manufacturers, distributors and those involved in hospital procurement. The guide provides an overview of how biosimilar medicines are regulated and outlines the difference between a biosimilar medicine and a generic (chemical) medicine. Topics such as pharmacovigilance considerations, adverse drug reaction reporting, prescribing and interchangeability are also addressed. While the publication of such guidance documents can help in addressing some of the misconceptions surrounding biosimilar medicines, the HPRA is continuing in its efforts to bridge the information gap on biosimilar medicines by providing dedicated resources to the RSI Biosimilar Research Project.

RSI Biosimilar Research Project Biosimilar medicines were highlighted as being a key area of interest for the development of the regulatory science knowledge base in Ireland and therefore, a biosimilar research project was launched as one of the first major projects for RSI. The project, which has been ongoing since

Regulatory Science Ireland January 2016, involves a collaboration between the HPRA and University College Cork (UCC). A project advisory panel meet quarterly to share ideas about the direction of the research. In addition to HPRA and UCC, the advisory panel consists of stakeholders from industry, industry representative bodies, a patient representative and government agencies.

The project objectives include: Peer reviewed scientific publications on biosimilar medicines, particularly concerning the practical considerations for health care professionals; Conducting surveys of healthcare professionals on perspectives and understandings of issues relating to biosimilar medicines; Development of training materials and online resources; Participation in outreach activities (e.g. running short training courses, information days, invited lectures).

• • • •

Research activities are conducted independently by the HPRA and UCC, which ensures the generation of neutral information relating to the use of biosimilar medicines by healthcare professionals.

Survey of Physicians An early goal of the project is to evaluate the level of understanding about biosimilar medicines amongst Irish healthcare professionals. In May 2016, a link to an online questionnaire was circulated to medical specialists (predominantly hospital consultants in specialities that use biological medicines) and general practitioners (GPs). The objective of this survey was to explore physicians’ perspectives and understanding of issues relating to biological and biosimilar medicines. The results from the survey are currently being analysed and will shortly be submitted for publication.

by distribution of the online questionnaire to their members. Continued engagement with the societies is envisaged after publication of the survey findings. Engagement with GPs has been facilitated by The Irish College of General Practitioners (ICGP). The ICGP is the professional body for General Practice in Ireland and its members and associates account for over 85% of practising GPs. The College agreed to distribute the questionnaire to its membership and organised a speaking slot for RSI at an educational conference organised for its members. Pharmacists have been kept informed of key aspects of biosimilar regulation and their use in clinical practice via RSI presentations at continuing education events and publication of papers in national pharmacy journals (Irish Pharmacy News and the Hospital Pharmacist News). An article highlighting the importance of traceability of biological medicines has been published on the RSI website and highlighted to registered pharmacists via a newsletter distributed by the Pharmaceutical Society of Ireland. The RSI project team also aims to facilitate knowledge transfer to patient communities. Representatives from various patient organisations have been made aware of the project at an event entitled ‘Biologics and Biosimilars’ organised by the Irish Platform for Patient Organisations Science and Industry (IPPOSI). IPPOSI has also conducted a recent survey of 150 arthritis patients. The findings suggest that awareness and understanding of biosimilars amongst patients is low. Respondents also felt that there was limited access to patient friendly, easily Research about biological and understandable information biosimilar medicines. This identified need has

resulted in the RSI publication of a patient Q&A on biosimilar medicines, which can be found on the RSI website. It is planned to produce a short informative video to accompany the Q&A. Once finalised, the materials will be publicised to relevant patient organisations.

Ongoing Activities Materials generated from the project will be available for download from the RSI website (www.regulatoryscienceireland.ie). Research findings will be disseminated to healthcare professionals, patients, payers and policy makers. Outreach activities will continue as the project gains momentum and it is planned to organise and contribute to future events involving key stakeholders.

Conclusion Since its inception, RSI has made significant progress in increasing the awareness and understanding of the regulation, prescription and use of biosimilar medicines in Ireland. However, a level of misunderstanding around the whole area still persists. Through our future research, outreach programmes and engagement activities, RSI plans to bridge the knowledge gap between industry, regulators, healthcare professionals and patients and contribute to the safe and effective use of biological medicines in Ireland.

Acknowledgements Regulatory Science Ireland acknowledge the financial support provided by the Health Products Regulatory Authority and the Irish Pharmaceutical Healthcare Association for the conduct of this research.

Research

Stakeholder Engagement Many medical specialists in Ireland are members of Education and Training professional societies. Societies, whose members are likely to be involved in the prescribing of Education and Training biological medicines, have facilitated the research

Regulatory Symposia Regulatory Symposia

Figure 1: Regulatory Science Ireland Membership

Academia

Regulatory Body Academia

Pharmaceutical Industry Regulatory Body

Medical Devices Industry

Government Agencies

Pharmaceutical Medical Devices Government Industry Irish PharmaChem | Industry Industry Agencies Buyers Guide 2017

Recruitment

The Scientific Approach to Recruitment the performance of the recruitment process,” notes Tina Dunne, Cofounder and Director. “We work with candidates that might be at the forefront of preventing the spread of a disease, pioneering research or developing that ground-breaking new product!” Thornshaw prides itself on the quality of service and commitment to its customers. Working at Thornshaw are a group of highly trained and skilled consultants, who take the time to keep up to date with market trends and who also make it a priority to get to know their clients and candidates, ensuring a perfect fit for each position filled.

Thornshaw Scientific is a leading and dedicated provider of specialist recruitment services to the pharmaceutical, medical device, biotechnology, clinical research and healthcare sectors. Since its founding in 1999, Thornshaw has grown into a trusted and sought after service provider to some of the top 20 global pharmaceutical and medical device companies. As a specialist science recruitment company, Thornshaw Scienfitic don’t just work with their clients; they connect with them, and just like scientists, they understand and control the process from beginning to end. “Our ultimate aim is to optimise

With its excellent reputation in the industry, it’s no surprise that Thornshaw has recently been nominated for the NRF Best in Practice Award. What sets Thornshaw apart is its determination and dedication to finding the best person for the job, because in the end the team at

Thornshaw know that “recruitment is all about the chemistry”. “Science is what we’re good at,” Dunne concludes. “We have the expertise, the knowledge, the passion, the consultants and the scientific knowhow.” For more information, log on to www.thornshaw.com.

Scientific Recruitment As a company we’re only as good as the people we work with, which is why we only work with the best – the best clients, the best candidates, the best employees.

For more information on our recruitment services contact us on: Telephone: +353 1 2784671 Email: info@thornshawscientific.com

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Research & Development Pictured at the Pharma Industry Awards 2016 are (l-r): Louise O’Neill, Aisling Arthur, Prof. Patrick Guiry, Donald McDonagh, Dr Joanne Conroy, Dr Lidia Tajber, presenting the award, Noel Killeen from The Sunday Post, Dr Sarah Hayes, Jon O’Halloran, Dr Kristy Butler and Rosaleen Archbold.

SSPC Wins Hat-trick at Pharma Industry Awards The Synthesis and Solid State Pharmaceutical Centre (SSPC), hosted at the Bernal Institute at the University of Limerick, was one of the winners at the Pharmaceutical Industry Awards, being named the Pharma Research Centre of the Year. “The judges recognised that the SSPC’s success is defined through its unique industryacademic collaboration and the way we are building R&D excellence in one of Ireland’s largest industries,” said SSPC general manager Jon O’Halloran.

A Model for Collaboration The SSPC has featured regularly in the pages of the Irish PharmaChem Yearbook since its establishment in 2008 for a very good reason. It is the largest collaborative scientific research organisation in the country and has become a model for collaboration between industry and academia, not just in Ireland but across the globe. A collaboration of 33 partners, made up of nine research performing institutions and 24 pharmaceutical and chemical companies, the SSPC research programme covers the pharmaceutical production chain, from molecule to medicine. It is jointly funded by the Irish Government, through Science Foundation Ireland and industry partners, with funding of €30m and €10m invested respectively. The SSPC has grown rapidly since it was founded in 2008, with €6.9m funding 24 researchers. In 2013, the centre achieved SFI Centre status and funding grew by €30m to support 90 researchers. “Since then, we have won an additional €38.5m competitively from numerous sources, making the total funding almost €70m,” said O’Halloran. “We are now one of the top five research centres globally in the pharma manufacturing space. From relatively modest Irish PharmaChem | Industry Buyers Guide 2017

The Synthesis and Solid State Pharmaceutical Centre (SSPC) has won the Pharma Research Centre of the Year award for the third year in a row for its contribution to the pharma sector in Ireland. beginnings in 2008 to now actively competing with the likes of MIT and Purdue is very gratifying.” This year, SSPC has been awarded its second largest SFI funded ‘spoke’ project in a collaborative engagement between Johnson & Johnson, Rusal Aughinish Alumina and the University of Limerick; focusing on automation in the biopharma industry. It has also been awarded one of the inaugural US/Ireland Centre to Centre Awards with CSOPs in the US and Queens University Belfast. Only two were awarded nationally. Significant research infrastructure funding was won by SSPC researchers in UCC and UL to the tune of €3.4m. In addition, SSPC spin-out APC in Cherrywood, Dublin, is going from strength to strength, having announced 100 new jobs in its plans earlier this year. “Working with our industry partners and partner research institutions, we are helping to solve the most pressing questions for the pharmaceutical industry worldwide, helping them to increase efficiencies, reduce costs and widen the variety of drugs and treatments available in the market,” O’Halloran explained. 2017 will be a pivotal year for the centre, the SSPC are leading a large consortium of Irish and European partners to engage at policy level within Europe to ensure (bio)pharma manufacturing is recognised as a Pan-European priority and deserving of commensurate funding. SSPC is leading this initiative with support from NIBRT, PMTC, SFI, IDA, EI and BioPharmaChem Ireland under the umbrella (bio)Pharma Ireland. We have energised support from partners in Austria, Germany, Belgium, Finland and the UK, and have a major event planned in late February in Brussels.

Delivering Real Results Indeed, the SSPC is getting real results in terms of problem solving and innovation, and continues to attract some of the biggest names in scientific research worldwide, supporting more than 130 researchers, including 41 research investigators, 35 post-doctorate researchers and over 60 PhD students. Meanwhile, the SSPC’s industry partners include some of the biggest names in global pharmaceuticals, like Pfizer, Eli Lilly, Glaxo SmithKline, Janssen, Merck, Roche, Bristol Myers Squibb, Alkermes and Abbvie. The SSPC research programme is organised into three interconnecting strands, which actively reflect the three distinct steps in the manufacture of modern medicines. Strand 1: New Frontiers in Pharmaceutical Synthesis This focuses on better and more environmentally sustainable ways to make active pharmaceutical ingredients; Strand 2: Crystal Growth and Design Investigating optimal ways to produce active pharmaceutical ingredients; Strand 3: Drug Product Formulation and Manufacture Developing the dosage forms of the future. The SSPC is hosted at the Bernal Institute at the University of Limerick and is partnered with University College Cork, University College Dublin, Trinity College Dublin, National University of Ireland Galway, Dublin City University, Athlone Institute of Technology, the National Institute for Bioprocessing Research and Training, and Waterford Institute of Technology. For more information, see www.sspc.ie.

Biotech Start-Ups Ireland’s pharmaceutical and biopharmaceutical sectors have been an ever-growing component of the Irish economy over the last three decades. The cost of DNA synthesis, sequencing and engineering of organisms has crashed dramatically. This has resulted in the era of DIY bio, garage BioHackers and of course the potential to create lean biotech start-ups. Biotechnology was once an incredibly cost and labour intensive industry, requiring millions in investment before even clinical testing of products began. Biotechnology is commonly associated with drugs and biopharma products, but its application in tackling other major global issues has made it more applicable than ever. Issues such as environmental bioremediation and sourcing new antimicrobials, as well as creating first in class functional foods are all being approached by a bevy of biotechnology companies. Ireland’s strategic location as one of the only English-speaking EU countries located between the US and mainland Europe offers young companies numerous strategic benefits. Our competitive corporate tax rate makes it easier for companies to generate first revenues, in addition to allowing companies to run leaner for longer. The large presence of technology institutes and leading universities offers start-ups the chance to partner and collaborate on meaningful projects and allows university researchers to commence industrial partnerships and further hone their skills.

Support Initiatives Enterprise Ireland offers a range of support initiatives for young life science start-ups, particularly enabling companies to become a High Potential Start Up, whereby EI will support the seed investment of companies up to €250,000. This gives Irish start-ups a competitive edge in fundraising compared to that of similar companies in the US. Furthermore, Research and Development Tax Credits give Irish companies up to 37% tax back on R&D expenditure. The advent of CRISPR has now altered how we fundamentally approach methods to create safe, effective genetically modified organisms. It is now possible to switch off genes that code for harmful products, such as the allergenic proteins in peanuts, all without inserting a rogue gene from a bacteria into a plant. There may be a surge in the rise of biotechnology companies using CRISPR-driven research to create impactful gene therapies, first in class functional foods and new antimicrobials to tackle infections.

Success Stories RebelBio, formely known as Indie Bio EU, has been a driving force behind creating young

Biotechnology is commonly associated with drugs and biopharma products, but its application in tackling other major global issues has made it more applicable than ever.

The Start of a BioRevolution There has never been a better time to back a young, lean biotechnology start-up, writes Steven O’Connell of RebelBio.

RebelBio EU is the Global Accelerator for Biotechnology & Synthetic Biology.

Irish PharmaChem | Industry Buyers Guide 2017

Biotech Start-Ups

The large presence of technology institutes and leading universities offers start-ups the chance to partner and collaborate on meaningful projects and allows university researchers to commence industrial partnerships and further hone their skills.

early stage biotechnology start-ups at the preseed stage, recruiting start-ups to participate and form emerging technology companies. At present, we have assembled 25 first in class companies to tackle existing and emerging issues with biotechnology, all supported by SOSV - The Accelerator VC. RebelBio is currently recruiting its fourth cohort in 2017 and has plans to scale to two programmes a year in partnership with UCC in 2018. Elsewhere, Genomics Medicine Ireland recently closed $40m in funding to create 150 jobs and develop novel therapies to treat Alzheimers and Multiple Sclerosis. The company is expanding its operations to better characterise diseases and create better patient outcomes for everyone globally. The growing interest in Ireland as a hub for

Steven O’Connell, Associate Director & Programme Manager, RebelBio.

access, financing and marketing can also get boosted by taking part in this programme, based in Dublin. The future looks bright for Ireland and it may very well be possible that the next big-bio company is formed to ferment a revolution.

Challenges & Opportunities

globally renowned accelerators is becoming more evident each day. The Yield Lab is beginning to assemble operations for its AgriTech Accelerator in Galway, investing $100,000 in agricultural technologies. The Pearse Lyons Accelerator, backed by Alltech, is soon to launch its inaugural ag-tech accelerator in 2017 for a period of five years to accelerate agribusiness, food technology and ag tech operations. Areas such as market

While Ireland is as advanced infrastructurally as the rest of the world, our start-ups must rely on sourcing investment flow from other countries, such as the UK and other countries in Europe, which can sometimes prove a lengthy process. Irish investors often look at life sciences as risky ventures, due to the project being largely outside of their domain knowledge. Contrary to this, I believe it has never been a better time to back a young lean biotechnology start-up that could become your very own “Genentech in your own backyard”. It’s important to encourage Irish investors to take the risk and trust the talented founders they will impact the world with their investment before the opportunity passes them by. The cost to scale these companies is gradually decreasing annually and partnering with more established corporates, many of whom are very eager to partner with startups, creates a new paradigm for emerging companies to build and operate laboratories efficiently.

Steven O Manage

About the Author Steven O’Connell is the Associate Director & Programme Manager for

RebelBio, formely known as Indie Bio EU,. He currently runs operations for the Irish programme and has experience in commercial biotechnology, research and the business of startups. Biology is the driving force fundamentally shaping outcomes to improve the human condition. RebelBio is the Global Accelerator for Biotechnology & Synthetic Biology. They work with IndieBio SF and leading founders to build the best early stage, investor ready biotechnology start-ups. They create new functional foods, develop first in class therapeutics and use bioremediation to improve the environment. SOSV - The Accelerator VC is its parent firm, which invests in start-ups globally to make the impossible inevitable. Prospective corporate partners and investors should contact with their team to learn more about their growing portfolio and embark with them on their ongoing mission to shape our future with biology.

Irish PharmaChem | Industry Buyers Guide 2017

Rebel Bio has been a driving force behind creating young early stage biotechnology start-ups at the pre-seed stage, recruiting start-ups to participate and form emerging technology companies.

Documentation Solutions

Documentation solutions 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 that may lead to confusion and human error; Creating user-friendly product information documents and user manuals; Achieving resource efficiencies, while maintaining quality and ensuring regulatory compliance; Developing the skills of your team.

• • • •

TWi’s Solutions

•

Consultancy and support on documentation and information management;

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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

•

High-quality CAPAs and reduced human errors; Standardised and user-friendly SOPs; Enhanced documentation quality, consistency, and usability; Greater operational efficiency, saving time and resources.

• • •

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

For more information, see www.technicallywriteit.com.

Information design and technical communication expertise;

Documentation Solutions  Improve documentation quality, consistency, and usability  More effectively comply with regulatory requirements  Standardise SOP’s and WI’s  Save time and resources  Enhance cross-organisational knowledge sharing  Flexible service offerings to meet your needs!

Stand Out TECHNICAL WRITING INFORMATION DESIGN TRAINING & CONSULTING

From the Crowd

Irish PharmaChem | Industry Buyers Guide 2017

EDUCATION & SKILLS DEVELOPMENT

Cultivating the talent pool of the future Ireland’s biopharmachem industry could generate up to 8,000 new jobs if we successfully nurture our talent pool. Siobhán Dean and Sophie Moran, BioPharmaChem Ireland, advise on how to do just that.

The biopharmachem industry is one of Ireland’s most influential sectors, employing 28,200 people and having annual exports in excess of €65 billion. The industry is experiencing a period of rapid change, as evidenced by the continued development and manufacture of complex biological medicines. In the past number of years, over €4 billion has been invested in the sector, marking a period of sustained growth. A report published by the Expert Group on Future Skills Needs stated that the sector could generate an additional 8,000 jobs, with a similar number being indirectly employed through a wide range of support services. Therefore, in order to fully maximise the benefits from this unprecedented growth, we need to start cultivating our future talent now. Ensuring a strong pipeline of highly skilled graduates to fill these new positions is extremely important to the life sciences Irish PharmaChem | Industry Buyers Guide 2017

sector and this begins at the secondary school level. BioPharmaChem Ireland (BPCI) and its members will promote the value of STEM subjects and educate students about the industry by running key events and collaborations throughout the year.

Future Talent Pool The depth and breadth of the Irish talent-pool is a critical factor for companies considering investing here. However, this pool can be quickly depleted if there isn’t a similar investment in young graduates. To maintain this position, it is important that we anticipate the changing skills requirements of the sector and ensure that there is a close alignment between the industry’s needs and the skills being taught in the education and training system. In a bid to achieve this goal, BPCI established the Biopharmachem Skills Forum in 2015. This is

a platform where industry and key stakeholders from education, training provision and state agencies could meet to discuss the emerging skills demand and establish an action plan to address the industry’s needs. In 2016, industry worked with the Expert Group on Future Skills Needs (EFGSN), in preparing the ‘Future Skills Needs of the Biopharma Sector’ report. This report advises that the anticipated skills needs of the sector should be available and met through a mix of graduate intake, upskilling and reskilling of those seeking employment and investing in continuous professional development of those already employed in the sector. The EGFSN outlined a number of recommendations for addressing the skills needs of the sector, which now form the basis of the industry Action Plan for Skills. The action plan covers a three-year period and is flexible and dynamic to encourage additional actions

EDUCATION & SKILLS DEVELOPMENT and ideas to be added as they emerge over this timeframe. The implementation of the actions will be driven by the industry skills forum, which has a strong industry representation, and quarterly progress reports will be published. Alignment between education, training provision and industry is vital to ensure programme content and delivery is relevant and meets industry’s needs. Therefore, a key focus of the action plan is to increase the engagement with education and training providers and to develop a structured framework to support improved engagement. In a bid to achieve this, BPCI are collaborating with the recently established Network of Regional Skills Fora, created as part of the Government’s National Skills Strategy. Through this collaboration, a series of industry/ education and training providers’ workshops will be held to analyse how to best bridge the gap between the demands of industry and the current output from third level and to enable the adaptation of programmes that meet the skills, knowledge and competency required by industry.

Internship/Work Placement Programmes There was a strong consensus by industry that work placements of least 6-9 months duration are key to improving the employability of graduates. While some courses have work placements, BPCI believe that all biopharmachem related courses should provide accredited practical work placements. They make graduates more work ready by improving both their technical skills and their soft skills, such as interpersonal, general business, communication and problem solving abilities, which have been highlighted as areas of concern in the industry.

New Apprenticeship Programmes Apprenticeship programmes have also been identified as an effective way for companies to meet their future skills needs. In 2015, a new apprenticeship council was established to review and expand this model of training from the traditional ‘craft’ training to other occupations with emerging skills demands. BPCI has established a working group, made up of industry representatives and training providers, to develop a new biopharmachem apprenticeship programme for the quality and operations functions of the business.

Pictured are Siobhán Dean, BioPharmaChem Ireland with John Stokes, Director of Technical Services, Pfizer; Lorraine Danaher, Midlands Regional Skills Manager; and Mairead Cummins, Talent Acquisition Manager, Pfizer; at the Life Science Career Opportunities BioPharma, Medtech and Engineering Fair in Athlone IT. of exciting career and placement opportunities in their companies. The event resulted in over 200 open positions being filled. Building on this success, 2017 will see a number of similar industry awareness/career events take place in the regions, to continue to enhance the profile of the sector at a regional level.

the-shelf programmes, more than 7,500 people have been upskilled over a 10-year period. The network also runs interventional courses for jobseekers, giving them the necessary skills to break into the industry. Further funding through Springboard is currently being sought, which would grant even more opportunities to jobseekers to begin a new career in our industry.

Investing in Continuous Professional Development (CPD)

Employment Activation Initiatives

The development of talent of those already working within the sector is critical to fully embrace the changing technology and processes, especially in the manufacturing of biologics. In 2016, BPCI established a new partnership with Pharmachem Skillnet, a network that offers enterprise-led, subsidised training for our industry. Using a mixture of bespoke and off-

Investment in the upskilling of job-seekers for the sector will provide an immediate additional source of talent supply for the sector. In 2015, Pharmachem Skillnet collaborated with BPCI to deliver two bio-pharma upskilling programmes to 36 life science graduates who were on the live register. All 36 graduates successfully completed the course and have since found employment within our industry.

Creating Awareness of Opportunities In order to showcase the career opportunities in the sector, a pilot event entitled ‘Life Science Career Opportunities – Biopharma, Medtech & Engineering Fair’, was held in the midlands, where significant investment has been seen in the past 18 months. Over 40 biopharmachem and medtech companies showcased the variety

Irish PharmaChem | Industry Buyers Guide 2017

Supply Chain

Your Premier Supply Chain Partner As a premier global supply chain solutions partner to the pharmaceutical industry, the experts at Univar Pharmaceutical Ingredients understand the importance of having access to a safe and dependable supply of quality and performance-based ingredients for your pharmaceutical formulations. With long-standing, strong relationships with premier producers of technologies and ingredients, Univar’s extensive global network provides pharmaceutical manufacturers with one-stop access to a broad range of specialty active pharmaceutical ingredients (APIs), excipients, and process ingredients, when and where customers need them. On top of that, Univar offers broad technical and regulatory expertise that enables the safe delivery of a total solutions approach, from product

selection and regulatory compliance to scaleup and commercialisation. Univar Pharmaceutical Ingredients safely delivers value to customers in four key areas: ● Customer

Service: focused teams understanding customer needs, handling ingredient demand, managing supply chains, and delivering satisfaction;

● Quality Assurance: ensuring their customers

receive the right types of materials, with the correct audit trail and full traceability, along with change control processes; ● Security of Supply: global supply chains

with strong partners who are here today and tomorrow; ● Technical

Support: ensuring all documentation is completed on time and

in full, to meet the needs of the relevant authorities and providing product guidance as required. Univar’s team of dedicated pharmaceutical specialists are intimately familiar with the pressures facing today’s pharmaceutical manufacturers, from global economic effects on healthcare budgets and increased regulatory demand to competing in an increasingly competitive global market. Univar’s experts work closely with customers to address individual challenges by developing tailored solutions to help reduce total costs of operation, while providing a dependable and secure source of supply. For more information, email irelandsalesoffice@univar.com.

Ireland’s leading source of high quality pharmaceutical ingredients Univar is Ireland’s leading source of high quality ingredients to the pharmaceutical sector. Our purpose built site has been designed to meet the regulatory compliance demands of our pharmaceutical customers. We are serious about safety and we are committed to making a positive impact on environmental issues in handling fine chemicals. Univar is the partner of choice for many of the world’s leading pharmaceutical ingredient manufacturers. Whether you are looking for APIs, Excipients, Process chemicals, Solvents or Intermediates we can provide technical and regulatory support. To discuss your specific needs please contact our sales office on +353 1 4019817 or email us at Irelandsalesoffice@unviar.com www.univar.com

Irish PharmaChem | Industry Buyers Guide 2017

LABORATORIES

Major Expansion at Eurofins Lancaster Laboratories

n its quest to continually meet the growing needs of clients, deliver worldclass capabilities, and serve as a career destination, Eurofins Lancaster Laboratories has embarked on strategic plans for the expansion of its campus at Dungarvan, Co. Waterford, including development of a new building, as well as expansion of its current facility. A major employer in the South East, Eurofins Lancaster Laboratories is set to increase its workforce to over 500 staff by 2021 with this investment by its parent company, Eurofins Scientific. Over 175 new jobs have been created in the past 24 months. “This expansion is the result of successfully growing strategic partnerships with our clients and the value we bring to them and their target markets,” said Timothy S. Oostdyk, Ph.D., Chairman, Eurofins Lancaster Laboratories, and Group Senior Vice President, Eurofins BioPharma Product Testing. “It reinforces Eurofins’ absolute commitment to aggressively funding growth to enhance the way we serve our customers, as well as to build the best and widest-reaching testing network in the biopharmaceutical market.”

Increased Capacity The launch of this major building expansion programme combines the expansion of the existing 2,700m² laboratory with an additional 4,400 m² extension, as well as the development

of an 1,800 m² second site on the campus located in the IDA Business Park, Dungarvan. This means that the project will bring the Group’s capacity to almost 9,000m² of stateof-the-art laboratory surface to serve the biopharmaceutical industry in Ireland and the UK. Building works commence d in Q4 2016. The project is another example of the commitment of Eurofins Scientific to continued growth and investment in its laboratory operations in the region. “We currently serve 18 of the top 20 global pharmaceutical companies, and our success is attributable mostly to the excellent commitment and technical capability of our people,” said Carmel Fitzpatrick, Managing Director, Eurofins Lancaster Laboratories in Ireland. “Our broad base of clients means we work on a diverse range of products and development projects, which offers an excellent scope for continuous learning and development of technical depth that is unparalleled. We invest heavily in our internal training programmes, and we are grateful to be supported by the IDA and Skillnets to deliver technical competency in our team that is world class.” Fitzpatrick stressed that the company prides itself on a service offering that meets the complex and varying needs of their clients, many of whom avail of all their service tiers, whether in-house or at the client facility. “Our in-house testing services are complemented by

our innovative and award-winning Professional Scientific Services (PSS) programme that places full-time analysts, technicians, scientists and technical support personnel, managed by us, directly at the client facility to provide long term staffing needs, while maintaining the same services, expertise and cGMP compliance available at our facility in Dungarvan,” she explains. “We have PSS teams based at a variety of client locations in Ireland and UK.”

A Major Employer in the South East Speaking at the announcement, Mary Mitchell O’Connor TD, Minister for Jobs, Enterprise and Innovation, said, “It’s great to see an established successful company like Eurofins expanding its operations further in Waterford with the addition of over 160 staff over the next five years. That’s on top of the 175 jobs created in the past two years. A key priority for me as Minister is encouraging more companies to set up in our regions. Companies setting up and creating jobs in our regions ensures that there are opportunities for positive knock-on effects in the surrounding areas. Only a strong economy supporting people at work can pay for the services needed to create a fair society. Already a major employer in this key regional location, this further expansion and substantial number of new jobs will benefit the entire South East Region. It demonstrates great commitment by Eurofins Lancaster Laboratories’ parent company, Eurofins Scientific. I congratulate the Irish PharmaChem | Industry Buyers Guide 2017

LABORATORIES Global BioPharma Product Testing Within Your Reach Eurofins Lancaster Laboratories’ major expansion plans in Ireland enhance global biopharmaceutical services and create new jobs.

company and their workforce and wish them continued success.” CEO of IDA Ireland, Martin Shanahan added, “This investment demonstrates Eurofins Lancaster Laboratories’ commitment to Dungarvan, and the large cluster of biopharma companies based in Ireland. Achieving increased levels of investment in regional locations is an important focus of IDA’s strategy ‘Winning – FDI 2015-2019’ and this is an important step in that direction. I wish Eurofins every success as they continue to grow their operations in the South East Region.”

Company History Founded in 1961, Eurofins Lancaster Laboratories provides comprehensive bio/ pharmaceutical laboratory services for all stages of the drug development process and supports all functional areas of bio/ pharmaceutical manufacturing, including method development, microbiology, process validation and quality control. As a member of Eurofins Scientific’s BioPharma Product Testing Group, the largest network of harmonised bio/pharmaceutical GMP product testing laboratories worldwide, Eurofins Lancaster Laboratories partners with world’s largest pharmaceutical and biopharmaceutical companies to transform their science into outstanding solutions. For more information, please go to www.Eurofins LancasterLabs.com. Irish PharmaChem | Industry Buyers Guide 2017

As the largest international network of harmonised GMP product testing labs, Eurofins BioPharma Product Testing delivers a true local service experience. Eurofins BioPharma Product Testing offers the most complete range of testing services, harmonised quality systems and LIMS to more than 2,000 pharmaceutical and biopharmaceutical companies worldwide. Global Is Local Their local presence ensures personal service backed by a unique global breadth of harmonised capabilities that support all functional areas of bio/ pharmaceutical drug development and manufacturing, including method development, microbiology, process validation and quality control. With a global capacity of more than 65,000 square meters and 24 facilities located in Australia, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, the UK and the US, their network of GMP laboratories and vast experience allow Eurofins BioPharma Product Testing to support projects of any size from conception to market. They also have teams of scientists placed at more than 65 client facilities throughout Europe and the US through the award-winning Professional Scientific Services (PSS) insourcing program. Experience Their Expertise They offer complete CMC Testing Services for the Bio/Pharmaceutical industry, including all starting material, process intermediates, drug substance, drug product and manufacturing support, as well as broad technical expertise in Biochemistry, Molecular & Cell Biology, Virology, Chemistry and Microbiology. International Presence Means Global Regulatory Compliance Operating under the same strict quality procedures, their laboratories offer a broad range of methodologies under GMP authorisation, ISO 17025 accreditation and ISO 9000 certification, and all analysis are performed according to European and British Pharmacopeia (EP), United States Pharmacopeia (USP)

and Japanese Pharmacopeia (JP), as well as specific customer methods. Collaboration Drives Cost-Effectiveness Their fundamental philosophy is to help clients efficiently allocate their research and manufacturing expenditures by strategically engaging them to meet their unique outsourcing needs. As your project progresses to further enhance open dialogue and assist your decision making, they provide timely and secure access to comprehensive laboratory information through their innovative, 24-hour online data access tool, LabAccess.com. Comprehensive Services They offer the flexibility to manage your testing programmes more efficiently through your choice of three unique service models, including Professional Scientific Services (PSS), Full Time Equivalent (FTE) or traditional Fee-ForService. You can choose the best, most cost-effective service solution for your project goals. Their breadth of services include: • Method establishment, including method development, feasibility, optimisation, cGMP qualification and validation, as well as verification of compendial methods; • Comprehensive stability and release programmes for clinical and marketed products; • Complete biochemical and chemical characterisation and microbial identification; • Raw material and excipient testing (USP/NF, EP, JP); • Production and non-production cell banking, including full characterisation; • Lot release/unprocessed bulk testing; • Process/facilities validation, including viral clearance, residual impurities testing, extractables & leachables, water testing, environmental monitoring, disinfectant efficacy and on-site sample collection; • Consulting/protocol writing; • GMP manufacturing & support. For more information, email: pharma@eurofins.com or visit www.Eurofins.com/Biopharma.

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

52ireland pharma advert half page.indd

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.

Irish PharmaChem | Industry Buyers Guide 2017 12/19/2016 3:19:24 PM

Medtech Last year, the Irish Medtech Association, guided by our board, which includes business leaders from DePuy Synthes, Boston Scientific and Stryker as well as homegrown companies, set-out to develop a 2020 strategy which not only built on our past successes but showed a renewed sense of leadership. For 16 years, the Irish Medtech Association has, as part of Ibec, worked with industry, government and other key members of the ecosystem to make Ireland the best place for medtech business. Our recent strategy served us well. It supported the leadership and dynamism across this strong export-led sector which saw an increase in R&D investment across FDI and indigenous businesses.

Pictured at the launch of the Irish Medtech Association 2020 strategy are (l-r): Conor Russell, Vice Chairman, IMDA, and VP, Operations, Boston Scientific; James Winters, Chairman, IMDA, and Vice President Manufacturing, Global Joint Reconstruction Ireland, DePuy Orthopaedics Worldwide; and Sinead Keogh, IMDA Director.

Ambitious Strategy for 2020 This year we published an ambitious strategy for 2020: ‘The Global Medtech Hub: How Ireland is innovating for future healthcare and economic growth’. During the recent economic crisis, the medtech industry continued to grow, with exports quadrupling in 10 years, reaching €12.6 billion this year. This steady growth, which accounts for 10% of all Irish exports, has now been bolstered as the recovery takes hold in the domestic economy. In October, we held an international launch of our 2020 strategy at the world’s premier medtech conference, AdvaMed 2016, which sees as many as 2,500 medtech professionals and 1,000 companies gather to hear the latest trends and network. Ireland is a strategic location of choice for businesses who want to access Europe’s economy with its 500m consumers. While 39% of European medtech exports go to the US, nearly half (46%) of all Irish medtech exports go to the US. It was fantastic to be able to showcase how the dynamism in Ireland’s medtech sector is driving strong growth and why more than a third of all investments into Europe come to Ireland. Now the challenge is to maintain this momentum, which is why this new 2020 strategy is a vital roadmap for medtech business.

Innovating for Future Healthcare The Irish Medtech Association identified key priorities to ensure Ireland is innovating for future healthcare and economic growth, including:

Irish Medtech Association Develops Strategy for Future Success Sinead Keogh, Ibec Director of Medtech and Engineering, explains how Ireland is innovating for future healthcare and economic growth with medtech. Use technological innovations to help patients:

Employment Opportunities and Training

Identify and influence key areas of focus such as trade barriers, skills needs, and changes to the business environment.

Facilitate cooperation between sectors such as pharmaceuticals, biotechnology and ICT and realise the potential for advanced, additive and cell manufacturing.

Achieve the potential of the cluster:

Nurture entrepreneurship:

Assist companies to utilise the cluster to expand and achieve their potential, developing new technologies from concept to market.

Develop policies and conditions to ensure entrepreneurship can thrive, such as facilitating new funding opportunities.

With more than 29,000 people now working in the sector, Ireland is one of the largest employers of medtech professionals in Europe. Another 2,000 jobs have been announced since 2014, but that’s not enough: we want to make sure that Ireland an even more attractive place to work, because the more these companies expand, the greater the skills needs. In the broader Irish economy, employment is around 2m for the first time since 2009 and changes in

Drive our future:

Irish PharmaChem | Industry Buyers Guide 2017

Medtech

During the recent economic crisis, the medtech industry continued to grow, with exports quadrupling in 10 years, reaching €12.6 billion this year 54

migrations are seeing more people coming to Ireland than leaving. Ireland’s medtech sector is diverse and can offer people rewarding careers, developing and producing lifesaving technology. Programmes such as the Irish Medtech Association Skillnet have proven to be successful in giving people the skills they need to start new careers, with 4,000 people trained to date. Manufacturing is the second largest employer in Ireland with 160,000 people employed, and the Irish Medtech Association is delighted to have successfully gained approval for two major new manufacturing apprenticeships for technicians and engineers, as well as the polymer processing technologist apprenticeship, which we’re developing with Plastics Ireland: the polymer technology industry in Ireland is an important partner for the medtech industry, with 6,500 people working across more than 200 companies.

Connected Health One exciting new area which has the potential to not only create jobs, but also take pressure off our overburdened healthcare system, is connected health. Technological advances are creating new ways for healthcare to deliver better results for patients. These innovations require more, dedicated investment in R&D. However, with 10 out of 10 top global technology companies

Ireland’s medtech sector is diverse and can offer people rewarding careers, developing and producing lifesaving technology.

having bases in Ireland, we are uniquely placed to become a leader in this emerging area. The Irish Medtech Association is now driving collaboration between industries such as ICT to drive innovation among Irish businesses. We have established an Internet of Medical Things (IoMT) forum with ICT Ireland, the Ibec group which represents the sector, to develop a strategy to place Ireland at the forefront of this strategic area and develop the necessary skills. The global medtech industry is expected to reach €475 billion in 2018. Ireland may be a small country, but we’re a big player in the industry, with 18 of the world’s top 25 medtech companies located here. The move to value-based healthcare is revolutionising the commercial model used by healthcare systems across the world. The industry in Ireland must now adapt to these changes, so that it can continue to compete and be a global leader. Advanced medical technologies allow doctors to make an early diagnosis of diseases such as cancer and reduce recovery times for surgeries. New innovations in medtech save and improve lives, but we must do more to adapt to changes in international markets as a global medtech hub. Irish PharmaChem | Industry Buyers Guide 2017

Stockists and Distributors of Metal, Plastic & Fibre Drums, IBCs, FIBCs, UN Corrugated Boxes, Pots, Buckets & Pails. Over 30 years in Ireland. Our experience makes the difference. Quitmann O’Neill Packaging Ltd, a family owned business, we have been supplying the Pharmaceutical, Food, Beverage, Fine Chemical, Lubricant, Paint and Hazardous Waste Industries for over 30 years in Ireland.

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able solution

Volume m3

132.840 litres

PACKAGING SOLUTIONS introducing

A multifaceted packaging solution

sustainable solution

Intermediate Bulk Container packaging | storing | transporting

Interpac are proud to announce the launch of Multitank to the Irish Market. Multitank is the first reusable watertight container that doesn’t need a liner or a bag and Interpac feel this product will be useful to many industries throughout Ireland. Interpac has over 20 years experience in the supply and nationwide distribution of pharmaceutical, food and chemical packaging. multitankltd The Dublin based company specialises in UN and non-UN approved packaging for chemical, pharmaceutical and hazardous products and multitankltd waste. The company was formed with the goal of changing the way that packaging is sourced, Multitank designedLimited and delivered to the

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customer with the primary focus being on service and quality.

Highest Quality Products They supply the very highest UN Approved quality packaging components, with all of the internationally renowned manufacturers being audited by Interpac as a pre-requisite to entering any supply agreements with them. The food and pharmaceutical industry in particular, has a very high standard of quality food industry requirement materials and & solids for all packaging & others this is where Interpac specialises. With warehousing facilities in Dublin, Interpac can guarantee the shortest possible lead times, coupled with the stockholding of key materials to ensure that continuity of supply is never an issue. “We have improved the way that packaging is sourced, designed and delivered to the customer, with the primary focus being on service and quality,” states Ian Sutton, Managing Director, Interpac. “We consult with our clients on the correct, most cost-effective products they should use for their packaging.”

beverages & pulps

chemicals & pharma

“In recent years a large proportion of packaging containers and materials being used have been surpassed by technologically advanced new designs and materials that bring a host of benefits to the customer.” Sutton explains.

Multitank Interpac is the Irish distributor for Multitank, an innovative reusable storage and transport container, which provides a sustainable, safe and cost efficient solution for carrying products in bulk. Implementing innovative technologies in mould design and integrating modern features into Multitank, its developers succeeded in producing a unique and absolutely safe IBC container, creating a new point of reference in the packaging and logistics industry. Multitank is the first reusable watertight container that doesn’t need a liner bag. It Irish PharmaChem | Industry Buyers Guide 2017

49.20

40 litres

49.200 litres

101.680 litres

PACKAGING SOLUTIONS

Vestibul molesti tempus a

can be used for transporting chemicals or foodstuffs. Multitank is a replacement for barrels, IBC containers and foldable pallet boxes with liner bag. It’s also the first reusable HDPE plastic container with 400 litres capacity, designed for storage and transport of food (HACCP) and non-food products in bulk. An innovation in the field of solid and liquid handling and storage, Multitank offers absolute safety in transporting and storage without the need of special handling Multitank has a range of benefits, including: Pallet Feet, easily replaceable; Watertight and airtight lid with EPDM sealing gasket; Space-saving storage and transport; UV Protection; Safety pins holder when Multitank is empty; Conical design for easy nesting; Stackable (safely stacked up to three high when full); Pressure relief valve with O-ring gasket; Valve 2” (optional); 100% watertight without liner bag; Easy filling, emptying and cleaning; Nested Multitanks reduce storage space up to 75%; Possibility of sterile packaging with 400 litre aseptic bag; Easy to move with pallet truck or forklift, no need of pallet; Available in various colors; RFID and label placeholders. It also comes with a range of accessories: Aseptic Bag; Anti-elevation Nets; Wheels; Valves; Chemical resistance gaskets. This user-friendly container was designed for use in the food industry but it’s perfect for chemicals. Where previously, many solid and liquid products were packaged in plastic or metal containers, pallet boxes, cardboard boxes or foldable containers with plastic liner bags, the cost of transport to return these packaging materials often proved prohibitive,

• • • • • • • • • • • • • • • • • • • • •

Irish PharmaChem | Industry Buyers Guide 2017

so the suppliers, unable to receive them back, charged them in the final price of the product. Multitank removes that cost from the supply chain.

Transport Specifications and Benefits Multitank has many economic benefits when compared to barrels, drums and IBC containers. Wooden or plastic pallets are not needed because of Multitank’s integrated pallet base. Empty containers can be nested and in this way the user saves up to 75% storage space (when compared to barrels). If the containers are stacked, there is still access to the contents of the Multitank, so the quality and integrity of the product can be quickly and easily controlled. The existing drums and IBCs that are widely used in today’s market are not effective for re-use and the cost of return transport is very high. Multitank is a sustainable solution that eliminates the cost of packaging. There are no other packaging materials required, such as stretch film, strap belts or pallets in order to safely transport the product. The packaging and handling time for the supplier is drastically reduced and the recipient does not deal with big volume of packaging material or extra costs for disposal and recycling. Multitank is a sustainable solution. Since it is reusable, the amount of CO2 is greatly reduced. One Multitank saves 6.000kg over 10 years of use, compared to single use plastic barrels.

Maximum Safety “Multitank is an innovative, cost efficient and space-saving packaging system,” explains Jordan Sutton, Sales Interpac. “Three different kind of lids and its innovating way of sealing assures maximum safety and a watertight and airtight performance. The conical design makes it nestable when empty, increasing vehicle fill. Its robust construction makes Multitank stackable, saving 75% of storage space. In fact, the combination of many smart features, like the integrated plastic pallet, discharge hole, vent cap etc, makes Multitank easy and safe to handle. “Multitank is an efficient returnable and reusable bulk container that eliminates completely the packaging cost, optimises storage space and reduces carbon foot print.” Interpac can also provide all the machinery equipment needed for handling Multitank, designed and constructed by MultitankTech, including pallet trucks, dumpers and tippers. For more information, call Interpac on +353 1 2940600, visit www.interpac.ie or see www.multitank.co.uk.

Multitank, an innovative reusable storage and transport container, which provides a sustainable, safe and cost efficient solution for carrying products in bulk.

RIGID PLASTICS

OnePlastics opens state-of-the-art plastics packaging plant OnePlastics has opened an industry-leading packaging plant at its Protech site in Little Island, Cork. On Thursday September 22, 2016, The Minister for Agriculture, Food and the Marine, Michael Creed TD, opened one of the most modern rigid plastics packaging plants in Europe at “OnePlastics” Protech facility in Little Island, Cork. Representing a total investment of over €8m, the site is constructed to the highest standards in a Class 8 Clean room environment. It showcases the latest in fast cycling injection moulding technology, as well as industry leading in mould labelling robotics. Protech develops and manufactures specialist plastic components for multinational firms in the nutrition, pharmaceutical and computerstorage sectors. It also provides full onsite product design and development solutions

through its very own ICE Centre. “It is heartening to see an indigenous Irish company with local production facilities compete so successfully on a global stage in the area of high-spec manufacturing,” noted Minister Creed at the event.

About OnePlastics

OnePlastics has operations in Ireland, UK, China and North America. It is Irish owned by One51 Plc. It services a wide range of industries, providing industry leading injection moulding and related services.

“Our partnership-based approached is focused on providing the most cost effective and innovative solutions to our customers,” explains Managing Director, Donagh Murphy. “We work closely with our customers to fully understand their requirements and provide an integrated service solution to encompass product design and re-engineering, recycled material substitution and supply chain management. Our philosophy is to continually invest in the latest technologies and equipment to ensure that OnePlastics exceeds our customers’ expectations.” For more information, please visit www. oneplastics.com.

About Protech Protech specialises in rigid plastic packaging for a variety of industries and boasts an extensive product portfolio, from 155ml through to 65ltrs. It also designs, develops and manufactures bespoke products for its customers. Protech’s facility at Cork also hosts the OnePlastics Group’s dedicated Innovation Centre of Excellence, which was established in 2015 to foster innovation and new product development across the OnePlastics Group. For more information, please visit www. protechplastics.net.

Pictured are Donagh Murphy, Managing Director; Alan Walsh, CEO; and Minister for Agriculture, Food and the Marine, Michael Creed TD, opening one51’s new €8m rigid-plastic packaging plant in Little Island, Cork.

Irish PharmaChem | Industry Buyers Guide 2017

Design, Development and Manufacture of Rigid plastic packaging solutions for Industry. We operate from a Class 8 Clean room facility, based in Little Island Cork. Contact us to find out more of what we can do for you.

 +353 21 4355762  maurice.mccarthy@oneplastics.com  www.oneplastics.com

Material Handling

Your Trusted Business Partner

During the past 43 years, Toyota Ireland has firmly established the Toyota brand as a household name in Ireland and it continues to be a market leader today. Toyota Material Handling Ireland now brings to the market the full range of Toyota and BT products, offering the customer a one stop shop for all material handling needs. From hand trucks, pallet trucks and reach trucks to stacker and gas, diesel and electric counterbalance trucks, they offer their customers the widest product range in the business. “What we pride ourselves on, first and foremost, are our wonderful products,” states Terry O’Reilly, MD of Toyota Material Handling Ireland.

Toyota Traigo Toyota Material Handling Ireland has recently completed the launch of the brand new Toyota Traigo series of electric forklifts, a truck designed to deliver more productivity and offering safer and more energy-efficient operation than ever before. With load capacities ranging from 1.0 tonnes up to 8.5 tonnes, the Traigo range is the result of an intense and continuous collaboration between Toyota and its customers, whose feedback contributed to the parameters of the new design. The Traigo features a range of qualities to optimise driver comfort and increase performance, both indoors and outdoors. It also benefits from Toyota’s world-leading features and

The Toyota Traigo series of electric forklifts is designed to deliver more productivity and offering safer and more energy-efficient operation than ever before.

All the benefits, peace of mind and value for money that Toyota provide to make it the number one seller of motor cars in Ireland are also available in its material handling range, making Toyota Material Handling Ireland the ideal partner for your business. technologies to protect both driver and goods, including the company’s unique SAS safety feature, an exclusive technology designed to actively enhance forklift stability and safety. “During the course of the past couple of years, we have successfully introduced a lot of new products to the market and they have all been very well received by our customers,” O’Reilly explains. “It’s the most up-to-date and complete range there has ever been in our history, renowned for their reliability, efficiency and durability. We even have trucks in the field that are 30 years old.”

Excellent Dealer Network Toyota’s success in Ireland is the result of a combination of excellent products and the best dealer network. Toyota Ireland’s dealer network is strategically located throughout the country, offering the customer peace of mind in terms of sales and more importantly, after-sales service. The Toyota dealer has the knowhow and experience to recommend the right forklift for every job and provide advice on leasing, hire and finance etc. Furthermore, with 50 trained service engineers within the group, the Toyota Dealer offers first class customer service, with rapid response callout. Each dealer has a hire fleet and

can provide additional equipment if required at peak periods for the customer. Offering the highest standard of sales and aftersales is at the core of the business, according to O’Reilly “Toyota is one of the world’s best brand names and we are fortunate to have a great dealer network in place. Some of our dealers have been with us over 30 years; the majority have been with us for a long time. They have developed great relationships with their customers through lean years and good years. “We’re an Irish company and Toyota is well respected in Ireland. We’re lucky to have a sister company whose cars are seen on the road every day. Toyota cars are synonymous with reliability, durability and the best resale value in the business. The same applies to our material handling equipment. Our customers know they get value for money and quality when they purchase a Toyota, which is number one when it comes to material handling worldwide.” ‘The Toyota Way’ underlines Toyota’s managerial approach, with emphasis on continuous improvement, team work and respect for people. “The Toyota production system is real and tangible, and with its research and development, it’s amazing how Toyota keeps evolving,” concludes the MD. “It’s great to be part of that ‘Toyota Way’.” Irish PharmaChem | Industry Buyers Guide 2017

Whatever your business

TOYOTA â&#x20AC;&#x201C; TRUSTED BUSINESS PARTNER. Toyota Material Handling Ireland now brings to the market the complete range of Toyota counterbalanced forklift trucks and BT warehouse equipment, supported by services and added value solutions offering the customer a one stop shop for all your material handling needs. From hand trucks, pallet trucks, order pickers and reach trucks to gas, diesel and electric counterbalance trucks, we offer you the widest product range in the business, making Toyota Material Handling the ideal partner for your business, whatever it is. www.toyota-forklifts.ie

www.toyota-forklifts.ie or Toyota Material Handling Ireland at Toyota Ireland, Killeen Road, Dublin 12. Tel: 01 4190200.

DIR3930_TY_Forklift_A4_V3.indd 1

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Specialised Chemicals

Camida’s Chemistry with Customers Camida has been sourcing and supplying specialised chemicals for the life science, industrial and ingredient sectors for 28 years, over which time it has developed into one of the most customer-focused and flexible companies in the industry.

From organic intermediates to biochemicals, performance chemicals to industrial and ingredients, Camida can source, manage and deliver its customers’ requirements. Since its establishment in 1988, Camida has always been motivated and driven by the needs of its customers and continues to be a highly responsive, flexible company, bringing a comprehensive array of sourcing and supply options to customers.

Global Leaders With over 28 years’ experience in global supply and over 300 suppliers in more than 25 countries, Camida is uniquely equipped to meet high quality procurement needs

across a range of industry sectors, including: synthesis; biochemical manufacture; custom manufacture; packaging and distribution; process development; new compound development; and project management. For their clients, this invariably leads to improved performance and service. The team at Camida are proud of their long term relationship with global leaders in chemical manufacturing, including such well-known names as BASF, Lonza, Pennakem, Solvay, Contract Chemicals, Spectrum, Allnex, DuPont, Dorf Ketal, AgroHorizon and Kemtia.

Vendor Reduction Camida also have many years’ experience in vendor reduction programmes. These programmes include many additional customer benefits, are completely flexible and can be customised to meet the specific needs of customers.

Compliance & Quality Since its inception, Camida has been deeply involved in the pharmaceutical and life science Industries and is fully compliant with all appropriate regulatory requirements. Camida is certified to I.S EN ISO 9001:2008 and holds SQAS/ESAD for distributors.Camida is compliant with REACH Regulation (EC) No 1907/2006 for supply of chemicals.

Associations In addition to Camida’s long association with BioPharmaChem Ireland (BPCI) and the Chemical Business Association (CBA) in the UK, Camida are also members of (OCCA) the Oil and Colour Chemist’s Association and the British Adhesives and Sealants Association (BASA), the trade association for the adhesives and sealants industry in the UK and Ireland. “Camida is committed to meeting the highest industry standards and conforming to the most stringent international protocols,” explains a company spokesperson. “Tap into our global network and over 28 years’ experience in sourcing specialised chemicals. We understand your needs, we provide solutions, and above all, we exceed your expectations.” For more information, see www.camida.com or call + 353 52 6125455.

62Irish PharmaChem | Industry Buyers Guide 2016

Irish PharmaChem | Industry Buyers Guide 2017 1

Whether your business is in pharmaceuticals, food, biotechnology or surface coatings, we meet the highest industry standards and conform to the most stringent international protocols. Tap into our global network and over y 25 years in sourcing o uexperience r

Search specialised chemicals. We understand your needs, we provide solutions,

above all, we exceed your expectations.

i swww.camida.com o v e r Visit email us at info@camida.com From Organic Intermediates to

or phone us from at +353 52 6125455 Biochemicals, Performance Chemicals to Food Ingredients, Camida can source, manage and deliver your needs. Whether your business is in pharmaceuticals, food, biotechnology or surface coatings, we meet the highest industry standards and conform to the most stringent international protocols. Tap into our global network and

Industrial Cleaning

AQS: The Industrial Cleaning Experts From pipe surveying to chemical tank cleaning and hazardous waste removal, AQS delivers responsive and sustainable industrial cleaning and waste services nationwide. Unrivalled expertise and a commitment to innovation are at the core of its cleaning and waste management services for pharmaceuticals and chemicals clients, and this is an approach that will continue in 2017. The experience of its teams is backed by rigorous safety and quality standards. For example, AQS has achieved OHAS 18001 accreditation, and carries out training in line with all its clients’ quality and safety procedures.

Unrivalled expertise and a determination to innovate define AQS Environmental Solutions’ cleaning and waste management services for chemicals and pharma clients.

Bigger Team AQS is now part of Lanes Group plc, the UK’s largest drainage and asset maintenance specialist. It is a relationship that is paying dividends for pharma-chem clients. There has been additional investment in cutting edge technology. AQS now has access to Lanes‘ expertise, notably in chemically-resistant ultraviolet (UV) pipe lining.

End-to-End Service AQS acts as an end-to-end service partner. It carries out CCTV camera surveys and hydrostatic testing of pipes, sumps and industrial tanks. It can then devise effective cleaning and repair services for any issues identified. Its teams manage preventative maintenance programmes to ensure IPCC compliance, and respond 24 hours a day to urgent issues, including untoward incidents.

Technical Excellence AQS operates the most modern fleet of ADR combined suction and jetting tankers, operated by Hazchem-qualified drivers. Its custom-built DISAB vacuum technology can remove all types of wet and dry sludge, slurry, filter cakes and sediments, as well as powders, granular materials, aggregates, ash and soil. This technology enhances sustainability in a number of key ways. Productivity is increased. Risks are minimised, by reducing manual handling and the need for confined space

operation. Tasks can be carried out more easily within the envelope of a continuous production process.

reduced generation of hazardous by-products and lower impact on production are all key benefits.

Bespoke Solutions

Process Integration

Working closely with production, site management and HSQE teams, AQS often helps its pharma and chemical industry clients design and implement bespoke cleaning and waste solutions. Its teams regularly work closely with other contractors, for example during process and production development.

AQS is considered by many clients as a key manufacturing partner. Its range of services and problem-solving approach to their application are valued as an integral part of the pharma and chemical production process. Examples include scheduled changing of filter media, including activated carbon filters used in odour abatement or solvent recovery processes; catalyst exchange; and repackaging of hazardous goods. These specialist services are added to the full range of drainage services – sewer unblocking, gully cleaning and interceptor emptying – that AQS delivers. With AQS, it really is a case of one supplier, one call, many solutions. For more information, visit www. aqsenvironmentalsolutions.ie, email info@ aqsenvironmentalsolutions.ie or call 1800 500 020.

Pipe Rehabilitation Pipe rehabilitation, rather than replacement, is a growing trend in the pharma and chemicals sectors. The technology reduces costs and minimises lost production time. Pipe lining is a key service. Through Lanes Group, AQS has access to the latest expertise in UV cure in place pipeline (CIPP) systems. Faster installation,

Irish PharmaChem | Industry Buyers Guide 2017

www.irishpharmachem.com NOTES

CHEMICAL SUPPLIERS

2 0 1 2

Acids & alkalis Associated Chemicals Ltd Brenntag Ireland Camida Ltd Charles Tennant & Co Ltd Chemco Ireland Ltd Chemsource Industrial Division Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Goulding Chemicals Ltd Heterochem Dist Ltd National Chemical Company Ocon Chemicals Ltd Q1 Scientific SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Univar

Activated carbons

Associated Chemicals Ltd Brenntag Ireland Fisher Scientific Ireland Ltd National Chemical Company

biochemicals

Associated Chemicals Ltd Betco Marketing Ltd Camida Ltd Fisher Scientific Ireland Ltd National Chemical Company Ocon Chemicals Ltd

biocides

Associated Chemicals Ltd Brenntag Ireland Camida Ltd Heterochem Dist Ltd National Chemical Company Univar

catalysts

Associated Chemicals Ltd Camida Ltd Chemco Ireland Ltd National Chemical Company

chiral compounds

Associated Chemicals Ltd Camida Ltd National Chemical Company

excipients

Associated Chemicals Ltd Betco Marketing Ltd Brenntag Ireland Camida Ltd Charles Tennant & Co Ltd Chemco Ireland Ltd Corcoran Chemicals Limited Heterochem Dist Ltd National Chemical Company P.K. Chemicals Ltd Univar Irish PharmaChem | Industry Buyers Guide 2017

fine chemicals

Associated Chemicals Ltd Betco Marketing Ltd Brenntag Ireland Camida Ltd Chemco Ireland Ltd Chemsource Industrial Division Fisher Scientific Ireland Ltd National Chemical Company Ocon Chemicals Ltd Solv-Echem Ireland Ltd Univar

gases

Corcoran Chemicals Limited National Chemical Company

heterocyclics

Associated Chemicals Ltd Camida Ltd National Chemical Company

inorganic chemicals

Associated Chemicals Ltd Brenntag Ireland Camida Ltd Chemco Ireland Ltd Chemsource Industrial Division Fisher Scientific Ireland Ltd Heterochem Dist Ltd Langanbach Services Ltd National Chemical Company SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Univar

laboratory reagents

Fisher Scientific Ireland Ltd National Chemical Company Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Water Chromatography Ireland

Misc chemicals

Associated Chemicals Ltd Brenntag Ireland Camida Ltd Chemco Ireland Ltd Chemsource Industrial Division Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company Ocon Chemicals Ltd P.K. Chemicals Ltd SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Univar

oilS, fats and waxes

Associated Chemicals Ltd Brenntag Ireland

Charles Tennant & Co Ltd Corcoran Chemicals Limited Heterochem Dist Ltd National Chemical Company

organic intermediates

Associated Chemicals Ltd Betco Marketing Ltd Camida Ltd National Chemical Company Roche Ireland Ltd Univar

organometallics

Associated Chemicals Ltd Camida Ltd National Chemical Company

reagents

Associated Chemicals Ltd Camida Ltd Fisher Scientific Ireland Ltd National Chemical Company Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin Water Chromatography Ireland

silanes

Associiated Chemicals Ltd Brenntag Ireland Camida Ltd Heterochem Dist Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

solvents

Betco Marketing Ltd Brenntag Ireland Camida Ltd Charles Tennant & Co Ltd Chemco Ireland Ltd Chemsource Industrial Division Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin Teva Pharmaceuticals Ireland Univar Water Chromatography Ireland

surfactants

Associated Chemicals Ltd Brenntag Ireland Camida Ltd Charles Tennant & Co Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd Langanbach Services Ltd National Chemical Company Univar

GENERAL SUPPLIERS

2 0 1 2

Actuators Tyco Valves & Controls Ireland Ltd WrenTech Ltd

Aerators WrenTech Ltd

Agitators CPI Technology Ltd WrenTech Ltd

air filtration / monitoring / pollution control SciChem - Cork SciChem - Dublin

Air / Road / Ocean Freight KWE (Ireland) Ltd

ALUMINIUM PRODUCTS SteriPack

ANALYSIS SERVICES Anecto Catalent Pharma Solutions Eurofins Lancaster Laboratories

ANALYTICAL EQUIPMENT ABB Ltd Fisher Scientific Ireland Ltd LABPLAN P.J. Bonner & Company SciChem - Cork SciChem - Dublin

Associations GS1 Ireland

AUTOCLAVES Fisher Scientific Ireland Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

AUTOMATION ABB Ltd Callaghan Engineering Endress & Hauser (Ireland) Ltd LABPLAN O’Flynn Medical Ltd P.J. Bonner & Company Weber Packaging Solutions Ltd

BALANCES Fisher Scientific Ireland Ltd

Ocon Chemicals Ltd P.J. Bonner & Company SciChem - Cork SciChem - Dublin

BARCODING / LABELLING TRACEABILITY GS1 Ireland Indaver Ireland Millmount Healthcare Weber Packaging Solutions Ltd

Biopharmaceuticals Alkermes Pharma Ireland Limited

BIOTECHNOLOGY ABB Ltd BS&B Safety Systems Ltd Callaghan Engineering Catalent Pharma Solutions Labplan Ocon Chemicals Ltd Particular Sciences Ltd SciChem - Cork SciChem – Dublin Thornshaw Scientific

BLENDERS Fisher Scientific Ireland Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

BLISTERING / DE-BLISTERING Catalent Pharma Solutions SteriPack

BLOWERS CPI Technology Ltd Flexachem Manufacturing Ltd

BPRV BS&B Safety Systems Ltd

Breather Vents BS&B Safety Systems Ltd

BURSTING / RUPTURE DISCS BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd

CABINETS Fisher Scientific Ireland Ltd ProSys Containment and Sampling Technology

Sartorius Mechatronics Weber Packaging Solutions Ltd

CAD Callaghan Engineering

CALIBRATION Endress & Hauser (Ireland) Ltd Labplan Ocon Chemicals Ltd P.J. Bonner & Company Sartorius Mechatronics Veolia Water Chromatography Ireland

CENTRIFUGES CPI Technology Ltd Fisher Scientific Ireland Ltd Labplan Ocon Chemicals Ltd Sartorius Mechatronics SciChem - Cork SciChem - Dublin

CHEMICAL CONSULTANTS Callaghan Engineering

CHILLED WATER Daikin Europe

CHROMATOGRAPHY Fisher Scientific Ireland Ltd Labplan Merck Ocon Chemicals Ltd Particular Sciences Ltd SciChem - Cork SciChem - Dublin Water Chromatography Ireland

CLEANROOMS Callaghan Engineering Millmount Healthcare Ocon Chemicals Ltd Veolia

CLEANING SERVICES / EQUIPMENT AQS Environmental Solutions WrenTech Ltd

CLINICAL RESEARCH Eurofins Lancaster Laboratories Irish PharmaChem | Industry Buyers Guide 2017

GENERAL SUPPLIERS

COLD CHAIN PACKAGING Catalent Pharma Solutions Cold Move CRS Pharma Solutions Millmount Healthcare

COMPRESSED AIR / COMPRESSORS Festo Ltd Veolia

COMPUTER SYSTEMS Premier Validation Weber Packaging Solutions Ltd

DiSPERSERS Fisher Scientific Ireland Ltd Ocon Chemicals Ltd WrenTech Ltd

DISTILLATION CPI Technology Ltd Fisher Scientific Ireland Ltd Graham Hart (Process Technology) Ltd Labplan Ocon Chemicals Ltd Soltec (Ireland) Ltd

Documentation Solutions TWi

CONDENSORS CPI Technology Ltd Cross Technical Solutions Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

CONDITION MONITORING Flexachem Manufacturing Ltd Q1 Scientific Veolia

CONSTRUCTION MANAGEMENT Callaghan Engineering Portakabin Allspace

Contract Development & Marketing Hovione

Contract Pharma Services Alkermes Pharma Ireland Limited Hovione Indaver Ireland McGee Pharma International

CONVEYORS Weber Packaging Solutions Ltd WrenTech Ltd

COOLING SYSTEMS CPI Technology Ltd Cross Technical Solutions Daikin Europe Veolia

DATA ACQUISITION ABB Ltd Labplan P.J. Bonner & Company Weber Packaging Solutions Ltd

DESIGN Callaghan Engineering Cross Technical Solutions Graham Hart (Process Technology) Ltd Pilz Ireland Protech Plastics SteriPack Irish PharmaChem | Industry Buyers Guide 2017

DRAINS AQS Environmental Solutions

DRIERS CPI Technology Ltd

DRUMS / CONTAINERS Carbon Group Complas Packaging Ltd Industrial Packaging Ltd Interpac Ocon Chemicals Ltd Protech Plastics Quitmann Oâ&#x20AC;&#x2122;Neill WrenTech Ltd

EDUCATION & TRAINING CPI Technology Ltd Euraxess GS1 Ireland HRB Clinic Research Facility Pilz Ireland Science Foundation Ireland (SFI) Water Chromatography Ireland

EFFLUENT MONITORING TREATMENT Carbon Group Flexachem Manufacturing Ltd Veolia

ELECTRICAL Callaghan Engineering Veolia

ELECTRICAL SUPPLY Bord Gais

ELECTRONIC COMPONENTS Pilz Ireland

ENERGY EFFICIENCY / MANAGEMENT Berkley Group Callaghan Engineering Daikin Europe Sustainable Energy Authority of Ireland Veolia

ENGINEERING SERVICES Berkley Group Callaghan Engineering Cross Technical Solutions Henley Forklift Group Limited Pilz Ireland P.J. Bonner & Company Veolia

ENVIRONMENTAL CONSULTING ABB Ltd Callaghan Engineering Pilz Ireland Veolia

ENVIRONMENTAL SERVICES/ EQUIPMENT ABB Ltd AQS Environmental Solutions Pilz Ireland P.J. Bonner & Company

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 BS&B Safety Systems Ltd Henley Forklift Group Limited Pilz Ireland Sartorius Mechatronics

EXPLOSION PROTECTION / PANELS BS&B Safety Systems Ltd CPI Technology Ltd Henley Forklift Group Limited Pilz Ireland

FACILITY DESIGN Callaghan Engineering McGee Pharma International

FACILITIES MANAGEMENT Hochtief Facility Management Portakabin Allspace

FILLING EQUIPMENT WrenTech Ltd

FILTERS CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Idex Pump Technologies (Ireland) Ltd Ocon Chemicals Ltd

FILTRATION Associated Chemicals Ltd CPI Technology Ltd

GENERAL SUPPLIERS Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

Fire Detection / Prevention / protection BS&B Safety Systems Ltd

Flame Arresters BS&B Safety Systems Ltd

FLOW CONTROL CPI Technology Ltd Flexachem Manufacturing Ltd P. J. Bonner & Company Tyco Valves & Controls Ireland Ltd

FLUID HANDLING CPI Technology Ltd Idex Pump Technologies (Ireland) Ltd Interpac Labplan SciChem - Cork SciChem - Dublin WrenTech Ltd

FUME CUPBOARDS Fisher Scientific Ireland Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

FURNACES Fisher Scientific Ireland Ltd SciChem - Cork SciChem - Dublin

GAS DETECTION Bord Gais Cross Technical Solutions P. J. Bonner & Company SciChem - Cork SciChem – Dublin

Gas Supply Bord Gais

GAUGES Endress & Hauser (Ireland) Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd P.J. Bonner & Company

Generators Fisher Scientific Ireland Ltd

GLASSWARE Associated Chemicals Ltd CPI Technology Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Quitmann O’Neill SciChem - Cork SciChem - Dublin

GRINDING CPI Technology Ltd Fisher Scientific Ireland Ltd

HAZARDOUS WASTE DISPOSAL / TREATMENT AQS Environmental Solutions Indaver Ireland Industrial Packaging Ltd Interpac Ocon Chemicals Ltd Soltec (Ireland) Ltd Veolia

HEALTH & SAFETY / FIRST AID Ocon Chemicals Ltd Pilz Ireland

HEAT EXCHANGERS CPI Technology Ltd Graham Hart (Process Technology) Ltd Labplan ProSys Containment and Sampling Technology

HOMOGENISERS CPI Technology Ltd Fisher Scientific Ireland Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

HOSES CPI Technology Ltd

Humidity / Humidifiers Interpac P. J. Bonner & Company

HYDRAULICS Henley Forklift Group Limited WrenTech Ltd

INCINERATION Indaver Ireland Tyco Valves & Controls Ireland Ltd

INCUBATORS Fisher Scientific Ireland Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

INJECTION MOULDING Allstop Europe Ltd

INSPECTION EQUIPMENT Lister Machine Tools Ltd P.J. Bonner & Company Sartorius Mechatronics Weber Packaging Solutions Ltd

INSTRUMENTATION ABB Ltd Callaghan Engineering Endress & Hauser (Ireland) Ltd

Fisher Scientific Ireland Ltd Labplan Ocon Chemicals Ltd P.J. Bonner & Company SciChem - Cork SciChem - Dublin Tyco Valves & Controls Ireland Ltd Veolia

IT Callaghan Engineering Weber Packaging Solutions Ltd

INVESTMENT Goodbody Stockbrokers

INVESTMENT promotion ageny IDA Ireland

lab equipment / supplies Carbon Group Endress & Hauser (Ireland) Ltd Fisher Scientific Ireland Ltd Labplan Ocon Chemicals Ltd Solv-Echem Ireland Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

legal / financial / insurance Goodbody Stockbrokers

logistics C&G Logistics Group Cold Move KWE (Ireland) Ltd Quitmann O’Neill Solv-Echem Ireland Ltd Weber Packaging Solutions Ltd

lifts & hoists Henley Forklift Group Limited WrenTech Ltd

machine tools Lister Machine Tools Ltd Soltec (Ireland) Ltd

maintenance CPI Technology Ltd Endress & Hauser (Ireland) Ltd Hochtief Facility Management P. J. Bonner & Company Sartorius Mechatronics UK Ltd Veolia Water Chromatography Ireland Weber Packaging Solutions Ltd

Manufacturers Bemis Healthcare Packaging Daikin Europe Endress & Hauser (Ireland) Ltd Hovione Portakabin Allspace Sartorius Mechatronics Thornshaw Scientific Irish PharmaChem | Industry Buyers Guide 2017

GENERAL SUPPLIERS materials handling / forklifts / pallet trucks Henley Forklift Group Limited Interpac Toyota Material Handling Ireland Ltd Weber Packaging Solutions Ltd WrenTech Ltd

mechanical engineering services Berkley Group Callaghan Engineering CPI Technology Ltd Cross Technical Solutions Endress & Hauser (Ireland) Ltd Henley Forklift Group Limited Pilz Ireland Tyco Valves & Controls Ireland Ltd Veolia Weber Packaging Solutions Ltd

mechanical & process engiNeering Callaghan Engineering CPI Technology Ltd Endress & Hauser (Ireland) Ltd Tyco Valves & Controls Ireland Ltd Veolia Weber Packaging Solutions Ltd

medical device manufacture B. Braun Medical Bemis Healthcare Packaging Merck

membrane filtration systems Microfiltration: Fisher Scientific Ireland Ltd Merck

Nanofiltration: Fisher Scientific Ireland Ltd Merck Ocon Chemicals Ltd

Ultrafiltration: Fisher Scientific Ireland Ltd Merck Ocon Chemicals Ltd

Reverse osmosis: Fisher Scientific Ireland Ltd Merck Ocon Chemicals Ltd

Meters Bord Gais CPI Technology Ltd Endress & Hauser (Ireland) Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Veolia Irish PharmaChem | Industry Buyers Guide 2017

microscopes Fisher Scientific Ireland Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

milling CPI Technology Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

mixers CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd SciChem - Cork SciChem - Dublin Tyco Valves & Controls Ireland Ltd WrenTech Ltd

noise / odour control Associated Chemicals Ltd Flexachem Manufacturing Ltd

OEM manufacturing Anecto B. Braun Medical Tyco Valves & Controls Ireland Ltd

packaging / design Anecto Bemis Healthcare Packaging Catalent Pharma Solutions Charles Tennant & Co Ltd Complas Packaging Ltd Industrial Packaging Ltd Interpac Limerick Packaging Protech Plastics Quitmann O’Neill SteriPack Weber Packaging Solutions Ltd

packaging / machinery Interpac Millmount Healthcare NPP Group Ltd Limerick Packaging Quitmann O’Neill Smurfit Kappa Ireland Weber Packaging Solutions Ltd WrenTech Ltd

pallets Interpac Limerick Packaging Quitmann O’Neill

Pharmaceutical Fabrication Roche Ireland Ltd Tyco Valves & Controls Ireland Ltd

Pipes / Cores CPI Technology Ltd

Flexachem Manufacturing Ltd Smurfit Kappa Ireland

Plastic Containers Carbon Group Measom Freer Medisize Ireland Ltd Interpac Ocon Chemicals Ltd PrimePac Ltd Protech Plastics Quitmann O’Neill SciChem - Cork SciChem - Dublin

Plastic Cores / Tubes Ocon Chemicals Ltd Protech Plastics Quitmann O’Neill Smurfit Kappa Ireland

Pneumatics Flexachem Manufacturing Ltd

Pollution Control AQS Environmental Solutions Callaghan Engineering Veolia

Powder Handling Carbon Group CPI Technology Ltd Industrial Packaging Ltd Interpac ProSys Containment and Sampling Technology Tyco Valves & Controls Ireland Ltd WrenTech Ltd

Pressure measurements / Switches / Vessels CPI Technology 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 Pilz Ireland Tyco Valves & Controls Ireland Ltd

Print Packaging Bemis Healthcare Packaging Contego Packaging Group SteriPack Limerick Packaging Protech Plastics Quitmann O’Neill Weber Packaging Solutions Ltd

Process Control ABB Ltd Callaghan Engineering Pilz Ireland P.J. Bonner & Company Sartorius Mechatronics Tyco Valves & Controls Ireland Ltd

GENERAL SUPPLIERS process design ABB Ltd Callaghan Engineering Pilz Ireland Tyco Valves & Controls Ireland Ltd

process & mechanical engineering contractors Pilz Ireland Tyco Valves & Controls Ireland Ltd

project management ABB Ltd Callaghan Engineering Pilz Ireland

protective clothing / apparatus Ocon Chemicals Ltd

pumps CPI Technology Ltd Fisher Scientific Ireland Ltd Idex Pump Technologies (Ireland) Ltd Water Chromatography Ireland

Quality & compliance ABB Ltd Indaver Ireland McGee Pharma International Weber Packaging Solutions Ltd

r&d Euraxess Ireland Hovione Protech Plastics SciChem - Cork SciChem - Dublin Synthesis and Solid State Pharmaceutical Centre TopChem Pharmaceuticals Ltd Tyco Valves & Controls Ireland Ltd

REACTORS CPI Technology Ltd Flexachem Manufacturing Ltd Tyco Valves & Controls Ireland Ltd

recruitment Berkley Group Brightwater ICDS Recruitment Consultants Thornshaw Scientific

refrigeration / freezing Cross Technical Solutions CRS Pharma Solutions Daikin Europe Fisher Scientific Ireland Ltd Langanbach Services Ltd Q1 Scientific SciChem - Cork SciChem - Dublin Veolia

renewable energy ABB Ltd Callaghan Engineering Daikin Europe Indaver Ireland Sustainable Energy Authority of Ireland Veolia

RESPIRATORY PHARMACEUTICALS Teva Pharmaceuticals Ireland Thornshaw Scientific

robotics Labplan

sanitary tubing CPI Technology Ltd Flexachem Manufacturing Ltd

scada / dcs / mis ABB Ltd Callaghan Engineering

scrubbers Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

seals & gaskets Flexachem Manufacturing Ltd Tyco Valves & Controls Ireland Ltd

sieving Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Particular Sciences Ltd WrenTech Ltd

software Sartorius Mechatronics

solvent recovery / services Carbon Group CPI Technology Ltd Indaver Ireland Soltec (Ireland) Ltd

Stability Storage Eurofins Lancaster Laboratories Q1 Scientific

stainless steel / fittings / products CPI Technology Ltd Interpac Quitmann O’Neill Tyco Valves & Controls Ireland Ltd WrenTech Ltd Weber Packaging Solutions Ltd

stEAM EQUIPMENT CPI Technology Ltd Flexachem Manufacturing Ltd Tyco Valves & Controls Ireland Ltd

storage / bunding CRS Pharma Solutions Interpac KWE (Ireland) Ltd Quitmann O’Neill SciChem - Cork SciChem - Dublin

storage of hazardous materials C&G Logistics Group Fisher Scientific Ireland Ltd Indaver Ireland Johnston Logistics Ltd

supply chain management Bemis Healthcare Packaging C&G Logistics Group Catalent Pharma Solutions Cold Move GS1 Ireland KWE (Ireland) Ltd Limerick Packaging McGee Pharma International Solv-Echem Ireland Ltd Thornshaw Scientific

tableting equipment Flexachem Manufacturing Ltd WrenTech Ltd

tanks Celtic Forwarding Ltd Complas Packaging Ltd Flexachem Manufacturing Ltd Quitmann O’Neill

temperature control Bord Gais Daikin Europe Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Labplan Ocon Chemicals Ltd P.J. Bonner & Company Q1 Scientific Tyco Valves & Controls Ireland Ltd

temporary lab & office accommodation Hovione Portakabin Allspace

testing services Anecto CPI Technology Ltd Bemis Healthcare Packaging Henley Forklift Group Limited Eurofins Lancaster Laboratories P.J. Bonner & Company SteriPack

transport & logistics C&G Logistics Group Celtic Forwarding Ltd Cold Move Henley Forklift Group Limited Johnston Logistics Ltd Irish PharmaChem | Industry Buyers Guide 2017

GENERAL SUPPLIERS KWE (Ireland) Ltd Quitmann O’Neill Weber Packaging Solutions Ltd

tube sets / disposables Langanbach Services Ltd Ocon Chemicals Ltd

Vacuum systems CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd WrenTech Ltd

valves CPI Technology Ltd Flexachem Manufacturing Ltd Tyco Valves & Controls Ireland Ltd WrenTech Ltd

validation ABB Ltd Callaghan Engineering Cross Technical Solutions McGee Pharma International Pilz Ireland

ventilation Callaghan Engineering Daikin Europe Pilz Ireland Veolia

vision systems Weber Packaging Solutions Ltd

warehouse management C&G Logistics Group Celtic Forwarding Ltd Chemsource Industrial Division Chemsource Logistics Cold Move Complas Packaging Ltd KWE (Ireland) Ltd Portakabin Allspace Weber Packaging Solutions Ltd

washing equipment Fisher Scientific Ireland Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

waste management / balers /recycling AQS Environmental Solutions Indaver Ireland Ocon Chemicals Ltd Quitmann O’Neill Veolia

water treatment Carbon Group Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Industrial Packaging Ltd Ocon Chemicals Ltd Tyco Valves & Controls Ireland Ltd Veolia

weighing Fisher Scientific Ireland Ltd P.J. Bonner & Company Sartorius Mechatronics SciChem - Cork SciChem - Dublin Weber Packaging Solutions Ltd

www.irishpharmachem.com NOTES

Irish PharmaChem | Industry Buyers Guide 2017

COMPANY LISTINGS

2 0 1 2

ABB Ltd Address: Belgard Road, Tallaght, Dublin 24. Tel: (01) 405 7300 Fax: (01) 405 7327 Email: marketing@ie.abb.com Web: www.abb.ie Business: Lifescience solutions. Analytical Equipment, Automation, Biotechnology, Data Acquisition, Environmental Consulting Environmental Services / Equipment, Instrumentation, Process Control, Process Design, Project Management, Quality & Compliance, Renewable Energy, SCADA / DCS / MIS, Validation

Alkermes Pharma Ireland Limited Global. Diversified.

Address: Monksland, Athlone, Co. Westmeath. Tel: (090) 649500 Web: www.alkermes.com Business: Global Biopharmaceutical Company. Contact: Vice President & Athlone General Manager : Kevin Brady

allsop europe ltd Address: Industrial Park, Waterford. Tel: +353 51 355091 Fax: +353 51 377717 Email: noel.kinsella@allsop.eu Web: www.allsopmould.ie Business: Injection moulding products. Contact: Manufacturing & Quality Manager: Noel Kinsella

anecto Address: Mervue Business Park, Co. Galway. Tel: (091) 757 404 Fax: (091) 757 387 Email: sales@anecto.com Web: www.anecto.com Business: Dangerous goods packaging testing laboratory.

BEMIS HEALTHCARE PACKAGING Address: Kilbeggan Road, Clara, Co. Offaly. R35 F583 Tel: (057) 933 1888 Fax: (057) 933 1887 Email: bhpeu@bemis.com Web: www.bemis.com/healthcare-packaging Business: Contract Packing Services, Medical and Pharmaceutical Packaging, Test Laboratory Services.

ASSOCIATED CHEMICALS LTD

BERKLEY GROUP

Address: 16D Euro Business Park Little Island, Co. Cork. Tel: (021) 435 1014 Fax: (021) 435 1015 Email: info@acl.ie Business: Chemical Suppliers & Distributors Contact: Managing Director: Sylvester Cotter

Address: Dublin: 509 The Capel Building, Maryâ&#x20AC;&#x2122;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

Transformative. AQS ENVIRONMENTAL SOLUTIONS Address: Archerstown Industrial Estate, Thurles, Co. Tipperary. Tel: +353 (0)504 57800 Freephone: 1800 500 020 Fax: +353 (0)504 57801 Email: info@aqsenvironmentalsolutions.ie Web: www.aqsenvironmentalsolutions.ie Business: Provider of drainage, industrial cleaning, waste management and processing services. Contact: Commercial Director: Stan Oâ&#x20AC;&#x2122;Reilly

Alkermes plc is a fully integrated, global biopharmaceutical

74company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. Headquartered in Dublin, Ireland, Alkermes has its principal solid oral pharmaceutical development and

BETCO MARKETING LTD Address: Exham House, The Fingerpost, Douglas, Co. Cork. Tel: (021) 436 4999 Fax: (021) 436 5739 Email: dhalpin@betco.ie Web: www.betco.ie Business: Agent and distributors in Ireland for Cargill Starches and Sweeteners Europe and Cargill Texturising Solutions. Contact: Managing Director: Diarmuid Halpin

Irish PharmaChem | Industry Buyers Guide 2017

COMPANY LISTINGS

Address: 35 Western Parkway Business Centre, Ballymount Drive, Ballymount, Dublin 12. Tel: (01) 450 5050 Fax: (01) 450 5183 Email: info@pjbonner.com Web: www.pjbonner.com Business: Instrumentation & Weighing Specialists. Calibrations and Product Sales. Contact: Managing Director: Patrick M Bonner Service Manager: Roddy Jefferson Instrumentation Sales: Thomas McDonnell

BRIGHTWATER

CAMIDA LTD

Address: 36 Merrion Square, Dublin 2. or 49 Sth Mall, Cork Tel: (01) 662 1000 (Dublin) (021) 4221000 (Cork) Email: b.mcgrath@brightwater.ie Web: www.brightwater.ie Contact: Barbara McGrath, Deputy Managing Director

Address: New Quay, Clonmel, Co. Tipperary. Tel: +353 52 6125455 Fax: +353 52 6125466 Email: info@camida.com Web: www.camida.com Contact: Company Secretary: Deirdre McGrath

carbon group

BS&B SAFETY SYSTEMS LTD Address: Raheen Business Park, Raheen, Co. Limerick. Tel: (061) 484 700 Mobile: (086) 8385556 Email: sales@bsb.ie Web: www.bsb.ie Business: Pressure Relief Safety Devices Contact: Ireland Direct Sales Manager: Patrick Murphy

B. Braun MEDICAL Address: Mobile: Fax: Email: Web: Business: Contact:

3 Naas Road Industrial Park, Dublin 12. 086 833 9836 +353 (0)1 709 1889 robert.bannon@bbraun.com www.bbraun.ie OEM manufacturing. Sales Consultant Robert Bannon

C+G LOGISTICS GROUP Address: Westpoint Business Park, Navan Road, Mulhuddart, Dublin 15. Tel: (01) 820 8455 Fax: (01) 820 8457 Email: info@cglogistics.ie Web: www.cglogistics.ie rIsh harma hem Contact: General Manager/ Director: Patrick Wogan Business Development Manager: Duncan Breen

Address: Unit 405, Address: Unit 405, Greenogue Greenogue Business Business Park, Rathcoole, Park, Rathcoole, Dublin 24. Tel: Dublin 24. +353 (0) 1 4013500 Tel: (01) 401 3500 Fax: +353 (0) 1 4013599 Fax: (01) 405 3501 Email: dublin.sales@brenntag.ie Email: dublin.sales@brenntag.ie Web: www.brenntag.ie Web: www.brenntag.ie Business: Chemical Suppliers & Contact: Sales Desk Distributors Contact:

cormac.mccarthy@brenntag.ie

Irish PharmaChem | Industry Buyers Guide 2017

Building 1000,

briGhtwAter Address:

36 Merrion Square,

City Gate, Mahon, Dublin Address: Wentworth House, Cork. 19/20 Hogan Place, (021) 240 9099 Tel: Lower Grand Canal St, Fax: Dublin 2. (021) 240 9009 Cork Address: Suite 201, Building 1000, Email: mail@calleng.ie Web: Units 1201& 1202, www.calleng.ie Business: CityMulti-discipline Gate, Mahon, Cork. Tel: (01) 661 4420 consulting engineering Fax: (01) 661 4424 and project managment Email: mail@calleng.ie company. Web: www.calleng.ie Business: Multi-discipline cAmidA Ltd consulting engineering Address: andTower House, project managment company. New Quay, Tel: Fax: Email: Web:

catalent pharma solutions Address: Unit 26, Cherry Orchard Industrial Estate, Dublin 10. Tel: (01) 620 0600 Email: diarmuid.wilson@catalent.com Web: www.catalent.com Business: Contract manufacturing capabilities as well as packaging and printed components to the pharmaceutical industry. Contact: Director of Business Development: Diarmuid Wilson

2012

Units 1201& 1202, CALLAGHAN ENGINEERING

b renntAG ireLAnd Brenntag Ireland

Address: Factory Cross, Ringaskiddy, Co. Cork. Tel: +353 (0)21 437 8988 Mobile: 086 2612 485 Fax: +353 (0)21 437 8950 Email: carol.deegan@carbon.ie sales@carbon.ie Web: www.carbon.ie Business: Pharmachemicals. Contact: Area Sales Manager: Carol Deegan

Clonmel, Co. Tipperary. (052) 612 5455 (052) 612 5466 info@camida.com www.camida.com

Contact:

Director of Business Development: Diarmuid Wilson Celtic Forwarding Ltd

Address: Dublin: Celtic House, Ltd ceLtic forwArdinG 30 Marlborough St., Dublin 1. Dublin: Address: Waterford: Belview Port, Celtic House, Slieverue, Co. Waterford 30 Marlborough Tel: (01) 865 6000 (051)Street, 851 821 Dublin 1. Fax: (01) 874 6745 (051)Waterford: 851 823 Belview Port, Email: info@celticfwd.ie www.celticfwd.ie Slieverue, Web: Co. Waterford. Business: Shipping

Tel: Fax: Email: Web: Business: Contact:

(01) 865 6000 (051) 851 821 (01) 874 6745 (051) 851 823 info@celticfwd.ie www.celticfwd.ie Shipping. Director:

ComPany LIstIngs

P.J. BonNer & Company Instrumentation & Weighing Specialists

COMPANY LISTINGS

Charles Tennant & co Ltd

complas packaging ltd

Address: 71 Cookstown Ind Estate, Belgard Road, Tallaght, Dublin 24. Tel: (01) 451 4099 Fax: (01) 451 4702 Email: jgrehan@ctennant.ie Web: www.charlestennant.com Business: Chemical and Packaging supplier. Contact: Chemical Manager: Jim Grehan

Address: Naas Industrial Estate, Dublin Road, Naas, Co. Kildare. Tel: (045) 874 088/9 Fax: (045) 874 090 Email: sales@complas.ie Web: www.complas.ie

CORCORAN CHEMICALS LIMITED

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

CLIP LTD IRELAND Address: Clip Ltd Ireland, Alexandra House, The Sweepstakes, Ballsbridge, Dublin 4 Tel: (086) 828 3620 Email: paul.smith@clipdisplay.ie Web: www.clipdisplay.ie Business: Exhibition and display equipment manufacture and service. Contact: Irish Sales Manager: Paul Smith

COLDMOVE LIMITED Address: Tel: Email: Web: Business: Contact:

Glenascaul Industrial Park, Oranmore, Co. Galway, Ireland (091) 792926 info@coldmove.ie www.coldmove.ie Logistics & Distribution Jason Mallon

Address: 17 Parkgate Street, Dublin 8. Tel: (01) 633 0400 Fax: (01) 679 3521 Email: info@corcoranchemicals.com Web: www.corcoranchemicals.com Business: Distributors of polymers & raw materials for the food, pharmaceutical & chemical industry. Contact: Sales Department

CROSS TECHNICAL SOLUTIONS Address: Unit 26, Second Avenue, Cookstown Industrial Estate, Cookstown, Tallaght, Dublin 24. Tel: (01) 405 6777 Fax: (01) 413 6932 Email: jmcgrath@crosstechnicalsolutions.ie Web: www.crosstechnicalsolutions.ie Business: Refrigeration Contact: Technical Director: Jonathan McGrath General Manager: Jason Keating

CRS Pharma Solutions

CORCORAN PRODUCTS LIMITED Address: Tel: Fax: Email: Web: Business: Contact:

17 Parkgate Street, Dublin 8. (01) 633 0400 (01) 679 3521 info@corcoranproducts.com www.corcoranproducts.com Suppliers of packaging to the Food, Retail, Industrial, Agri & Pharmaceutical Industries. Derek Lennon

Address: Tel: LoCall: Email: Web: Business:

CPI technology ltd 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

Contact:

Dublin, Belfast, London, Manchester. +353 46 943 5000 1890 929 824 info@crspharmasolutions.ie www.crspharmasolutions.ie GxP Compliant Pharmaceutical Portable Storage Solutions, temperature range from -65°C to +60°C 2-8 Degree Cold Stores, Close Control Freezer Stores, Hot Boxes, Incubators, Blast Chillers/ Freezers, Commissioning and Validation Team in-house, IQ, OQ, PQ Validation including Empty and Full thermal Mapping studies. Technical Director: Patrick Tyrrell

Irish PharmaChem | Industry Buyers Guide 2017

COMPANY LISTINGS

flexachem manufacturing ltd

Daikin Europe Address:

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 Contact: Mark Smyth, Applied Product Responsible

Eurofins Lancaster Laboratories Address: IDA Business Park, Clogherane, Dungarvan, Co. Waterford. Tel: (058) 48 300 Fax: (058) 42 855 Email: mglass@lancasterlabs.com Web: www.lancasterlabspharm.com Business: Contract Analytical Services. Contact: Business Development Director: Mark Glass

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 Oâ&#x20AC;&#x2122;Connell

festo ltd Address: Tel: Fax: Email: Web: Business:

Unit 5, Sandyford Park, Sandyford Industrial Estate, Dublin 18. (01) 295 4955 (01) 295 5680 sales_ie@festo.com/ie www.festo.com/ie Automation company specialising in factory and process automation.

eurolec instrumentation ltd Address: Technology House, Cluan Enda, Dundalk, Co. Louth. Tel: (042) 933 3423 Fax: (042) 933 1758 Email: eurolec@esatclear.ie Web: www.eurolec-instruments.com Business: Electronic instrumentation.

Irish PharmaChem | Industry Buyers Guide 2017

Web: Business: Contact:

Donnybrook, Commercial Centre, Douglas, Co. Cork. (021) 461 7200 / (021) 4617209 (021) 489 1297 sales@flexachem.com tim.quigley@flexachem.com www.flexachem.com Manufacturer/ Distributor. Operations Manager: Tim Quigley

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. Contact: Portfolio Manager: Kathryn Hannon

IrIsh PharmaChem 2011 Goulding chemicals ltd

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

Address: Tel: Fax: Email:

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

Address: Centre Park Road, Marina, Cork City. Tel: (021) 491 1611 Fax: 491 1660 GoLiAth (021) pAckAGinG Email: kellyt@gouldings.ie systeMs Ltd Web: www.gouldings.ie Address: Beechwood, Nenagh, Business: Chemical distributor.

Suite 3, Plaza 212, Address: Blanchardstown Co. Tipperary. Blanchardstown, Corporate Park 2, Tel: Graham Hart (067) 37893 (Process Corporate Park, Ballycoolin, Fax: (067) 34794 Technology) Ltd Ballycoolin, Dublin 15. Dublin 15. Email: info@goliath.ie Address: Friars Industrial Estate, D15 VY66. Tel: (01) 885 5854 Web: Bradfordwww.goliath.ie Road, Tel: (01) 885 5854 Fax: (01) 899 1855 Business: Supply & Idle, Bradford, Fax: (01) 899 1855 BD10 8SW, UK. Email: fsie.sales@thermofisher.com installation of Email: fsie.sales@thermofisher.com Tel: (0044) 1274 617021 Web: www.ie.fishersci.com packaging equipment Web: www.ie.fishersci.com Fax: (0044) 1274 618614 Business: Laboratory and materials Business: Laboratory supplies, Email: sales@graham-hart.com supplies. handling systems. Chemicals, Consumables, Web: www.graham-hart.com Contact: Marketing Contact: Director: Reagents, Equipment & Business: Chemical Engineers Instruments. Manager: George Oâ&#x20AC;&#x2122;Leary Design and Contact: Gerry Fitzmaurice Commercial Manufacturers of Heat

Product Manager:

f LexAcheMGerry Fitzmaurice MAnufActurinG Ltd Address: Tel: Fax: Email: Web:

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

GouLdinG Exchangers and Process cheMicALs Ltd Plant. Address: Centre Park Road, Contact: Sales Director: Stephen Hart Marina, Cork City.

Tel: (021) 491 1611 Fax: (021) 491 1660 Email: pollockm@gouldings.ie 77 Web: www.gouldings.ie Business: Chemical distributor.

hAzch

Addres Tel: Fax: Email: Web: Contac

henLe Grou

Addres Tel: Fax: Email: Web: Busine

COMPANY LISTINGS

GS1 Ireland Address: Tel: Fax: Email: Web: Business: Contact:

Second Floor, The Merrion Centre, Nutley Lane, Donnybrook, Dublin 4. (01) 208 0660 (01) 208 0670 info@gs1ie.org www.gs1ie.org Global Supply Chain Standards Body. Chairman: John O’Callaghan Vice Chairman: Thomas Shortall Chief Executive Officer: Mike Byrne

hazchem training ltd Address: G10, Maynooth Business Campus, Maynooth, Co. Kildare. Tel: (01) 629 1800 Fax: (01) 629 1822 Email: info@hazchem.ie Web: www.hazchem.ie Contact: Director: Michelle Cleere

HENLEY FORKLIFT GROUP LIMITED Address: Henley Industrial Park, Killeen Road, Dublin 10. Tel: (01) 620 9200 Fax: (01) 626 5406 Email: fwilson@henley.ie phammett@henley.ie Web: www.henley.ie Business: Forklift and warehousing equipment, sales, service, hire, parts, driver training, thorough examinations. Contact: Director: Brian O’Connell boconnell@henley.ie

HETEROCHEM DIST LTD

Address: Tel: Fax: Email: Web: Business: Contact:

Unit 49, Robertson House, Baldoyle Industrial Est., Dublin 13. (01) 839 3127 (01) 832 5746 info@heterochem.com www.heterochem.com Chemical Distributors & Raw Material Specialists. Managing Director: Kim Doran

idex pump technologies (ireland) ltd Address: R79, Shannon Industrial Estate, Shannon, Co. Clare. Tel: (061) 471933 Fax: (061) 475046 Email: vsicsipti@idexcorp.com Web: www.blagdonpump.com www.vikingpump.com Contact: Customer Services: Ann O’Gorman

Hovione Ltd Address: Tel: Fax: Email: Web: Contact:

Loughbec, Ringaskiddy, Co. Cork, Ireland +353 21 451 2856 +353 21 437 8697 hello@hovione.com www.hovione.com General Manager: Dr. Paul Dowling

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. Contact: Recruitment Director: Anthony McLoughlin

INDAVER IRELAND Address: Tel: Fax: Email: Web: Business:

4th Floor, Block 1, West Pier Business Campus, Old Dunleary Road, Dun Laoghaire, Co. Dublin. (01) 280 4534 (01) 280 7865 info@indaver.ie www.indaver.ie Hazardous & nonhazardous waste disposal and recovery ensuring full compliance.

interpac IDA IRELAND Address: Wilton Park House, Wilton Place, Dublin 2. Tel: (01) 603 4000 Email: idaireland@ida.ie Web: www.idaireland.com Business: Investment promotion agency.

Address: Tel: Fax: Email: Web:

67E Heather Road, Sandyford Industrial Estate, Sandyford, Dublin 18. (01) 294 0600 (01) 294 0602 ian@interpac.ie www.interpac.ie

Irish PharmaChem | Industry Buyers Guide 2017

COMPANY LISTINGS

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 Business: Economic development agency.

irish exporters association - life sciences ireland Address: 28 Merrion Square, 2012 Dublin 2. IrIsh P harma Chem

Avenue, ll Business donnell, 2. 4100 4183 hlifttrucks.ie hlifttrucks.ie Handling nt / Hyster / Lancer rs Manager: cCourt

reditAtion

ark House, ace,

J Park, Rathcoole, Co. Dublin. Tel: + 353 1 401 3333 Fax: + 353 1 458 8015 Email: info@jol.ie niallh@jol.ie Address: Blackchurch Business Web: www.johnstonlogistics.ie Park, Rathcoole, Co. Dublin. Business: Logistics & distribution Tel: (01) 401 3333 Email: (Complete Supply niallh@jol.ie Web: Chain Management). www.johnstonlogistics.ie Contact: Business Development Business: Warehousing & Logistics Manager: (Complete Supply Chain Management) Niall Hickey Contact:

Sales Manager: Niall Hickey

3003 3109 b.ie b.ie

tion ories, on & n bodies. on Officer: yle

Arch

Tel: (01) 661 2182 Fax: (01) 661 2315 Email: niallstobie@irishexporters.ie Web: www.irishexporters.ie Business: Life Sciences Ireland is Industry Grouping with the Irish Exporters Association. Manager Life Science JContact: ohnston LoGistics Ltd Ireland: Niall Stobie. Address: Blackchurch Business

Ltd

m Buiness 6 Upper e St,

903 907 acr.com acr.com Research g Director: len

KWE (Ireland) Ltd kwe (ireLAnd Ltd Controlled Dublin Head Office & )Temperature

Address: Dublin: Unit 4 Warehouse Facility Address: Horizon Logistics Park, Horizon Logistics Harristown, Swords, Co. Dublin. Park, New Naul Rd, (01) 823 9600 Tel: Harristown, Fax: (01) 836 1111Co. Dublin. Swords, kwedub@kwe.com Email: Cork: Unit 4&5, dubsls@kwe.com South Ring Web: www.kwe.com West Business Pk, Cork Regional Office & Warehouse Facility Tramore Road, South Ring West Business Park, Address: Co. Cork. Tramore Road, Cork. Tel: (01) 823 9600 Tel: (021) 497 5722 Fax: (021) 497 5722 (021) 497 5727 Fax: (01) 836 1111 Email: kweork@kwe.com (021) 497 5727 Email: Irish PharmaChemkwedub@ea.kwe.com | Industry Buyers Guide 2017 kweork@ea.kwe.com Web: www.kwe.com Contact: Sales Manager: Karl O’Reilly

LABPLAN Address: Tel: Fax: Email: Web: Business: Contact:

Allenwood Enterprise Park, Allenwood, Naas, Co Kildare. (045) 870 560 (045) 870 811 info@labplan.ie www.labplan.ie Lab supplier of analytical instrumentation, services, technical support. Managing Director: Aidan Smyth

langanbach services ltd

Web: Address: Business:

www.labplan.ie Unit 4, Cedar Estate, Laboratory supplier Killarney Road, Bray, Co. Wicklow. to pharmaceutical Tel: (01) 276 2510 businesses. Fax: (01) 276 2472 Contact: Managing Director: sales@langanbach.ie Email: Aidan Smyth Web: www.langanbach.ie Business: Supply of laboratory L AnGAnbAch services Ltd equipment and diagnostic Address: Unit 4, Cedar Estate, tests. Infection control Killarney Road, products for human and Bray, Co. Wicklow. animal health. Tel: (01) 276 2510 Contact: Sales and Marketing Fax: (01) 276 2472 Director: Jim Woods

Email: sales@langanbach.ie lennox laboratory Web: www.langanbach.ie supplies ltd Business: Supply of laboratory John F. Kennedy Drive, Address: equipment and Naas Road, Dublin 12. diagnostic tests. Tel: (01) 455 2201 Fax: Infection control (01) 450 7906 Email: products for human sales@lennox.ie and animal health. greg@lennox.ie Contact: Sales and Marketing Web: www.lennox.ie Director: Jim Woods Business: Laboratory suppliers.

LAncAster LAborAtories Address:

IDA Business Park, Clogherane, Dungarvan, LIMERICK PACKAGING Co. Waterford. Address: Eastlink Business Park, Tel: (058) 48 300 Ballysimon Rd., Fax: (058) 42 855 Limerick. Email: info@lancasterlabs.com Tel: 061-400035 Web: www.lancasterlabspharm.com Fax: 061-400036 Business: Contract Analytical Email: info@lmkpkg.ie Services Web: www.limerickpackaging.ie Contact: Business Development Business: Packaging manufacturers, Distributors, Director:Designers and Auditors. Mark Glass Contact:

Sales Director: Mike Boland

Lennox LAborAtory suppLies Ltd Address: Tel:

John F. Kennedy Drive, Naas Road, Dublin 12. (01) 455 2201

LISTER MACHINE TOOLS LTD Address:

PO Box 838, Bluebell Industrial Estate, Dublin 12. Tel: (01) 450 8866 Fax: (01) 450 9836 Email: sales@listermachinetools.com Web: www.listermachinetools.com Business: Sales and service of Machine Tools and related accessories, consumables and metrology equipment.

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

McGee Pharma International Address: 1st Floor, Stafford House, Strand Road, Portmarnock, Co. Dublin. Tel: (01) 846 4742 Email: info@mcgeepharma.com Web: www.mcgeepharma.com Business: Consulting: • Quality, Compliance & Technical Advice • GMP Facility Design Review • Supply Chain Mapping • Technical Transfer Contact: Jane Lyons

COMPANY LISTINGS

measom freer Address: Tel: Fax: Email: Web: Business: Contact:

37-41 Charwell Drive, Wigston, Leicester, LE18 2FL, UK. (0044) 1162 881588 (0044) 1162 813000 sales@measomfreer.co.uk www.measomfreer.co.uk Manufacturer. Sales Director: Mark Freer

medisize ireland ltd Address: High Road, Letterkenny, Co. Donegal. Tel: (074) 918 8549 Email: info@medisize.com Web: www.medisize.com Business: Contract manufacturer of primary pharmaceutical packaging and medical and diagnostic devices. Contact: Business Development Manager: Marie Nelis

merck Address: Tullagreen, Carrigtwohill, Co. Cork. T45 KD29 Tel: (021) 488 3666 Fax: (021) 488 3048 Email: martin.mcauliffe@merckgroup.com Web: www.merckgroup.com Business: Life Science. Contact: Site Leader: Martin McAuliffe

micro Address: Unit 2003 Orchard Avenue, Citywest Business Campus, Dublin 24. Tel: (01) 463 9100 Email: info@mirco.ie Web: www.micro.ie Business: High Purity hose, manifolds / tube sets, disposable solutions for the Bio-Pharma Industry. Contact: Ralph Fitzsimons

OBEECO LTD

Address:

Annaville Avenue,

Blackrock,

Co. Dublin.

Tel: Fax: Email: Web:

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: Sales Director: Christy Smith

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. Contact: Sales Director: Eoin McDonagh

(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 Contact: Managing Director: Frank Mulcahy

particular sciences ltd Address: 2 Birch House, Rosemount Business Park, Ballycoolin Road, Dublin 11. Tel: (01) 820 5395 Fax: (01) 822 8813 Email: info@particular.ie Web: www.particular.ie Business: Scientific instruments, sales and support, material characterisation.

pilz ireland

o’flynn medical ltd Address: Tel: Fax: Email: Web: Business: Contact:

Westend, Millstreet, Co Cork. (029) 21 799 (029) 70 191 info@oflynnmedical.com www.oflynnmedical.com Distributor of Scrubex “Automated Protective Clothing Distributor”. Managing Director: Tadhg O’Flynn

Address: Tel: Fax: Email: Web: Business: Contact:

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. Sales Manager: Andrew Donnelly MD: John McAuliffe

www.irishpharmachem.com 80

Irish PharmaChem | Industry Buyers Guide 2017

COMPANY LISTINGS

ProSys Containment And Sampling Technology

PK CHEMICALS LTD Address: Tel: Fax: Email: Business: Contact:

Unit 23, Sandyford Office Park, Blackthorn Avenue, Sandyford Industrial Estate, Foxrock, Dublin 18. (01) 295 6977 (01) 295 8338 graeme@pkchemicals.com Chemical Distributor Technical Sales Manager: Graeme Locke

PPD, Inc. Address: Tel: Fax: Email: Web: Business: Contact:

Building C, Athlone Business & Technology Park, Garrycastle, Athlone, Co. Westmeath. (0906) 460 300 (0906) 460 301 susan.neenan@ppdi.com www.ppdi.com Contract Research Organisation. Director, GMP Labs, Europe: Susan Neenan

Premier Validation Address: Tyone, Nenagh, Co. Tipperary. Tel: (01) 443 4016 Fax: (0906) 460 301 Email: graham.okeeffe@ premiervalidation.com Web: www.premiervalidation.com Business: Validation and regulatory compliance specialist. Contact: Director of Operations: Graham O’Keefe

Protech Plastics Address: Tel: Fax: Email: Web: Business: Contact:

2 Eastgate Avenue, Little Island, Cork. (021) 435 5762 (021) 435 5907 dmurphy@protechplastics.org www.protechplastics.net Design, development and manufacture of injection moulded packaging, for use in food and pharma. General Manager: Donagh Murphy

Irish PharmaChem | Industry Buyers Guide 2017

Address: Tel: Fax: Email: Web:

UIDA Business Park, Carrigtohill, Co. Cork. (021) 485 3900 (021) 485 3866 mmcl@prosys.ie www.prosys.ie

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

Quintiles Ireland Ltd Address: Tel: Fax: Web: Business: Contact:

Eastpoint Business Park, Fairview, Dublin 3. (01) 819 5100 (01) 809 9500 www.quintiles.com Clinical Research and Development. Managing Director: John Kiernan

SARTORIUS MECHATRONICS UK LTD Address: Tel: Fax: Email: Web: Business: Contact:

Unit 41, The Business Centre, Stadium Business Park, Ballycoolin Road, Dublin 11. (01) 808 3050 (01) 808 9388 info.ireland@sartorius.com www.sartorius.com Laboratory & Process technology provider. Sales & service of laboratory & process weighing equipment. Nick Parsons

SCICHEM - CORK Address: Tel: Fax: Email: Web: Business: Contact:

Unit 14, Barryscourt Business Park, Carrigtwohill, Co. Cork. (021) 488 2388 (021) 488 2389 cork@scichem.com www.scichem.com Laboratory Suppliers. Branch Manager: John Molloy

SCICHEM – DUBLIN

Quitmann O’Neill Packaging Ltd Address: Tel: Fax: Email: Web: Business: Contact:

St. Brendan’s Road, Portumna, Co. Galway. (090) 974 1148 (090) 974 1459 sales@quitmannoneill.com www.qonpack.com Packaging Stockist & Distributors. David O’Neill (086) 6992693 Shane McEnroy (085) 8022626 Gareth Reville (086) 8118154

Address: Tel: Fax: Email: Web: Business: Contact:

Greenhills Industrial Estate, Walkinstown, Dublin 12. (01) 450 4077 (01) 450 4328 dublin@scichem.com www.scichem.com Laboratory Suppliers. Branch Manager: Seamus Amond

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.

COMPANY LISTINGS

SOLTEC (IRELAND) LTD Address: Tel: Email: Web: Business: Contact:

Zone A, Mullingar Business Park, Mullingar, Co. Westmeath. (044) 933 5133 info@soltec.ie www.soltec.ie Soltec is Ireland’s only commercially operated solvent recycling plant. Solid hazardous waste collections also provided. Business Development Manager: Michael Corcoran

SOLV-ECHEM IRELAND LTD Address: Tel: Email: Web: Business: Contact:

Great Island Industrial Park, Ballincollig, Co. Cork. (021) 487 7066 tony@solvechem.com www.solvechem.com Chemical distribution, chemicals, solvents, water treatment, warehousing. Director: Tony Murray

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

STERIPACK Address: Kilbeggan Road, Clara, Co. Offaly. Tel: (057) 933 1888 Fax: (057) 933 1887 Email: info@steripackgroup.com Web: www.steripackgroup.com Business: Contract Manufacturing Services, Medical And Pharmaceutical Packaging, Test Laboratory Services. Contact: Sales Manager: Colm Flood

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.

SYNTHESIS AND SOLID STATE PHARMACEUTICAL CENTRE Address: University of Limerick, Limerick, Ireland. Tel: +353 (0)61 234629 Web: www.sspc.ie Business: Research Centre Contact: General Manager: Jon O’Halloran

THORNSHAW SCIENTIFIC RECRUITMENT Address: Tel: Email: Web: Business: Contact:

6 Old Dublin Road, Stillorgan, Co. Dublin. +353 1 278 4671 info@thornshaw.com www.thornshaw.com Scientific Recruitment Tina Dunne

Toyota Material Handling Ireland Ltd Address: Tel: Fax: Business: Contact:

Killeen Road, Dublin 12. (01) 419 0200 (01) 419 0325 Forklift and Warehouse Supplies. Terry O’ Reilly

TEDAC LTD Address: 31 Cleeve Lodge Road, Downend, Bristol, England, BS16 6AF. Tel: 004417 910 4821 Fax: 0044751 566 0775 Email: info@tedac.co.uk Web: www.tedac.co.uk Business: Temperature and humidity mapping services. Contact: Director: Chris Bell

teva pharmaceuticals ireland Address: Unit 301, IDA Industrial Park, Waterford. Tel: (051) 331 331 Web: www.teva.ie Business: Respiratory Pharmaceutical R&D and Manufacture. Contact: Managing Director: Andy Crowley

TWi Address: West Building, Carrigaline Industrial Park, Carrigaline, 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

Univar Address: Tel: Email: Business: Contact:

536 Grants Crescent, Greenogue Business Park, Rathcoole, Co. Dublin. (01) 401 9800 pharma.sales@univar.com Chemical Distribution Key Account Manager: Niall Behan

Irish PharmaChem | Industry Buyers Guide 2017

COMPANY LISTINGS

Veolia Address: Tel: Fax: Email: Web: Business: Contact:

Innovation House, DCU Innovation Campus, Old Finglas Road, Glasnevin, Dublin 11 +353 (0)1 870 1200 +353 (0)1 870 1201 info@veolia.ie www.veolia.ie Energy, Water and Waste management solutions Business Development Manager Pharma Sector: Sean Molloy

waters chromatography ireland Address: Unit 3.1 Woodford Business Park, Santry, Dublin 9. Tel: (01) 448 1500 Fax: (01) 448 1510 Email: ireland@waters.com Web: www.waters.com Business: The company designs, manufactures, sells and

services HPLC, UPLC, mass spectrometry instrument systems and support products, including chemistry consumables and post-warranty service plans. Contact: National Sales Manager: Davnet Donnelly

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 Contact: General Manager UK & Ireland: Patrick Hughes

UK & Ireland: Patrick Hughes

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 Contact: Sales Administrator: Siobhan Murray

www.irishpharmachem.com

NOTES

Irish PharmaChem | Industry Buyers Guide 2017

Ye ar Pl a nne r 2 0 1 7

SUN MON TUE WED THU

FRI

SAT SUN MON TUE WED THU

New Year’s Day Public Holiday

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

F E B

St. Valentine’s Day

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

M A R

1 2 3 4 5 6 7 8 9 10 11 12 13

A P R

J U N

SAT SUN MON TUE WED THU

1 2 3 4 5 6 7 8 9 10 11 12

J A N

M A Y

FRI

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

Public Holiday

1 2 3 4 5 6 7 8 9 10 11 12 13 14

Public Holiday

J U L

1 2 3 4 5 6 7 8 9 10 11 12 13

A U G

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

S E P

1 2 3 4 5 6 7 8 9 10 11 12 13 14

O C T

Public Holiday

1 2 3 4 5 6 7 8 9 10 11 12

N O V

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

D E C

1 2 3 4 5 6 7 8 9 10 11 12 13 14

SUN MON TUE WED THU FRI SAT SUN MON TUE WED THU FRI SAT SUN MON TUE WED THU

FRI

SAT

SUN

MON

TUE

WED

THU

FRI

SAT

SUN

MON

TUE

WED

THU

FRI

SAT

SUN

MON TUE

13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

J A N

17 18 19 20 21 22 23 24 25 26 27 28

F E B

17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Summer Time Begins

Public Holiday

14 15 16 Good Friday

M A R

Mother’s Day

St. Patrick’s Day

Easter Sunday

27 28 29 30

A P R

Easter Monday

Public Holiday

19 20 21 22 23 24 25 26 27 28 29 30 31

M A Y

16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

J U N

Father’s Day

14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

J U L

18 19 20 21 22 23 24 25 26 27 28 29 30 31

A U G

15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

S E P

14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Halloween

Summer Time Ends Public Holiday

17 18 19 20 21 22 23 24 25 26 27 28 29 30

15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Christmas St.Stephen’s Day Day

Public Holiday

FRI SAT SUN MON TUE WED THU FRI SAT SUN MON TUE WED THU FRI SAT SUN MON TUE

O C T N O V D E C

USEFUL REFERENCES ACADEMY OF CLINICAL

DEPT. OF JOBS, ENTERPRISE

INSTITUTE OF CHEMISTRY OF IRELAND

IRISH PATENTS OFFICE

SCIENCE AND LABORATORY

& INNOVATION

E-mail: info@instituteofchemistry.org

Tel: (056) 772 0111

MEDICINE

Tel: (01) 631 2121

Web: www.instituteofchemistry.org

E-mail: patlib@patentsoffice.ie

Tel: (01) 905 9730

LoCall: 1890 220 222

E-mail: mail@acslm.ie

E-mail: info@djei.ie

INTERNATIONAL SOCIETY

Web: www.acslm.ie

Web: www.djei.ie

FOR PHARMACEUTICAL

Web: www.patentsoffice.ie IRISH PHARMACY UNION

ENGINERING (ISPE)

Tel: (01) 493 6401

ADVISORY COUNCIL FOR

ELECTRICITY SUPPLY BOARD

Tel: +1 (813) 960 2105

SCIENCE, TECHNOLOGY

Tel: 1850 372 757

E-mail: info@ipu.ie

E-mail: ask@ispe.org

& INNOVATION

E-mail: esbnetworks@esb.ie

Web: www.ipu.ie

Web: www.ispe.org

Tel: (01) 631 2858

Web: www.esb.ie

E-mail: firstname.surname@djei.ie

IRISH VENTURE CAPITAL

IRISH BIOINDUSTRY

ASSOCIATION

ENTERPRISE IRELAND

ASSOCIATION

Tel: (01) 727 2000

Tel: (01) 605 1584

AN BORD PLEANALA

E-mail: client.service@enterprise-ireland.com

E-mail: firstname.surname@ibec.ie

Tel: (01) 858 8100

Web: www.enterprise-ireland.com

Web: www.ibec.ie/ibia

Web: www.ivca.ie

ENVIRONMENTAL HEALTH

IRISH BUSINESS &

ASSOCIATION OF IRELAND

INVEST NORTHERN IRELAND

EMPLOYERS

Tel: (01) 865 1885

Tel: (01) 276 1211

CONFEDERATION (IBEC)

E-mail: dublin@investni.com

E-mail: info@ehoa.ie

Tel: (01) 605 1500

Web: www.investni.com

Web: www.ehai.ie

E-mail: info@ibec.ie

Web: www.sciencecouncil.ie

LoCall: 1890 275 175 E-mail: bord@pleanala.ie Web: www.pleanala.ie BIOPHARMACHEM IRELAND Tel: (01) 605 1584 E-mail: info@ibec.ie Web: www.biopharmachemireland.ie CHAMBERS IRELAND Tel: (01) 400 4300 E-mail: info@chambers.ie Web: www.chambers.ie COMPANIES REGISTRATION OFFICE Tel: (01) 804 5200 LoCall: 1890 220 226 E-mail: info@cro.ie Web: www.cro.ie UCD SCHOOL OF CHEMICAL & BIOPROCESS ENGINEERING Tel: (01) 716 1825 E-mail: chemical.eng@ucd.ie Web: www.ucd.ie/chembioeng DEPARTMENT OF COMMUNICATIONS, CLIMATE ACTION AND ENVIRONMENT Tel: 01 678 2000 E-mail: customer.service@dccae.gov.ie Web: www.dccae.gov.ie

ENVIRONMENTAL

Tel: (01) 276 4647

Web: www.ibec.ie

E-mail: secretary@ivca.ie

MANDATE TRADE UNION Tel: (01) 874 6321

PROTECTION AGENCY

IRISH CLEANROOM SOCIETY

Tel: (053) 916 0600

Tel: 087 958 8045

LoCall: 1890 335 599

E-mail: info@cleanrooms-ireland.ie

E-mail: info@epa.ie

Web: www.cleanrooms-ireland.ie

E-mail: mandate@mandate.ie Web: www.mandate.ie NATIONAL INSTITUTE

Web: www.epa.ie IRISH COSMETICS,

FOR TRANSPORT

HEALTH AND SAFETY AUTHORITY

DETERGENT & ALLIED

& LOGISTICS (NITL)

Tel: 01 614 7000

PRODUCTS ASSOCIATION

Tel: (01) 402 3000

LoCall: 1890 289 389

Tel: (01) 605 1671

E-mail: nitl@dit.ie

E-mail: wcu@hsa.ie

E-mail: siobhan.dean@ibec.ie

Web: www.nitl.ie

Web: www.hsa.ie

Web: www.icda.ie

HEALTH PRODUCTS

IRISH EXPORTERS

REGULATORY AUTHORITY

ASSOCIATION

Tel: (01) 676 4971

Tel: (01) 661 2182

E-mail: info@hpra.ie

E-mail: iea@irishexporters.ie

Web: www.hpra.ie

Web: www.irishexporters.ie

HEALTH RESEARCH

IRISH MEDICAL DEVICES ASSOCIATION

BOARD

Tel: (01) 605 1500

Tel: (01) 234 5000

E-mail: imda@ibec.ie

E-mail: hrb@hrb.ie

Web: www.imda.ie

Web: www.hrb.ie

PARENTERAL DRUG ASSOCIATION (PDA) Tel: +1 (301) 656 5900 E-mail: info@pda.org Web: www.pda.org PHARMACEUTICAL SOCIETY OF IRELAND Tel: (01) 218 4000 E-mail: info@psi.ie Web: www.thepsi.ie

IRISH MEDTECH

REPAK

HIGHER EDUCATION AUTHORITY

ASSOCIATION

Tel: (01) 231 7100

Tel: (01) 605 1500

E-mail: info@hea.ie

E-mail: imda@ibec.ie

Web: www.hea.ie

Web: www.irishmedtechassoc.ie

GOVERNMENT

IDA - INDUSTRIAL

IRISH NATIONAL

SCIENCE FOUNDATION

Tel: (01) 888 2000

DEVELOPMENT AGENCY

ACCREDITATION BOARD

IRELAND

LoCall: 1890 20 20 21

Tel: (01) 603 4000

Tel: 1890 289 389

Tel: (01) 607 3200

E-mail: qcsofficer@housing.gov.ie

E-mail: idaireland@ida.ie

E-mail: info@inab.ie

E-mail: info@sfi.ie

Web: www.housing.gov.ie

Web: www.idaireland.com

Web: www.inab.ie

Web: www.sfi.ie

DEPT. OF THE HOUSING, PLANNING, COMMUNITY & LOCAL

Tel: (01) 467 0190 E-mail: info@repak.ie Web: www.repak.ie

Irish PharmaChem | Industry Buyers Guide 2017

www.irishpharmachem.com PERSONAL CONTACTS Name:

Name:

Company:

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www.irishpharmachem.com PERSONAL CONTACTS Name:

Name:

Company:

Telephone:

Mobile:

Email:

www:

Name:

Company:

Telephone:

Mobile:

Email:

www:

Name:

Company:

Telephone:

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Services Services

Process monitoring made Process monitoring made easy with Liquiline CM44P easy with Liquiline CM44P Transmitter for Memosens sensors Transmitter for Memosens sensors and process photometers and process photometers Multiparameter transmitter Multiparameter transmitter for monitoring processes for monitoring processes such as chromatography, suchfermentation as chromatography, and phase fermentation separationand phase separation • Makes it easier to set up complete measuring points for many • Makes it easier to set up complete industrial processes by combining measuring points for many process photometers with industrial processes by combining Memosens sensors process photometers with Memosens sensors • Provides Liquiline transmitter flexibility with multiple I/O • Provides Liquiline transmitter options and plug and play flexibility with multiple I/O functionality for Memosens options and plug and play sensors functionality for Memosens sensors • Offers easy and reliable operation thanks to the large, graphical • Offers easy and reliable operation display and a uniform, userthanks to the large, graphical friendly operating concept display and a uniform, userfriendly operating concept • Enables seamless integration into your control systems thanks to • Enables seamless integration into digital fieldbus protocols your control systems thanks to digital fieldbus protocols • Increases convenience through remote access via integrated web • Increases convenience through server remote access via integrated web server

Endress+Hauser (Ireland) Ltd. Tel: +353 (0)45 989 200 Endress+Hauser (Ireland) Ltd. Tel: +353 (0)45 989 200 info@ie.endress.com Exchequer House, House, info@ie.endress.com Exchequer Embassy Office Park, www.ie.endress.com Embassy www.ie.endress.com Kill, Office Park, Kill, Co. Kildare Co. Kildare