Irish PharmaChem 2018

The Indus tr y Buyer s Guide 2018

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CONTENTS 32 Serialisation

8 BioPharma Ambition Conference 2 Minister’s Foreword Ireland’s pharmaceutical sector deserves particular credit for its contribution to Ireland’s export-led recovery but there is no room for complacency if we are to continue to grow the sector, writes Heather Humphreys TD, Minister for Business, Enterprise and Innovation.

4 Sector Overview Corporate migration and Brexit are two of the biggest issues facing Ireland Inc. as we move forward. How will they effect the pharmaceutical and chemical sectors here? Matt Moran, Director, BioPharmaChem Ireland, investigates.

8 Biopharma Ambition 2018 BioPharma Ambition, which takes place in February 2018, is a multi-platform event to inspire and showcase innovation, writes Nessa Fennelly, Senior Executive, BioPharmaChem Ireland.

12 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.

17 REACH 2018 All chemical substances produced or imported from outside the EU between one and 100 tonnes per year need to be registered with the European Chemicals Agency by May 31, 2018.

22 Investment & Development IDA Ireland is working hard to achieve the continued pre-eminence of Ireland in the biopharma and broader life sciences sectors, writes Tommy Fanning, Head of Biopharmaceuticals & Food at IDA Ireland.

24 NIBRT NIBRT enjoyed a very strong 2017 with a number of significant developments across its research, training and facility development operations, writes Killian O’Driscoll, NIBRT’s Director of Projects.

28 Data Integrity

43 Research & Development

Enda Dempsey, BioPharmaChem Ireland, provides some industry insights for improving Data Integrity compliance in an increasingly regulated environment.

32 Serialisation GS1 Ireland and ESP teamed up to produce the second annual Pharma Serialisation Readiness Report. How do you measure up?

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

35 IT Services Westbourne IT Global Services Limited delivers multi-lingual technical service desk solutions to the biopharmaceutical, healthcare and food sectors on a global scale.

36 PRODUCT TESTING Eurofins BioPharma Product Testing offer one of the world’s most comprehensive harmonised GMP testing services, allied to the sharpest focus on data integrity.

38 Clinical Research Development Ireland Dr Fionnuala Keane, Chief Operating Officer, HRB CRCI, reports on the Strategic Plan 2017-2021 of Clinical Research Development Ireland and the important work of the Health Research Board Clinical Research Coordination Ireland.

40 Healthcare Packaging With facilities in Clara, Co. Offaly, Bemis Healthcare Packaging offers engineered healthcare packaging solutions.

42 Waste Management Indaver are planning on opening another facility in Cork, as well as the development of waste-toenergy facilities in Belfast.

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 6477 127 Email: kathleenbelton@tarapublications.ie Web: www.irishpharmachem.com

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

Managing Director: Patrick Aylward Editorial and Marketing Director: Kathleen Belton Editor: John Walshe Irish PharmaChem | Industry Buyers Guide 2018

The Synthesis and Solid State Pharmaceutical Centre is a world leading Science Foundation Ireland Centre co-funded with industry partners, and focuses on excellent science across chemistry, pharmaceutics and process engineering.

46 Supply Chain Univar Pharmaceutical Ingredients is a premier global supply chain solutions partner to the pharmaceutical industry.

47 Calibration The iTHERM TrustSens from Endress + Hauser is the world’s first self-calibrating thermometer.

48 Documentation Solutions TWi is a leading technical writing and information design service provider.

49 Investment MSD Ireland’s announcement of 330 new jobs and a €280m investment in Carlow and Cork is a reflection of Ireland’s positive standing in MSD global network

52 Pharmaceutical Manufacturing Technology Centre The Pharmaceutical Manufacturing Technology Centre funds multiple teams of researchers in the discovery of advanced technology solutions for the pharma sector.

56 Logistics Adam O’Sullivan, Director of Pharmaceutical + Healthcare, Kuehne + Nagel Ireland, writes about the importance of innovation and future-focused solutions for customers in the pharma industry.

59 Workplace Wellbeing The KeepWell Mark is an evidence-based accreditation and award from Ibec, designed to recognise organisations’ impressive work to look after staff health and wellbeing.

LISTINGS SECTION

Chemical Suppliers General Suppliers Company Listings 2018 Year Planner Useful References

61 62 68 78 80

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Minister’s Foreword

No Room for Complacency Ireland’s pharmaceutical sector deserves particular credit for its contribution to Ireland’s export-led recovery but there is no room for complacency if we are to continue to grow the sector, writes Heather Humphreys TD, Minister for Business, Enterprise and Innovation.

As Minister for Business, Enterprise and Innovation, I am delighted to provide the foreword to the 2018 Irish PharmaChem Yearbook and Directory.

Ireland has a long tradition of pharmaceutical operational excellence and has been attracting major manufacturing facilities for over 50 years.

That’s why we have developed deep expertise and an experienced, talented skills base in manufacturing. We are now determined to help the industry develop further across Ireland.

It has been especially encouraging, in that context, to see the increasing regional spread of investment from this sector over the last number of years. Cork, of course, is longestablished as a cluster of global significance, but we are now witnessing the additional development of growing regional clusters in Waterford, Athlone and Sligo. This bodes well for the future of the sector and the Government will continue doing everything it can to help support its growth.

a backdrop of continuing strong levels of foreign direct investment (FDI) from a range of industries with record multinational companydriven job creation. The expertise of the IDA in driving this forward has been paramount, not just in terms of winning new investment but also supporting the continued growth of companies who have long made Ireland their home. But the most credit for Ireland’s continued success with FDI lies with our people.

Our young workforce is educated, dynamic and flexible and has deservedly forged a stellar reputation across the world. They continue to be the main reason why companies from all over the world are attracted to our island.

The NIBRT Effect Pharmaceutical and biopharma companies, of course, come to Ireland for many different reasons. One of those is because of our worldclass National Institute for Bioprocessing Research and Training (NIBRT). This purpose-

Heather Humphreys TD, Minister for Business, Enterprise and Innovation.

More generally, Ireland remains, despite the challenges presented by global economic and political uncertainties, a stable, competitive and pro-business economy. As has been welldocumented, we have emerged from a period of recovery and have now entered a phase of strong and sustained economic growth. We have, in fact, been the fastest growing economy in the Eurozone for the last three years, with unemployment decreasing steadily.

The Pharma Contribution Getting Ireland back on that upward economic trajectory has required significant hard work from across the public and private sectors. The pharmaceutical sector, it must be said, deserves particular credit for their contribution to that export-led recovery.

The statistics make compelling reading: ● Medical and pharmaceutical products worth over €30 billion were exported in 2016 alone, accounting for 25% of the country’s total exports; ● Ireland was the world’s seventh largest exporter of medicinal and pharmaceutical productions in 2015; ● The country is now home to the top 10 global biopharma companies.

These impressive figures come against

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Irish PharmaChem | Industry Buyers Guide 2018

Minister’s Foreword built and state-of-the-art facility is a global leader in cutting-edge, high quality training and research. It is testament to the quality of NIBRT and its staff that many of the pharmaceutical companies that have located in Ireland cite it as a critical factor in their decision to invest here.

While this sector has seen significant success in recent years, we know that competition for global investment remains intense and that there can be no room for complacency.

That is why the Government is committed to enhancing our growing reputation for research excellence and increasing the number of enterprises engaged in first-class research.

The Government will continue to invest too in Ireland’s education system, thereby ensuring the continuing pipeline of talent for the industry. We are committed as well to improving Ireland’s competitiveness so that the country is best-placed to secure new investment, whether from companies already located here or those seeking a new European base from which to do business.

While there is much work to do, I think the future is bright for the industry and for its partnership with Ireland. I wish PharmChem Ireland every success in the coming year and I look forward to working together in the time ahead.

Heather Humphries TD, Minister for Business, Enterprise and Innovation.

Irish PharmaChem | Industry Buyers Guide 2018

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Sector Overview

Corporate migration and Brexit are two of the biggest issues facing Ireland Inc. as we move forward. How will they effect the pharmaceutical and chemical sectors here?

Matt Moran, Director, BioPharmaChem Ireland, investigates.

A Model of Substance As the sector here continues to grow and prosper, the world becomes a more uncertain place. Given the global nature of the biopharmachem sector, it behoves us all to pay proper attention to international trends and developments. Firmly on our radar are Brexit and the evolving situation in the USA. Ibec sees this as a major challenge for the country.

According to Ibec CEO, Danny McCoy, Ireland remains the strongest performer in a resurgent EU economy, with annual output up 5.8% in the second quarter of 2017. The strength of the performance is all the more remarkable given the unique extent of the exposure the island of Ireland has to the Brexit process. Brexit’s effects are already impacting upon the Irish economy as a result of the rapid depreciation of Sterling against the euro, and the falling purchasing power of UK households has already resulted in slower exports for Ireland from tourism and agri-food sales.

Growth, however, continues to be propelled

by Ireland’s role as a global trading hub. These countervailing forces reflect the open nature of Ireland, which has been ranked as the world’s most globalised nation. The transformation of the country is reflected in recent Census figures, which report that 17% of the population were

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born outside of the country, as well as the facts that trade, as measured by combined exports and imports, is 216% of GDP; that foreign direct investment levels per capita are among the top five countries in the world and; that business migration looks set to have doubled in a half decade, propelled by the OECD corporate tax process.

The Double Helix in Our DNA It is no exaggeration to say that globalisation is part of the Irish DNA, and the ‘Double Helix’ the country is grappling with currently relates to the positive and negative effects that both corporate migration and Brexit present.

The expansion of business migration in 2015 alone was an increase of 40% that gave rise to an extraction of activity that propelled Irish GDP growth to 34% in cash terms and boosted corporate tax revenue by 47%. This is equivalent to a modern-day resource find, in this case with intellectual capital or intangible assets, which brings with it opportunities to transform the national growth potential through increased infrastructure investment; whilst in the short term, increases competitiveness pressures as costs continue to rise from a lack of supply.

The latter is most acute in housing stock for Irish PharmaChem | Industry Buyers Guide 2018

Sector Overview Ireland, where the speed of supply cannot keep up with the speed of current demands.

The population of Ireland is rising significantly, yet building has not returned to the levels seen before the international financial crisis of more than a decade ago. The housing shortage problem is somewhat ironic, given that some prominent commentators forecast that Ireland would need to knock down housing stock to deal with perceived oversupply.

The positives outweigh the negatives from the corporate migration trend, but this requires moving the policy mind-set from one of austerity to one of expansiveness. It also requires greater innovation in adapting to the constraints of EU fiscal rules by greater participation in public-private partnerships.

The extension of the Juncker investment plan and the role of the European Investment Bank should greatly help Ireland rise to maximise the opportunity.

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Brexit and the Pharma Sector By far the greatest competitor for Ireland in attracting international business migration has been the UK. In the context of Brexit, a win for Ireland is a win for the EU in the future. The EU-27 needs to allow countries to compete, fairly but aggressively. The speculation on EU consolidated common corporate tax changes are unhelpful and ultimately King Canute-like in their effectiveness.

Brexit is not without positives for Ireland in the race for corporate investment, and Dublin in particular is seen as a serious contender for financial institutional migration from the

Ibec is leading a campaign, Ireland: A Model of Substance, designed to ensure that the entire globe will be made aware of the success of the Irish business model (www.ibec.ie/ irishsubstance).

UK. Overall, however, the impact of Brexit on Ireland is likely to be negative. Trade with the UK, which accounts for nearly 80% for small and medium enterprises’ exports, is crucial for the indigenous business community. Many of these companies are engaged in low margin, high volume trade, which is very sensitive to sharp exchange rate movements, as have already occurred. The Irish labour market is heavily correlated with the UK labour market, such that any significant downturn for the UK economy will be promulgated through that channel also. In the case of a hard Brexit,

Ireland will need to diversify away more significantly from the UK, but this will neither be costless nor immediate.

Ibec, which represents Irish business in all its forms, see the opportunities from globalisation continuing to dominate the short-term frictional costs. The length of the transition period offered to the UK in Brexit discussions will also be important.

Indeed, discussions on the future of a multispeed EU should be advanced to show a path for greater future UK participation within the Single Market and customs union. It is the

Greenfield Foreign Direct Investment per capita in Ireland 1985 to 2016.

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Sector Overview

“Six of the world’s top 10 selling pharmaceutical products are produced in Ireland.”

“Ireland has all of the top 10 global technology companies, 18 of the world’s top 25 medtech companies and 18 of the world’s top 20 pharma companies.”

desire of Irish business to have the UK as a partner, not just a competitor.

The Investment Flow The BioPharma sector is a major component of the continued flow of FDI into the country.

The flow of investment has not stalled as some commentators suggested might happen as a result of developments in the USA. Cumulative capital investment this century will easily top the €10 billion mark and Janssen, MSD, Eli Lilly, and Henkel Ireland have all made major announcements in 2017. Key to this is the fact that Ireland continues to invest in substance, tangible substance, manifesting itself in high end manufacturing and innovation centres, now the top 10 biopharma companies in the world are all in this country.

Ibec will lead a campaign, Ireland: A Model of Substance, which BPCI will be a major supporter of, designed to ensure that the entire globe will be made aware of the success of the Irish business model. My ask to all of you is to share the content of this campaign with your employees, with decision makers, with your customers and suppliers, your investors and any stakeholder who you think could be of influence. Use the attached link to help spread the word: www.ibec.ie/irishsubstance.

As Danny McCoy says, now is the time for the country to seize this opportunity and use it to further copperfasten the biopharma and other sectors important to our economy.

Model representing inward cross-border investment projects in R&D by major OECD cities 2003 to 2011 (Dublin highlighted in red).

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Irish PharmaChem | Industry Buyers Guide 2018

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Biopharma Ambition 2018

Realising our Bio Ambition The island of Ireland has established itself as a place of global significance for the biopharmaceutical industry and is set to capitalise on this and host a major international multi-function convention in Dublin on February 21-22, 2018, at The Printworks, Dublin Castle.

The Irish Pharmaceutical Healthcare Association and BioPharmaChem Ireland, representing the research based and manufacturing biopharmaceutical industries respectively, together with the National Institute for BioProcessing Research and Training will host BioPharma Ambition, a multi-platform event to inspire and showcase innovation.

With international policy leaders, renowned researchers and senior industry personnel, the event will highlight the ambition of the industry for the health and well-being of populations. It will also highlight where the research is pointing and how Ireland will support innovation in discovery, development, manufacturing and healthcare solutions.

BioPharma Ambition, which takes place in February 2018, is a multi-platform event to inspire and showcase innovation, writes Nessa Fennelly, Senior Executive, BioPharmaChem Ireland.

Nessa Fennelly, Senior Executive, BioPharmaChem Ireland. and planning, and when necessary, with remediation planning and health regulatory authority communications.

Dr Lorraine Nolan The Chief Executive of the HPRA, Dr Nolan joined the organisation in 2001 and since that time has held a number of different roles at

senior level across a range of areas, including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming the role of Chief Executive, she was Director of Human Products Authorisation & Registration.

Nolan is a member of the Management Board of the European Medicines Agency.

Conference Sessions will include: Ambition for Medical and Biopharma Innovation; ● The Future for Genomics and Advanced Therapeutics; ● Unlocking the Collaborative Potential of Data and Clinical Research; ● Manufacturing for the Future; ● Adopting Innovation; Delivering Value; ● Industry 4.0 – The Impact on Biopharma Manufacturing; ●

Several of the internationally renowned speakers confirmed for the event include: David Chesney The Principal and General Manager, DL Chesney Consulting, LLC, David Chesney’s career includes 23 years with the FDA and over 21 years in GMP and GCP consulting worldwide. In his consulting practice, Chesney helps clients prevent quality and compliance problems through proactive assessment

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Pictured at the launch of BioPharma Ambition 2018 are: Oliver O’Connor, Chief Executive of IPHA; Aidan Gough, Acting CEO, Intertrade Ireland; Matt Moran, Director of BPCI, and Dominic Carolan, CEO of NIBRT. Irish PharmaChem | Industry Buyers Guide 2018

Biopharma Ambition 2018

Kári Stefánsson Founder and CEO of deCODE Genetics, which he founded in 1996, Dr Stefánsson is recognised as a leading figure in human genetics and the man who began an approach to population genetics that is being adopted all over the world. He has shaped deCODE’s scientific approach and been actively engaged in leading its work on human genetics. Dr Stefánsson has received numerous awards for his work, including the Sackler Lecture at MIT (2009), the European Society of Human Genetics Award (2009), the American Alzheimer’s Association’s Inge Grundke-Iqbal Award (2014), and the Federation of European Biomedical Societies’ Sir Hans Krebs Medal (2016), while The American Society of Human Genetics (ASHG) has named Dr Stefánsson the 2017 recipient of the annual William Allan Award. He has published more than 500 scientific papers.

Dr Richard L. Schilsky MD, FACP, FASCO Senior Vice President of Center for Research & Analytics (CENTRA) and Chief Medical Officer (CMO) of ASCO, Dr Schilsky assumed this newly created position with the Society in February of 2013. Formerly the Chief of Hematology/ Oncology in the Department of Medicine and Deputy Director of the University of Chicago Comprehensive Cancer Center, he is a highly respected leader in the field of clinical oncology. He specialises in new drug development and treatment of gastrointestinal cancers. Dr Schilsky is a Past President of ASCO, having served in the role during 2008-2009, and also a Past Chair of one of the National Cancer Institute’s (NCI) Cooperative Groups, Cancer and Leukemia Group B (CALGB). Dr Schilsky’s impressive experience and many accomplishments in both clinical medicine and clinical research reflect his deep passion for cancer medicine. Having served in prior leadership positions within ASCO, Dr Schilsky has an in-depth understanding of the current trends and issues affecting oncology clinical practice. He has spent the majority of his career at the University of Chicago, where he joined the faculty in 1984, subsequently rising to the rank of Professor of Medicine and serving in Irish PharmaChem | Industry Buyers Guide 2018

many roles, including Associate Dean for Clinical Research in the Biological Sciences Division and Director of the University of Chicago Cancer Research Center. He has extensive experience working with both the NCI and the Food and Drug Administration (FDA), having served as a member and chair of the NCI Board of Scientific Advisors, as a member of the NCI Clinical and Translational Research Committee, and as a member and chair of the Oncologic Drugs Advisory Committee of the FDA. Dr Schilsky has served on the editorial boards of many cancer journals, including the Journal of Clinical Oncology. Most recently, he served as an Associate Editor of the Journal of the National Cancer Institute and Senior Associate Editor of Molecular Oncology, among other journals.

Dr Muhammed Ali Dr Ali is the Executive Director for Healthcare Solutions Strategy in a regional role across Europe and Canada in the Commercial and Operations Team, MSD International. He leads the development of the healthcare solutions strategy across Europe and Canada.

The strategy focuses on working with payers / healthcare providers to mutually focus on improving population health outcomes.

Dr Lynn Allen-Hoffmann, PhD A Senior Vice President, Regenerative Medicine, Stratatech Corporation, a Subsidiary of Mallinckrodt, and Professor at the Department of Pathology and Department of Surgery, University of Wisconsin-Madison, Dr AllenHoffman is a tenured, full Professor in the Departments of Pathology and Laboratory Medicine and Surgery at the UW School of Medicine and Public Health. She is internationally recognised for her innovative research and clinical development of human skin replacements, including the world’s first genetically-enhanced human skin replacements. The NIKS cells, discovered in her UW laboratory, are a consistent source of genetically uniform, non-tumorigenic, pathogen free human keratinocytes amenable to genetic manipulation. As a result of the

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Biopharma Ambition 2018

discovery in her laboratory, Dr Allen-Hoffmann founded Stratatech Corporation to deliver cell-based therapies to patients with complex skin loss. She has received numerous state and national awards and is the first woman at the UW to start a biotechnology company. Dr AllenHoffmann has contributed to numerous peer-reviewed publications and patents. Her basic and clinical research has received continuous research support, including grants from the NIH, NIST, AFIRM, BARDA, and DOD. Recently, Stratatech Corporation has been one of the top 10 companies to receive SBIR and STTR funding in the United States. In 2015, BARDA released a solicitation through Project BioShield for the late stage clinical development and use of cell-based therapies for skin replacement caused by thermal burns in the event of a mass casualty event resulting from the detonation of an improvised nuclear device. Stratatech was the only academic or private sector organisation in the United States to successfully compete for a BioShield award. The $247m Project BioShield award will enable the NIKS technology to be used prior to FDA approval through the FDA’s Pre-Emergency Use Authorisation mechanism.

Stratatech received a 2016 Tibbitts Award, which was accepted by Dr Allen-Hoffmann at a White House ceremony. Dr Allen-Hoffmann recently received the Hector F. DeLuca Scientific Achievement Award. Stratatech Corporation was acquired by Mallinckrodt Specialty Pharmaceuticals on August 31, 2016.

Nathalie Moll Nathalie Moll is Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 40 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world. Moll previously worked as the Secretary General of EuropaBio, ranked as the most effective European Trade Association in Brussels in 2013. In 2013, Moll won the Technovisionaries Women Innovation Award organised by Women & Technologies, while in 2009, Moll and the Green Biotech Team at EuropaBio were presented with the Leadership and Excellence in Advancing Ag-Biotech and Food Issues Award. She was also named one of the 15 leading women in biotech in Europe in 2017.

Global Significance Speaking at the launch of BioPharma Ambition on October 24, Matt Moran, Director of BPCI, said, ““The island of Ireland has established itself as a place of global significance for the biopharmaceutical industry, winning much international investment, with the top 10 global biopharmaceutical companies already having an international base here. It is a testament to the substance behind the Irish business model that Ireland is considered a global champion of innovation and drug development, positively impacting the healthcare needs of patients across the world.

“Currently, more than 28,000 people work within the industry here, but with the right investment from policy makers, we could see that figure rise to more than 36,000 by 2020. To remain the global location of choice for the development and manufacturing of biopharmaceuticals, and to help the industry navigate Brexit uncertainty, it is essential that the Government increases investment in education, research and development for our industry. An increase in spending on science, technology and innovation to 2.5% of GDP by 2020 would be an important step in the right direction.”

To register to attend BioPharma Ambition, please go to the event website: http://www.biopharmaambition.com/Sectors/BPCI/Conference2018. nsf/vPages/Home?OpenDocument

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Science Foundation Ireland

Supporting the Future of Science Over the last fifteen years, Science Foundation Ireland has reformed and transformed the Irish research landscape through a series of prioritised and focused funding programmes and a determined vision to grow global excellence and impact.

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.

in Agriculture Sciences and 5th in Chemistry; ● SFI researchers have reported over 1,600 collaborations with industry, 929 collaborations with Multinational Key Milestones and Achievements Corporations (MNCs) and 674 with Small and Over the past number of years through Medium Enterprises (SMEs); sustained Government investment by Science ● Ireland now has a global scientific reach, Foundation Ireland: given that SFI-funded researchers engage in 2,359 international academic ● Ireland has climbed the international collaborations spanning 63 countries; scientific rankings for the quality of its ● SFI researchers produce 4,000 scientific research from a position of 36th in 2003 to publications; 10th in 2016; ● Training the next generation of researchers ● 2nd in Nanotechnology, Immunology and by supporting over 1,400 postgraduate Animal and Dairy; 3rd in Materials Science; 4th students in Ireland;

● The establishment of world-leading SFI Research Centres.

The Science Foundation Ireland Strategy: Agenda 2020 Agenda 2020, Science Foundation Ireland’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 Ireland’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;

Professor Conor McCarthy, University of Limerick, Director of CONFIRM.

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Irish PharmaChem | Industry Buyers Guide 2018

Science Foundation Ireland 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; 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.

Science Foundation Ireland Awards Science Foundation Ireland makes competitive grants/awards based upon merit review for excellence and impact by international distinguished scientists. As the largest competitive research funder in Ireland, Science Foundation Ireland offers a balanced portfolio of programmes, many involving national and international collaborations with industry (small and large), charities (Wellcome Trust, Irish Cancer Society) international funders (National Science Foundation, National Institute of Health (USA), Royal Society, EPSRC and BBSRC (UK), Department of Education and Learning (N Ire), National Natural Science Foundation China) and national funders in Ireland (Teagasc, HRB, EPA, SEAI, Marine Institute, etc.).

This balanced portfolio includes both investigator initiated and thematic calls, project grants and large-scale centre awards, short and long-term funding support for early career researchers, emerging and established research leaders, individual and collaborative awards.

Science Foundation Ireland offers a number of funding mechanisms, which help industry and academia build competitive advantage by enhancing their R&D capabilities; enable them to engage in projects of scale, excellence and relevance; and allow them to explore novel opportunities and priorities – all with significant state funding.

The agency has a range of funding programmes that suit industry informed research and industry-academic interactions at a number of levels, ranging from seeding an initial engagement with an academic group to large scale collaborative research endeavours.

Science Foundation Ireland Research Centres SFI Research Centres are major funding awards which link world-class scientists and engineers in large-scale partnerships across academia and industry to address crucial research questions.

In 2017, four new world-class Science Foundation Ireland Research Centres were approved through an investment of €74m from the Government over the next six years, and a further investment of €40m from industry. The Irish PharmaChem | Industry Buyers Guide 2018

four SFI Research Centres will engage in over 80 collaborations with industry partners; both indigenous and foreign; large and small.

The four new SFI Research Centres will address the following: CONFIRM aims to transform Ireland’s manufacturing industry to become a world-leader in smart manufacturing. The manufacturing sector is the second largest employer in Ireland and accounts for €110 billion in exports. Smart manufacturing optimises production systems, adding intelligence and enhanced information technology. These new technologies will be at the heart of the factories of the future, increasing product line adaptability, enabling real-time decision making, shortening supplychains, and speeding up the development of new innovations to produce higher-quality goods at reduced costs across all industry sectors. CONFIRM will be revolutionary for Irish manufacturing competitiveness, delivering the technological advances and expertise for a smart manufacturing innovation ecosystem, enabling companies to compete within the rapidly changing global landscape, and boosting Ireland’s reputation as a leading international manufacturing location.

BEACON - Bioeconomy Research Centre: The modern world is dependent upon fossil resources to produce everyday items that we consume. Since these resources are finite and depleting, it is essential to develop alternative technologies based on renewable biological resources. The future economy must use biological resources sustainably to produce valuable goods, such as bioactive molecules, chemical building block, plastics, fuels, and energy. This future economic activity is referred to as the bioeconomy. In Ireland, the agri-food and marine sectors produce high volumes of residues during food production.

The conversion of these residues to higher value products will create new business opportunities. New value chains will allow

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Science Foundation Ireland these industries to diversify and add value to the sector, increase resource efficiency and complement food production activities. 80% of agri-food companies are in rural Ireland; thus, the bioeconomy will be a key driver to stimulate rural and agricultural redevelopment.

The BEACON SFI Research Centre addresses multiple scientific, technological and social challenges to convert this vision into reality.

FutureNeuro is focused on addressing the socio-economic burden caused by chronic and rare neurological diseases. In an internationally unique manner, FutureNeuro links innovative neurotherapeutics development with genomic and biomarker-based patient stratification, a national eHealth infrastructure and a nationwide clinical network. Building initially on world-leading pre-clinical and clinical research into epilepsy and motor neurone disease, the FutureNeuro Centre is a scalable platform that will expand quickly to focus on other chronic and rare neurological diseases. FutureNeuro is relevant to the 700,000 people living with a neurological condition in Ireland, with an associated health and societal cost greater than €3 billion each year. It will strengthen Ireland’s ability to attract foreign direct investment from companies active in the multi-trillion euro global market for diagnostics, treatments and medtech for neurological diseases, and facilitate indigenous companies seeking to access this market.

I-FORM Advanced Manufacturing Research Centre will enhance processing efficiency for Irish manufacturing, allowing the production of highly customised 3-D printed components exhibiting superior performance. This will be achieved through the efficient use of advanced process monitoring, incorporating embedded sensors and process control in the entire value chain from “powder to final product”. Advanced data analytic techniques will ensure superior product quality and reduce manufacturing waste. The Centre will enhance the manufacturability of bespoke components and products using 3D printing techniques.

This technology enables manufactured components to be customised for individual end users. For example, artificial joints and implantable medical devices can be tailored to match the needs of individual patients. The I-FORM Centre will make a distinct and positive impact on the international competitiveness of Irish additive manufacturing.

These new centres will join the network of 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. A number of SFI Research Centres which have a strong focus on pharma-related investments include: The Alimentary Pharmabiotic Centre (APC) Microbiome Institute investigates the close

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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 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) 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) aims 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 ‘moleculeto-medicine’ approach that encompasses chemical synthesis, crystal engineering, and drug production and manufacture.

For more information about Science Foundation Ireland supported research and details of upcoming calls, go to www.sfi.ie.

Irish PharmaChem | Industry Buyers Guide 2018

Ireland’s Raw Materials Specialists Unit 49, Baldoyle Industrial Estate, Baldoyle, Dublin 13, Ireland T. +353 1 839 3127 F. +353 1 832 5746 E. info@heterochem.com W. www.heterochem.com

hovione.ie

REACH 2018

Are You Ready for

REACH 2018?

All chemical substances produced or imported from outside the EU between one and 100 tonnes per year, need to be registered with the European Chemicals Agency (ECHA) by May 31, 2018. Are you ready?

May 31, 2018, is the last deadline for registering chemicals under the REACH Regulation, by which time companies need to register to be legally permitted to import or place chemical substances on the EU market.

It is anticipated that this last deadline for manufacturers and importers into the EU, will involve a much wider group of participants with varied levels of knowledge of the process. For those registering for the first time in 2018, it is important to plan well in advance by becoming familiar with the process and the information requirements to register to ensure successful registration before the deadline.

In an effort to simplify the process of registration, ECHA have published a REACH 2018 web site (https://echa. europa.eu/reach-2018) which breaks the process down into seven steps: 1. Know your portfolio 2. Find your co-registrants 3. Get organised with your co-registrants 4. Assess hazard and risk 5. Prepare your registration as a

IUCLID dossier 6. Submit your registration dossier 7. Keep your registration up-to- date

1. Know Your Portfolio Starting from your portfolio, you need to identify those substances which are subject to registration by May 31, 2018. Refresh your knowledge on REACH duties and decide for which substances you want to continue on the market.

Irish PharmaChem | Industry Buyers Guide 2018

Unambiguous and correct identification of your substances is essential to a successful and compliant registration. Review that the substance identity information you provided in the pre-registration is still valid. Familiarise yourself with the REACH information requirements triggered by the tonnage and uses of your substances. Later in the process, you will need to compile all the required information in a registration dossier using the IUCLID software application (See step 5: Prepare your registration dossier in IUCLID).

2. Find Your Co-registrants All co-registrants for the same substance are part of a cooperation group called a substance information exchange forum (SIEF). They all have to share scientific data on the substance and register jointly.

Find who intends to register or has already registered your substance.

Many substances have already been registered. A list of already registered substances is published on ECHA’s website.

If your substance is already registered, find out who the lead registrant is. You probably received emails from that company already.

Otherwise, check from the Joint submission pages in REACH-IT. The lead registrant will put you in contact with the SIEF. If your substance has not been registered yet, find the contact details of your potential co-registrants in the pre-SIEF pages of REACH-IT. Review your own contact details.

Once you are in contact with the SIEF, confirm that your substance is the same as in the existing registration. If your substance has not been registered yet, check with

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REACH 2018 all co-registrants that you intend to register the same substance before forming a SIEF.

3. Get Organised with Your Co-registrants If no registration for your substance exists yet, you have to agree with your co-registrants how to work and communicate within your SIEF. This can include hiring a consultant or sharing the workload among SIEF members.

Each SIEF must also select a lead registrant who will submit the lead registration dossier, to enable the co-registrants to submit their member registration dossiers.

Model SIEF agreements have been set up by industry associations.

Links to their web pages are available from the Accredited Stakeholders page on ECHA’s website.

If the lead registrant registered for the 2010 or 2013 deadlines, it is likely that the preparatory work has already been done. You need to contact the lead registrant and ask to become a member of the joint submission after agreeing on data and cost sharing.

SIEF members must share available scientific data and decide how to fill data gaps. This takes time and has to be done before preparing and submitting the registration dossier. You need to discuss the relevance, reliability and adequacy of the data available. Additionally, you may need to select from overlapping data.

If a registration already exists, you need to negotiate with the existing registrants to get access to the submitted data. However, you might not need access to all the data, but only to the data required for your tonnage band. You might also consider using your own data.

This needs to be discussed with your co-registrants.

Under REACH, the costs of registration need to be shared in a fair, transparent and non-discriminatory way. Data sharing is not designed to generate profit for any party, but to share the actual costs. SIEF members must reach an agreement on how to share the cost of data and the cost of SIEF administration. Importantly, you only pay for the information and the management of the SIEF that directly relates to your own registration.

You also have the right to know the basis for the costs you pay.

Remember that data submitted

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Unambiguous and correct identification of your substances is essential to a successful and compliant registration.

more than 12 years ago can be used free of charge.

As a last resort, if you cannot agree on data and cost sharing with your co-registrants, ECHA can assess your case. This applies to disagreements on performing missing tests, as well as disputes on sharing the data and its cost. The data-sharing dispute procedure is free of charge and can be managed without legal support.

● If manufacturing or importing more than 10 tonnes per year, you need to carry out the chemical safety assessment (CSA) and record it in a chemical safety report (CSR).

Additionally, during the SIEF discussions, the co-registrants decide if the lead registrant will submit the chemical safety report jointly on behalf of the co-registrants or if the individual registrants will submit their own CSR separately.

If you are a lead registrant, your registration dossier includes the information submitted by you on behalf of all the co-registrants, such as the boundary composition of the substance, classification and labelling of the substance, uses, and (robust) study summaries, where applicable. In addition, as a lead registrant, you also add your own company-specific and substancespecific registration information in the same dossier.

It is good practice that you share the common parts of the registration dossier with the other members of the joint submission in the IUCLID format, as it contains information related to the safe use of the substance that needs to be known by the co-registrants.

The lead dossier must be successfully submitted before the members can send their own dossiers to ECHA. Therefore, as a lead, prepare your registration dossier well before the deadline, so that your co-registrants have enough time to meet the deadline as well.

4. Assess Hazard and Risk An important part of the SIEF work with your co-registrants is to compile information on uses, hazards and risks in order to demonstrate safe use of the substance.

You will need to consider the following regulatory, scientific and technical requirements: ● Gather information on uses and current conditions of use from the supply chain. Contact your industry association for best practice in your sector; ● Collect hazard data as requested

by REACH information requirements triggered by the tonnage and uses of the substance; ● Assess the coverage and quality of the hazard information about the substance available within the SIEF; ● Define the strategy to fill in any resulting data gaps (e.g. carrying out new studies, justifying missing information using scientifically solid read across, data waivers etc.); ● Agree classification and labelling within the SIEF (based on the hazard data); ● Record all hazard data and classification in the registration dossier; and

5. Prepare Your Registration as a IUCLID Dossier After you discuss and exchange data within the SIEF, the lead registrant and each member registrant should have all the relevant information available to create their registration dossiers using the IUCLID format. There are three options: IUCLID Cloud for SMEs, IUCLID 6 and REACH-IT. If you are an SME or a consultant working for an SME, the IUCLID Cloud for SMEs helps you to avoid any installation and gives you easy access, automated, regular back-ups and updates by ECHA. As a consultant, the cloud version enables you to transparently collaborate with your SME clients and to easily and securely share IUCLID information with them.

Irish PharmaChem | Industry Buyers Guide 2018

REACH 2018 If you are a member registrant, your registration dossier includes information specific to your company and your substance. This covers, for example, information about the identity of your substance (composition, analytical data), the identified uses that are relevant for your company, and the estimated volumes of manufacture or import.

If you choose not to participate in the joint submission for some information requirements, you need to include your own data for that requirement in your dossier, together with an appropriate justification on why you are opting out.

If you agree with all information submitted on your behalf by the lead registrant, you can also create your member registration dossier directly in REACH-IT. The dossier creation wizard in REACH-IT guides you through this process by showing you which data you need to provide.

ECHA has developed supporting material and tools which are directly available in IUCLID to help you prepare your registration dossier: ● The

Validation Assistant will show if your registration dossier is complete, apart from information checked manually by the ECHA staff;

● The

Dossier Quality Assistant (included in the Validation Assistant) will help detect potential inconsistencies in your registration dossier;

●

The Report generator will allow you to generate your chemical safety report (CSR);

●

The Dissemination preview will show which parts of your registration will be published by ECHA, based on the legal requirements and your requests to keep certain information confidential.

6. Submit Your Registration Dossier Your registration dossier should now be ready to submit in REACH-IT. If you submit before April 2018, you will benefit from a reduced processing time and receive ECHA’s decision on your registration within three weeks of your submission. Otherwise, you may only receive your decision at the end of August 2018.

Before the submission process can begin, the lead and member registrants need to identify themselves and the joint submission to which they belong to in REACH-

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All co-registrants for the same substance are part of a cooperation group called a substance information exchange forum (SIEF), who have to share scientific data on the substance and register jointly.

IT. Remember also to check that the contact details of your company are up-to-date in REACH-IT. If you are a lead registrant, you will need to submit your registration dossier before the members can submit theirs. To give the member registrants sufficient time to submit before the May 31, 2018 deadline, you are advised to submit your dossier before April 2018.

If you are a member registrant, be active in the substance information exchange forum (SIEF) and follow the progress of the joint part of the registration so that you know when the lead registrant submits their dossier.

Whether you are submitting a IUCLID dossier, or using the ‘prepare and submit’ functionality in REACHIT, submitting your registration is easy. The REACH-IT submission wizard and the embedded help text will guide you through every step of the submission process.

After submission, ECHA will perform a series of checks on your dossier and will keep you informed every step of the way. Check your Tasks page in REACH-IT as you may be requested to perform additional tasks within a set timeframe. At this stage, these may include updating your dossier if the initial dossier fails one of ECHA’s checks, or you may be required to pay the registration fee.

ECHA cannot accept late payments for registration fees, so it is very important that you pay the fee by the due date of the invoice. You will receive a registration number once your dossier has passed all of ECHA’s checks and the invoice for the registration fee has been paid.

7. Keep Your Registration Up-to-date ECHA may examine any registration to verify if the information submitted by registrants is compliant with the legal requirements. The selection for

compliance check is either random or concern-based (targeted).

Registration under REACH is not just a one-time exercise and your legal obligations do not end after you receive a registration number.

Up-to-date information is needed to ensure that chemicals are being used safely. You should update your registrations whenever new information becomes available. You should also check ECHA’s annual evaluation reports.

By reading the reports and the recommendations, you can learn what are the most common shortcomings and avoid having the same problems in your own registrations. For example, you should check whether a harmonised classification and labelling has become available for your substance.

New information may also come from your supply chain or when new members join the joint submission.

Data sharing obligations also apply when new members join.

Being proactive is not only good practice, but also a legal requirement.

You need to keep your registrations up to date even after receiving the registration number. This will most likely avoid you being asked to update your dossiers.

For more information: REACH 2018 web site: http://echa. europa.eu/reach-2018 ECHA’s Getting Started web page: http://echa.europa.eu/support/ getting-started ECHA’s SME Guidance Assess hazard and risk Irish Helpdesk: chemicals@hsa.ie

If you are a lead registrant, you will need to submit your registration dossier before the members can submit theirs, so lead registrants are advised to submit your dossier before April 2018.

Irish PharmaChem | Industry Buyers Guide 2018

SF AbbVie Ad A4.qxp_Layout 1 20/10/2017 12:29 Page 1

Investment & Development Pictured at the announcement by Janssen Sciences Ireland UC of the €300m expansion of its facility at Ringaskiddy, Co. Cork, are (l-r): Martin Shanahan, CEO, IDA Ireland; Kyran Johnson, General Manager, Janssen Supply Chain Ireland; Carin Huibers, Global Platform Leader, Parenterals, Janssen; and Remo Colarusso, Vice President, Manufacturing and Technical Operations.

Highlighting Ireland’s Key Role in Global Life Sciences Benchmarking the development of the Biopharma sector in Ireland at IDA Ireland, we continually question where is the industry at now? What has been achieved? And where do we go next?

What we in IDA wish to achieve is continued pre-eminence of Ireland in the biopharma and broader life sciences sectors. I am particularly interested in the growth and success of the biopharma sector and what is happening among the strong cohort of global companies that currently populate the island of Ireland, not just those based in Dublin or Cork but the many other growing regional clusters in Waterford, Athlone and Sligo.

Investing in the Building Blocks of Biologics The big story in this sector is the continued investment in biologics manufacturing facilities, both by new players and also through the expansion of existing sites. All of the top 10 global biopharma companies, by revenue, have international manufacturing activities in Ireland, with over €10 billion invested by them in the last decade and a continued run rate on investment of €1 billion per year.

To its credit, Ireland has invested in the building blocks and supports for the sector, including research, skills and construction. In particular, investment in NIBRT to support the research and training of staff for all biopharma

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IDA Ireland is working hard to achieve the continued pre-eminence of Ireland in the biopharma and broader life sciences sectors, writes Tommy Fanning, Head of Biopharmaceuticals & Food at IDA Ireland, who outlines what is required for our island to continue to play a strong role in future products and technologies. companies has been a real success story. Many companies have cited the Institute as a key influencer in their decision-making process when selecting Ireland over other international locations.

In August 2016, the expert skills group within our Department of Business, Enterprise & Innovation produced a report on the skills needs of the biopharma sector until 2021. This report projected a need for an additional 8,500 employees across the sector, split between new hires and the replacement of existing positions. This report is now being actioned and implemented by BioPharmaChem Ireland, in conjunction with the regional skills officers across the country and collaborating with local educational institutions.

Benefits to the Wider Economy Extra investment in the broader Irish economy, namely in terms of construction jobs, consulting engineering and more local supply

by Irish indigenous companies supported by our sister agency Enterprise Ireland (EI), has been a key component in the growth of the sector.

Most construction projects require hundreds of workers over a three or four year term to achieve completion and validation of a new facility. In response, EI launched a programme and created a team under the ‘Global Sourcing’ label, whereby, with the assistance of IDA Ireland, introductions are made to the procurement teams of key biopharma companies. In doing so, they are inviting local suppliers to bid for contracts, in addition to exploring longer term technology partnerships around the manufacture of next-generation products.

This year saw Dublin bid for the European Medicines Agency (EMA) and while no decision has yet been taken, it has been a real opportunity for a whole of government working group, alongside a number of outside stakeholders, to truly understand the strong and positive attributes of Dublin for a major European agency. We have a very strong background in life sciences, IT and data analytics. Right now, Dublin and Ireland are in a strong growth phase due to the quality of skills available here and the strong ‘right first time’ regulatory culture that pervades all of our Irish PharmaChem | Industry Buyers Guide 2018

Investment & Development companies both in biopharma and medical technologies.

The Role of the HPRA A key aspect of this has been the work of our Irish regulator, the HPRA. The HPRA has had a major role to play in the regulatory culture that exists in Ireland today. Its current openness to engaging with companies and related bodies to learn and to future scan on what challenges will arrive is a testament to a broader Irish attitude to take on the next generation of developments in biopharmaceuticals.

Going forward, Ireland needs to develop a stronger understanding of what is required for our island to continue to play a strong role in future products and technologies. For example, 2017 has seen the first approval of a cell therapy product, using CarT technology to produce the first of what is projected to be a burgeoning new sector in the years to come. As it will be more targeted at individual patients, it will require a very different delivery platform, which might be hard to describe or classify as manufacturing. The proposal by NIBRT to Science Foundation Ireland (approved but not yet funded), ‘Biologic’, could create an opportunity for Ireland to reaffirm its status as an international location of choice for global life sciences companies.

Broadening Role in the Value Chain Ireland has a deep experience and skills base in manufacturing, but a trend that we see continuing in 2017 in particular, is a broadening of Ireland’s role in the wider value chain for biopharmaceuticals. This would entail moving backwards into clinical batch development and forwards into clinical stage IV of a product’s life cycle, where data analytics and digital platforms will play a much stronger role.

The then Tánaiste and Minister for Business, Enterprise and Innovation Frances Fitzgerald TD with Niall O’Leary, Senior Manager, Biotech Production, Regeneron, and Michael Lohan, Head of Lifescience, Engineering & Industrial Technology, IDA Ireland, at the announcement of 300 additional jobs and a €100m investment at Regeneron’s Limerick facility.

The role that data will play in the future will see it cover all elements, from clinical trials to digital factories to digital sales forces. This will require the skills which are already available to other sectors of our economy today working for companies such as Google, IBM or LinkedIn and will now be deployed by biopharma companies.

We strive to maintain the global view that the Irish site is the centre of expertise and excellence in any global company and, therefore, the obvious choice for the launch of new products.

Today, this has been a reality, and while there will always be challenges to Ireland’s continued success in the future, greater convergence across biopharma, medical technologies, IT, data analytics and industrial automation will help to elevate our importance among the biopharma and broader life sciences sectors in Ireland.

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

Taoiseach Leo Varadkar TD and then Tánaiste and Enterprise Minister Frances Fitzgerald TD are among those pictured at the official opening of the €85m extension at Bausch + Lomb earlier in the year.

Irish PharmaChem | Industry Buyers Guide 2018

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NIBRT

Biopharma Growth Continues at Pace NIBRT single use Centre of Excellence.

Over the last decade, the Irish biopharma sector has seen $8 billion in capital investment in new facilities, which represents close to the largest wave of investment in biopharma manufacturing anywhere in the globe. There was further good news for the Irish biopharma sector throughout 2017, with the announcement of several major investments, including: ● Merck & Co. investing €280m in their latest commitment to their Irish biomanufacturing sites; ● Janssen’s $350m expansion of their Ringaskiddy site; ● Regeneron’s announcement of 300 additional jobs in Limerick; ● SK Biotek’s acquisition of Bristol-Myers Squibb’s Active Pharmaceutical Ingredients manufacturing facility in Swords; ● Theravance Biopharma’s opening of a new corporate office and labs in Dublin.

The National Institute for Bioprocessing Research and Training (NIBRT) works with all stakeholders from industry, government and academia to support the development of the sector by providing bespoke training and research solutions in state-of-the-art facilities.

NIBRT continued to have a very strong 2017, with

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NIBRT continued to have a very strong 2017, with a number of significant developments across its research, training and facility development operations, writes Killian O’Driscoll, NIBRT’s Director of Projects, who also points to a number of important projects for 2018.

a number of significant developments across its research, training and facility development operations.

Research Collaborations Pfizer and NIBRT commenced a new collaboration, focused on the development and application of advanced process and analytical methods for inline monitoring and continuous characterisation of bio-pharmaceutical manufacturing processes.

The collaboration aims to reduce the requirement for offline analytical testing by integrating automated sampling and analytical characterisation, using high resolution liquid chromatography mass spectrometry directly with the bioreactor systems. The system will generate

both process and product quality data in near real time, to provide process and analytical scientists with key information to guide development of their bio-pharmaceutical processes.

Speaking on behalf of Pfizer, Brian Fitzpatrick, Senior Director, Bio Aseptic Sciences Group, explained, “Pfizer are excited to collaborate with Dr Jonathan Bones, Dr Colin Clarke and their teams at NIBRT to develop and apply more automated process and analytical characterisation platforms for the near real time analysis of bio-pharmaceuticals during the manufacturing process. The range of information we can get from such integrated systems will be a real step forward and can really help us to develop a much greater understanding of our Irish PharmaChem | Industry Buyers Guide 2018

NIBRT manufacturing processes and their influence on the characteristics of our products.”

The science-based technology company 3M also began a collaborative research project with NIBRT. The first study, which is currently underway, is examining the effect of chromatographic clarification on host cell DNA, and the specific type and quantity of host cell proteins removed prior to downstream processing.

NIBRT’s research team was further strengthened with the appointment of Professor Niall Barron as NIBRT Principal Investigator and Professor of Biochemical Engineering in the School of Chemical and Bioprocess Engineering in UCD. Prof. Barron’s research interests focus on targeted genetic engineering strategies to improve or control the production of recombinant therapeutic proteins from Chinese Hamster Ovary (CHO) cells. Prior to joining NIBRT, Niall was instrumental in growing the mammalian cell engineering group in National Institute for Cellular Biotechnology (NICB), with a specific focus on the production of recombinant therapeutic proteins.

Facility Development June 2017 saw the official opening, of the NIBRTGE Single-Use Centre of Excellence, featuring the latest single use technologies that will further boost biomanufacturing skills and expertise in Ireland, Europe and globally. The new centre also supports the GE BioPark Cork, a GE-managed campus including four prefabricated, off-theshelf biologics factories owned by independent biopharma companies manufacturing proprietary medicines, creating up to 500 jobs.

Commenting on the opening, David Radspinner, General Manager, BioPark, GE Healthcare, stated, “The biopharma industry is growing rapidly; of the top 10 therapeutics on the market today, eight are biopharmaceuticals. Our customers are constantly looking for flexible ways to improve capacity and the efficiency of their manufacturing operations.

We need to foster innovation and partner with the best to respond to this need: with the NIBRT partnership and GE BioPark Cork, we are doing exactly this.”

Building on the successful partnership, NIBRT was delighted to open the Thermo Scientific biopharma characterisation lab, where NIBRT will develop workflows on the Thermo Scientific biomolecule column range, with its associated consumable portfolio, in conjunction with sophisticated Thermo Scientific liquid chromatography systems and advanced Thermo Scientific Orbitrap high resolution mass spectrometers.

“Analytical characterisation of biopharmaceuticals remains a challenge for scientists and requires cutting edge chromatography solutions and mass spectrometry detection,”commented Jakob Gudbrand, President of Chromatography and Analytical Technologies at Thermo Fisher. “NIBRT is an independent centre of excellence with collaborations across the major biopharmaceutical companies in the industry.

Irish PharmaChem | Industry Buyers Guide 2018

NIBRT and Pfizer teams pictured at the announcement of their collaboration.

This allows them to provide valuable insights to improve the technology, simplify analysis, generate informative characterisation data and understand these complex molecules, ultimately enabling scientists to move from sample to knowledge quickly and efficiently.”

Training 4,000+ 2017 was one of NIBRT’s busiest training years, with over 4,000 people trained and close to 19,000 days of training delivered. The diverse portfolio of training ranged from one-day introductory courses to bespoke courses for Industry and online Masters programmes, with particular highlights including: ● Springboard courses, which provided approximately 400 jobseekers with free, accredited training programmes. In an exciting development from 2017 onwards, Springboard courses are now also available for those in employment who wish to upskill. ●

Customised

training

programmes

to

support clients who are developing biopharma manufacturing capacity. In particular, NIBRT was delighted to partner with Bristol Myers Squibb as they developed their $900m Cruiserath facility for the manufacture of immuno-oncology products. ● Delivery of training to international clients, which accounts for approximately 25% of NIBRT’s training. For example, NIBRT was pleased to further partner with AbbVie to provide training to global Health Care Practitioners and Key Opinion Leaders.

Partnering with 14 Higher Education Institutes and Institutes of Technology to provide undergraduate training programmes to ensure the supply of skilled graduates throughout all regions.

●

The Next Generation of Biopharma Talent A key component of NIBRT’s remit is to help develop the next generation of biopharma talent, with a number of exciting initiatives

Former Minister Mary Mitchell O’Connor, TD with NIBRT, GE and IDA representatives at the opening of the NIBRT-GE Single Use Centre of Excellence.

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NIBRT Participants on the Citywise ‘Biotechies’ programmes.

launched in 2017, including: Collaboration with Citywise ‘Biotechies’ programmes, which provides young people growing up in difficult or hostile city environments with after-school and out-of-school educational support. Citywise’s educational programmes raise the sights of young people, giving them an enthusiasm for learning and opening up possibilities for further education. ● Amgen’s School of Biotech Excellence (ABE), which is an innovative science education programme that empowers teachers to bring biotechnology into their classrooms. ABE Ireland offers training in molecular biology experiments for secondary school teachers at locations in University College Dublin, Dublin City University and NIBRT. ● The launch of NIBRT’s Biopharmaceutical Science Transition Year Competition. The very popular competition invites transition year students to submit an essay focusing on the biopharma sector in Ireland. The successful students will then receive a one week structured placement in NIBRT, where they will have the opportunity to experience the state-of-the-art facilities and learn from scientists working in the research and training team. ● NIBRT’s Annual Careers Day and Biotech Cluster at CareerZoo continue to be very popular events to connect the industry with high quality prospective employees. ●

Awards The ongoing success of NIBRT was reflected in a number of prestigious national and international awards in 2017, including: ● Dr Colin Clarke won the Young Leader of the Year award at the Irish Lab Awards; ● Professor Pauline Rudd and Dr Jonathan Bones were both recognised within the Medicine Maker’s Top 100 Power List; ● NIBRT was shortlisted for the CPHI bioprocessing award; ● NIBRT and GE won the Collaboration of the Year Award at the Irish Pharma Awards.

What’s Next?

Biopharma continues to develop at a rapid pace and in NIBRT’s annual survey, 69% of respondents indicated they are “highly optimistic” for the future growth of the sector. While current investment is focused mainly on CHO based production of monoclonal antibodies, it’s clear that there is an exciting diversification in product pipelines. Most notably in 2017 was the breakthrough in CAR-T

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cancer therapy with FDA approval for Novartis and Gilead. These therapies combine aspects of personalised medicine, cell and gene therapy to provide a new frontier in cancer treatment, while posing many manufacturing and supply chain challenges.

The underlying manufacturing technologies are also constantly evolving, with a lot of debate in 2017 on “Industry 4.0” and the impact of digitisation, automation, robotics and related technologies on manufacturing strategies. In 2018, NIBRT will be launching its Online Academy to assist the sector in keeping current with this fast-paced change.

Also in February 2018, the Irish Pharmaceutical Healthcare Association and BioPharmaChem Ireland, representing the research based and manufacturing biopharmaceutical industries respectively, together with NIBRT, will host BioPharma Ambition, a multi-platform event to inspire and showcase innovation. With international policy leaders, renowned researchers and senior industry personnel, the event will highlight the ambition of the industry for the health and well-being of populations. It will also highlight where the research is pointing and how all stakeholders in Ireland will support innovation in discovery, development, manufacturing and healthcare solutions to ensure Ireland builds on its success in establishing a thriving biopharma sector.

About the Author Killian O’Driscoll is the Director of Projects at the National Institute for Bioprocessing Research and Training (NIBRT).

Killian is a Genetics Graduate from Trinity College Dublin with an MSc in the Management of Innovation from the University of London.

He also is an Associate Lecturer in Project Management at Dublin Business School.

Prior to joining NIBRT, Killian worked at Microsoft European Operations Centre as Senior Global Project Manager and at Ericsson Competence Development Centre in the area of technology education and development. Killian, working closely with all stakeholders in the biopharmaceutical industry, has been involved in the successful establishment of NIBRT, which has numerous international accolades, including ISPE Facility of The Year, Bioprocess International Manufacturing Collaboration of the Decade and NIBRT is now recognised as a global leader in biopharma research and training.

Irish PharmaChem | Industry Buyers Guide 2018

Where Your Critical Lab and IT Technologies Always Work Westbourne Global Laboratory and IT Services delivers multi-lingual technical service desk solutions to the biopharmaceutical, healthcare and food sectors, on a global scale.

We are a flexible, niche provider of top-end, high-quality services on a 24x7x365 operating from Ireland, NZ, USA and UK, where the focus is always on providing a cost-efficient, high quality customer experience combined with delivering constant improvement through innovation.

Elite Performance is achieved by our Engineers aligning to your company values and processes while operating with ITIL and SDI frame work/best practices. Elite client experience is delivered as our Engineers are highly educated and experienced in Lab/IT environments.

Find out how we can transform your technical support from bug bear to strategic advantage. +353 21 431 4310 James.symington@westbourne.ie www.westbourne.ie

Data Integrity

Data Integrity Enda Dempsey, BioPharmaChem Ireland, provides some industry insights for improving Data Integrity compliance in an increasingly regulated environment.

The concept of Data Integrity (DI) is not new to the industry but it is still one of the most cited causes for non-compliance. In 2015, 35% of all the EU Statements of Non Compliance were related to DI, while last year it featured in 37 out 46 FDA warning letters (excluding compounding pharmacies).

At its core, DI is “the extent to which all data are complete, consistent and accurate, throughout the data lifecycle” – PIC/S. The basic principles for DI, ALCOA, centre on the generation and quality of the information. In recent years though, this has been expanded to include four new parameters; Complete, Consistent, Enduring and Available, so that the process and management oversights are also covered.

This has increased the pressure on companies to develop a robust data governance model, which can be flexible enough to implement new recommendations from guidelines or regulations, create a consistent culture of

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awareness across the entire organisation, and have enough expertise within the workforce to tackle the more pernicious technical challenges that arise.

Despite the wealth of information already available from numerous influential healthcare organisations, the regulatory authorities themselves, specifically the FDA, MHRA, EMA and WHO, have demonstrated unprecedented activity covering this topic by releasing at least seven major publications since March 2015, each with more granular detail. This just reflects the scale and complexity of the topic.

Enda Dempsey, BioPharmaChem Ireland.

Serialisation of Medicines Adding to the burden, serialisation of medicines to prevent counterfeiting is being rolled out in different instances globally; the Falsified Medicine Directive (FMD) in Europe, the Drug Supply Chain Security Act in the US and the federal repository and tracking system FGIS MDLP in Russia, to name but a few. This will

Irish PharmaChem | Industry Buyers Guide 2018

Data Integrity yield several terabytes of extra data per product that will have to be managed, plus the not insubstantial costs for updating manufacturing lines and in Europe, paying for repository costs (approximately €15,000 annually per product per country).

The FMD further complicates the system by requiring the unique, randomised code being assigned to a pack. This in effect means that each pack is its own batch and that will impact on the reconciliation process all the way through the supply chain, until the pack is eventually sold. Therefore, the need for companies to have a tractable, reliable and accurate data governance model is greater than ever.

Most, if not all, pharmaceutical companies are actively strengthening their data integrity systems to improve their drug quality and ultimately increase patient safety. While there are no off-the-shelf solutions to develop a DI culture, several companies have previously shared some of their strategies for getting started.

The Steps to Good Data Governance As a first step, it was recommended to establish a dedicated Data Governance Committee that includes a broad spectrum of roles and seniority within the company; ideally senior leadership plus managers or SMEs from quality, manufacturing and the laboratory divisions.

The group should establish a charter outlining their site improvement plan, specific roles and responsibilities within the group, a progress tracker and some aspirational goals or milestones to aim for. The group should review training initiatives, site communications, set up projects to identify DI gaps and participate in informal process inspections e.g. Gemba walks.

This is important as it demonstrates that there is a real interest in the programme locally as opposed to be pushed out from a corporate level only.

The Gemba walks for the committee help improve their general knowledge of the site, particularly what is working well and what isn’t.

However, it is critical that it’s not used as an informal audit.

The DI gap analysis should be done by the divisions that are involved in the process rather than relying on the Data Governance team, although they would need the findings relayed to them.

Utilise Multiple Communication Tools To maintain awareness and change employee behaviour, it is worth utilising multiple different communication tools, such as newsletters, crossword campaigns and posters. Tackling quality control and production areas tend to be easiest as these sections are already quite structured. To increase responses from the employees, anonymous suggestion boxes and Irish PharmaChem | Industry Buyers Guide 2018

rewards are typically given. These are usually small monetary prizes but in at least one case, an extra day’s leave was offered and this prompted a huge response.

To foster a culture of awareness and engagement, the focus should be on the problems, not the person. Also, Human Error is attributed to 36% of all deviations but retraining is the appropriate CAPA for only 6% of the time, the other 94% of errors will not be solved or prevented by retraining, making it even more important not to blame the employee.

Sometimes errors are the result of forms being too complex or easily confused. A good example of this is the different calendar formats the EU and US use, which is an issue when recording raw material expiry dates. There is a CAPA ranking table – Level 1 is complete prevention of an incident taking place but level 4 is the lowest strategy for preventing an error and one that is still commonly used throughout the industry.

1) Automate – No human so highest level of prevention; 2) Prevent – Resist access or extra safety feature;

3) Detect and recover – Determine fault and stop it before it causes any damage;

4) Duplication – Second review/second signature.

Companies should use a system to rate their DI maturity level. The ISPE GAMP guidelines utilises a Red, Amber and Green (RAG) system, which is based on a checklist they have developed. This would allow a company to track their performance but also identify gaps in their journey.

Finally, implementing a successful DI programme requires several years for it to be embedded properly. Therefore, it is crucial that if there is a change of leadership, the programme is still retained or else the entire concept of being on a DI journey could falter.

New DI Issues Even with a robust data governance model deeply ingrained into the quality management system, new DI issues are constantly arising which auditors are picking up on. Some citations were issued to companies who did not change the default passwords on their validated equipment, e.g. a HPLC machine, which would theoretically allow an operator to bypass the controls systems and then manipulate their own data. This is also a problem with field engineers from the equipment vendor, who may be able to override all the security settings by plugging in their own laptop. As a result, several companies prevent external, nonvalidated computers or even USB keys onto their site. There is also a risk that these devices

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Data Integrity An analysis of FDA warning letters on data governance and data integrity (Source: www.pharmaceuticalonline.com).

harbour malicious software.

Other unique problems centre around data retention, which can be as long as 15-20 years.

If the contract lab is liquidated in that time, then the data will be sent back to the customer but they will not have the instrument to read it.

Alternatively, due to obsolesces of programmes, e.g. MS Dos or equipment upgrades, some data may no longer be readable or may become corrupt over time. Most companies are considering implementing cloud based systems but that would still leave a significant amount of old data at risk.

Digitalising old data so it becomes readable in the future is also fraught with difficulties, as you create the ‘True Copy’ issue. This is case whereby a ‘certified’ true copy is both electronically time stamped and has the necessary metadata surrounding it. A typical example would arise when a CMO is producing data for a MAH. If either partner makes an alteration on their document, there is a DI breach as they would both have a ‘certified’ true copy. Blockchain technology or using a shared cloud platform will probably help mitigate this risk, although it does demonstrate how unintentionally complex this topic can become.

Even though the concept and regulations for Data Integrity have been around for several decades, it is still very much a hot topic for the industry. Changes in regulations and technology create and solve new issues constantly. However, there has been a global trend of fewer defects and counterfeit medicines getting onto the market, which ultimately means safer drugs for the end-user.

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Irish PharmaChem | Industry Buyers Guide 2018

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Serialisation

Serialisation Readiness:

An Industry Benchmark

GS1 Ireland and ESP team up to produce the second annual Pharma Serialisation Readiness Report.

How do you measure up?

With the EU FMD deadline just over a year away, the challenge of serialisation is a top priority for pharmaceutical companies. Many stakeholders in the pharmaceutical supply chain are wondering if they are doing enough to meet the deadline.

GS1 Ireland and Enterprise System Partners (ESP) have teamed up to produce the second annual Pharma Serialisation Industry Readiness Report. This year’s report focuses on the industry’s ongoing efforts to meet the EU FMD deadline, and includes expert analysis from ESP and GS1 Ireland.

Rather than simply read the report, it is recommended that industry stakeholders use it as a tool with which to benchmark their own progress. This may provide the reader with reassurance that they are not behind the curve, as many companies appear to have a lot left to do. It will also highlight areas requiring action which may not have become apparent yet.

We have chosen three key questions to focus on within this article. If you would like to read the full report, visit https://www.gs1ie.org/ healthcare/serialisation-report.

Survey Composition The report draws from the results of a survey issued to key industry stakeholders between May and July 2017. The majority of the respondents were pharmaceutical manufacturers (65%), contract manufacturers (11%), and virtual pharmaceutical companies (8%). Third-party logistics providers (5%) and wholesale distributor re-packagers (6%) made up the balance. 91% of respondents were Marketing Authorisation Holders.

So how do you rate your overall readiness for EU FMD?

This year’s survey indicates that progress is being made in preparing for the EU FMD deadline. With under a year and a half to go, these results are as one would expect.

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Irish PharmaChem | Industry Buyers Guide 2018

Serialisation ensure the requirements of the regulation are complied with.

If you, like 56% of respondents, do not have a company-wide education programme relating to serialisation, there is still time to start. Firstly, identify the staff that need to have at least a basic understanding of what is involved in serialisation. Develop a foundational programme that is more business and regulatory focused. From there, facilitate a more technically advanced learning path for those who require it. GS1 Ireland and ESP are available to help with any training requirements that may arise.

Are you ready to leverage value beyond compliance?

Serialisation is a work in progress for 78% of companies surveyed, while only 7% of respondents felt ready for the deadline. 15% have yet to start their serialisation efforts.

If your serialisation preparations are running into obstacles, you may find comfort in knowing that you’re not alone. 15% of respondents reported having issues with their implementation.

What are the Principal Concerns?

What are your principal concerns in meeting your obligations? Preparations for serialisation are complex, and resource intensive. Several concerns were highlighted by the survey.

59% of respondents identified resource availability as a serious issue for them. (See graph above).

With serialisation, getting the packaging lines EU FMD compliant is only the start of the journey. A variety of proficiencies and systems are necessary to meet the requirements for packaging lines and these can be accessed by experts such as ESP.

Changing the Way Companies Do Business Is there a Company-Wide Education Programme to support your Serialisation Strategy?

However, there is a scarcity in the skills required to manage and execute activities supporting the readiness of the downstream supply chain.

Experience shows that practically all Market Authorisation Holders significantly underestimate the complexity and volume of work required to make their downstream supply chain EU FMD compliant. Therefore, it is expected that in the run-up to the February 2019 deadline, availability of these highly skilled resources will become even more of a constraint.

44% of respondents reported issues with uncertainty surrounding regulations. This regulatory uncertainty is derived from the legislative complexity of the EU FMD, which is compounded by the need to consider individual EU market nuances during serialisation implementations. GS1 has a global policy forum which tracks developments in market legislation. To find out more, please contact healthcare@gs1ie.org.

Irish PharmaChem | Industry Buyers Guide 2018

The Critical Driver As one would expect, the critical driver for most companies implementing serialisation is regulatory compliance. The deadline for the EU FMD is fast approaching and compliance has to be the number one priority. However, additional benefits can be leveraged from serialisation.

These range from improving patient safety to increasing brand protection. Industry 4.0 visibility and the order-to-cash process can also be enhanced. Underlying infrastructure and mechanisms are needed to realise value beyond compliance. These systems are enabled by the use of GS1 standards, such as EPCIS & GS1 identification keys.

Complete your own industry benchmark

The EU FMD will change the way companies do business. A host of business units within the company, from regulatory, to packaging, to engineering, need to be involved to

For more benchmark information, you can download a copy of GS1 Ireland and ESP’s Serialisation Industry Readiness Report for 2017 at https://www.gs1ie.org/healthcare/ serialisation-report.

For further information and support regarding serialisation, visit the GS1 Ireland website at www.gs1ie.org/healthcare or contact healthcare@gs1ie.org.

Visit the ESP website at www.esp.ie or contact marketing@esp.ie.

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Brenntag Pharma

Brenntag Pharma: Your Partner for Success needs are fulfilled quickly and efficiently.

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

Supply Chain Solutions

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

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

parenteral administration, such as injections and infusions.

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

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

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

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

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

34ireland pharma advert half page.indd

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

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

Irish PharmaChem | Industry Buyers Guide 2018 12/19/2016 3:19:24 PM

IT Services

Westbourne’s World: Where Your Critical Lab and IT Technologies Always Work Founded by Chief Executive Officer, John O’Sullivan in 1994, Westbourne IT Global Services Limited delivers multi-lingual technical service desk solutions to the biopharmaceutical, healthcare and food sectors, on a global scale.

They are a flexible, niche provider of top-end, high-quality services on a 24 x 7 x 365 basis operating from Ireland, New Zealand, the USA and the UK, where the focus is always on providing a cost-efficient, high quality customer experience, combined with delivering constant improvement through innovation.

Challenges

• Constant, rapid change; • Ever-increasing digitalisation of our world is

increasing expectations on IT support; • Supporting an increasingly diverse range of technologies and platforms; • Wanting to rely less on individual “experts’ in your organisation for specialist knowledge;

• Murphy’s Lab Law - Instruments always seem to act up during the busiest times; - Back-up equipment always seems to go down at the same time too; - Always happens when the one person that knows how to fix it is on holidays.

• Previous cost efficiency strategies impacted internal customers with quality of service.

Why Westbourne?

• Confidence in people supporting your labs

enjoyable technical experience: Effective communication (native, local language and engaging); Expert lab and IT skills (degree qualified); Bench of engineers to ensure uninterrupted service levels; ITIL and SDI trained.

• Confidence in your IT Infrastructure and applications: - ITIL driven ticket resolution; - High first time fix levels; - Metric driven continuous improvement.

- -

- -

-

• GxP Compliance: - -

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Fully compliant engineers; Rigorous up-skill training programme, driven by forward thinking and highly qualified training department; Fully documented processes.

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

Impressive Client List Westbourne IT Global Services’ impressive client list ranges from start-ups to global pharma, biotech and food companies.

For more information, contact: Westbourne Global IT Solutions Ltd The Atrium, Blackpool Business Park, Cork Tel: (021) 431 4310 Web: www.westbourne.ie Contact details: James Symington Email: James.symington@westbourne.ie

Irish PharmaChem | Industry Buyers Guide 2018

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Product Testing

Global Reach; Local Support!

Largest scope of global services.

F

Sharpest focus on data integrity.

rom starting materials through finished Ireland, Italy, India, Netherlands, New Zealand, States Pharmacopoeia (USP) and Japanese product testing, Eurofins BioPharma Spain, Sweden, Switzerland, UK and the US, their Pharmacopoeia (JP), as well as specific customer Product Testing’s 28 facilities in 16 countries network of GMP laboratories and vast experience methods. deliver the world’s most comprehensive allow them to support projects of any size from scope of harmonised GMP testing services and conception to market. Furthermore, they have Collaboration Drives Cost-Effectiveness teams of scientists placed at more than 70 client At Eurofins BioPharma Product Testing, seamless regulatory acceptance.

As they have grown to become the world’s facilities worldwide through their award-winning their fundamental philosophy is to help (PSS) insourcing clients efficiently allocate their research and largest network of GMP product testing Professional Scientific Services From Starting Materials through Finished ProductbyTesting, manufacturing expenditures strategically programme. laboratories, they continue to uphold their Eurofins BioPharma Product Testing’s 28 their facilities 16 engaging them to meet uniquein outsourcing founding promise of personal service and countries deliver the world’s most comprehensive scope offurther Experience the Expertise needs.

As your project progresses to impeccable quality. harmonized services seamless regulatory enhance open and dialogue and assist your decision Eurofins BioPharma Product TestingGMP offertesting When the world awaits your product, choose acceptance. complete CMC Testing Services for the bio/ making, they provide timely and secure access to the laboratory that provides complete capabilities BioPharma pharmaceutical industry, including all starting comprehensive laboratory information through and rigorous quality systems you can trust. their innovative, 24-hour onlinenetwork data access material, process intermediates, As wedrug havesubstance, grown to become the world’s largest of tool, Product Testing LabAccess.com. drug product and manufacturing support, as labs, GMP product testing we continue to uphold our founding Global Is Local www.eurofins.com/biopharma well as broad technical expertise in biochemistry, promise of personal service and impeccable quality.

Eurofins BioPharma Product Testing’s local molecular & cell biology, virology, chemistry and Comprehensive Services presence ensures personal service, backed microbiology.

Eurofins BioPharma Product Testing offer the When the world awaits your product, the labprogrammes that by a unique global breadth of harmonised flexibility to managechoose your testing complete capabilities and rigorous quality systems capabilities that support all functional areas of International Presence provides more efficiently through your choice of three Means Global bio/pharmaceutical drug development and Regulatory Complianceyou can trust. unique service models, including their awardmanufacturing, including method development, Operating under strict, harmonised quality winning Professional Scientific Services (PSS), Full microbiology, process validation and quality procedures, their laboratories offer a broad range Time Equivalent (FTE) or traditional fee-for-service. control. of methodologies under GMP authorisation, ISO You can choose the best, most cost-effective With a global capacity of more than 92,000 17025 accreditation and ISO 9000 certification, service solution for your project goals. Their square metres and 28 facilities located in Australia, and all analyses are performed according breadth of services includes: Belgium, Canada, Denmark, France, Germany, to European Pharmacopoeia (EP), United ● Method establishment, including method Comprehensive GMP Testing Services

Flexible Service Models

Global Facilities

Method Development & Validation • Release Testing • Stability Testing & Storage

Fee For Service (FFS)

Australia

France

Italy

Sweden

Cell Banking Services • Virology Services • Facility & Process Validation

Full-Time-Equivalent (FTE)

Belgium

Germany

Netherlands

Switzerland

Canada

India

New Zealand UK

Denmark

Ireland

Spain

Chemistry • Biochemistry • Molecular & Cell Biology • Microbiology Raw Materials Testing • Primary & Secondary Package Testing

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Professional Scientific Services® (PSS)

US

Irish PharmaChem | Industry Buyers Guide 2018

Product Testing Eurofins BioPharma Product Testing PSS Insourcing Solutions is a programme that places their exclusively managed laboratory services team to execute a scope of work or project directly at the client’s site, using the client’s laboratories and quality systems. Eurofins collaborate with clients as a strategic partner to understand their distinct body of work. Their PSS management team hires, trains and exclusively manages their highly skilled staff that can perform work in a variety of technical disciplines, spanning the drug development pipeline.

Adopting this insourcing approach allows organisations to benefit from the expertise of an experienced laboratory testing provider, while affording clients the security associated with keeping projects, proprietary methods and analytical techniques in-house.

This model frees organisations to devote their focus and resources on navigating today’s increasingly challenging R&D landscape, as well as provides a more flexible and cost-effective route to putting in place teams of specialists that can help meet shorter development timescale demands.

Do you have the workload but not the workforce?

Typically, bio/pharmaceutical companies use two types of staff: either their own employees or a temporary workforce. In today’s economic

Professional Scientific Services (PSS) environment, fewer firms are adding employees to their payroll and instead are turning to temporary workers to meet their expanded workloads; however, temporary staffing solutions pose a magnitude of challenges for the end user, including: ● Companies using temporary workers face many restrictions to avoid co-employment concerns, including turnover and continual training; ● European regulations, such as the EU Temporary Agency’s Workers Directive 2008/104, enforce equal treatment of permanent and agency workers in respect to working time, pay and other employment rights.

Insourcing Solutions Eurofins BioPharma Product Testing Professional Scientific Services (PSS) provides insourcing solutions specifically designed to give you laboratory services support with flexible timeframes and no worries about co-employment and other regulatory concerns.

They utilise a 55-year-plus track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services at your site, using your

quality systems and equipment. Their teams will even help you set up your laboratory and validate equipment according to your SOPs. Lean laboratory practices are implemented where beneficial.

Eurofins BioPharma Product Testing Professional Scientific Services employs and manages full-time employees and provides a comprehensive benefits package, as well as training, development and career advancement opportunities. Offering these additional benefits allows them to attract, retain and motivate high-calibre employees to serve you.

What are the key benefits of PSS? Benefits of insourcing include: ● Headcount reduction; ● Avoids the turnover rate associated with traditional temporary staffing programmes; ● Frees up client’s limited resources to focus on core priorities; ● Eliminates co-employment and project- management worries; ● Offers flexibility for short-term or long-term projects; ● Provides the security of keeping projects at the client’s facility; ● Minimises costs.

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.

For more information, contact: Eurofins BioPharma Product Testing Clogherane, Dungarvan, County Waterford X35 T628, Ireland Telephone: +353 (0) 58 48300 E-mail: pharma@eurofins.com Website: www.Eurofins.com/ Biopharma

Irish PharmaChem | Industry Buyers Guide 2018

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Clinical Research Development Ireland Investment & Development Pictured at the launch of Clinical Research Development Ireland in October 2017 are (l-r): Dr Pat O’Mahony, Chief Executive of CRDI; Simon Harris TD, Minister for Health; and Thomas Lynch, Chairman of CRDI.

A Force for Clinical Research Dr Fionnuala Keane, Chief Operating Officer, HRB CRCI, reports on the Strategic Plan 2017-2021 of Clinical Research Development Ireland, formerly known as Molecular Medicine Ireland, and the important work of the Health Research Board Clinical Research Coordination Ireland.

In October 2017, Molecular Medicine Ireland rebranded as Clinical Research Development Ireland and launched its new Strategic Plan 2017-2021, with a clear vision and focus on the development of clinical and translational research in Ireland.

CRDI is a not-for-profit research partnership comprising NUI Galway, Royal College of Surgeons in Ireland, Trinity College Dublin, University College Cork and University College Dublin, their medical schools, associated academic hospitals and clinical research facilities, with the objective of accelerating the translation of biomedical research into improved diagnostics, therapies and devices for patients.

CRDI builds on the achievements of Molecular Medicine Ireland, which was established in 2008 by the five aforementioned universities, together with its predecessor, the Dublin Molecular Medicine Centre (DMMC), a partnership initiated

by UCD and Trinity College Dublin in 2002, with the inclusion of Royal College of Surgeons in Ireland in 2005.

Evidence-Based Patient Care The strategic vision for CRDI is to be an effective and innovative force for the development of clinical and translational research in Ireland, and to be recognised both nationally and internationally as a model of organisational excellence, focused

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on advancing evidence-based patient care and network coordination.

The mission of CRDI is to advance patient care and health service delivery by supporting the development of clinical and translational research across its partner academic institutions, their medical schools and associated hospitals.

CRDI acts as the host institution for a number of programmes, which enables it to deliver on its vision and mission.

Since 2002, CRDI and its partner institutions have succeeded in winning funding from Enterprise Ireland, EU FP6 & 7, Higher Education Authority PRTLI Cycles 1-5, Health Research Board, Health Service Executive, Irish Cancer Society/Movember, Science Foundation Ireland and the Wellcome Trust, for cross-institutional initiatives, such as; the Clinician Scientist Fellowship Programme and Clinical and Translational Research Scholars PhD programmes, Irish Clinical Research Infrastructure Network, Dublin Centre for Clinical Research, iPROSPECT and IPCOR prostate cancer research programmes, HRB Clinical Research Co-ordination Ireland, CURAM (SFI Centre for Research in Medical Devices) and the Irish Clinical Academic Training (ICAT) programme.

CRDI Strategic Plan The CRDI Strategic Plan set outs six clear goals, as follows:

●

Advance the development of a sophisticated, coordinated clinical and translational research partnership across our partner academic institutions, their medical schools and associated hospitals; ● Develop and support clinical and translational research infrastructure and delivery; ● Develop and support clinical trials delivery; ● Develop and support education and training; ● Develop capability across network partners and CRDI; ● Advocate for adequate funding for the development of clinical and translational research.

Success on the delivery of the ambitious agenda of the CRDI Strategic plan will require the combined efforts of all stakeholders. For further information on CRDI, please visit www.crdi.ie.

HRB CRCI: Dedicated to Clinical Trials An important programme within CRDI is the Health Research Board Clinical Research Coordination Ireland (HRB CRCI), which is dedicated to the delivery of clinical trials in Ireland.

HRB CRCI is an independent integrated national clinical research network, providing centralised support in the conduct of multicentre clinical trials (both commercial and academic) across Ireland.

It is funded by extramural grants from the Health Research Board (HRB) and Enterprise Ireland (EI), supported by the five largest Irish Universities, and is hosted by Clinical Research Development Ireland (CRDI).

In 2014, the Directors of five University Clinical Research Facilities/Centres (CRF/Cs) responded to a HRB and EI invitation to submit a proposal for the development of a network to support the Irish PharmaChem | Industry Buyers Guide 2018

Clinical Research Development Ireland conduct of multicentre clinical trials across the island of Ireland. The application was successful, and led to the establishment of HRB CRCI as a collaborative partnership of the five university based CRF/Cs and their associated hospitals. HRB CRCI subsequently became operational as an organisation in May 2015.

Overarching Support and Expertise The HRB CRCI central office provides overarching support and expertise, through a range of services and activities to academia and industry.

CRDI provides corporate support services to the central office. The partner CRF/Cs provide the infrastructure, physical space and facilities, experienced research and specialist support staff and the necessary quality and oversight programmes that are critical for the successful conduct of world-class patient-focused research.

HRB CRCI and the CRF/Cs facilitate research but are not in a position to independently fund research. Our partner CRF/Cs have over 40 years of combined research experience and include: ● HRB CRF Cork at University College Cork and Mercy University Hospital; ● HRB CRF Galway at University Hospital Galway; ● Royal College of Surgeons Ireland CRC at Beaumont Hospital; ● University College Dublin CRCs at Mater Misericordiae University Hospital and St. Vincent’s University Hospital; ● Wellcome Trust – HRB CRF at St. James’s Hospital; ● The National Children’s Research Centre, Crumlin.

The key aims of HRB CRCI are as follows: 1. To enhance Ireland’s capacity for conducting innovative high quality clinical research for the benefit of people’s health and the economy; 2. To advance the care of patients by enabling a connected and coordinated Clinical Trial Network; 3. To provide the skills, expertise and infrastructure to design, conduct and analyse multi-centre clinical trials involving human participants in Ireland;

Pictured at the launch of HRB Clinical Research Development Ireland (HRB CRCI) in Sept 2016 are members of the Senior Management Team and the then Minister for Health Promotion, Marcella Corcoran Kennedy TD: (l-r): Professor Dermot Kenny, Director, RCSI Clinical Research Centre; Dr Peter Doran, Director, UCD Clinical Research Centre; Dr Fionnuala Keane, HRB CRCI Chief Operating Officer; Professor Joe Eustace, HRB CRCI Chair & Director HRB Clinical Research Facility at UCC; Marcella Corcoran Kennedy TD, former Minister of State for Health Promotion; and Professor Michael Gill, Director, Wellcome Trust HRB Clinical Research Facility, St James’s Hospital.

4. To support both academic and industry initiated clinical trials involving pharmaceuticals, neutraceuticals or clinical care pathways, as well as clinical investigation of medical devices.

HRB CRCI is involved in a range of activities to support all aspects of clinical research and offers services to academia and industry. One such service is the HRB CRCI National Study Feasibility Programme.

Study feasibility is a process through which a clinical trial sponsor or representative (e.g. Clinical Research Organisations) identifies potential investigator sites and evaluates if they are suitable to conduct the clinical trial. HRB CRCI provides a service to streamline the clinical trial investigator site identification and study feasibility process nationally, delivering consistency and efficiency in the process.

Its study feasibility service is free of charge and aims to secure more research opportunities for Irish patients and to ensure that Ireland is recognised internationally as a preferred location for clinical trials.

Connecting Sponsors with Potential Investigators The HRB CRCI National Study Feasibility Programme connects academic and industry sponsors with potential investigators. HRB CRCI acts as the channel through which study feasibility assessments can be distributed and completed efficiently. The HRB CRCI Investigator Membership Database and Clinical Research Facility/Centre (CRF/C) network is utilised to significantly reduce the time taken to identify investigator sites and to assess study feasibility.

The programme is actively managed by the Clinical Trial Liaison Officer with an aim to feedback to the source within two weeks of initial receipt of a feasibility request. Dedicated CRCI staff based in each CRF/C support investigators with the rapid and accurate completion of the feasibility assessment and timely delivery of study start-up and first patient first visit (FPFV).

For more information on HRB CRCI, please go to www.HRB-CRCI.ie or to contact the HRB CRCI Feasibility Service directly, please email feasibility@hrb-crci.ie.

International Clinical Trials Day 2017 included a patient and research focused event hosted by HRB CRCI in the Mansion House, Dublin.

Irish PharmaChem | Industry Buyers Guide 2018

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Healthcare Packaging

High Quality Packaging Solutions With facilities in Clara, Co. Offaly, Bemis Healthcare Packaging offers engineered healthcare packaging solutions.

Bemis Healthcare Packaging provides highquality, engineered packaging solutions tailored for the protection of your sensitive drugs, sophisticated diagnostic systems and cutting edge medical devices. They specialise in the manufacture of coextruded, laminated and flexible films, foil barrier laminations, pouches, bags, thermoformed trays, lids, labels, heat seal coated DuPont Tyvek packaging materials and medical grades of paper.

Their singular focus on healthcare packaging makes Bemis unique in the industry, and the

company promises exciting news throughout the coming year.

Quality With eight ISOcertified international facilities, Bemis Healthcare Packaging reduces your risk by providing redundant Jorg Schneewind, manufacturing. Their President, Bemis on-going contingency Healthcare Packaging. plans include security, redundant manufacturing capabilities and standardisation of global product specifications.

Sustainability

With eight ISO-certified international facilities, Bemis Healthcare Packaging reduces your risk by providing redundant manufacturing.

Bemis are committed to reducing their impact on the planet and conserving their resources.

Areas of focus include helping customers to use less packaging overall; developing effective new sustainable materials; reducing waste in the supply chain through enhanced protective packaging; minimising manufacturing waste; and producing materials efficiently through responsible use of energy and resources.

Your Leading Packaging Technology Partner “Together we create better ways to move your business forward,” says Jorg Schneewind, President, Bemis Healthcare Packaging.

“From providing breakthrough innovation, to collaborating on more efficient packaging, Bemis Healthcare Packaging can help you achieve your business goals.

“Passionate commitment to the growth and success of our customers will make Bemis the clear choice for inspired packaging solutions,” he continues. “Our focus on you, our customer, will drive our business. We will be the provider of risk-free products, with the highest standards for quality. We will deliver breakthrough innovation. We will manage our business globally, becoming your trusted advisor for your healthcare packaging requirements.”

For more information, contact Bemis Healthcare Ireland, Clara, Co. Offaly. Tel: (057) 9331888. Email:bhp@bemis.com.

Web: www.bemis.com/bhp.

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Irish PharmaChem | Industry Buyers Guide 2018

Bemis Healthcare Packaging understands your packaging needs: • Transdermal patch packaging & CR disposal pouches From the high barrier materials you need to protect your transdermal patches to the CR pouches necessary for safe disposal of the used product • Prefilled syringes Offering both flexible pouch and rigid trays to provide the level of protection to meet your barrier requirements • Blister Forming Film - PerfecForm® SkyBlue™ II PET Barrier Blister Film contains no chlorinated polymers, has wide variety of barrier options and provides sustainability

Bemis Healthcare Packaging North America • Latin America • Europe • Asia Pacific www.bemis.com/healthcare-packaging

Waste Management

Indaver to Succeed Ruth Appelbe, Industrial Waste Services Sales Manager Ireland, Indaver, with Aidan Kennedy, Waste to Energy Plant Manager.

A privately owned company headquartered in Belgium, Indaver has a turnover of €500k, thus making it one of the largest waste management companies in Europe.

Since their Duleek plant opened eight years ago, Indaver have revolutionised waste management in Ireland. Duleek incinerates over 200,000 tonnes of waste annually, which is then converted to supply 20,000 households with electricity.

Curiously, over 2,600 people have visited the site. Furthermore, the company has donated €1.7m to local projects as a planning condition donation.

With this track record, Indaver are planning on opening another facility in Cork, explains Ruth Appelbe, Industrial Waste Services Sales Manager Ireland at Indaver. They are also currently involved in the development of waste-to-energy facilities in Belfast.

Sustainable Waste Management According to Appelbe, waste-to-energy can help achieve the EU’s aim of improving resource efficiency: “In order to achieve sustainable waste management, waste should be diverted from landfills and recycled as much as possible, with the remaining waste

(i.e. waste not suitable for recycling) used to generate energy. Recycling and waste-toenergy are complementary options to divert waste from landfills. This helps the EU to reach a circular economy.”

As part of their commitment to Ireland, Indaver have made a considerable amount of capital investment. “We have invested heavily in Ireland,” Appelbe explains. “For example, Dublin Port has a €15m capital investment, which is a significant investment in hazardous infrastructure. Also, the Meath waste-to-energy facility was an investment of over €140m.”

The Meath facility represented the largest ever single investment in solid waste management infrastructure in Ireland at that time. It also reflects the technology being deployed. “It’s more efficient,” Appelbe reveals.

“We recover more energy and materials and it has a lower impact on people, the environment and society.”

Indaver have a strong Quality, Environment, Safety and Health (QESH) culture and are ISO 9001, ISO 14001 and OHSAS 18001 certified.

According to Appelbe, the current trend within the industry is to harness as much energy as possible. With this in mind, they ensure that their plant designs produce as much electricity as they can and harness as much heat as possible.

Pharma Waste Experts ■ Over 30 years Irish and international experience ■ Best available technology – Ireland’s first Waste-to-Energy facility ■ Hi-tech and efficient online data reporting ■ International organisation offering a broad range of solutions ■ Publisher of the Transport of Waste Legislation Guide - order your complimentary copy today info@indaver.ie Tel. +353 1 280 4534

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Irish PharmaChem | Industry Buyers Guide 2018

Research & Development SSPC Co-Directors Professor Michael Zaworotko and Professor Gavin Walker.

SSPC Research Centre Driving Innovation Through Partnerships The Synthesis and Solid State Pharmaceutical Centre (SSPC) is a hub of Irish research expertise, comprising nine Research Performing Organisations (RPOs), 24 industry partners and 12 international academic collaborators. Their mission is to position Ireland as a global hub of pharmaceutical process innovation and advanced manufacturing.

SSPC supports the research projects of 60 postgraduate students, each of whom is enrolled on their award winning structured PhD Programme, and 43 post- doctoral fellows. A significant focus of the graduate and post-doctoral fellowship programmes is to prepare the researchers for successful careers in industry and 46% of SSPC trainees take up employment in industry following departure from the Centre.

Their industry partners benefitted in many ways from SSPC research activities, including the development of scientific and technological advances, a shift in emphasis for the Irish sites within their corporations, and advanced education and training of company employees. In addition, the academic institutions have invested heavily in new appointments that enables seamless succession planning for the Centre.

Partnerships The Centre has undertaken significant Irish PharmaChem | Industry Buyers Guide 2018

The Synthesis and Solid State Pharmaceutical Centre (SSPC) is a world leading Science Foundation Ireland Centre co-funded with industry partners, and focuses on excellent science across chemistry, pharmaceutics and process engineering. partnership activities that have contributed to business growth. For example, a national working group called (bio)Pharma Ireland, formed to highlight the importance of innovation in pharmaceutical manufacturing in Europe. The (bio)Pharma Ireland working group, chaired by SSPC, has representation from the pharmaceutical industry, BioPharma Chemical Ireland (BPCI), government agencies like Science Foundation Ireland, Enterprise Ireland and the IDA; and academic research organisations: National Institute for Bioprocessing Research and Training (NIBRT) and the Pharmaceutical Manufacturing and Technology Centre (PMTC).

Through SSPC leadership, (bio)Pharma Ireland led the development of a white paper, with input from other European participants, which will contribute to and influence European policy-making for this sector. One outcome of the seminar has been that a number of MEPs, including Paul Ruebig (Austria), have agreed to table an amendment on the European Parliament’s discharge report in respect of the European Medicines Agency for 2017. The proposed amendment, based on the (bio)Pharma Ireland White Paper,

will recognise the need for innovation in pharmaceutical manufacturing in the EU and for the enabling regulatory environment to allow this to take place.

SSPC is also part of the first ever US-Ireland Centre-to-Centre Partnership Programme in continuous manufacturing for nanobased drug products. This partnership links together three of the world’s major pharmaceutical manufacturing and drug delivery research centres, including The Centre for Pharmaceutical Sciences (CPS) at Queen’s University Belfast and The Centre for Structured Organic Particulate Systems (CSOPS), as well as SSPC. The benefit is associated with the complementarity of expertise and equipment between the three centres. The team in CPS bring a pharmacy insight to the work, whereas the CSOPS colleagues bring expertise in the area of continuous manufacturing, with a strong emphasis on process analytical technology, modelling and control strategies.

SSPC is continuing to engage with global pharma companies at a corporate level, as evidenced strongly in the MOMEnTUM SPOKE project. SSPC researchers are delivering significant value to J&J by developing next

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Research & Development generation manufacturing technologies, while being afforded the opportunity to work on proprietary company background IP. This level of interest from corporate R&D highlights the value of SSPC research to the company and the potential for its commercial impact.

Award Winning Research 2017 proved to be a very successful year for SSPC. This year, SSPC were named winners for Excellence in Education and Training at the HR Leadership and Management Awards 2017 for the SSPC Structured PhD programme.

SSPC Co-Director, Professor Gavin Walker won three awards at the Irish Laboratory Awards for The Bernal Process Engineering Laboratory based in SSPC operations headquarters in the University of Limerick. The Centre was awarded Research Centre of the Year at the Pharma Industry Awards 2017.

At the Science Foundation Ireland Summit 2017, the Advanced Biopharmaceutical Technologies Spokes Project won Industry Partnership Alliance. This is a project that bring together seven of the leading biopharmaceutical companies in Ireland, Pfizer, Allergan, Eli Lilly, Janssen, Merck, Biomarin and Genzyme, working in collaboration with The National Institute for Bioprocessing Resarch and Training (NIBRT).

It’s a link that places Ireland in a unique position globally where there is real industryacademic collaboration across small and large molecule research and innovation.

Benchmarking exercises carried out would indicate that other international Centres focus almost entirely on the small molecule. SSPC Co-Director, Professor Michael Zaworotko was honoured with the accolade of SFI Researcher of the Year 2017.

Leadership SSPC supports 10 Principal Investigators, 21 Funded Investigators, including four Spoke Leaders and 13 Collaborators, each

SSPC team members, Kristy Butler, Louise O’Neill, Jon O’Halloran, General Manager, and Aisling Arthur are pictured receiving the Research Centre of the Year Award at the Pharma Industry Awards 2017. contributing knowledge, expertise, skill, and a commitment to SSPC’s culture of ‘inclusivity and equity of resources’. SSPC appointed two new Co-Directors, Professor Michael Zaworotko, who is among the top 20 research chemists in the world, and Professor Gavin Walker, who is the Bernal Chair in Pharmaceutical Powder Engineering at University of Limerick.

Commenting on his appointment, Professor Zaworotko, said, “Taking up this position and working with the SSPC to make strategic collaboration a top priority will help to potentially push the frontiers of knowledge.

We are looking forward to ‘going global’ by delivering results through national and international partnerships with industry to enable innovation throughout all areas of SSPC.” Professor Walker said, “It will be a privilege to

lead the SSPC, which is now an internationally recognised Centre of Excellence. The SSPC is particularly committed to breaking down traditional boundaries across academia and promoting new research and I am looking forward to pioneering further partnerships in the future.”

Dr Denise Croker will take up the role of General Manager of the Centre in January 2018, marking the departure of Jon O’Halloran, who stands down as the first General Manager of SSPC after 10 years.

As the largest national pharmaceutical research centre, SSPC brings together the expertise and experience of leading researchers. This enables knowledge exchange and collaboration between industry and academia, an inter-disciplinary connection that would not be possible without a central hub driving and facilitating collaboration.

SSPC’s Education and Public Engagement extensive programme plays a key role in communicating the importance and value of this sector to the wider society in Ireland.

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Irish PharmaChem | Industry Buyers Guide 2018

Whatever your business

TOYOTA – 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.

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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

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Irish PharmaChem | Industry Buyers Guide 2018

Calibration

The iTHERM TrustSens from Endress + Hauser is the world’s first self-calibrating thermometer, offering outstanding sensor technology with selfcalibrating function.

A World First: Self-Calibrating Thermometer The Swiss Process Automation group, Endress + Hauser, one of the world’s leading suppliers of industrial process solutions, has unveiled the first process temperature sensor with a self-calibration function.

The iTherm TrustSens TM37x incorporates a classic Pt100 with a reference based on a ceramic element with a Curie point of +121°C (TrustSens). For each sterilisation in place (SIP) which takes place at a temperature higher than +121°C, the value measured by the Pt100 is correlated with the Curie point, which makes it possible to know exactly the possible drift of the sensor .

This automated, traceable online process (data storage for 350 calibration points, automated documentation) ensures continuous monitoring, avoiding the risk of undetected non-conformities and production stoppages.

HeartBeat Technology In this configuration, Endress + Hauser designed the iTherm TrustSens TM37x with a measurement range of -40 to +160°C and it incorporates proprietary ‘HeartBeat’ technology, applications in life sciences and agri-food . But nothing prevents answering other applications, for example in chemistry, to develop ceramics with a Curie point higher (or lower).

The iTHERM TrustSens stands out from other thermometers by its fully automated inline self-calibration. This results in high product safety and increased plant availability. Continuous inline process

Expansion at Endress+Hauser

Endress+Hauser is further expanding its portfolio of products, solutions and services in the field of process analytical measurement. The Group has acquired Blue Ocean Nova AG, a manufacturer of innovative inline spectrometers for monitoring quality-relevant process parameters. The company’s 15 employees located in Aalen, Germany will be retained.

Blue Ocean Nova will operate under the umbrella of Endress+Hauser’s centre of competence for liquid analysis, headquartered in Gerlingen, Germany. “The intelligent process sensors developed by Blue Ocean Irish PharmaChem | Industry Buyers Guide 2018

Nova will enhance our offering in the field of process analytical measurement, adding a strategic building block,” says Dr Manfred Jagiella, Managing Director of Endress+Hauser Conducta GmbH+Co. KG. As a member of the Group’s Executive Board, he is also responsible for the analytics business.

The process sensors developed by Blue Ocean Nova cover the relevant optical spectroscopy regions of UV-VIS, NIR and MIR to analyse liquids, gases and solids inline. The innovative technology allows the spectrometer to be directly integrated into the

verification is already recommended in the “Good Manufacturing Practice Rules” (GMP Annex 15).

The iTHERM TrustSens hygienic thermometer is perfect for users in the life sciences and food and beverage industries who want seamless compliance to FDA regulations and/or GMP rules. iTHERM TrustSens eliminates the risk of undetected non–conformities.

Benefits The iTHERM TrustSens has a range of benefits, including: ● Risk and cost reduction thanks to self- calibration and ‘Heartbeat Technology’; ● No production downtime due to an automated and fully traceable inline self- calibration; ● Automated documentation, memory for 350 calibration points; ● Printable calibration certificate - audit proof; ● Highest accuracy of measuring point through sensor-transmitter-matching; ● International certifications and approvals: EHEDG, ASME BPE, FDA, 3-A, 1935/2004, 2023/2006, 10/2011, CE CRN, CSA General Purpose; ● Measuring range: –40 to +160°C (–40 to +320°F); ● More than 50 sterile and hygienic process connections available e.g. Thread, Clamp, APV-Inline, Varivent, DIN11851.

measurement probe, even in explosion-hazardous areas. The sensors can furthermore be automatically cleaned and easily integrated into process control systems.

The systems from Blue Ocean Nova are utilised for applications such as concentration and moisture measurements and for measuring relevant quality parameters. The technology enhances the Group’s portfolio, which already encompasses Raman spectroscopy, tunable diode laser absorption spectroscopy (TDLAS) and process photometers.

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Documentation Solutions

Reduce Human Error and Enhance Training •

TWi is a leading technical writing and information design service provider, offering high-quality, flexible, and scalable documentation solutions for bio/pharma and medical device companies.

Consultancy and support on documentation and information management;

Your Challenges:

Flexible, scalable, and customised service offerings that can integrate with your teams;

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Producing effective CAPAs to improve your Human Error Reduction (HER) programme;

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User-focused approach to documentation development;

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Tailored training in technical communication skills and strategies.

The Results

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

maintaining quality and ensuring regulatory compliance;

• Developing the skills of your team.

and IFUs; Enhanced documentation quality, consistency, and usability; Greater operational efficiency, saving time and resources.

TWi’s Solutions

Partner with TWi

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

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

Information design and technical communication expertise;

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

For more information, see www.technicallywriteit.com.

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Creating user-friendly product information documents and user manuals;

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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!

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From the Crowd

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Irish PharmaChem | Industry Buyers Guide 2018

INVESTMENT

MSD Continues to Invest in Ireland MSD is set to create 330 new jobs and invest €280m over the next three years at two of its Irish manufacturing sites, in Carlow and Cork, important links in MSD’s global network of manufacturing plants.

The new jobs in Carlow and Cork are being created as a result of increased global demand for MSD’s medicines and vaccines produced in Ireland, while the investment will see both sites expand production facilities and capacity to meet that demand.

The MSD facility in Brinny, Co. Cork, is an integrated site for the development, testing and manufacturing of biologics, specialising in the fermentation, purification and sterile filling of biotech products. More than 200 new hires will be needed to meet demand for its work on some of the company’s important treatments – medicines for lung cancer, melanoma, hepatitis C and rheumatoid arthritis.

Meanwhile, MSD in Carlow, a state-of-the-art manufacturing facility, and the company’s first stand-alone vaccine and biologics facility outside the US, plans to create 120 new roles. Carlow also is an important link in MSD’s network of sites producing their new immuno-oncology treatment for the global market.

Available roles at the sites include technical, engineering, biochemistry, biology, quality and operations positions.

The announcement was welcomed by then Irish PharmaChem | Industry Buyers Guide 2018

MSD Ireland’s announcement of 330 new jobs and a €280m investment in Carlow and Cork is a reflection of Ireland’s positive standing in MSD global network.

Pictured at the MSD announcement of 330 new jobs and a €280m investment are Ger Brennan, Managing Director of MSD Human Health in Ireland, and former Taoiseach, Enda Kenny TD.

Minister for Jobs, Enterprise & Innovation, Mary Mitchell O’Connor TD, who addressed over 1,200 senior MSD business leaders from 50 countries, who were gathered in Dublin for MSD’s annual EMEAC (Europe, Middle East, Africa & Canada) Congress in May 2017.

“MSD has been at the cutting edge of bio pharmaceutical innovation over recent years and their Irish operations are at the heart of many of the company’s exciting new products,” enthused Minister Mary Mitchell O’Connor. “It is particularly gratifying that this expansion and additional job creation will take place in two regional locations,

thereby strengthening the Government’s efforts to ensure balanced industrial development around the country.”

Sanat Chattopadhyay, MSD Executive Vice President and President of MSD’s Manufacturing Division, described the announcement as “a reflection of MSD Ireland’s positive standing in our global network, a vote of confidence in our people and their work, and a sign of MSD’s future commitment to Ireland. The expansion of our presence in Ireland is a testament to the talent of our Irish employees. In recent years, our Irish businesses have played an increasingly important role in the production of some of MSD’s most important breakthrough medicines for the global market.”

Ger Brennan, Managing Director of MSD Human Health in Ireland, said: “Sustained investment in Ireland over the last five decades has positioned MSD and our employees to play

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INVESTMENT a significant role in responding to the world’s most vital, unmet health needs. Our existing portfolio and future pipeline ensure current and future employees can operate at the cutting edge of science and technology. Today, our Irish sites are involved in the production of over 50% of MSD’s global top 20 products, exporting to over 60 countries worldwide and helping lead the development of new life-changing medicines for patients, including MSD’s new treatments for cancer and hepatitis C.” The MSD announcement was also warmly welcomed by IDA Ireland, with CEO, Martin Shanahan revealing that “MSD’s decision to invest in its Irish operations across a number of regional locations further strengthens Ireland’s positioning as a global destination for manufacturing excellence in biopharmaceuticals. It is pleasing that MSD continues to evolve, grow and innovate from Ireland to continue to meet patient needs around the world.”

MSD currently employs over 1,600 people across four sites in Ireland – in Carlow, Cork, Dublin and Tipperary. Its extensive Irish operations, encompassing manufacturing, commercial, global financial services and marketing facilities, had a turnover of €4.7 billion in 2016.

MSD has a strong legacy in Ireland that stretches back over the last 50 years, and has seen the company invest over $2.5 billion in expanding and developing its facilities here. MSD provides healthcare solutions and innovative medicines in areas such as diabetes, heart disease, immunooncology, infectious diseases and vaccines. The company, which is known as Merck & Co., Inc. in the US and Canada, maintains headquarters for the company and manufacturing division in Kenilworth, New Jersey, USA. The company has been in operation for more than a century, and operates in more than 140 countries, delivering innovative health solutions via prescription medicines, vaccines, biologic therapies and animal health products.

Details on open roles at MSD are available at www.msd.ie/careers

Sanat Chattopadhyay, MSD Executive Vice President and President of MSD’s Manufacturing Division, pictured with former Minister for Jobs, Enterprise & Innovation, Mary Mitchell O’Connor TD.

Former TD to Advance Healthcare Debate with MSD Role Former TD and Minister of State, Liz O’Donnell, is a key figure in the debate over Ireland’s future healthcare system, since she was announced as MSD Human Health in Ireland’s Director of Policy, Government Affairs and Communications in January 2017.

MSD’s annual EMEAC (Europe, Middle East, Africa & Canada) Congress in Dublin in May 2017 attracted over 1,200 senior MSD business leaders from 50 countries.

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“As healthcare in Ireland continues to evolve, the industry’s significant contribution to delivering the latest innovative healthcare solutions to Irish patients, as well as its contribution to the wider economy, will become even more critical. In recent years, MSD has engaged proactively with partners Ger Brennan, across the public policy Managing landscape to encourage an Director of MSD open debate about the future Human Health in of the Irish healthcare system, Ireland, former with the needs of the patient Taoiseach, Enda at its heart - Liz will play a Kenny TD, and leading role in maintaining Liz O’Donnell, and advancing that debate,” MSD Ireland Director of Policy, noted Ger Brennan, Managing Government Director of MSD Human Affairs and Health.

Communications.

O’Donnell is responsible for developing and delivering collaborative public affairs strategies and policy initiatives in order to maintain MSD’s position as a key stakeholder in Irish healthcare sector, ensuring the delivery of better healthcare outcomes for patients.

Liz O’Donnell represented South Dublin as TD for 15 years from 1992 to 2007. In 1997, she was appointed Minister of State at the Department of Foreign Affairs with responsibility for Overseas Development Assistance and Human Rights. As Minister of State, she was a key member of the Government’s negotiating team in the multi-party talks at Stormont, which culminated in the Good Friday Agreement in 1998.

Since retiring from politics in 2007, O’Donnell has worked as an adviser and public affairs consultant and in print and broadcast media, including as a weekly columnist with the Irish Independent. She was appointed as Chair of the Road Safety Authority in 2014 and continues to serve in this non-executive role.

Irish PharmaChem | Industry Buyers Guide 2018

Pharmaceutical Manufacturing Technology Centre

PMTC: Sharing Knowledge for the Benefit of All

The Pharmaceutical Manufacturing Technology Centre (PMTC), was established in 2013 and is led by Dr Chris Edlin, the Centre’s Director. The PMTC focuses on the innovation of cleaning technologies, processes and PAT to enhance and advance Ireland-based biopharmaceutical firms.

The PMTC is a collegiate research centre with over 30 industrial partners located throughout Ireland. The centre resources and manages projects using a core grant from the government, directly funded projects from industry and state/industry leverage funded projects.

Currently, the centre funds multiple virtual teams of researchers in higher educational institutes in Ireland, engaging over 25 researchers and principal investigators (PIs) covering five research themes. The partnership community consists of the majority of research, providing organisations (RPOs) in the country; the top multinational pharmaceutical companies and a growing cohort of small to medium sized enterprises.

A Global Hub of Pharmaceutical Process Innovation The vision of the PMTC is to make Ireland the global hub of pharmaceutical process innovation and advanced manufacturing through applied research into advanced technology solutions:

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The Pharmaceutical Manufacturing Technology Centre funds multiple teams of researchers in the discovery of advanced technology solutions for the pharma sector.

Improving pharmaceutical manufacturing competitiveness; ● Enhancing the R&D mandate of Irish pharmaceutical manufacturing sites; ● Provide opportunities to de-risk and showcase novel technologies for SMEs. The PMTC is developing a reputation as a world class centre of excellence for pharmaceutical manufacturing issues, with the ability to attract significant future R&D funding from both industrial and EU/National funding agencies. ●

Partnership Growth: Outstanding project performance relating to industry-informed research activities at PMTC has led to significant growth for the centre. When founded, the PMTC had nine industrial partners.

In 2017, this has grown to 32 paying members, who were all attracted by the work programme, agile approach to projects and access to highly skilled researchers and recruits. During 2017, the PMTC has received very positive feedback from its members, such as those below: “The PMTC creates links between industry, academic subject matter experts, regulators and vendors to understand what companies really

need help with to explore common challenges.”

“The PMTC facilitates interactions and considers the challenges and problems facing the industry and makes connection to share knowledge and develops knowhow and skills to address needs gaps.”

“The PMTC offers and better, more efficient way of approaching problems.”

Research Impact: The PMTC is a leading global research and innovation organisation, synonymous with excellence in chemical and process engineering.

It is committed to the creation of an innovation ecosystem in pharmaceutical processing.

With state of the art facilities, it is proactive to emerging opportunities that deliver economic and social impact, through the creation and application of knowledge. In the last year, the PMTC has achieved significant success in its research programmes.

Industrial Impact: Much of the research within PMTC focuses on model predictive control and hybrid technologies, which offers opportunities to substantially reduce costs, reduce Irish PharmaChem | Industry Buyers Guide 2018

Our pursuit. Life’s Potential. ™

Allergan Pharmaceuticals Ireland Castlebar Road Westport, County Mayo Ireland Tel: 098 25222

Block J Longphort House, Lower Leeson Street Dublin 2 Ireland Tel: 01 6445200

www.allergan.com

Pharmaceutical Manufacturing and Technology Centre manufacturing times and improve product defects, by the integrated manufacturing approach, and move Irish operations up the ‘value chain’ to create a global hub for innovative manufacturing. Moreover, the projects will improve process efficiencies and lead to ‘greener’, more environmentally sustainable routes to drug product manufacture, by eliminating several unit operations, thus creating novel hybrid processes.

Innovation in Cleaning Technology One of the PMTC’s main focus areas is on innovation in the field of cleaning technology, and the creation of cleaning innovation programmes for the pharmaceutical manufacturing industry.

Additionally, the PMTC has programmes researching enabling of continuous processing, powder processing and the development of soft sensors. PMTC aims to create an environment to support all manufacturing challenges.

PMTC continues to position itself to enable the pharmaceutical industry to respond to macroeconomic challenges. At a global level, manufacturing facilities must become flexible.

Emerging markets pose unique challenges that require flexible approaches to achieve patient benefits. To achieve these desired outcomes, medicines are becoming personalised and stratified, which will require a paradigm shift in manufacturing.

A central strategy of the PMTC is to leverage state investment to create larger projects with significant industrial impact. One of the central approaches to this is to access the Innovation Partnership Programme managed by Enterprise Ireland. An area of recent focus has investigated efforts to improve cleaning processes in the industry, and contribute to network competitiveness in areas such as product-toproduct changeover. The research will lead to increased cost savings, and will ensure improved effectiveness in the biopharmaceutical industry, helping to secure jobs.

Innovation Programme The PMTC recently received €1.3m to resource an innovation programme between four multinational pharma companies based in Ireland, including Pfizer. This was recently reported in the press (https://www. siliconrepublic.com/innovation/ul-pharmapharmaceutical-manufacturing-technologycentre).

Dr Liam Tully, Director of Pfizer API Technology, said that PMTC enhances his company’s competitiveness and added that it “ensures, through direct engagement on innovative partnership projects, a sustained focus on applying innovative science and technology in our manufacturing facilities”. Outstanding project performance relating to industry-informed research activities at PMTC led to the winning of the funding. In addition to the research output, this investment will deliver highly skilled postgraduate jobs, driving enterprise and employment growth in the region.

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Pictured at third annual Pharmaceutical Manufacturing Technology Centre Knowledge Day at University of Limerick are Prof. Gavin Walker, Bernal Chair in Pharmaceutical Powder Engineering, UL, Sean Kelly MEP and Chris Edlin, PMTC Director.

PMTC Knowledge Day Leaders in the pharmaceutical manufacturing sector in Ireland gathered for the third annual PMTC Knowledge Day in August 2017. The event provided a showcase for the cuttingedge research supported by the centre, with key note addresses from industry thought leaders who shared their vision of the future for the pharmaceutical sector.

Speakers included industry experts and academic leaders, from international organisations such as Hyde Engineering, Pfizer, University of Cambridge, Novartis and Ecolabs, among others. Dr Majella Majer discussed Enterprise Ireland Supports for Innovation, Dr Ian Wilson spoke about ‘The Scientific Side of Cleaning in Place’ and Dr Jay Chopra’s presentation covered ‘Top Tips to Inspire

Innovation in Your Organisation’ “Ireland has a renowned pharmaceutical sector: Research and development in pharmaceutical manufacturing and process efficiencies is critical to strengthening and developing it. PMTC research is bringing forward novel technologies to advance Irish-based biopharmaceutical companies which ultimately will deliver highly-skilled postgraduate jobs, driving enterprise and employment growth in the region,” noted PMTC Director, Chris Edlin. “This annual event brings together academic groups, industry and government agencies to showcase stateof-the-art applied research into contemporary industry problems. It was extremely pleasing to welcome established partners plus a growing cohort of new companies interested in collaboration.”

Sandra Lenihan, lecturer, Department of Process Energy and Transport Engineering, Cork Institute of Technology, and principlal investigator with PMTC.

Irish PharmaChem | Industry Buyers Guide 2018

DawsonPharma Ireland Leaders in temperature controlled storage systems

Nationwide Since 1978.

CALIBRATION

INSTRUMENTATION

- Expert Calibration Service - ISO9001:2008 Certified - Nationwide Service

- Instrumentation Sales - Measurement & Control - Leading Manufacturers

- Flexible Schedules - Traceable Calibrations - Fully Qualified Staff

- Technical Support - Calibration Prior to Dispatch - Project Procurement

- Online Certificates & Reports

SYSTEMS - Wireless Temperature Monitoring Systems - Weighing Control Systems Including Batching

WEIGHING

Management System

Designed specifically for the pharmaceutical industry to meet all stringent regulatory requirements of the sector.

The only provider of specialised rooms that come with LPCB ‘Red Book’ listed.

The storage applications our rooms are being used as follows: +2º C to +8ºC, close control freezers, +15ºC to +25ºC, Hot boxes up to +80ºC and low temperature -42ºC rooms.

- Calibration, Service and Sales - Legal Metrology Service Authorised Verifiers - Analytical/Precision Balances - Bench/Platform Scales

- Alarm Monitoring - Calibration & Maintenance

Short, medium and long term rental of temperature controlled rooms.

- Retail EC Approved - Platform, Check, Counting

Pharmaceutical - Medical Device - Food - Dairy - Beverage Manufacturing - Water - Chemical - Retail P.J. Bonner & Company Dublin, Ireland www.pjbonner.com sales@pjbonner.com +353 (0)1 4505050

For more information and to arrange a consultation please contact our offices on:

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LOGISTICS

Kuehne + Nagel Lead The Way Innovation and future focused solutions are critical to Kuehne + Nagel. Their strategy pays particular attention to this by analysing customers’ supply chain as a whole and improving efficiency and cost.

“Ireland is one of the leading locations for the pharmaceutical industry in the world and accounts for just over half of Ireland’s goods exports, circa €64 billion,” states Adam O’Sullivan, Director of Pharmaceutical + Healthcare, Kuehne + Nagel Ireland. “This means that logistics companies need to stay innovative to keep up: Kuehne + Nagel are leading the way in the transportation of pharmaceutical goods in Ireland. We work closely with our customers to stay abreast of the ever-changing needs of this industry to ensure we can offer sustainable and compliant solutions.”

Kuehne + Nagel has developed an innovative approach to pharmaceutical and healthcare logistics by adopting a lifecycle view of the supply chain, he explains: “This allows us to customise our services, ensuring that different capabilities are deployed to suit different stages of development, production, and distribution. Moreover, we have a dedicated team who can analyse the risks and offset those risks in advance of a shipment moving through our network with the use of technology.”

Impressive Accreditation In today’s strict regulatory environment, there is certainly no shortage of regulations that pertain directly to the pharmaceutical industry. “Quality is of utmost importance at Kuehne + Nagel and we have integrated high standards of quality into the heart of the operation of our business. In February 2017, our global KN PharmaChain airfreight network was certified by the International Air Transport Association as CEIV Pharma (Centre of Excellence for Independent Validators in Pharmaceutical Logistics), being the first logistics provider to receive this accreditation for the entire network.

“Locally here in Kuehne + Nagel Ireland, we go beyond just the industry standards of quality,” O’Sullivan continues. “We actively invite our customers to perform their own audits at our premises, allowing them to inspect our quality standards and procedures first hand.”

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The company continually invests in new technology and innovations and is in the process of building a brand new state-of-the-art 60,000 square feet warehousing facility, which will offer both temperature controlled storage (15-25°C) and chilled storage (2-8°C), which will be scalable to suit customer needs.

Complex Supply Chain Within the logistics industry, the transportation of goods often exchanges several hands as it will regularly have to travel through multiple countries and be handled by different carriers along the way. It is this complex supply chain that creates complications in the area of security, visibility and industry regulations for logistics companies when offering solutions to their customers.

“It is critical for pharmaceutical

products in particular to arrive at their intended destination in the same condition as they were shipped,” O’Sullivan explains. “Of equal importance is the visibility of this vital cargo. In order for our customers to be able to stand over their product, they need to know where it has been on each leg of its journey, so traceability at every contact point is fundamental.”

It’s this added value that allows Kuehne + Nagel to offer solutions to their customers that they don’t even know they need or want yet. “We are bucking the trends of the industry by being the first to market with intelligent supply-chain solutions for Irish companies,” concludes O’Sullivan.

“It’s through this expertise that Kuehne + Nagel play their part in ensuring that Irish companies continue to have their competitive edge in this market.”

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

Email:Adam.osullivan@kuehne-nagel. com. Tel: (01) 8239777.

Adam O’Sullivan, Director of Pharmaceutical + Healthcare, Kuehne + Nagel Ireland, talks about the importance of innovation and futurefocused solutions for customers in the pharma industry.

In February 2017, the global KN PharmaChain airfreight network was certified by the International Air Transport Association as CEIV Pharma.

Irish PharmaChem | Industry Buyers Guide 2018

Intelligent pharma logistics solutions.

Superior compliance. Greater reliability.

T: +353 18239777 | E: sales.ie@kuehne-nagel.com | W: www.kuehne-nagel.com

Workplace Wellbeing

Employee Wellbeing a Top Priority for Employers and Employees Alike Research conducted by Ibec earlier this year among 1,000 employees found that six out of 10 employees are more likely to stay longterm with an employer who shows an interest in their health and wellbeing. It also found that nearly half of those surveyed would leave a job where they perceive an employer not to care about their wellbeing. This data further cements what we already know about the importance of investment in, and a strategic approach to, employee wellbeing.

Evidence Based Accreditation The KeepWell Mark is an evidence-based accreditation and award from Ibec, designed to recognise and celebrate the fantastic work that organisations all over Ireland are doing to look after the health and wellbeing of their people. It offers a structured, allencompassing approach to corporate wellbeing and is the first national set of

The KeepWell Mark is an evidence-based accreditation and award from Ibec, designed to recognise and celebrate the impressive work carried out by organisations to look after the health and wellbeing of their staff, writes Sophie Moran, Executive, Food Drink Ireland, Ibec. standards and formal accreditation focusing solely on the health and wellness of staff, and it’s backed by business.

Aoife Ní Mhurchú, Head of HR for Sky Ireland, one of the first KeepWell accredited companies in Ireland, commented, “Workplace wellness is a key foundation of our people engagement strategy and The KeepWell Mark will help Sky Ireland maintain the focus on wellbeing going forward which is good for our people and good for our business.”

A Key HR Tool The accreditation is designed to act as a key tool for your HR and management team, identifying the strengths and weaknesses in

your existing approach, and mapping out the way forward, all in line with a national set of standards for best practice.

In the recently published Ibec Autumn 2017 HR survey update, three in five respondents rated employee wellbeing as ‘very important’ in their organisation, with 55% highlighting investment in employee wellbeing as a key initiate for retention of staff. While this is indeed positive, the approach in many cases lacks clear direction, as indicated by the fact that only 27% of respondents confirmed that they have a formal strategy in place that relates specifically to employee wellbeing.

Without having a formalised, consistent approach across the organisation, businesses are missing out on the chance to identify key

Minister for Health, Simon Harris TD, is pictured at the launch of The KeepWell Mark with Ibec’s KeepWell Team, Sophie Moran, FDI Executive; Kevin McPartlan, Director of Prepared Consumer Foods; and Dermot Doherty, Project Manager for the FDI Health Initiative.

Irish PharmaChem | Industry Buyers Guide 2018

59

Workplace Wellbeing trends and areas of weakness which will inform more meaningful engagement with staff.

Making Health & Wellbeing A Core Workplace Value “A healthy workforce is vital for us to create a healthy Ireland, so it’s great to see a business representative organisation like Ibec making a significant commitment to promoting wellbeing in the workplace,” noted Minister for Health, Simon Harris TD, at the launch of the KeepWell Mark in September 2017. “We look forward to working in partnership with all stakeholders to make health and wellbeing a core value of workplaces in Ireland.”

Speaking about The KeepWell Mark, Ibec CEO Danny McCoy said, “It is really positive to see that workplace wellbeing is high on the agenda of Irish employers and that future increased investment in this area is in the pipeline for a large majority of organisations.”

With talent attraction and retention so key to the continued success of Irish employers, it’s crucial that employers remain competitive and maintain an employer of choice status.

Ibec is encouraging companies of all sizes in all sectors to participate in this initiative.

For those wishing to get involved, visit www.thekeepwellmark.ie or contact info@thekeepwellmark.ie.

Cathriona Hallahan, Managing Director, Microsoft Ireland; Minister for Health Simon Harris TD; Danny McCoy, CEO of Ibec; and Olympian athlete Jessie Barr at the launch of The KeepWell We can provide the best tailor made cooling Mark. solution to suit your requirements

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Cross Technical Solutions Ltd. kathleenbelton@tarapublications.ie Unit 26, Cookstown Industrial Estate Cross Technical Solutions Ltd. www.retailnews.ie Cookstown, Tallaght, Dublin 24 Unit 26, Cookstown Industrial Estate Co. Dublin ‐ Ireland Cookstown, Tallaght, Dublin 24 Tel (+353) 01 405 6777 Co. Dublin ‐ Ireland Fax (+353) 01 4136932 Tel (+353) 01 405 6777 sales@crosstechnicalsolutions.ie Fax (+353) 01 4136932 www.crosstechnicalsolutions.ie sales@crosstechnicalsolutions.ie

www.crosstechnicalsolutions.ie Irish PharmaChem | Industry Buyers Guide 2018

CHEMICAL SUPPLIERS

2 0 1 2

Acids & alkalis

Associated Chemicals Ltd Brenntag Ireland Camida Ltd Charles Tennant & Co Ltd Chemco Ireland Ltd Fisher Scientific Ireland Ltd Goulding Chemicals 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 Camida Ltd National Chemical Company Univar

biochemicals

Associated Chemicals Ltd Betco Marketing Ltd Camida Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Univar

biocides

Associated Chemicals Ltd Brenntag Ireland Corcoran Chemicals Limited Heterochem Dist Ltd National Chemical Company Univar

catalysts

Associated Chemicals Ltd Camida Ltd National Chemical Company

chiral compounds

Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Camida Ltd Corcoran Chemicals Limited 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 2018

fine chemicals

Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Betco Marketing Ltd Brenntag Ireland Camida Ltd Chemco Ireland Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company Ocon Chemicals Ltd Solv-Echem Ireland Ltd

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 Corcoran Chemicals Limited 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 P.J. Bonner & Company SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Water Chromatography Ireland

Misc chemicals

Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Brenntag Ireland Camida Ltd Chemco Ireland Ltd Corcoran Chemicals Limited Fisher Scientific Ireland 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 Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company

organic intermediates

Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Betco Marketing Ltd Camida Ltd Corcoran Chemicals Limited National Chemical Company Roche Ireland Ltd Univar

organometallics

Associated Chemicals Ltd Camida Ltd Heterochem Dist Ltd National Chemical Company

reagents

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

silanes

Associated Chemicals Ltd Brenntag Ireland Camida Ltd Corcoran Chemicals Limited Heterochem Dist Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin Univar

solvents

Betco Marketing Ltd Brenntag Ireland Camida Ltd Charles Tennant & Co Ltd Chemco Ireland Ltd 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

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GENERAL SUPPLIERS

2 0 1 2

ACTUATORS P.J. Bonner & Company 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

ANALYSIS SERVICES Anecto Catalent Pharma Solutions Corcoran Products Ltd

ANALYTICAL EQUIPMENT ABB 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 LABPLAN O’Flynn Medical Ltd Weber Packaging Solutions Ltd

GS1 Ireland Holfeld Graphics Indaver Ireland Millmount Healthcare Weber Packaging Solutions Ltd

BARCODE VERIFICATION Holfeld Graphics

BARRIERS SAFETY P.J. Bonner & Company

BIOPHARMACEUTICALS Alkermes Pharma Ireland Limited MSD Ireland

BIOTECHNOLOGY ABB 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 Holfeld Graphics

BLOWERS CPI Technology Ltd Flexachem Manufacturing Ltd

BPRV BS&B Safety Systems Ltd

BREATHER VENTS BS&B Safety Systems Ltd

BALANCES Fisher Scientific Ireland Ltd Ocon Chemicals Ltd P.J. Bonner & Company SciChem - Cork SciChem - Dublin

BARCODING / LABELLING/ TRACEABILITY Corcoran Products Ltd

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

CABINETS Cross Technical Solutions Fisher Scientific Ireland Ltd ProSys Containment and Sampling Technology

Sartorius Mechatronics Weber Packaging Solutions Ltd

CAD Callaghan Engineering

CALIBRATION Endress & Hauser (Ireland) Ltd Fisher Scientific Ireland Ltd Holfeld Graphics 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 P.J. Bonner & Company Sartorius Mechatronics SciChem - Cork SciChem - Dublin

CHEMICAL CONSULTANTS Callaghan Engineering Corcoran Chemicals Limited

CHILLED WATER Daikin Europe P.J. Bonner & Company

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

CLEANROOMS Callaghan Engineering Cross Technical Solutions Dawson Rentals Ireland Ltd Millmount Healthcare Ocon Chemicals Ltd P.J. Bonner & Company Veolia

CLEANING SERVICES / EQUIPMENT AQS Environmental Solutions WrenTech Ltd Irish PharmaChem | Industry Buyers Guide 2018

GENERAL SUPPLIERS COLD CHAIN PACKAGING Catalent Pharma Solutions Cold Move CRS Pharma Solutions Cross Technical Solutions Millmount Healthcare

COMPRESSED AIR / COMPRESSORS Festo Ltd P.J. Bonner & Company Veolia

COMPUTER SYSTEMS Premier Validation Weber Packaging Solutions Ltd

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 PHARMA SERVICES Alkermes Pharma Ireland Limited Avara Shannon Pharmaceutical Services Eurofins Biopharma Product Testing Hovione Indaver Ireland McGee Pharma International

CONVEYORS Weber Packaging Solutions Ltd WrenTech Ltd

COOLING SYSTEMS CPI Technology Ltd Cross Technical Solutions Daikin Europe Dawson Rentals Ireland Ltd Veolia

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

DESIGN Callaghan Engineering Graham Hart (Process Technology) Ltd Pilz Ireland Protech Plastics Ocon Chemicals Ltd WrenTech Ltd

DISTILLATION CPI Technology Ltd Fisher Scientific Ireland Ltd Irish PharmaChem | Industry Buyers Guide 2018

Graham Hart (Process Technology) Ltd Labplan Ocon Chemicals Ltd Soltec (Ireland) Ltd

DOCUMENTATION SOLUTIONS TWi

DRAINS AQS Environmental Solutions

DRIERS CPI Technology Ltd

DRUMS / CONTAINERS Carbon Group Complas Packaging Ltd Corcoran Products Ltd Industrial Packaging Ltd Interpac Ocon Chemicals Ltd Protech Plastics Quitmann O’Neill WrenTech Ltd

DRY ICE P.J. Bonner & Company

ECONOMIC DEVELOPMENT AGENCY IDA Ireland

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

EFFLUENT MONITORING TREATMENT Carbon Group Flexachem Manufacturing Ltd P.J. Bonner & Company Veolia

ELECTRICAL Callaghan Engineering P.J. Bonner & Company 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 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

EVAPORATORS Cross Technical Solutions 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 P. J. Bonner & Company Sartorius Mechatronics

EXPLOSION PROTECTION / PANELS BS&B Safety Systems Ltd CPI Technology Ltd Henley Forklift Group Limited Pilz Ireland P. J. Bonner & Company

EXTRUDERS BS&B Safety Systems Ltd

FACILITY DESIGN Callaghan Engineering McGee Pharma International

FACILITIES MANAGEMENT Hochtief Facility Management Portakabin Allspace

FILLING EQUIPMENT Idex Pump Technologies (Ireland) Ltd 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

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

Ocon Chemicals Ltd

FIRE DETECTION / PREVENTION/ PROTECTION

CPI Technology Ltd

BS&B Safety Systems Ltd P. J. Bonner & Company

FLAME ARRESTERS BS&B Safety Systems Ltd

Quitmann O’Neill SciChem - Cork SciChem - Dublin

GRINDING Fisher Scientific Ireland Ltd

HAZARDOUS WASTE DISPOSAL / TREATMENT AQS Environmental Solutions Indaver Ireland Industrial Packaging Ltd

FLEXCO PLATES Holfeld Graphics

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

FLUID HANDLING CPI Technology 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 P. J. Bonner & Company SciChem - Cork SciChem – Dublin

GAS SUPPLY Bord Gais Corcoran Products Ltd

GAUGES 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

64

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 P. J. Bonner & Company ProSys Containment and Sampling Technology

HEATERS P. J. Bonner & Company

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

HOSES CPI Technology Ltd

HUMIDITY / HUMIDIFIERS Dawson Rentals Ireland Ltd Interpac P. J. Bonner & Company

HYDRAULICS Henley Forklift Group Limited P. J. Bonner & Company WrenTech Ltd

INCINERATION Indaver Ireland Tyco Valves & Controls Ireland Ltd

INCUBATORS Cross Technical Solutions Fisher Scientific Ireland Ltd Ocon Chemicals Ltd P. J. Bonner & Company SciChem - Cork SciChem - Dublin

INJECTION MOULDING Allstop Europe Ltd P. J. Bonner & Company

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 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 Westbourne Global IT Solutions Ltd

INVESTMENT Goodbody Stockbrokers

LAB EQUIPMENT / SUPPLIES Carbon Group Labplan Ocon Chemicals Ltd P. J. Bonner & Company Solv-Echem Ireland Ltd SciChem - Cork SciChem - Dublin Westbourne Global IT Solutions Ltd WrenTech Ltd

LEGAL / FINANCIAL / INSURANCE Goodbody Stockbrokers

LOGISTICS C&G Logistics Group Cold Move Kuehne + Nagel 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 Cross Technical Solutions Hochtief Facility Management Sartorius Mechatronics UK Ltd Veolia Irish PharmaChem | Industry Buyers Guide 2018

GENERAL SUPPLIERS Water Chromatography Ireland Weber Packaging Solutions Ltd

MANUFACTURERS Abbvie Bemis Healthcare Packaging BS&B Safety Systems Ltd Daikin Europe Endress & Hauser (Ireland) Ltd Hovione Portakabin Allspace Sartorius Mechatronics Thornshaw Scientific

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 Henley Forklift Group Limited Pilz Ireland Tyco Valves & Controls Ireland Ltd Veolia Weber Packaging Solutions Ltd

MECHANICAL & PROCESS ENGINEERING Callaghan Engineering CPI Technology Ltd Tyco Valves & Controls Ireland Ltd Veolia Weber Packaging Solutions Ltd

MEDICAL DEVICE MANUFACTURE B. Braun Medical

MEMBRANE FILTRATION SYSTEMS Microfiltration: Fisher Scientific Ireland Ltd Nanofiltration: Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Ultrafiltration: Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Reverse osmosis: Fisher Scientific Ireland Ltd Ocon Chemicals Ltd

METERS Bord Gais CPI Technology Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd P. J. Bonner & Company Veolia

MICROSCOPES Fisher Scientific Ireland Ltd Irish PharmaChem | Industry Buyers Guide 2018

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

MILLING Avara Shannon Pharmaceutical Services CPI Technology Ltd Fisher Scientific Ireland Ltd Hovione 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 BS&B Safety Systems Ltd 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 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 Fisher Scientific Ireland Ltd Measom Freer Medisize Ireland Ltd Interpac Ocon Chemicals Ltd P. J. Bonner & Company 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 P. J. Bonner & Company

POLLUTION CONTROL AQS Environmental Solutions Callaghan Engineering Veolia

POWDER HANDLING Carbon Group CPI Technology Ltd Fisher Scientific Ireland 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 Contego Packaging Group Limerick Packaging Protech Plastics Quitmann O’Neill Weber Packaging Solutions Ltd

PROCESS CONTROL ABB Ltd Callaghan Engineering Pilz Ireland Sartorius Mechatronics TWi Tyco Valves & Controls Ireland Ltd

65

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 P. J. Bonner & Company Water Chromatography Ireland

QUALITY & COMPLIANCE ABB Ltd Holfeld Graphics Hovione Indaver Ireland McGee Pharma International TWi Weber Packaging Solutions Ltd

R&D Avara Shannon Pharmaceutical Services Euraxess Ireland MSD Ireland 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 Dawson Rentals Ireland Ltd Fisher Scientific Ireland Ltd Langanbach Services Ltd P. J. Bonner & Company

66

Q1 Scientific SciChem - Cork SciChem - Dublin Veolia

RENEWABLE ENERGY ABB Ltd Callaghan Engineering Daikin Europe Indaver Ireland Sustainable Energy Authority of Ireland Veolia

RESEARCH FUNDING Science Foundation Ireland (SFI)

RESPIRATORY PHARMACEUTICALS Hovione 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 Corcoran Products Ltd Dawson Rentals Ireland Ltd Eurofins Biopharma Product Testing Q1 Scientific

STAINLESS STEEL / FITTINGS / PRODUCTS CPI Technology Ltd Interpac P. J. Bonner & Company 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 Dawson Rentals Ireland Ltd Hovione Interpac Kuehne + Nagel Quitmann O’Neill SciChem - Cork SciChem - Dublin

STORAGE OF HAZARDOUS MATERIALS C&G Logistics Group Corcoran Products Ltd Dawson Rentals Ireland Ltd Hovione Indaver Ireland Johnston Logistics Ltd

SUPPLY CHAIN MANAGEMENT C&G Logistics Group Catalent Pharma Solutions Cold Move GS1 Ireland Hovione Kuehne + Nagel KWE (Ireland) Ltd Limerick Packaging McGee Pharma International National Chemical Company Solv-Echem Ireland Ltd Thornshaw Scientific

TABLETING EQUIPMENT Flexachem Manufacturing Ltd Hovione P. J. Bonner & Company WrenTech Ltd

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

TEMPERATURE CONTROL Bord Gais Corcoran Products Ltd Cross Technical Solutions Daikin Europe Dawson Rentals Ireland Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Kuehne + Nagel KWE (Ireland) Ltd Labplan Ocon Chemicals Ltd Irish PharmaChem | Industry Buyers Guide 2018

GENERAL SUPPLIERS P.J. Bonner & Company Q1 Scientific Tyco Valves & Controls Ireland Ltd

TEMPORARY LAB & OFFICE ACCOMMODATION Portakabin Allspace

TESTING SERVICES Anecto CPI Technology Ltd Bemis Healthcare Packaging Henley Forklift Group Limited Eurofins Biopharma Product Testing

THERMAL IMAGING / THERMOGRAPHY P. J. Bonner & Company

TRANSPORT & LOGISTICS C&G Logistics Group Celtic Forwarding Ltd Cold Move Henley Forklift Group Limited Johnston Logistics Ltd Kuehne + Nagel 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 BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd P. J. Bonner & Company Tyco Valves & Controls Ireland Ltd WrenTech Ltd

VALIDATION ABB Ltd Callaghan Engineering Dawson Rentals Ireland Ltd Holfeld Graphics McGee Pharma International Pilz Ireland P. J. Bonner & Company

VENTILATION Callaghan Engineering Daikin Europe Pilz Ireland Veolia

VISION SYSTEMS Weber Packaging Solutions Ltd

WAREHOUSE MANAGEMENT C&G Logistics Group Celtic Forwarding Ltd Chemco Ireland Ltd Cold Move Complas Packaging Ltd Hovione

Kuehne + Nagel 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 P. J. Bonner & Company 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 2018

67

COMPANY LISTINGS

2 0 1 2

A

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

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.

ASSOCIATED CHEMICALS LTD

Abbvie Address: ABBVIE Sligo – Manorhamilton Road Tel: 071 913 6600 Address: ABBVIE Cork - IDA Business &

Technology Park, Carrigtohill,

Co. Cork.

Tel: ( 021)4881400 Business: Pharmaceutical

Alkermes Pharma Ireland Limited 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

68

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

Avara Shannon Pharmaceutical Services Limited Address: Shannon Industrial Estate, Shannon,

Co. Clare, V14 FX09, Ireland.

Tel: 00353-61-714114 Fax: 00353-61-714101 Email: wjkunz@avara.com Web: www.avara.com Business: US / European based CDMO for API,

Bulk Drug Product, Finished

Product, Packaging and Distribution.

Contact: Mr. Werner Kunz: VP & Site Director

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 O’Reilly

B

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.

BERKLEY GROUP Address: Dublin: 509 The Capel

Building, Mary’s Abbey,

Dublin 7.

Cork:

Mill House, Carrigrohane,

Co. Cork.

International Offices: Singapore, London & Dubai.

Tel: (01) 872 4666

(021) 428 9600 Email: sgreenwood@Berkley-group.com Web: www.berkley-group.com Contact: Steve Greenwood

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 2018

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

carbon group 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: Pharma/biopharma chemicals Contact: Area Sales Manager:

Carol Deegan

36 Merrion Square, Dublin 2. or 49 Sth Mall, Cork (01) 662 1000 (Dublin) (021) 4221000 (Cork) b.mcgrath@brightwater.ie www.brightwater.ie

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.bsbflamearrester.ie www.bsb.ie Business: Flame Arresters, Detonation

Arresters, Breather Vents, and

Pressure/Vacuum Vents, Pressure Relief Safety Devices Ireland Direct Sales Contact: Manager: Patrick Murphy

C

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

CALLAGHAN ENGINEERING Dublin Address: Wentworth House,

19/20 Hogan Place,

Lower Grand Canal St,

Dublin 2.

Cork Address: Suite 201, Building 1000,

Units 1201& 1202,

City Gate, Mahon, Cork.

Tel: (01) 661 4420 Fax: (01) 661 4424 Email:

mail@calleng.ie Web: www.calleng.ie rIsh harma hem Business: Multi-discipline

consulting engineering

and project managment company.

Building 1000,

I

P

C

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

Dublin 24.

Park, Rathcoole, +353 (0) 1 4013500 Tel: Dublin 24.

Fax: +353 (0) 1 4013599 Tel: (01) 401 3500 Email:

dublin.sales@brenntag.ie Fax: (01) 405 3501 Web: www.brenntag.ie Email: dublin.sales@brenntag.ie Business: Chemical Suppliers & Web: www.brenntag.ie Distributors Contact: Sales Desk Contact: cormac.mccarthy@brenntag.ie

Irish PharmaChem | Industry Buyers Guide 2018

briGhtwAter Address:

36 Merrion Square,

Units 1201& 1202, Â City Gate, Mahon, Cork.

Tel: (021) 240 9099 Fax: (021) 240 9009 Email: LTD mail@calleng.ie CAMIDA Web: www.calleng.ie Address: New Quay, Clonmel, Business: Co.Multi-discipline Tipperary, E91 YV66, Ireland.

consulting engineering Tel: +353 52 6125455 and project managment Fax: +353 52 6125466 company.

Email:

info@camida.com Web: www.camida.com cAmidA Ltd Contact: Company Secretary: Address: Deirdre Tower House,

McGrath

Tel: Fax: Email: Web:

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

Charles Tennant & co Ltd Address: 71 Cookstown Ind Estate,

Belgard Road, Tallaght,

Dublin 24.

Tel: (01) 451 4099 Fax: (01) 451 4702 Email: jgrehan@ctennant.ie Web: www.charlestennant.com Business: Chemical and Packaging supplier.

Contact: Chemical Manager:

Jim Grehan

2012

b renntAG ireLAnd Brenntag Ireland

catalent pharma solutions

New Quay, 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, Chemco Ireland Limited

Address:

Unit 30 Marlborough 2, Stadium Business Park, Street,

Ballycoolin, Cappagh, Dublin 11

D11 Dublin 1.

X205 Tel: +353Waterford: (0)1 8293600 Fax: +353Belview Port, (0)1 8855029

Email:

info@chemco.ie

Slieverue, Web: www.chemco.ie Co. Waterford.

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:

69

ComPany LIstIngs

P.J. BonNer & Company Instrumentation & Weighing Specialists

BRIGHTWATER Address:

Tel:

Email: Web:

COMPANY LISTINGS

COLD MOVE 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

CPI technology ltd

D

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

Address:

complas packaging ltd Address: Naas Industrial Estate,

Dublin Road, Naas, Co. Kildare.

Tel: (045) 874 088/9 Fax: (045) 874 090 Email: sales@complas.ie Web: www.complas.ie

CORCORAN CHEMICALS LIMITED 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

CORCORAN PRODUCTS LIMITED Address:

Tel: Email:

Web:

Business:

Contact:

70

Unit 12, Northern Cross Business Park, Finglas, Dublin 11.

(01) 8644422 info@corcoranproducts.com www.corcoranproducts.com Suppliers of packaging to the Food, Retail, Industrial, Agri & Pharmaceutical Industries.

Derek Lennon

Daikin Europe

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

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

Dawson Rentals Ireland Ltd Address:

Unit JB Beech Avenue, Newhall, Naas, Co. Kildare

Tel: 045 448810 Fax: 045 448811 Email: aidanmccauley@ dawsongroup.ie Web: www.dawsongroup.ie Business: Temperature Controlled Solutions Contact: Managing Director:

Aidan McCauley

CRS Pharma Solutions Address:

Tel: LoCall: Email: Web: Business:

Contact:

Dublin, Belfast, London, Manchester. +353 46 943 5000 1890 929 824 info@crspharmasolutions.ie www.crspharmasolutions.ie GxP Compliant Pharmaceutical Portable 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

E

ENDRESS+HAUSER (IRELAND) LTD. Address:

Tel: Email: Web: Business:

Contact:

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

(045) 989 200 info@ie.endress.com www.ie.endress.com Leading supplier of products, services and solutions for industrial process measurement and automation industry.

Sales Manager: Brian O’Connell

Irish PharmaChem | Industry Buyers Guide 2018

COMPANY LISTINGS IrIsh PharmaChem 2011 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

H

hAzche FISHER SCIENTIFIC fisher scientific IRELAND LTD Address: Suite 4, Plaza 212,

Address: Suite 3, Plaza 212,

Blanchardstown Blanchardstown,

Corporate Park 2, Corporate Park,

Ballycoolin,

Ballycoolin, Dublin 15. eurolec

Dublin 15.

D15 VY66. instrumentation ltd Tel: (01) 885 5854 (01) 885 5854 Address: Technology House, Cluan Enda, Tel: Fax:

(01) 899 1855 Fax:

(01) 899 1855

Dundalk, Co. Louth.

Email: fsie.sales@thermofisher.com Tel: (042) 933 3423 Email: fsie.sales@thermofisher.com Web: www.ie.fishersci.com Fax: (042) 933 1758 Web: www.ie.fishersci.com Email: eurolec@esatclear.ie Business: Laboratory supplies, Business: Laboratory Web: www.eurolec-instruments.com

Chemicals, Consumables, Business: Electronic

supplies.

Reagents, Equipment & instrumentation.

Contact:

Marketing

Instruments.

Commercial Contact: Manager: Product Manager:

Gerry Fitzmaurice

Gerry Fitzmaurice

Eurofins BioPharma Product Testing Address: Clogherane, Dungarvan,

Co. Waterford, X35 T628 Ireland.

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

www.Eurofins.com/Biopharma

F

festo ltd Address:

Tel: Fax: Email: Web:

Business:

Unit 5, Sandyford Park, Sandyford Industrial Estate, Dublin 18.

(01) 295 4955 (01) 295 5680 sales_ie@festo.com/ie www.festo.com/ie Automation company specialising in factory and process automation.

fLexAcheM MAnufActurinG Ltd

Address: Donnybrook flexachemCommercial Centre, manufacturing ltd

Douglas, Co. Cork.

Address: Donnybrook, Commercial Tel: (021) 461 7200

Centre, Douglas, Co. Cork.

Fax:

(021) 489 1297 Tel: (021) 461 7200 / (021) 4617209 Email: sales@flexachem.com Fax: (021) 489 1297 Web: www.flexachem.com Email: sales@flexachem.com Business: tim.quigley@flexachem.com Manufacturer/

www.flexachem.com Web: Distributor.

Business: Manufacturer/ Distributor.

Contact: Commercial Director: Contact: Operations Manager:

Agnes Mullins

Tim Quigley

g

G

Goodbody Stockbrokers Address: Ballsbridge Park, Ballsbridge, Dublin 4.

(01) 667 0400 GTel: LAnbiA estAtes Fax: (01) 667 0230 Address: Glanbia House, Email: goodbody@goodbody.ie Web: www.goodbody.ie Ring Road, Business: Co. Kilkenny.

Capital Markets,

Investment Management, Tel: +353 (0) 87 256 4339

Wealth Management.

Email: gmullally@glanbia.com Contact: Portfolio Manager: Web: www.kilmeadenfields.com

Kathryn Hannon

Business:

Contact:

Irish PharmaChem | Industry Buyers Guide 2018

Property Business Unit of Glanbia PLC. CEO: Ger Mullally

GoLiAth pAckAGinG Goulding chemicals ltd systeMs Ltd

Address: Park Road, Address: CentreBeechwood, Nenagh,

Marina, Cork City.

Co. Tipperary.

Tel: (021) 491 1611 Tel: (067) 37893 Fax: (021) 491 1660 Fax: (067) 34794 Email: kellyt@gouldings.ie Web: www.gouldings.ie Email: info@goliath.ie Business: Chemical distributor.

Web: www.goliath.ie

Business: Supply &

installation of

packaging equipment

Graham Hartand materials (Process Technology) Ltd

handling systems.

Contact: Address:

Friars Director: Industrial Estate,

Bradford Road, George O’Leary

Idle, Bradford,

8SW, UK. GouLdinGBD10 cheMicALs Ltd Tel: (0044) 1274 617021 Address: Centre Park Road, Fax: (0044) 1274 618614

Marina, Cork City.

Email: sales@graham-hart.com

Tel: (021) 491 1611 Web: www.graham-hart.com Fax: (021) 491 1660 Business: Chemical Engineers Email: pollockm@gouldings.ie Design and Web: Manufacturers of Heat www.gouldings.ie

Exchangers and Process Business: Chemical Plant.

distributor.

Contact: Sales Director: Stephen Hart

GrAhAM hArt (process technoLoGy) Ltd

Address: Friars Ind. Estate,

Bradford Road,

Idle, Bradford,

BD10 8SW, UK. Tel: (0044) 1274 617021 GS1 Fax: Ireland (0044) 1274 618614 Address: Second Floor, The Merrion Email: sales@graham-hart.com Web: www.graham-hart.com Centre, Nutley Lane,

Dublin 4.

Contact: Donnybrook, Sales Director: Tel: (01) 208 0660

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

Standards Body.

Contact: Chairman: John O’Callaghan

Vice Chairman: Thomas Shortall

Chief Executive Officer: Gs1 ireLAnd

Mike Byrne

Address: The Nutley Building,

Merrion Road,

Dublin 4.

Tel: (01) 208 0660 Fax: (01) 208 0670 Email: info@gs1ie.org Web: www.gs1ie.org 71 Contact: Member Support Services: Karen Murphy 57

Address:

Tel: Fax: Email: Web: Contact:

henLey Group

Address:

Tel: Fax: Email:

Web: Business

Contact:

hoch MAnAG

Address:

Tel:

Fax:

Email: Web:

COMPANY LISTINGS

H

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:

72

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

Holfeld Graphics

Address:

Unit 3, Jamestown Industrial Estate, Kylemore Way, Dublin D08 PF1C

Tel: Email: Web: Business:

Contact:

01 2855233 rory@holfeldgraphics.com www.holfeldgraphics.com Manufacturer of Flexo plates for Hapa Blister printers, Agents for Axicon, ISO Barcode Verifiers (GS1 128, GS1 Datamatrix, etc.,) Managing Director: Rory Connaughton

idex pump technologies (ireland) ltd Address: R79, Shannon Industrial

Estate, Shannon,

Co. Clare.

Tel: (061) 471933 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:

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

I

ICDS Recruitment Consultants Address: Connacht House,

24 Upper Fitzwilliam Street,

Dublin 2.

Tel: +353 1 632 1200 Email: info@icds.ie Web: www.icds.ie Business: Specialist Recruitment Consultants to the

Pharmaceutical, Life Science,

Chemical, Medical Device,

Food and Technology sectors.

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.

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 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

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 PharmaChem | Industry Buyers Guide 2018

Contact:

Forklifts / Lancer Sideloaders General Manager: Conal McCourt

irish nAtionAL AccreditAtion boArd, the

Address: Wilton Park House,

Wilton Place,

Dublin 2.

Tel: (01) 607 3003 Fax: (01) 607 3109 irish exporters Email: inab@inab.ie association - life Web: www.inab.ie sciences ireland Business: Provides Address: 28 Merrion Square, Dublin 2.

(01) 661 2182 Tel: accreditation (01) 661 2315 Fax: of laboratories, Email: niallstobie@irishexporters.ie Web: certification &

www.irishexporters.ie Business: inspection bodies.

Life Sciences Ireland is Contact: Information Officer:

Industry Grouping with the Irish Exporters

Orla Doyle Association.

Contact: Manager Life Science

Ireland: Niall Stobie.

J

JAvA cLinicAL reseArch Ltd Address: J

Tel: Fax: Email: Address: Web:

Business: Tel: Contact: Email: Web:

Fitzwilliam Buiness Centre, 26 Upper Pembroke St, Dublin 2.

01 637 3903 01 637 3907 info@javacr.com Blackchurch Business www.javacr.com Park, Rathcoole, Co. Dublin.

Clinical Research (01) 401 3333 Managing Director: niallh@jol.ie Ruth Nallen www.johnstonlogistics.ie

Business:

Contact:

Warehousing & Logistics (Complete Supply Chain Management) Sales Manager: Niall Hickey

K

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

(Complete Supply

Chain Management).

Contact: Business Development Manager:

Niall Hickey

K

Kuehne + Nagel Unit 5 Dublin Horizon Logistics Park, Harristown, Swords, Co. Dublin

52,63 Company Listings 2012.indd 7

Tel: Email: Web: Business: Contact:

01 8239777 Alison.moore@kuehne-nagel.com www.kuehne-nagel.ie Logistics & Supply Chain Marketing & Communications Manager: Alison Moore

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

Infection control products for human and animal health.

Sales and Marketing Director: Jim Woods

COMPANY LISTINGS

Contact:

LIMERICK PACKAGING

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

Karl O’Reilly Park, Allenwood,

Tel:

Fax:

LAbpLAn Email:

Web:

Address: Business:

Tel: Contact: Fax:

L

Email:

Address:

Tel: Fax: Email: Web: Business:

Naas, Co Kildare.

(045) 870 560 (045) 870 811 info@labplan.ie www.labplan.ie Allenwood Business Lab supplier of analytical Park, Allenwood, instrumentation, services, Naas, Co. Kildare. technical support.

(045) 870 560 Managing Director: (045) 870 811 Aidan Smyth

info@labplan.ie 58

lennox laboratory supplies ltd

Address: John F. Kennedy Drive,

Naas Road, Dublin 12.

Tel: (01) 455 2201 Fax: (01) 450 7906 Email: sales@lennox.ie greg@lennox.ie Web: www.lennox.ie

Business: Laboratory suppliers.

Address: Eastlink Business Park,

Ballysimon Rd., Limerick.

Tel: 061-400035 LFax: 061-400036 AncAster LAborAtories Email: info@lmkpkg.ie Address: IDA Business Park, Web: www.limerickpackaging.ie Clogherane,

Business: Packaging manufacturers, Dungarvan, Distributors, Designers

Co. Waterford.

and Auditors.

Tel: (058) 48 300 Contact: Sales Director: Fax: (058) 42 855

Mike Boland

Email: info@lancasterlabs.com Web: www.lancasterlabspharm.com Business: Contract Analytical Services Contact: Business Development

Director: LISTER MACHINE Mark Glass

TOOLS LTD LAddress: ennox L AborAtory PO Box 838, Bluebell Industrial Estate, suppLies Ltd

12.

Address: Dublin John F. Kennedy

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

(01) 450 9836 Fax: Dublin 12.

Email: sales@listermachinetools.com Tel: (01) 455 2201 Web:

www.listermachinetools.com Fax: (01) 450 7906 Business: Sales and service of Machine Email: sales@lennox.ie

Tools and related accessories,

greg@lennox.ie consumables and metrology Web: www.lennox.ie equipment.

Business: Laboratory suppliers.

M

maclachlan & donaldson Address: 47 Merrion Square,

Dublin 2.

Tel: (01) 676 3465 Fax: (01) 661 2083 Email: mail@maclachlan.ie Web:

www.maclachlan.ie Business: Intellectual Property Attorneys.

Contact: Dr. Yvonne McKeown

30/05/2012 16:57

www.irishpharmachem.com Irish PharmaChem | Industry Buyers Guide 2018

73

COMPANY LISTINGS

micro

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

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

N

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

MSD Ireland Address:

Oak North Rd, South County Business Park, Leopardstown, Dublin 18.

Tel: +353 (0)1 2998700 Email: info@msd.ie Web: www.msd.ie Business: MSD Ireland is one of the

country’s leading healthcare

companies, having first

established here over 50 years

ago. We currently employ over

1,600 employees, across

four sites in Ballydine, Co.

Tipperary, Brinny, Co. Cork,

Carlow and Dublin and operate

substantial Human Health and

Animal Health businesses.

Contact: Ger Brennan

MSD Ireland (Human Health) LTD

NATIONAL CHEMICAL COMPANY Address: NCC House,

42 Lower Leeson St., Dublin 2,

D02 FX39 Tel: (01) 613 1400 Fax: (01) 634 0132 Email: sales@ncc.ie Web: www.ncc.ie Business: Supply Chain Partner Life Sciences Industry Contact: Leonard Lloyd, NCC Group

Sales & Marketing Director.

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

O

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

www.irishpharmachem.com 74

Irish PharmaChem | Industry Buyers Guide 2018

COMPANY LISTINGS

OBEECO LTD

Q

Address:

Annaville Avenue, Blackrock,

Co. Dublin.

Tel: Fax: Email: Web:

(01) 278 2323 (01) 278 2374 sales@obeeco.ie www.obeeco.ie

OCON CHEMICALS LTD Address: Unit 5, South Cork

Industrial Estate, Vicars Road,

Pouladuff, Co. Cork.

Tel: (021) 431 8555 Fax: (021) 431 8560 Email: info@oconchemicals.com Web: www.oconchemicals.ie Contact: Managing Director:

Frank Mulcahy

P

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 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

Irish PharmaChem | Industry Buyers Guide 2018

PK CHEMICALS LTD

Q1 SCIENTIFIC

Address:

Tel: Fax: Email: Business: Contact:

Address:

Tel: Email: Web: 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 Lock

PPD, Inc. Address:

Tel: Fax: Email: Web: Business:

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.

Protech Plastics Address: 2 Eastgate Avenue,

Little Island, Cork.

Tel: (021) 435 5762 Fax: (021) 435 5907 Email: dmurphy@protechplastics.org Web: www.protechplastics.net Business: Design, development and

manufacture of injection

moulded packaging, for use in

food and pharma.

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

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

S

ProSys Containment And Sampling Technology

SARTORIUS MECHATRONICS UK LTD

Address: Tel: Fax: Email: Web:

Address:

Tel: Fax: Email: Web: Business:

Contact:

UIDA Business Park, Carrigtohill, Co. Cork.

(021) 485 3900 (021) 485 3866 mmcl@prosys.ie www.prosys.ie

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

75

COMPANY LISTINGS

SCICHEM - CORK

SOLTEC (IRELAND) LTD

Address: Unit 14, Barryscourt

Business Park, Carrigtwohill,

Co. Cork.

Tel: (021) 488 2388 Fax: (021) 488 2389 Email: cork@scichem.com Web: www.scichem.com Business: Laboratory Suppliers.

Contact: Branch Manager:

John Molloy

Address:

Tel: Email: Web: Business:

Contact:

SCICHEM – DUBLIN 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

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

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

T

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

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

SUSTAINABLE ENERGY AUTHORITY OF IRELAND

Toyota Material Handling Ireland Ltd

Address: Glasnevin, Dublin 9.

Tel: (01) 836 9080 Email: info@sei.ie Web: www.sei.ie Business: Energy advice & information.

Address: Tel: Fax: Business: Contact:

Killeen Road, Dublin 12.

(01) 419 0200 (01) 419 0325 Forklift and Warehouse Supplies.

Terry O’ Reilly

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.

76

TWi 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

Address: West Building,

Carrigaline Industrial Park,

Carrigaline, Cork, Ireland.

Tel: +353 (0)21 242 8800 Email: info@technicallywriteit.com Web: www.technicallywriteit.com Business: Technical writing, information

design, and documentation

solutions service provider.

Contact: Emmet Kearney, Business

Development Manager

Irish PharmaChem | Industry Buyers Guide 2018

COMPANY LISTINGS

W

U

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

Westbourne Global IT Solutions Limited Address: Tel: Email: Web: Business:

Contact:

The Atrium, Blackpool, Co. Cork 021 431 4310 sales@westbourne.ie www.westbourne.ie Outsourced Service Desks for Labs and IT. Sales Manager: James Symington

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

V

Veolia Address:

Tel: Fax: Email: Web: Business:

Contact:

W

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

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

NOTES

Irish PharmaChem | Industry Buyers Guide 2018

77

Ye ar Pl a nne r 2 0 1 8

SUN MON TUE WED THU

1

J A N

4

5

6

7

1

2

3

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8

FRI

SAT SUN MON TUE WED THU

9

10

11

12

13

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17

18

8

9

10

11

12

13

14

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17

Public Holiday

7

St. Valentine’s Day

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

M A R

Mother’s Day

1

Easter Sunday

2

Easter Monday

3

4

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1

2

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

14

Public Holiday

M A Y

12

13

14

Public Holiday

J U N J U L

SAT SUN MON TUE WED THU

3

New Year’s Day

F E B

A P R

FRI

2

Public Holiday

1

2

3

4

5

6

7

8

9

10

11

12

13

14 15 16 17 18 19

A U G

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

S E P

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

O C T

Public Holiday

1

2

3

4

5

6

7

8

9

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12

13

14

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18

N O V

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

D E C

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

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

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

J A N

18

19 20 21 22 23 24 25 26 27 28

F E B

16

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

St. Patrick’s Day

M A R

Good Friday

Public Holiday

20

21

18

19

15

16

22

20

17

23

24

25

26

27 28 29 30

21

22

23

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24

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A P R M A Y 29

30

J U N

Father’s Day

20

21

22

17

18

19

20

21

22

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24

25

26

27

28

29

30

31

14

15

16

17

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19

20

21

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23

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25

26

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28

19

20

22

23

25

26

27

28

29

30

31

21

24

J U L A U G 29

30

S E P O C T

Halloween

Summer Time Ends

Public Holiday

16

17

18

14

15

16

FRI

SAT

19

17

20

21

22

23

24

25

26

18

19

20

21

22

23

24

SUN MON TUE

WED THU FRI

SAT

27

28

29

30

26

27

28

29

30

31

SUN MON TUE WED THU FRI

SAT

SUN

MON TUE

25

Christmas Day

St.Stephen’s Day

Public Holiday

Public Holiday

N O V D E C

USEFUL REFERENCES ACADEMY OF CLINICAL SCIENCE AND LABORATORY

ELECTRICITY SUPPLY

INSTITUTE OF CHEMISTRY

IRISH PATENTS OFFICE

BOARD

OF IRELAND

Tel: (056) 772 0111

MEDICINE

Tel: 1850 372 757

E-mail: info@instituteofchemistry.org

E-mail: patlib@patentsoffice.ie

Tel: (01) 905 9730

E-mail: esbnetworks@esb.ie

Web: www.instituteofchemistry.org

Web: www.patentsoffice.ie

E-mail: mail@acslm.ie

Web: www.esb.ie INTERNATIONAL SOCIETY

IRISH PHARMACY UNION

ENTERPRISE IRELAND

FOR PHARMACEUTICAL

Tel: (01) 493 6401

Tel: (01) 727 2000

ENGINERING (ISPE)

E-mail: info@ipu.ie

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

Tel: +1 (813) 960 2105

Web: www.ipu.ie

Web: www.enterprise-ireland.com

E-mail: ask@ispe.org

Web: www.acslm.ie ADVISORY COUNCIL FOR SCIENCE, TECHNOLOGY & INNOVATION Tel: (01) 631 2858 E-mail: firstname.surname@djei.ie Web: www.sciencecouncil.ie AN BORD PLEANALA Tel: (01) 858 8100 LoCall: 1890 275 175 E-mail: bord@pleanala.ie

IRISH VENTURE CAPITAL

Web: www.ispe.org

ASSOCIATION

ENVIRONMENTAL HEALTH ASSOCIATION OF IRELAND

INVEST NORTHERN IRELAND

Tel: (01) 276 4647

Tel: (01) 276 1211

Tel: (01) 865 1885

E-mail: secretary@ivca.ie

E-mail: info@ehoa.ie

E-mail: dublin@investni.com

Web: www.ivca.ie

Web: www.ehai.ie

Web: www.investni.com MANDATE TRADE UNION

ENVIRONMENTAL

IRISH BUSINESS &

Tel: (01) 874 6321

PROTECTION AGENCY

EMPLOYERS

E-mail: mandate@mandate.ie

Tel: (053) 916 0600

CONFEDERATION (IBEC)

Web: www.mandate.ie

LoCall: 1890 335 599

Tel: (01) 605 1500

E-mail: info@ibec.ie

E-mail: info@epa.ie

E-mail: info@ibec.ie

Web: www.biopharmachemireland.ie

Web: www.epa.ie

Web: www.ibec.ie

CHAMBERS IRELAND

HEALTH AND SAFETY

IRISH CLEANROOM

Tel: (01) 400 4300

AUTHORITY

SOCIETY

E-mail: info@chambers.ie

Tel: 01 614 7000

Tel: 087 958 8045

Web: www.chambers.ie

LoCall: 1890 289 389

E-mail: info@cleanrooms-ireland.ie

E-mail: wcu@hsa.ie

Web: www.cleanrooms-ireland.ie

Web: www.pleanala.ie BIOPHARMACHEM IRELAND Tel: (01) 605 1500

COMPANIES REGISTRATION OFFICE Tel: (01) 804 5200 LoCall: 1890 220 226 E-mail: info@cro.ie

Web: www.hsa.ie

Web: www.cro.ie

NATIONAL INSTITUTE FOR TRANSPORT & LOGISTICS (NITL) Tel: (01) 402 3000 E-mail: nitl@dit.ie Web: www.nitl.ie PARENTERAL DRUG ASSOCIATION (PDA) Tel: +1 (301) 656 5900 E-mail: info@pda.org

IRISH COSMETICS, HEALTH PRODUCTS

DETERGENT & ALLIED

REGULATORY AUTHORITY

PRODUCTS ASSOCIATION

Tel: (01) 676 4971

Tel: (01) 605 1671

PHARMACEUTICAL

E-mail: info@hpra.ie

E-mail: siobhan.dean@ibec.ie

SOCIETY OF IRELAND

Web: www.hpra.ie

Web: www.icda.ie

Tel: (01) 218 4000 E-mail: info@psi.ie

HEALTH RESEARCH

IRISH EXPORTERS

Web: www.thepsi.ie

BOARD

ASSOCIATION

Tel: (01) 234 5000

Tel: (01) 661 2182

E-mail: hrb@hrb.ie

E-mail: iea@irishexporters.ie

Web: www.hrb.ie

Web: www.irishexporters.ie

HIGHER EDUCATION

IRISH MEDTECH

AUTHORITY

ASSOCIATION

Tel: (01) 231 7100

Tel: (01) 605 1500

E-mail: info@hea.ie

E-mail: info@irishmedtechassoc.ie

Web: www.hea.ie

Web: www.irishmedtechassoc.ie

& LOCAL GOVERNMENT

IDA - INDUSTRIAL

IRISH NATIONAL

Tel: (01) 888 2000

DEVELOPMENT AGENCY

ACCREDITATION BOARD

LoCall: 1890 20 20 21

Tel: (01) 603 4000

Tel: 1890 289 389

Tel: (01) 716 1825

E-mail: qcsofficer@housing.gov.ie

E-mail: idaireland@ida.ie

E-mail: info@inab.ie

E-mail: chemical.eng@ucd.ie

Web: www.housing.gov.ie

Web: www.idaireland.com

Web: www.inab.ie

Web: www.ucd.ie/chembioeng

Web: www.pda.org

DEPARTMENT OF COMMUNICATIONS, CLIMATE ACTION AND ENVIRONMENT Tel: 01 678 2000 E-mail: customer.service@dccae.gov.ie Web: www.dccae.gov.ie DEPT. OF Business, ENTERPRISE & INNOVATION Tel: (01) 631 2121 LoCall: 1890 220 222 E-mail: info@dbei.gov.ie Web: www.dbei.gov.ie

REPAK Tel: (01) 467 0190 E-mail: info@repak.ie Web: www.repak.ie SCIENCE FOUNDATION IRELAND Tel: (01) 607 3200 E-mail: info@sfi.ie Web: www.sfi.ie

DEPT. OF HOUSING, PLANNING

80

UCD SCHOOL OF CHEMICAL & BIOPROCESS ENGINEERING

Irish PharmaChem | Industry Buyers Guide 2018

er.indd 1

On Time, Everytime!

Packaging Manufacturers, Distributors & Packaging Consultants • Corrugated Boxes (RSC, Die Cut, Sheets, Pads, Divs, Etc) • Protective Foam Packs (EPS, EPE, EPP, EPU) • Industrial Polyethylene Bags, Sleeves & Sheets

• Pallet Edgeguards • Litho Printed Cartons & Litho Laminated Outers 11/01/2012

• High Quality Post Printed Corrugated Boxes

T: + 353 61 400035 F: + 353 61 400036 E: info@lmkpkg.ie • Shelf-Ready/Retail-Ready Packs.

• Pallet Wrap / Strapping Strapping Accessories / Tapes / Labels

Limerick ad.indd 1 Food Cover.indd 1

T: + 353 61 400035

21/12/2010 11:58

E: info@lmkpkg.ie

11/01/2012 15:56

W: www.limerickpackaging.ie

The new Daikin Inverter water cooled chiller delivers the highest efficiency in it’s range. With it’s small footprint, low noise level and wide operation range, the VZ chiller can be used for a variety of applications. In addition to this, the VZ chiller is future ready, using the best refrigerant today and ready for the new refrigerants of tomorrow.