Irish PharmaChem Yearbook 2024

2024

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CONTENTS

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4 MINISTER’S FOREWORD

Simon Coveney TD, Minister for Enterprise, Trade & Employment, reflects on a tremendously busy year for Life Sciences in Ireland and looks forward to Ireland’s continued success as a thriving health enterprise ecosystem.

6 SECTOR OVERVIEW

Newly appointed Director of BioPharmaChem Ireland, Dr Sinead Keogh, Ibec Head of Sectors, stresses the importance of the biopharma sector to Ireland’s economy, and details the next steps necessary to ensuring Ireland remains at the top table internationally.

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10 MANUFACTURING IN IRELAND

Ireland’s manufacturing sector is high-tech, highend, global and offers incredible value, explains Sharon Higgins, Executive Director, Membership & Sectors, Ibec, who summarises Ibec’s latest report on Manufacturing in Ireland.

18 A HISTORY OF BPCI

Retired Director of BioPharmaChem Ireland, Matt Moran, reflects on the history of the organisation he established back in 1994, its evolution along with the industry it serves, and why both the organisation and the biopharma sector in Ireland can look to the future with confidence.

24 MATT MORAN

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Some of those who worked with Matt Moran during his 29 years at the helm of BioPharmaChem Ireland, pay tribute to this dynamic and visionary leader and consider the legacy he leaves behind.

26 HEALTH & SAFETY

Michael Gillen, BioPharmaChem Ireland, reports on the development of the EU-OSHA Healthy Workplaces Campaign 2023-2025.

29 DIGITAL HEALTH

Sinead Keogh, Director, BioPharmaChem Ireland, analyses the revolution in Digital Health, examining the European Health Data Space and what it will mean for Ireland.

34 IDA IRELAND

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Rory Mullen, Head of BioPharma and Food at IDA Ireland, reflects on another positive year for Foreign Direct Investment, as Ireland continues to attract the world’s top biopharma companies.

36 MERCK

Merck continues to grow its presence globally and here in Ireland, with the company currently investing over €440 million in its Cork site, which will lead to 370 new jobs.

38 MEDICAL DEVICE REGULATION

43 RECRUITMENT

Cpl Group’s Talent Evolution Group and Life Sciences recruitment division have been instrumental in fostering the industry’s growth from its inception to the billion-dollar powerhouse it is today.

44 ACCESS TO TALENT

Siobhán Dean, BioPharmaChem Ireland, stresses the importance of addressing skill needs and gaps in the biopharma sector, as companies revolutionise their acquisition strategies to attract and retain staff.

50 CONCEPT AT NIBRT

CONCEPT at NIBRT is a cutting-edge core facility for early-stage biotherapy development, which underscores Ireland’s commitment to fostering innovation in the biopharmaceutical sector, writes Dr Fiona C. Killard-Lynch, CSO & Director of Research and Innovation, NIBRT.

56 ELLAB

Ellab has always taken an innovative approach to product development, allied to a dedication to performance and quality, which combine to ensure its range exceeds customer expectations.

58 SHORLA ONCOLOGY

Tipperary-based Shorla Oncology recently secured $35 million in series B funding to advance its oncology product portfolio.

60 LOGISTICS & TRANSPORT: DHL SUPPLY CHAIN DHL Supply Chain has become a key strategic partner to pharmaceutical manufacturers in Ireland and around the world, specialising in supporting biologics customers with their time-critical temperature sensitive needs.

62 SSPC

The SSPC research centre, headquartered in University of Limerick, is celebrating 15 years of providing worldleading pharma research and talent development via unique academic-industry partnerships.

64 PMTC

Dr Rabah Mouras, Interim Director of the Pharmaceutical Manufacturing Technology Centre, highlights the valuable work the PMTC carries out across its key research areas, how industry needs are at the heart of everything PMTC does and the growing importance of sustainability and digitalisation.

68 ASTELLAS

Astellas Pharma Inc. recently announced its intention to submit a planning application to build a new €330 million facility in Tralee, Co. Kerry.

70 SPECIALIST INTEGRATED CDMO

Hovione has 60 years of experience as a Specialist Integrated CDMO.

Dr Emer Sherry, Senior Executive, Irish Medtech Association, and Karina Cassidy, Senior Executive, 71 BIOPHARMACHEM SKILLNET BioPharmaChem Ireland, assess the impact of Susan Costello, Network Director, BioPharmaChem the Medical Device Regulation on the regulatory Skillnet, reflects on an extremely busy but rewarding pathways for drug-devices and combination products. year, the evolution of the steering group and how

Irish PharmaChem | Industry Buyers Guide 2024

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CONTENTS the organisation continues to create and deliver effective learning and development courses for the biopharma sector in Ireland.

of professional cleanroom services, from the routine maintenance of your facility to a bespoke designed service.

75 ENTERPRISE IRELAND

98 ANALYTICAL TESTING

79 SCIENCE FOUNDATION IRELAND AWARDS

100 ROBOTICS

The indigenous Life Sciences sector in Ireland continues to scale, writes Garrett Murray, Head of Life Sciences, Enterprise Ireland.

Some of Ireland’s most outstanding researchers were recognised at the 2023 Science Foundation Ireland Awards.

81 LOGISTICS: KUEHNE+NAGEL

114 SCIENTIFIC EQUIPMENT/ TECHNICAL SOLUTIONS

Mason Technology is a trusted provider of high-quality scientific equipment and technical solutions to the pharma and biopharma sectors.

Almac’s state-of-the-art analytical testing labs support drug substance (API) and drug product 115 CONTRAST MEDIA: GE HEALTHCARE (finished product) analytics across all phases of GE HealthCare has been supporting patients clinical development and into commercial release. across the globe for three decades from its Irish base in Carrigtohill, Co. Cork.

Robotics and automation have emerged as 116 HUBBCAT: ERT COMMUNICATION indispensable tools, empowering manufacturers Hubbcat offers the most up-to-date within the cleanroom and pharmaceutical communication solutions, providing you with the industries. ability to know when your team members are in difficulty and need support.

Kuehne+Nagel’s HealthChain helps to set the gold 102 WASTE MANAGEMENT standard in healthcare logistics.

Why the current market requires flexible planning 118 LOGISTICS: KWE IRELAND in waste management.

KWE Ireland offers intelligent ‘best in class’ 83 ABBVIE logistics solutions, overlooking Dublin Airport.

AbbVie’s new state-of-the-art European services 104 NCC: HIGH-PURITY SOLVENTS hub in Clonshaugh, North Dublin, supports The National Chemical Company understands 120 INTELLIGENT AUTHORING manufacturing plants and company operations in the importance of high-purity solvents for Intelligent authoring aligns with Industry 5.0, Ireland and across the continent. pharmaceutical production. blending mass production efficiency with human intuition and vision.

84 AUTOMATION AND ROBOTICS

Horan Automation and Robotics’ core business is the design, integration and commissioning of precision engineered bespoke solutions for the Irish manufacturing sector.

106 ACTYLIS

Actylis’ unique offering of both manufactured and sourced raw materials and performance ingredients provides unparalleled choice for customers’ supply chains.

85 IT SERVICES

108 MODULAR BUILDING SOLUTIONS

86 ELI LILLY

110 DATA ACQUISITION AND CONNECTIVITY

Dennis Blanck, Business Development Manager, explains why Westbourne IT Global Solutions have the solutions and talent for your transformation journey.

Eli Lilly is leading the way on sustainable manufacturing, with a whole-of-company approach delivering real results.

88 CHEMICAL SOLUTIONS / TECHNICAL SERVICES Chemifloc Group provides specialist chemical solutions and technical services for multiple applications and use in industry.

90 SK PHARMTECO

Christian Visser of Dawsongroup TCS Ireland explores the benefits that modular construction brings to the table for pharma and biotech companies.

Astatine’s ground-breaking renewable heat and power solutions are helping their clients to reduce energy costs, carbon emissions and overall environmental impacts.

121 122 128 140

Chemical Suppliers General Suppliers Company Listings Useful References

Bonner specialise in providing tailor-made, comprehensive systems that empower customers to leverage their data effectively.

111 EDUCATION & TRAINING: UCC & MTU The iEd Hub at UCC and MTU is a Life Science industry-focused knowledge and education provider, where pharma, biopharma and medtech companies are directly involved in course design and delivery.

SK pharmteco is investing in the future with increased investments across the globe, including 112 INGREDIENTS Ireland.

Barentz offers pharmaceutical manufacturers a range of ingredients to suit every application, including challenging formulations.

92 INSTRUMENTATION Save time and costs throughout the life cycle of your measurement devices with remote technical support from Endress+Hauser.

94 RENEWABLE ENERGY

LISTINGS SECTION

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

Tel: 00 353 (0) 1 678 5165 Web: www.irishpharmachem.com Managing Director: Patrick Aylward Editorial and Marketing Director: Kathleen Belton Email: kathleenbelton@tarapublications.ie Editor: John Walshe

96 CLEANROOM SOLUTIONS SERVICES & MAINTENANCE

Advertising Sales: Brian Clark, Aaron Stewart Design: Niall McHugh Production: Ciara Conway Printed by: W&G Baird

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Irish PharmaChem | Industry Buyers Guide 2024

Asgard Cleanroom Solutions cover a wide range

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MINISTER’S FOREWORD

Life Sciences thriving in Ireland

Simon Coveney TD, Minister for Enterprise, Trade & Employment, reflects on a tremendously busy year for Life Sciences in Ireland and looks forward to Ireland’s continued success as a thriving health enterprise ecosystem.

It’s a pleasure to preface the Irish PharmaChem Yearbook once again. Earlier this year, I took the opportunity to introduce the special edition of the Yearbook, focusing on future-proofing the sector as we navigate the twin digital and green transitions. Now at the end of the year, I am glad to celebrate with you the tremendous work that you do in the pharmaceutical and chemical sectors, as well as in the biotechnology and medical devices sectors too.

As you all know, these sectors are hugely important to the Irish economy: the growth of the Life Sciences in Ireland has been a cornerstone of our economic success and we are proud of a thriving sector that brings high-quality jobs all around the country.

You’re already familiar with the great work achieved over the last year but as we face into the coming year and take stock of the year that was, it’s a good time to reflect on all that we have achieved and what we can build on in the year to come.

2023 marked 50 years since we joined the European Union, and we celebrated this milestone throughout the year. I think it’s safe to say that since joining, we haven’t looked back and in 50 years, we have gained a lot through our collaboration with other European countries and our commitment to a Single Market.

Strengthening connections Our strengths lie in sharing what connects us, and these connections continue to grow.

In 2023, we formally commenced Ireland’s participation in the One Million Plus Genome Initiative. This means that we will be able to link genomic databases across Europe, and to share health data across borders. In mapping

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Irish PharmaChem | Industry Buyers Guide 2024

MINISTER’S FOREWORD way that we do business and consume the resources of our planet must change.

But with imperative to change come new opportunities and new ways of doing things. We can no longer rely on cheap fossil fuels to drive our progress. In Ireland, we are already adapting to a decarbonised future and the energy opportunities that renewables afford.

We all have a part to play in delivering a 35% reduction in carbon emissions by 2030. I know that many of you have already started on this journey and I look forward to seeing the results of your dedication.

As an island, we are uniquely positioned to deliver once-in-a-century industrial development opportunities. The scale of our offshore wind potential, as well as our hydrogen production, will make us global leaders in decarbonising industry.

Government working for you our unique signifiers, we create high-quality and interoperable databases for the benefit of patients across Europe. By understanding the beautiful complexities of who we are, we can also better understand, prevent and treat disease for ourselves and our friends across the Union.

This year we also turned the page in terms of the types of medicines being developed in Ireland. Through IDA Ireland, the Government invested €15 million in the new Cell and Gene Therapy expansion at the National Institute for Bioprocessing Research and Treatment. When the Taoiseach turned the sod at the site last year, we doubled down on our commitments to support innovative medical treatments and to help to train the next generation of researchers.

2023 also saw the publication of the National Hydrogen Strategy, which sets out how we will decarbonise our economy, enhance our energy security and develop the industrial potentials that developing our hydrogen infrastructure will bring.

The capabilities and knowledge of Irish SMEs are highly regarded by international firms and deepening our connections offers an array of potential opportunities, both at home and further afield.

Significant linkages and spill-overs between MNCs and SMEs benefit communities across Ireland but also provide lucrative opportunities for international networks.

We know that we are stronger together.

Ireland will continue to foster a strong mutually supporting enterprise base through its multinational companies partnering with Irish enterprise to support the ongoing growth and development of the Irish economy.

Shaping our industry for future generations As we ring in 2024, let us consider the kind of year we would like to have, and how we can shape this for future generations. The

And as your Government, we will also work to maintain and refine our competitive business taxation regime and ensure that Ireland continues to be a destination of choice for workers. Our education and training systems will continue to provide people with the skills to thrive in a low carbon and digitalised society, which are so important for the biopharma sector.

Innovation will remain a cornerstone of our enterprise policy and we are working to enhance our international reputation for research that supports industry operating at the digital frontier.

My Department is here to support industry and ensure that sectors such as the Life Sciences continue to thrive and flourish.

Wishing you and yours every success for the coming year!

Simon Coveney TD, Minister for Enterprise, Trade & Employment.

White Paper on Enterprise Last year, my Department, the Department of Enterprise, Trade and Employment, published the White Paper on Enterprise, which establishes the enterprise policy that will see us to the end of the decade.

It outlines the necessary steps towards achieving our net zero and decarbonisation commitments. This year we published the first of three Implementation Plans.

Strengthening collaboration between MNCs and SMEs is a top priority for my Government and one that I know is important to stakeholders in the Life Sciences sectors.

From the largest MNCs to the microenterprises and spin-outs, Government recognises that a thriving health enterprise ecosystem supports each of its constituents.

Irish PharmaChem | Industry Buyers Guide 2024

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SECTOR OVERVIEW

Futureproofing our biopharma industry Newly appointed Director of BioPharmaChem Ireland, Dr Sinead Keogh, Ibec Head of Sectors, stresses the importance of the biopharma sector to Ireland’s economy, and details the next steps necessary to ensuring Ireland remains at the top table internationally.

Dr Sinead Keogh, Head of Sectors and Director of BioPharmaChem Ireland.

I was honoured to be appointed to the position of Director of BioPharmaChem Ireland (BPCI) on November 1, 2023, having led Ibec’s Irish Medtech Association for the past 10 years. Since my transition to BPCI, I have prioritised meeting with our members, as well as key representatives from across the broader ecosystem, to hear firsthand their assessment of the current business environment, as well as their current challenges and potential opportunities ahead.

The importance of the biopharmachem sector to the Irish economy and its impact on patients globally is very well accepted. The sector here is the third largest exporter of complex pharmaceutical goods and medicines and the second largest exporter of vaccines in Europe.

With over €100 billion in annual exports, 84,000 people directly and indirectly employed and a further 10,000 jobs to be created over the next five years, it is clear confidence remains high within the established base. This sentiment has been backed by some landmark announcements this year and it’s not surprising that IDA Ireland selected a biopharma company for its most prestigious award.

It was a pleasure to attend IDA Ireland’s Special Recognition Award ceremony in early November, where Albert Bourla, CEO of Pfizer, was recognised for his commitment to Ireland. The award reflected the incredible journey Pfizer has made in Ireland over the past 50 years; a journey that has included €9 billion in investments and 5,000 people now employed across five sites. It is nearly 12 months since Pfizer announced its €1.2 billion investment in its Grange Castle

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manufacturing site, which is Pfizer’s biggest expansion investment to date in Ireland. This investment will see a new facility built on the site and will double the capacity for biological drug substance manufacturing at the facility.

In the last quarter of 2023 alone, AbbVie, a global research-driven biopharmaceutical company with a significant presence across six Irish locations, opened a new €23 million European services hub in Clonshaugh, North Dublin, with 400 jobs added. Astellas Pharma announced its intention to submit a planning application to build a new state-of-the-art facility, at an approximate cost of €330 million, in Tralee, Co. Kerry, and MSD Ireland also announced the official opening of a new, state-of-the-art site in Meath, in addition to a significant expansion at its Carlow site. These MSD projects represent an investment in Ireland of over €1 billion across both facilities. The expansion projects have led to the creation of 670 new jobs across both sites, further building on the company’s successful recruitment drive in recent years and bringing total employee numbers in Ireland to over 3,100 people.

Building innovation capacity for what’s next The presence of world class institutions including the National Institute for Bioprocessing, Research and Training (NIBRT) offers access to a pool of highly skilled researchers and scientists. I was delighted to attend the opening and tour of NIBRT’s new CONCEPT facility in December of this year, representing a major milestone for Irish PharmaChem | Industry Buyers Guide 2024

SECTOR OVERVIEW Cell and Gene Therapy (CGT) research here.

This world class facility will be dedicated to fostering innovation, collaboration and cutting-edge early-stage biotherapy research. It will provide state-of-the-art solutions for next-generation therapeutic research, including Biologics, Cell, Gene and RNA therapies.

It is widely predicted that advanced therapeutics and vaccines will be the next big wave of biopharma growth, with analysts now predicting that CGT revenues will reach US$1060 billion globally by 2025/26.

CGT is a central pillar of BPCI’s strategy, ‘Make Ireland the Global Leader in Sustainable Biopharmaceutical and Chemical Manufacturing 2027’.

We must ensure that we realise the potential of CONCEPT not only for inward investment, but also for the development of a thriving indigenous and start-up CGT ecosystem.

Additionally, Ireland’s strong collaboration between academic, industry and government Ireland’s biopharma sector employs 84,000 people directly and indirectly, with a further 10,000 jobs to be through SFI Research Centres, created over the next five years (image from rawpixel.com). such as the Science Foundation Ireland Research Centre for Pharmaceuticals (SSPC), and Technology Gate way Networks such as to establish consistency around the ‘scientific test’ in terms of how the Pharmaceutical Manufacturing Technology Centre (PMTC), enables auditors assess claims. companies to leverage cutting-edge research and development capability. I was honoured to join the Industry Advisory Board for SSPC in November this year. This world-leading hub of Irish research expertise A long-term ecosystem strategy for talent to chart the way is developing innovative technologies to address some of the key The availability of a skilled and adaptable workforce in Ireland has been challenges facing the pharmaceutical and biopharmaceutical industry. a significant factor in attracting pharma and biopharma investment To truly maximise the potential for innovation and establish and it has never been more important to have a joined-up, long-term Ireland as a research hub in new modalities, we need to ensure we strategic roadmap to direct and future-proof the sector here. have the right incentives in place. In Ibec, we lobbied extensively for The Expert Group on Future Skills Needs established the enhancements to the R&D tax credit in the recent Budget. The increase Biopharmachem Skills Steering Group to develop a strategy on skills in the R&D tax credit to 30% is very welcome and will ensure that large and is due to be launched in early 2024. BPCI’s Siobhán Dean has been MNCs retain the benefits of the credit as we move to a new Global an active member of the Group, and the roadmap makes a number of Minimum Tax, while SMEs will also see improved benefit from the credit. recommendations, including increasing the capacity for education and Notwithstanding progress made, we continue to advocate to training, promoting career pathways including apprenticeships, fostering reduce the administration burden and the need diversity and inclusion, and growing digital skills. We look forward to

“The development of a national industrial Life Sciences and

health technology office and strategy will enable the adoption of industrial policies that promote clustering, so that Ireland can realise more strategic cross-sectoral cooperation, as well as respond to cross-cutting EU regulation.”

Irish PharmaChem | Industry Buyers Guide 2024

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SECTOR OVERVIEW continuing to work with the Department of Enterprise and the Expert Group to realise the goals set out in this report.

Attracting, retaining and up-skilling talent continues to be major priority for companies, against a backdrop of soaring demand, limited resources and evolving technologies, such as advanced manufacturing, AI and more.

Skillnets, apprenticeships and Springboard all have an important role to play in shaping the future talent mix.

To build capability in response to member needs, BPCI launched its consortialed Laboratory Apprenticeship at TU Dublin in 2018. The programme now has 48 companies involved, with 50+ graduates and 126 students in the pipeline. The programme has expanded to SETU and MTU and is being updated to include digitalisation modules.

We’re in the process of developing a new technician programme on Bio Process and Chemical Process, with recruitment planned for intake from September 2024.

As part of the Government’s Action Plan for Apprenticeships 2021-2025, work is underway by the National Apprenticeship Office to bring together craft and consortialed apprenticeships into a single integrated apprenticeship model. The new model of apprenticeships is scheduled to be launched in 2024 and will impact all apprenticeship programmes. In the interim, we’re lobbying Government to ensure that existing apprenticeships programmes have the much-needed funding to scale sustainably.

The BioPharmaChem Skillnet and Digital Health Skillnet offers bespoke training for the pharma, biopharma, chemical, digital health and digital therapeutics industries.

Earlier this year ,the BioPharmaChem Skillnet won the Pharma Education and Training Award 2023 for their Women in Leadership Development (WiLD) programme at the Pharma Awards. Since the pilot programme in 2022, over 170 women have embarked on their WiLD journey, with fantastic feedback and results from both the individuals and their respective organisations.

The Connected Health Skillnet was established under Ibec’s ‘Where Digital Health Thrives’ campaign to develop high-end niche talent at the healthtech intersection. This Network recently launched the ‘Future Skill Needs Analysis for Digital Health’ report, which showed that 87% of companies surveyed here are planning to increase their digital health activity over the next four years, and they intend to invest.

AI was identified by 52% of companies as a top current and future skills need. This Network is upskilling talent to navigate the growing complexities across the value chain, with a strong emphasis on regulation and R&D. In the EU alone, having the skills to navigate the evolving regulatory landscape, including

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the AI Act, Data Act, Cyber Resilience Act and proposed European Health Data Space Regualtion will be key, as well as ensuring we continue to build innovation capability.

Digitalisation and sustainability – the twin transition The two most significant challenges facing Europe over the next decade are the transition towards a climate neutral society and the retention of our industrial competitiveness.

Industry 5.0 can help drive this twin transition and involves the interpretation of Industry 4.0 technologies through a humancentric lens. It broadens the focus from solely shareholder value to value for all stakeholders in society and indeed greater resilience,

particularly of supply chains and the manufacture of strategically important goods.

Recent disruptions have highlighted the importance for Europe to be more selfreliant and/or flexible in manufacturing and supply to adapt to changing conditions.

BPCI and IDA Ireland are collaborating on a Factory 5.0 ‘Lighthouse Project’ with the aim of digitising the sector. Advancements in automation, artificial intelligence (AI) and machine learning in recent years have improved the success rate in the structural design of small molecules.

Companies are adding more sustainable manufacturing processes, in line with stated aims to achieve zero carbon emissions from global operations by the mid-2020s onwards.

To help companies on their sustainability

Make Ireland the Global Leader in Sustainable Biopharmaceutical and Chemical Manufacturing A strategy for the sector 2023-2027

BioPharmaChem Ireland’s strategy for 2023-37 aims to ‘Make Ireland the Global Leader in Sustainable Biopharmaceutical and Chemical Manufacturing’.

Irish PharmaChem | Industry Buyers Guide 2024

SECTOR OVERVIEW

With the right support, we can maximise the potential for innovation and establish Ireland as a research hub in new modalities (image from rawpixel.com).

journey, Ibec launched its ‘Climate Action: A toolkit for business’ in collaboration with Accenture. This comprehensive toolkit provides businesses with the information they need for their climate action journey and provides practical guidance on how to develop an enduring climate action strategy. Through this Climate Action Toolkit, we share learnings, experience and best practice, which can be used by executives to understand the business imperative, and more importantly to develop a best practice approach, to support businesses to deliver on carbon reduction.

Building on this, BPCI will launch its Responsible Care Report, outlining the performance of the sector over the previous three years (2020-2022) in Q1 2024.

Responsible Care is acknowledged as the fundamental non-corporate Environmental, Health and Safety initiative. As such, while activity in the sector continues to grow, Irish PharmaChem | Industry Buyers Guide 2024

the green performance, the focus on the wellbeing and the safety of our people in our member companies continues to improve. Over 90% of our members have engaged in the research and this is a tangible demonstration of our commitment to sustainability.

Calling for an Office of Life Sciences In BPCI we’re advocating for the Government to develop a national health technology and Life Sciences strategy led by the Department of Enterprise, Trade and Employment, with the appropriate resources appointed to support a clearing house within the department to manage and support implementation.

To sustain our hard-won competitiveness, we need to bring key stakeholders across Government, industry and beyond to ensure that we have the right policies, while leveraging our unique position.

Our reputation for manufacturing is of an indisputably high calibre. However, to keep pace with the international business trends, including digitalisation and the increasing complexity of the health innovation ecosystem, we need to adapt and evolve.

The development of a national industrial Life Sciences and health technology office and strategy will enable the adoption of industrial policies that promote clustering, so that Ireland can realise more strategic cross-sectoral cooperation, as well as respond to crosscutting EU regulation. With the AI Act, Data Act, Cyber Resilience Act, proposed European Health Data Space, the restriction proposal for the Per- and polyfluoroalkyl substances (PFAS) under REACH Regulation and the upcoming EU Pharmaceutical Legislation all in play, there has never been a more important time to come together as an ecosystem.

In BPCI, we look forward to supporting our members in navigating the path ahead.

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MANUFACTURING IN IRELAND 2023

Ensuring the future for manufacturing in Ireland In a world marked by global shifts and unpredictable events, Ireland has solidified its position as a dependable hub for business.

The world we live in today poses unique challenges, but our journey so far, filled with many similar challenges in the past, has prepared us for anything. There is lots to be done, but as we face these global shifts, Ireland’s resilience and adaptability make us stand out in the global landscape.

Ibec’s latest report on Manufacturing in Ireland 2023 stands as a testament to the sector’s strength. As unpredictable as the world seems right now, Ireland has withstood storms of equal size, ranging from economic downturns to geopolitical issues.

The backbone of the country’s resilience? A thriving manufacturing sector.

The numbers speak volumes. Each year, the manufacturing sector adds an impressive €13.4 billion in wages and employment taxes. Ireland’s manufacturing sector set new records, exporting goods worth €208 billion in 2022. Additionally, it shoulders a significant portion of our nation’s corporation tax revenue at over 44%, or more than €10 billion, ensuring that our Government has the resources to support essential public services.

Ireland’s manufacturing sector is high-tech, high-end, global and offers many unique advantages. Beyond that, our manufacturing sector’s yearly injection of €22 billion through its local spending not only sustains our domestic industries, but also fosters economic growth across the board.

Between 2012 and 2022, Irish-owned manufacturing exporters experienced a significant sales surge of 76%, while the foreign direct investment (FDI) manufacturers increased their exports by 66%. This growth emphasises the sector’s ability to flourish amidst global challenges.

According to Ibec’s latest survey, the manufacturing industry is committed to sustainability and digital technology. These represent the future of growth. We are also welcoming an exciting new era. Ireland is well-placed to use the potential of Artificial Intelligence (AI), robotics, and other cuttingedge technologies. Our investments in research and development, with 29% of respondents expecting to increase investment in R&D in the short term, along with our technology ecosystem, place us in a position to be frontrunners in these new developments.

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Ireland’s manufacturing sector is high-tech, high-end, global and offers incredible value, explains Sharon Higgins, Executive Director, Membership & Sectors, Ibec, who summarises Ibec’s latest report on Manufacturing in Ireland 2023.

Sharon Higgins, Executive Director, Membership & Sectors, Ibec.

The Ibec report also delves into key policy issues essential for Ireland’s manufacturing success, as well as recommendations for how to make Ireland even more attractive as a manufacturing hub.

On the skills front, while we have a world-class formal education system, there’s a growing need to emphasise lifelong learning and continuous upskilling. This has become especially crucial in the digital age, where roles evolve rapidly.

Our trade environment and strong relationships, especially with major players, like the single market and the US, have also been pivotal.

Sustainability, trade, innovation, digital transformation, taxation and regulation are critical areas of focus now too. We must continually evolve to stay ahead of international competition.

But attractiveness as an investment destination isn’t just about business policies.

Irish PharmaChem | Industry Buyers Guide 2024

MANUFACTURING IN IRELAND 2023 It also revolves around strong social infrastructure such as broadband and other amenities, while areas like housing demand serious attention.

Ensuring that these facilities are strong and accessible is vital in making Ireland a great place to live and work.

Unlocking Ireland’s manufacturing potential Currently, the most pressing for the next manufacturing evolution challenge for businesses is the rising costs. Considering inflation and labour demand, it is essential that we maintain a stable footing and remain as cost competitive as possible.

In his foreword to the Ibec report, Paul Duffy, Ibec President and Senior Vice President at Pfizer Global Supply, argues that manufacturing “plays a pivotal role in Ireland’s economy, employing over 275,000 people Manufacturing in Ireland 2023: Ibec’s latest report into the industry is a testament to the sector’s strength. and contributing more than 12% to total employment. The sector’s growth is driven by the dedication and innovation of the Irish workforce, who have continued to enhance Manufacturing in Ireland: International rankings their skills over the years. Ireland’s manufacturing base extends beyond Ireland is the: major cities, fostering regional development and offering substantial • No. 2 exporter of medical devices in Europe economic benefits.”

• No. 2 exporter of contact lenses in Europe Duffy believes that as the only English-speaking country in the EU following the UK’s departure, “Ireland is well-positioned as a hub for • No. 2 exporter of orthopaedic products in Europe European trade”. He cites availability of talent as critical to the growth • No. 3 exporter of complex pharmaceutical goods and of the industry and with Ireland currently experiencing close to full medicines in Europe employment, stresses the importance of attracting “a steady influx of talent to sustain the industry and facilitate its transition toward • No. 3 exporter of antisera and immunological products in digitalisation and sustainability”.

Europe The Pfizer Senior VP highlighted the role of new technologies in • No. 2 exporter of vaccines in Europe the evolution of the manufacturing industry, pointing to advanced • No. 1 net exporter of dairy ingredients, beef, lamb, and automation and Artificial Intelligence. spirits in Europe Ibec’s Manufacturing in Ireland survey found that overall, • No. 1 exporter in Europe of specialised nutrition products confidence is up. Manufacturers are cautiously more optimistic about the current business environment (70%) compared to 2022 (53%).

• No. 6 exporter of data processing machines.

They are similarly more optimistic about their own business this year (73%) compared to last year (65%).

The top challenges for manufacturers are: As the war in Ukraine faced into winter last year, the sector was • Attracting and retaining talent (major challenge 67%) and acutely impacted by the threat of energy shortages, escalating cost of labour (major challenge 61%) energy costs and supply chain issues. One year on, and while the war • Availability of housing for employees (major challenge 47%) continues, and indeed we’re now seeing another war in the middle east, energy availability is secure (though prices remain high), and • Cost of energy (major challenge for 47%) supply chains are approaching more normative levels. However, • Weaker global growth (major challenge for 39%) more businesses (39%) expect weaker global growth for their business over the short term compared to 32% last year.

• Cost of raw materials (36%) Manufacturing businesses have slightly higher expectations in terms of profitability this year, presumably as the cost of doing The number 1 priority identified for companies was: business is believed to be improving.

30% Improving profitability (30%) Sustainability and digitalisation remain key priorities, with an 11% Access to labour (11%) impressive 85% of companies engaged in sustainability initiatives, and 68% 9% Increasing production (9%) actively participating in digitalisation projects, with half of organisations involved in each of these expecting to save money as a result.

9% Expansion in Ireland (9%) The search for talent is a key concern. Attracting and/or retaining 8% Energy cost/efficiency (8%), with staff is identified by 67% of business leaders as a major challenge, with

26% citing it as a top 3 priority.

72% expecting to see wage increases. This will pose a challenge for 5% Cost of labour (5%) with 29% businesses over the short term, given our full employment status, with

citing it as in the top 3 priorities 32% expecting to increase employee numbers, on top of the regulated labour cost increases scheduled in 2024.

Manufacturing in Ireland 2023

Irish PharmaChem | Industry Buyers Guide 2024

11

MANUFACTURING IN IRELAND 2023 Manufacturing in Ireland by the numbers 2023 Manufacturing in Ireland by the numbers 2023.

275,000

€13.4 billion

44%

€22 billion

275,000 people 11% of total employment.

€13.4 billion in wages and employment taxes annually.

44%, or over €10 billion of corporation tax.

76%

€22 billion spent each year on goods and services from suppliers in the Irish economy.

Irish owned manufacturing exporters grew sales by over 76% between 2012 and 2022.

66%

€208bn

Inward FDI manufacturers grew their exports by 66% between 2012 and 2022.

The state exported a record €208 billion worth of goods in 2022.

There is a marked uplift in R&D investment this year, with 29% of business leaders planning to invest, compared to 21% last year.

Manufacturers are cautiously optimistic about the current business environment compared to last year (70%), although still not as high as 2021, where confidence was at 89%, with business leaders more optimistic about the outlook for the next six months than last year (up from 39% to 66%).

Manufacturing businesses have slightly higher expectations in terms of profitability, increased total and export sales compared

to last year, presumably a consequence of the marked decline in expected energy cost increases and supply chain related issues.

Businesses expect to invest in sustainability, digitilisation, capital investment and R&D.

Business challenges Businesses face a range of major challenges, with attracting and/or retaining staff and the cost of labour most widely mentioned.

While the geopolitical circumstances that brought energy and supply chains to the fore in 2022 have abated, in their absence many of the issues that have challenged businesses

the manufacturing environment (2021 v 2022 v 2023) How CEOs feel about the manufacturing environment.

Currently 2021 2022

tic ent d Very Good

25%

14%

2023 16%

Next 6 Months 2021 2022 9% 21%

in the past are still evident. Expectation of increased costs across energy, labour, raw materials and transport are lower than in 2022. More businesses (39%) expect weaker global growth to be a major challenge for their manufacturing business over the next six months, compared to 32% over the same time frame last year.

Digitalisation Digitalisation is a priority for seven in 10 businesses and one that also increases with company size. Plans to implement digitalisation match digitalisation as a priority, with increased efficiency (88%) and continuous improvement (82%) the main drivers for adoption, along with reducing costs (59%), gaining a competitive edge (57%), data 2023 insights (49%), new product/ service offerings (25%), with just 19% engaging in digitalisation 12% to keep up with competitors.

th 39%

54%

54%

Good

66%

64%

32%

33%

26% Average Poor Don’t know

9% 2%

14%

12% 4%

How would you assess the manufacturing environment in Ireland as it is currently and how it will be over the next 6 months?

12

26% 1%

3%

25%

8% 1%

Manufacturing In Ireland 2023

Sustainability

30%

An impressive nine in 10 companies agree that sustainability is a priority for their business, and again, agreement levels increase with company size.

Given the priority attached to sustainability and impending reporting directives, 85% are introducing initiatives in the next 1-2 years that will lessen their environmental impact and address customer expectations.

67% expect investment in environmental sustainability to increase.

Irish PharmaChem | Industry Buyers 12 Guide 2024

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Irish PharmaChem | Industry Buyers Guide 2024

13

MANUFACTURING IN IRELAND 2023 The reasons given for implementing sustainability initiatives are driven by an environmental conscience as the business wishes to lessen the impact of climate destruction (85%), followed by delivering on customers’ expectations (65%).

Recommendations to Government The Ibec report makes a number of recommendations to Government to support the manufacturing sector going forward, particularly around the costs of doing business here.

2022

2023

Attracting/retaining workforce

63%

62%

67%

Cost of labour

45%

74%

61%

Cost of energy

70%

94%

47%

Availability of housing for employees*

N/A

N/A

47%

Weaker global growth

8%

32%

39%

Cost of raw materials

57%

77%

39%

Sustainablity measure

17%

20%

26%

Regulatory environment

18%

29%

25%

Managing carbon emissions

20%

20%

23%

Availability of raw materials

62%

68%

22%

Cyber security

20%

23%

20%

Trade uncertainties

22%

36%

19%

Transport/logistics costs

64%

62%

18%

Irish planning regulations

15%

24%

15%

Remote/hybrid working

7%

11%

14%

Increase digitalisation

15%

18%

11%

Access to capital/finance

4%

6%

10%

Access to EU/Governement supports

6%

11%

10%

Availability of energy

28%

70%

9%

Land/plant costs

11%

5%

8%

Returning employees on-site

10%

9%

8%

Taxation environment

4%

11%

8%

Covid related issues

12%

9%

1%

Other

6%

5%

3%

• Introduce accelerated capital allowances for advanced manufacturing. This should include computerised/computer-aided machinery and robotic machines.

• Simplify our corporate tax regime to reflect new realities. Ibec supports a move to a territorial system of taxation for Ireland on the basis that there are many wide-reaching policy benefits of such a move.

Talent and innovation:

*Availability of housing for employees is a new question added in 2023 survey.

Companies are embracing digitalisation for a host of different reasons.

Reasons for initiatives 88%

To allow for continuous improvement

82%

To reduce costs

59%

To improve work practices/increase efficiency 88% To have a competative edge/advantage

57%

To reduce costs 59% To improve work practices/increase efficiency offerings 88% New product/service

25%

To have a competative edge/advantage 57% To allow for continuous improvement 82% To keep up with competitors

19%

Data insights 49% To reduce costs demand 59% Customer

10%

Reasons for initiatives

Reasons for initiatives To allow for continuous improvement 82% Data insights 49%

New product/service offerings To have a competative edge/advantage

25% 57%

14

19% 49%

To keep up with competitors Data insights

• Leverage the National Training Fund to support enterprise-led skills development and boost enterprise education engagement.

• Close the €307 million funding gap in higher education to deliver a sustainable funding model to support Ireland’s universities to remain at the cutting edge.

• Deliver a sustainable funding model to support an integrated apprenticeship system and to reduce anomalies between craft and consortia-led apprenticeship in relation to off-the-job training costs.

15

Better Housing, Better Business An inadequate supply of homes is the single largest impediment to attracting and retaining talented workers, without whom business investment and expansions are not possible. Ibec recently launched its Better Housing, Better Business campaign, which outlines several recommendations to address the housing crisis.

Ibec recommends a review of the National Planning Framework and National Development Plan to prioritise infrastructure- and jobs-led housing delivery in our regions. It also calls for stronger collective momentum to addressing the housing crises, including work via the Labour Employer Economic Forum (LEEF) to address sustainable solutions for the delivery of adequate supply of affordable housing in the private market and through public provision. Delivery timelines need to be improved, via the Planning and Development Bill, while funding should be significantly increased through the Irish

Manufacturing In Ireland 202

To improve work practices/increase efficiency

es to /or ss?

• Continue to improve the R&D tax credit, which would benefit from greater certainty around decision-making consistency and broader administration.

Manufacturing In Ireland 2023

2021

ergy many ot as n of nd raw ne our

h to s same

Taxation and incentives:

Companies identified the top challenges facing their business in 2023.

22 v 2023)

e cost ajor full ee es

The report has a number of recommendations for Government across a host of areas. They include:

Ibec is calling on the Government to ensure supports for rising employment costs are in place. It is critical that the State effectively operationalises the comprehensive support programme put in place in Budget 2024 for companies who are struggling with the introduction of the living wage and other employment costs. Indeed, the Government must produce a clear roadmap on other tax measures to ensure that the introduction of the living wage does not lead to high marginal effective tax rates for workers.

Irish PharmaChem | Industry Buyers Guide 2024

Irish PharmaChem | Industry Buyers Guide 2024

15

MANUFACTURING IN IRELAND 2023 Reasons for sustainability initiatives.

2023

2023

2023 Yes

89%

Yes 89%

Yes 89%

No 11%

No 11%

Reasons Reasons for initiatives for initiatives Environmental Environmental conscience/less conscience/less impact of climate impactdestruction of climate destruction 85%

85%

Customers expectations Customers expectations 65%

65%

Environmental conscience/less impact of climate destruction 85% Parent company/Board Parent company/Board requirementrequirement 62%

62%

No 11%

Is sustainability, defined as “the ability to develop 2023 depleting 2023 natural resources or impacting without on the environment” a priority for your business?

2023 Yes

85%

ting

Yes 85%

t will and

Customers expectations 65% To reduce costs To reduce 46%costs

46%

Parent company/Board requirement 62% Staff expectations Staff expectations 35%

35%

To reduce costs 46% Tendering/Green Tendering/Green procurementprocurement 28%

28%

Staff expectations Other

2%

Yes 85%

No 2%

No 2%

35% 2% Other

Tendering/Green procurement

28%

Other

2%

Don’t Don’t know know 13% 13% No 2%

Manufacturing In Ireland 2023

Reasons for initiatives

Don’t know 13%

Is your business introducing any sustainability initiatives in Ireland in the next 1 to 2 years?

Why is your business introducing sustainability initiatives in Ireland in the next 1 – 2 years?

17

Strategic Investment Fund (ISIF) and Home Building Finance Ireland (HBFI) to ensure adequate development finance in the market. Ibec also recognises that a better functioning rental sector is crucial, calling for improved tax treatment of landlords’ expenses, while also ensuring greater security for tenants.

Digitalisation and advanced manufacturing: • Intensify political commitment to the digital agenda and work with business and other partners to lead and shape EU governance and conditions impacting further digital transformation of manufacturing.

• Develop, co-ordinate and adequately resource national cybersecurity and regulatory capacities in expected digital regulation, impacting advanced manufacturing.

• Introduce a new multiannual ‘National Digital Agenda Accelerator’ Fund, with €500 million in the period 2024-2030.

Sustainability and energy: • Strengthen financial and advisory supports for Irish firms developing sustainability strategies in line with industry best practice and legislative requirements.

• Accelerate the transition to carbon neutrality by scaling up and expanding industry supports for renewables and energy efficiency.

• Ensure that the EU energy market reform proposals currently being

16

developed by the European Commission take sufficient account of the cross-border nature of the all-island Single Energy Market.

There will also be a continuing need to support Irish firms whose viability remains under threat due to energy costs.

Ibec recently launched ‘Climate Action: A toolkit for business’ in collaboration with Accenture, which provides businesses with the information they need for their climate action journey and delivers practical guidance on how to develop an enduring climate action strategy. https://www.ibec.ie/connect-and-learn/insights/ insights/2023/09/28/climate-action-a-toolkit-for-business

Trade and international relations: • The EU should deepen the single market by creating a predictable regulatory environment that drives innovation, removes barriers, enforces existing rules and does more in the areas of services and capital.

• The EU must work with major trading partners to achieve WTO reform, and secure new and diversified bilateral agreements that support trade, including digital and data flows.

Manufacturing plays a pivotal role in Ireland’s economic ecosystem. We need to ensure our policy environment is finetuned to our current and future needs. The world may be uncertain, but with the right policies and recommendations, we can deepen investment and innovation, securing a prosperous future for all.

Irish PharmaChem | Industry Buyers Guide 2024

“From drug-eluting stents to implantable defibrillators and from imaging scopes to stroke prevention, we are always innovating and advancing the way we deliver healthcare. In fact, one-third of our revenues came from products released on the market over the past three years, which include those that were acquired through strategic acquisitions.”

For Boston Scientific, Conor says talent and culture are “what sets us apart and what will define our long-term success”. For the company, people development isn’t just a strategy, it’s an essential part of the DNA.

MANUFACTURING IN IRELAND 2023 Case Study: Eli Lilly

Case Study: Boston Scientific Boston Scientific in Clonmel, Co. Tipperary, is at the hub of Ireland’s medtech evolution, having been “a leader in innovation and our best ideas are as a result of the diverse perspectives of our people and of course insights from our customers and their patients,” according to Conor Russell, Vice President of Operations.

“From drug-eluting stents to implantable defibrillators and from imaging scopes to stroke prevention, we are always innovating and advancing the way we deliver healthcare. In fact, one-third of our revenues came from products released on the market over the past three years, which include those that were acquired through strategic acquisitions.”

Conor says talent and culture are “what sets us apart and what will define our long-term success”. At Boston Scientific, “people development isn’t just a strategy, it’s an essential part of the DNA.” The company places a strong emphasis on supporting continuous education, to help employees hone their skills and work toward advancing their careers in their manufacturing and R&D teams. “Skills like data analytics, software, additive manufacturing, and automation are in short supply and are critical to our continued success,” Conor reveals.

This strategy has been hugely successful: “We encourage managers to promote from within, which leads to strong retention, as well as high engagement and employee satisfaction.”

From internal talent development to forging partnerships with universities, Conor says Boston Scientific is committed to nurturing the next generation of innovators.

“We have also furthered our recruiting efforts with a very strong graduate recruitment programme in combination with the Irish Medtech Association’s apprenticeship programmes, which have had tremendous success in introducing new technical apprenticeship qualifications into our industry.”

Conor believes the need for continued focus on education is critical to ensure Ireland remains competitive as a manufacturing leader: “Investment in STEM skills and our public research infrastructure is crucial. Our graduates need to be equipped to compete globally. An investment in education is an investment in the next generation and in our future economy.”

Irish PharmaChem | Industry Buyers Guide 2024

Environmental responsibility has always been important to us,” “This has of been hugely We says Jean strategy Casey, Director Public Affairssuccessful. at Lilly. “At a corporate encourage managers to promote from within, level, we have a number of 2030 goals that we are working towards.” which leads to strong retention, as well as high Making medicines requires the usesatisfaction.” of valuable resources, engagement and employee including energy, water and raw materials, and Lilly has ambitious 2030 goals to reduce their usage.

Gerard O’Shea, Director for Health, Safety and Environment at Lilly Kinsale, emphasises that the company have identified five key focus areas, with five deliverables in each area.

Plastic waste reduction is one area where Lilly are making real progress, as Gerard explains: “Our employees are passionate about sustainability, and they’ve spearheaded a plastic recycling initiative, partnering with a company in Ireland, to repurpose recycled plastic into a raw material used for garden benches and planters, for example. In the last 12 months, we have diverted a significant proportion of what would otherwise be waste plastic to make 570 garden benches and planters. It’s a real testament to the team, who also make great efforts to reduce the use of plastic right across the company.”

Sustainable travel is another focus, with Lilly finding alternative ways staff can travel to their rural site, instead of bringing their cars. Their bus service has seen over 50 people travelling from Cork City to Kinsale and has been such a success that they are now launching a second route, while they also have 50 new electric vehicle chargers on-site.

Reducing energy usage is also a priority for Lilly. Paul O’Sullivan, Utilities Engineer at Lilly, explains how the company’s 26-acre solar farm, adjacent to their Kinsale site, is one of Ireland’s largest solar farms and can provide about 15% of the site’s electricity per annum. “On a very sunny Irish day, the solar farm can generate about 4.5MW on the site, which is over 60% of the site’s daily demand. So, at times, two-thirds of our power is coming from our solar farm, which is something we’re very proud of,” Paul notes.

Lilly’s greenfield Limerick site has sustainability at the core of its design. “Compared to a traditional pharma site, our Limerick site will have 35% lower energy intensity. It’ll use 40% less water and have 15% less waste,” says Jean Casey.

Looking forward, Paul O’Sullivan feels decarbonisation will be a major challenge for the manufacturing industry: “Decarbonisation by increasing electrification is going to present a challenge to the wider industry and Ireland’s infrastructure as a whole, so we need to invest in the national electricity network to prepare for that extra demand.”

Eli Lilly’s ground-mounted Solar Farm will produce up to 5.6MW of power.

17

Manufacturing In Ireland 2023

“It’s become a much more competitive market in recent times,” says Conor. “We focus a lot on developing our people. The company places a strong emphasis on supporting continuous education, to help our employees hone their skills and work toward advancing their careers in our manufacturing and R&D teams. Skills like data analytics, software, additive manufacturing, and automation are in short supply and are critical to ouron continued success”. journey for the last 40 years.

“We’ve been a sustainability

32

A HISTORY OF BPCI

A

s I sit here penning my final article for The PharmaChem Buyers Guide, it’s hard to believe that my journey with BioPharmaChem Ireland (BPCI) came to an end on October 31, 2023, a journey that started back in August 1994 with the establishment of The Irish Pharmaceutical and Chemical Manufacturers Federation (IPCMF). And what a journey it proved to be!

It has been an absolute privilege to be allowed to lead this wonderful sector for nearly 30 years. The PharmaChem Buyers Guide have asked me to reflect on my time with the industry – so here it goes. When I look back, I see three distinct phases in the development of the sector and indeed of BPCI – which went through three name changes during my time there – firstly as IPCMF, then PharmaChemical Ireland finally its current name, BioPharmaChem Ireland, which is actually a merger between PharmaChemical Ireland (PCI) and The Irish BioIndustry Association (IBIA).

Retired Director of BioPharmaChem Ireland, Matt Moran, reflects on the history of the organisation he established back in 1994, its evolution along with the industry it serves, and why both the organisation and the biopharma sector in Ireland can look to the future with confidence.

Phase 1 As I already mentioned, IPCMF was established by Ibec in 1994 at the request of the industry at that time. I was given the job of setting up and establishing IPCMF as a voice for the pharmaceutical and chemical manufacturing sector at the time.

The first Chair of the organisation was Bob Rutledge – Chief Executive of Henkel (since sadly deceased) – a German based chemical company based in Little Island, Cork. The primary reason that the industry asked Ibec to establish IPCMF was to help the industry rebuild its reputation at the time. In the 1990s, the sector had a reputation as being a so-called dirty or polluting industry, associated with the fact that the primary route for producing Active Pharmaceutical Ingredients or APIs was through chemical synthesis, so in effect this was a branch of the chemical industry.

In fact, the very same weekend that IPCMF was established, Greenpeace published its ‘Dirty Dozen Report’; this report listed the top 12 so-called biggest polluters in the country. A number of chemical and pharmaceutical companies were on this list. In fact, one of my first tasks as newly appointed Director of IPCMF was to defend the industry in the studios of

18

RTE’s Morning Ireland in a head-to-head debate with Greenpeace. Examination of this report revealed significant exaggeration of the impact on the environment by the industry. Nevertheless, there certainly was a problem, with odours generated by waste treatment plants in the Cork area and there had been two high profile incidents in Cork at Hickson Pharmachem and ADM. Hence, IPCMF dedicated most of its efforts towards communicating the industry’s commitment to minimising its impact on the environment, with all stakeholders, including communities, government and the public at large.

IPCMF embraced Responsible Care – an international chemical industry programme whereby the sector shared its environmental performance publicly. All of these efforts helped greatly to reverse the impression that this was a polluting sector and today the sector would be viewed as a leader in terms of environmental performance and sustainability, as espoused in the recent publication of the industry’s seventh Strategy Report – Make Ireland the Global Leader in Sustainable Biopharmaceutical and Chemical Manufacturing.

Phase 2 During the rest of the ’90s, we saw ongoing investment in the sector and it continued to grow strongly. Following the wave of investment in mainly API production by companies such as Pfizer, MSD, Smithkline Beecham and Janssen, came ongoing investment in drug product or finished product manufacture. Wyeth established a tabletting plant in Newbridge; Sterling Drug was established in Waterford; Warner Lambert operated out of Dublin; and of course you had Elan in Athlone.

IPCMF expanded the scope of its operations and focused its efforts on supporting regulatory compliance with the Irish Medicines Board (now the HPRA) and with the United States’ FDA’s stringent requirements. It was also recognised that with growth came the challenge of ensuring that the talent base was adequate for the needs of the sector. IPCMF, renamed as PharmaChemical Ireland in 2004, became very active in the promotion of the study of science at secondary level and was an active supporter of the Young Scientists Exhibition; it also actively promoted careers within the sector.

Irish PharmaChem | Industry Buyers Guide 2024

A HISTORY OF BPCI

Irish PharmaChem | Industry Buyers Guide 2024

19

A HISTORY OF BPCI

This activity has continued to evolve and BPCI now supports an Apprenticeship Programme for the sector and also promotes the Biopharmachem Skillnet, managed by Susan Costello.

BPCI has been and still is involved with Government on the Expert Group on Future Skills Needs (EGFSN) that addresses the issue of provision of skills for the sector. This group is due to publish its second report on the sector in early 2024. This work is being led

by Patricia Quane, formerly of Astellas and former Chair of BPCI.

Phase 3 Towards the end of the ’90s, I remember a conversation with Sean Ward, Director of Corporate Affairs at Schering Plough in Brinny (now sadly deceased), where we identified the emerging role of biotechnology in pharmaceutical manufacturing. On his suggestion, we travelled to Penzburg in Germany to meet with the Vice President for Research of Boehringer Manheim, Dr Michael Comer, to discuss this. He enthusiastically encouraged us to urge Government to embrace biotechnology as the next wave of investment for the sector.

This led us to establish The Irish Bioindustry Association (IBIA) to drive this lobby. Michael relocated to Ireland to establish a new start-up, Caramed, and he became the inaugural Chair of IBIA. Around the same time, the government of the day announced a Technology Foresight Exercise. We became involved in two panels: Pharmaceuticals and Life Sciences. The primary aim of the exercise was to identify priority areas for investment in research and innovation for the country. An outcome of the exercise was the establishment of Science Foundation Ireland and the two areas prioritised by them were biotechnology and information technology – our voice had been heard and Ireland was positioned for the next wave of investment in biotechnology manufacturing. Mary Harney TD, who was Tánaiste at the time, deserves special mention here; she proved a real champion for the sector and her support to myself and to BPCI was invaluable.

There can be no doubt that the prioritisation of biotechnology by Government and its agencies such as the IDA and SFI helped greatly to drive the next wave of investment in biotechnology-based manufacturing. Wyeth were the first to establish what was at the time the largest biotechnology facility in the world to manufacture monoclonal antibodies (MABs) in Grangecastle, Dublin (now Pfizer). Soon, companies such as Eli Lilly, Janssen, Alexion and Bristol Myers Squibb followed suit and to this day we are still benefitting from this investment wave. We have recently seen an

20

Make Ireland the Global Leader in Sustainable Biopharmaceutical and Chemical Manufacturing A strategy for the sector 2023-2027

Make Ireland the Global Leader in Sustainable Biopharmaceutical and Chemical Manufacturing, the seventh strategy report for Ireland’s biopharmaceutical sector. announcement by Pfizer that it is investing a further €1 billion at Grangecastle; Eli Lilly is set to invest the same amount at a brand new MAB facility in Limerick; and MSD is investing a total of €2 billion on a brand new MAB facility in Swords, as well as in its biotech research development centre at Dunboyne and its vaccines facility in Carlow.

PCI has now merged with IBIA to form BioPharmaChem Ireland; this reflects the broad brief of the association where both small and large molecules are prioritised.

More recently, BPCI has tried to keep at the cutting edge – Advanced Therapeutics and Cell and Gene Therapies have been identified as a strategic pillar in their recent strategy report. Local start-up APC in Cherrywood, founded by Mark Barrett and Brian Glennon, has established VLE, headed up by Paul McCabe, former BPCI Chair.

This has prioritised contract research and development in the CGT space. Takeda has also established a cell based manufacturing

operation in Grange Castle, while Avectas, another start-up, has developed a platform technology for CGT, Solopure, out of Maynooth. Meanwhile, the National Institute for Bioprocessing Research and Training (NIBRT) have added a Cell and Gene Therapy wing to their centre in Belfield.

Industry strategies Much of my work and that of BPCI has been driven by the preparation and publication of industry strategies. The purpose of these strategies is to garner the views of members of the association and convert them into a series of strategic priorities for the sector.

They also provide a good snapshot of where the industry stands at any one time in terms of economic activity and facts about a selection of BPCI member companies.

They are designed to promote Ireland as a location of choice for the sector and can be used to support the efforts of Government and its agencies such as IDA Ireland.

Irish PharmaChem | Industry Buyers Guide 2024

A HISTORY OF BPCI

The first one, ‘Innovation and Excellence’ was launched at the meeting of The Drugs Chemicals and Associated Technologies (DCAT) meeting at The Waldorf Astoria in New York during the St Patrick’s Day celebrations in 2010. The document was presented at a workshop on Ireland, conducted in partnership with IDA Ireland, and the research community represented by Dr Kieran Hodnett of SSPC and University of Limerick– in fact, it was the first ever country day hosted at DCAT in the over 100 years since DCAT was established. The strategy was launched in the US in order to highlight its relevance and a number of BPCI

Irish PharmaChem | Industry Buyers Guide 2024

members, including Genzyme, Pfizer and MSD, presented case studies outlining the impact of the sector in Ireland. The strategy report was also launched in Brussels and back home in Ireland too.

Thereafter, BPCI produced an industry strategy approximately every three years and most recently launched its seventh such report at Biotech in Boston in 2022. Over the years, these strategy reports proved invaluable for the sector, as each was preceded by extensive consultation with all actors in the sector, which allowed the association and the industry to stay informed on the latest developments and

21

A HISTORY OF BPCI challenges. The latest consultation process and ensuing strategy report was used to brief stakeholders on current developments and to bring the sector together, thus enabling it to stay at the cutting edge and keep growing and developing.

Conclusion Now, as I look back at a sector which, when IPCMF was founded, exported products to the value of just over €5 billion, and which now posts exports of well over €100 billion, the question is: what has driven this success?

Talent and people have been a fantastic enabler and the ability of people within the sector to share knowledge and support one another. The willingness of people within the sector to work with Government and the research community and indeed the positive reception the industry

22

now receives from these important stakeholders is key.

We have a virtuous triangle of industry, Government and academia in Ireland. However, we do need to mind and protect this, as it underpins our competitive advantage. If we can maintain our attractive taxation environment, our excellent regulatory compliance and our ability to keep delivering and responding to the needs of our customers, there is no reason not to assume this industry is here for the long haul and will continue to play an increasingly important role within the Irish economy – indeed, the next phase has to be to build up our local industry base to match the success of the multinational sector here. So here is to the future and I wish my successor in BPCI, Sinead Keogh, and the industry in Ireland the very best of luck for the future.

Irish PharmaChem | Industry Buyers Guide 2024

Mallinckrodt is building on our 155-year history of providing medicines that address unmet patient needs. We have operated in Ireland - the home of our global corporate headquarters - for more than 25 years.

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

Irish PharmaChem | Industry Buyers Guide 2024

23

MATT MORAN

A dynamic and visionary leader After 29 years at the helm of BioPharmaChem Ireland, Matt Moran retired recently. Some of those who worked with him pay tribute to his tireless work on behalf of the Irish pharma and biopharma sector and the legacy he leaves behind.

October 31, 2023, was the day when Matt Moran stepped down as Director of BioPharmaChem Ireland, the industry group he helped to form back in 1994, which launched initially as PharmaChemical Ireland.

Elsewhere in this Yearbook, Matt reflects on the almost three decades of the organisation and how it has adapted alongside the industry it serves.

But here, some of those who worked with Matt over the years describe what was an outstanding contribution to the development of the Irish biopharma industry and the incredible legacy he leaves behind.

“In 1995, I met Matt for the first time. I was the outgoing President of the Federation of Irish Chemical Industries. The Federation had decided to wind up its activities and members had established more focused sectoral groups. PharmaChemIreland was created, with Matt as its Director.

“At that time, the chemical industry was facing several challenges because of negative press due to serious accidents in chemical plants, and concerns from residents, particularly in the Cork harbour area. This led to questions from the public and press about Government policy for attracting more inward investment from pharma companies. One major company cancelled its plans to build a plant in East Cork due to these concerns and local opposition.

“However, Matt defended the industry at every opportunity.

The internet was very much in its infancy and getting our message heard was difficult. He provided leadership and vision by creating a network of companies, working together, and being very open in their communications with all their stakeholders. Over the years, Matt presented the industry as providing quality employment while upholding very high environmental and regulatory standards.

“Thanks to Matt's efforts, the industry's reputation, particularly its compliance record with the FDA, generated massive Foreign Direct Investment and reinvestment.

As a result, Ireland is now the third largest exporter of pharma products.

“As Chairman of NIBRT at the time of its planning and establishment, Matt was very supportive of driving home the case with Government to establishing the facility to ensure the nascent sector got the supports it needed to grow and prosper. And grow it did.”

Joe Harford, MD at Joe Harford & Associates, former CEO of Astellas, and former Chair of BPCI

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“We have worked with Matt and his team since the inception of NIBRT, so it was somewhat bittersweet when we heard of Matt’s impending retirement. Matt has been a mainstay of the biopharmaceutical industry in Ireland for many years and his steadfast support for NIBRT was always very much appreciated.

“We collaborated on many initiatives together with the team in BPCI, including multiple workforce development initiatives, influencing national and EU policy, joint conferences and events, hosting clients both at home and internationally etc. A particular highlight was the Biopharma Ambition series of conferences in 2016, 2018 and 2020, which highlighted the global scale and impact of the biopharma sector to an international audience.

“Matt’s calm and measured approach, built on his many years of experience, were always a great asset in managing the interests of multiple stakeholders to drive effective outcomes. While he will be keenly missed, he has left a lasting legacy to position the industry for further success in the years to come.”

Killian O’Driscoll, Chief Commercial Officer, NIBRT Irish PharmaChem | Industry Buyers Guide 2024

MATT MORAN “As I think about Matt’s career in Ibec BPCI, which began in 1992, I thought about my own career in Ireland’s pharmaceutical sector and how intertwined they were. In 1989, I was in my final year in Science in UCD; employment options in the sector were limited. The sector was at a cliff edge, many multinational companies had medicines which were about to lose their patent and we had not evolved beyond traditional synthetic molecules and large-scale API manufacturing.

“Under Matt’s stewardship, his vision, and the work of the newly created BPCI, the sector was encouraged to bring a broader scope of operational activities to the country, such as Drug Product Fill Finish, Global Packaging & Distribution, Biologics, Global Business Services and most recently Advanced Therapeutics.

“I personally benefited as I subsequently worked in companies across all the other areas above. I have also been lucky to work closely with him as BPCI Industry Chair and enjoyed collaborating over the years.

Ireland is now the number three exporter of biopharmaceuticals globally, so the impact of Matt’s work and influence is clear for all to see, and I have been lucky to have benefited from his vision. Thank you, Matt and enjoy retirement.”

Paul McCabe, Chief Operating Officer, VLE Therapeutics, and former Chair of BPCI.

"Matt Moran, as the Director of BioPharmaChem Ireland, has not only significantly influenced the Irish biopharmaceutical sector but also made a mark on the international stage. His tenure of over three decades at Ibec has been characterised by dynamic leadership and strategic foresight, playing a crucial role in establishing Ireland as a global leader in biopharma manufacturing and development.

“Matt's involvement in various influential international bodies, including the European Chemical Industry Council (CEFIC), the Active Pharmaceuticals Ingredients Committee of CEFIC, and the European Association for Bioindustries (Europabio), highlights his widereaching impact.

“Under his guidance, BioPharmaChem Ireland, a part of the Ibec business representative group, consistently adapted to the everevolving challenges and opportunities, ensuring Ireland's strategic relevance in the global arena.

“Matt's educational background, with a BSc from Trinity College Dublin and an MBA from University College Dublin, further underscores his comprehensive understanding of both the scientific and business aspects of the industry.

“His retirement marks the end of an era of exceptional leadership and vision, leaving a legacy of innovation, growth and international collaboration in the biopharmaceutical sector."

Sharon Higgins, Executive Director, Membership & Sectors, Ibec.

Irish PharmaChem | Industry Buyers Guide 2024

“Matt's influence and contribution to the success of the biopharma industry over many years has been so significant. His calm demeanour and immense knowledge provided all companies with a solid support system. Matt helped us navigate the challenges and he celebrated our successes.

“Matt, along with his team, developed BPCI into a unique organisation that played an essential role in the remarkable growth of biopharma companies in Ireland. It was always a pleasure to work with Matt and I wish him every success in all his future endeavours.”

Patricia Quayne, former VP & General Manager of Astellas Europe, former Chair of BPCI, and current Chairperson of the Expert Group on Future Skills Needs for Biopharma Industry.

“I first starting discussing the potential for Global Business Services (GBS) as an integral part of the pharmaceutical sector with Matt back in 2017. Matt was unique in immediately understanding the significant opportunities presented by including GBS as part of the wider pharma footprint and Ireland’s pharma international offering. Through leveraging his incredible knowledge of the industry, his vision and his considerable contacts, Matt has helped us implement the BPCI GBS forum, supported the creation of the world’s first Masters in GBS, introduced the annual GBS awards and has facilitated our inclusion in the recent BPCI Strategy Document with strategic theme 5: GBS. “Matt you leave an enormous legacy; you’ll be sorely missed and on behalf of all of us in Pharma GBS, I want to say a huge thank you and wish you success, health and happiness in the next stage of your journey!”

Padraic O’Neill, VP of GBS, Pfizer.

“I always had a good working relationship with Matt Moran in BioPharmaChem Ireland. We worked together on lots of things, particularly around the area of skills development for the biopharma sector. Matt was a great proponent of that and the need for more skills in the country. So we worked with the Expert Skills Group in our Department of Enterprise on that and Matt continued to push that even after I moved on from that role in IDA. We always enjoyed a good working relationship; we would share ideas and thoughts with each other on issues that might arise and how to sort them.

Matt’s network was huge across the industry, not just in Ireland but across Europe, where he was very strongly connected. I wish him every success in his next chapter.”

Tommy Fanning, former Global Head of Biopharmaceuticals, IDA Ireland.

Background image from rawpixel.com

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HEALTH & SAFETY

Safe and Healthy Work in the Digital Age

Pictured at the launch of the EU-OSHA Healthy Workplaces Campaign 2023-2025 are Nicolas Schmit, European Commissioner for Jobs and Social Rights; Joaquín Pérez Rey, Acting Spanish State Secretary for Employment and Social Economy, and William Cockburn Salazar, Executive Director of the European Agency for Safety and Health at Work (EU-OSHA).

Michael Gillen, BioPharmaChem Ireland, reports on the development of the EU-OSHA Healthy Workplaces Campaign 2023-2025.

The 2023-25 Healthy Workplaces campaign from the European Agency for Safety and Health at Work (EU-OSHA) raises awareness about the impact of new digital technologies on work and workplaces and the associated occupational safety and health (OSH) challenges and opportunities.

Ensuring a human-centred approach to managing digital technologies in the workplace, the campaign runs from October 2023 until 2025 and provides a platform for the exchange of good practice solutions.

The campaign draws extensively on the research findings, outputs and resources developed in the framework of the OSH Overview on Digitalisation, as well as EU-OSHA’s research in other areas (e.g.

The Foresight studies, the OSH overview on supporting compliance), and is in line with the European Commission’s ‘Vision Zero’ approach, promoting a culture of prevention, which is a key priority of the 2021–2027 EU strategic framework on health and safety at work.

Political context The Healthy Workplaces Campaign 2023-2025 is timely, as it fits well in the increasingly wider range of initiatives undertaken by the EU and its institutions and bodies to support the digital transition of the European economy and society at large.

The 2023 European Declaration on Digital Rights and Principles aims at ‘Putting people at the centre of the digital transformation’.

In addition, the 2023-2025 Healthy Workplaces

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Campaign will contribute effectively to the achievement of the goals established by the EU in the European Digital Strategy and in the principles of the European Declaration on Digital Rights and Principles for the Digital Decade.

Finally, the campaign will also be an opportunity to promote and disseminate knowledge on and support the implementation of the most recent legislative and non-legislative initiatives with implications for workers, workplaces and OSH in areas related to digitalisation that have been put forward by the EU.

Priority areas The campaign has been organised into five priority areas looking into specific topics related to OSH and digitalisation. They are: 1. Digital platform work;

more generally, away from the employer’s premises or in a fixed location for most or part of the working time. It is important to acknowledge that not all jobs are suitable for remote or hybrid work and benefits are maximised if there are clear policies, risk assessment and preventive measures in place Smart digital systems: these include all intelligent applications or digital systems using AI, portable equipment and/or high-speed wireless networks, in combination with sensor technologies in order to enhance workers’ safety and health (e.g. smart Personal Protective Equipment, wearables or drone, etc.). The opportunities presented with such systems can be maximised if the systems are managed in a transparent, trustworthy, empowering and understandable way.

2. Automation of tasks; 3. Remote and hybrid work; 4. Worker management through Artificial Intelligence; 5. Smart digital systems.

The three areas that are of most interest to the biopharma and chemical industry are highlighted below.

Automation of task: this includes the use of systems or technical procedures with some degree of autonomy, to perform physical or cognitive tasks that were previously, or could potentially be, carried out by a human.

Remote and hybrid work: this includes any type of working arrangement involving the use of digital technologies (e.g. personal computers, smartphones, laptops, etc.) to work from home or,

Michael Gillen, Senior Executive, BioPharmaChem Ireland.

Irish PharmaChem | Industry Buyers Guide 2024

Dungarvan The Home of Panadol and Polident for the next generation.

Our behaviours.

Our constant hunger and irresistible energy drives us to be better, move with pace and outperform competitors.

We prioritise the important and challenge the unnecessary.

Our dedication to consumers, customers and each other demands unmatched understanding and empathy.

Irish PharmaChem | Industry Buyers Guide 2024

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INNOVATIVE PLASMA THERAPIES A pioneer in the plasma industry, Grifols manufactures lifesaving plasma-derived medicines to treat chronic and rare conditions, as well as infectious diseases.

Learn more about Grifols at www.grifols.com 28

Irish PharmaChem | Industry Buyers Guide 2024

DIGITAL HEALTH

Are you ready for the data revolution?

Dr Sinead Keogh, Director, BioPharmaChem Ireland, analyses the revolution in Digital Health, examining the European Health Data Space and what it will mean for Ireland.

Every second, an exponential amount of healthcare data is generated and mined for valuable insights. Today, approximately 30% of the world’s data volume is being generated by the healthcare industry. By 2025, the compound annual growth rate of data for healthcare will reach 36%.

Demographic shifts, accompanied by the rise of chronic diseases, allied to the recent impact of the greatest global health emergency in over a century, have highlighted the importance of fostering better health system resilience across the world. Digital Health is a solution that can unlock some of the challenges ahead, and we’re continuing to see strong growth in this segment. Internationally, the Life Sciences sector is forecast to reach €730 billion by 2025, with the Digital Health segment estimated to grow at over 17.4% between 2021 and 2027 to €426 billion.

Ibec’s ‘Where Digital Health Thrives’ is a cross-sectoral campaign with BioPharmaChem Ireland, the Irish Medtech Association and Technology Ireland. Its vision is to enable Ireland to become a recognised global hub for Digital Health, where companies can develop and commercialise products, as well as attract projects and investments.

We’ve already mapped 200 Digital Health companies in Ireland, with segments in personalised medicine and digital therapeutics growing.

The campaign has a number of strategic pillars, including raising the profile of the sector here, ensuring appropriate policy to thrive and building niche talent at the health-tech intersection under the Connected Health Skillnet, which was established under the campaign.

Irish PharmaChem | Industry Buyers Guide 2024

This year, the Digital Health Working Group collaborated with EIT Health to generate a policy report on successful implementation of the European Health Data Space in Ireland. The Working Group hosted its inaugural Digital Health Conference at Dublin’s Convention Centre in May, with significant support from the pharma and the biopharma sectors.

This year also saw Minister Coveney launch our Future Skills Needs Analysis in Digital Health. This work was led by the Connected Health Skillnet, with HealthXL commissioned to lead the research.

Digital and AI has emerged as a transformative force across industries and the Life Sciences sector is no exception. Globally, companies such as Amgen, Pfizer, MSD, Janssen and Eli Lilly are just some of the companies that are exploring AI for drug discovery, clinical trials, diagnosing diseases and manufacturing.

The European Health Data Space regulation aims to enhance European competitiveness In 2020, the European Commission published the European Strategy for Data, as part of Europe’s Digital Decade policy programme. The strategy aims to create a single market for data and introduced plans to establish 10 common European Data Spaces in areas such as health, mobility and agriculture. These will bring together relevant data infrastructures and governance frameworks to facilitate data pooling and sharing across Member States. Health is set to be the first common data space introduced and will allow for movement of electronic health information within the European Union (EU). The legislative proposal was adopted by the European Commission in May 2022, was approved by the European Parliament in December 2023, and the process will now enter trilogue negotiations across the EU institutions.

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DIGITAL HEALTH The European Health Data Space aims to build a common governance and infrastructure framework, for secure sharing of health information, for relevant purposes. There are benefits to unlocking this data for many stakeholders. Patients will have access to their data across borders, which will support more accurate diagnosis.

Policy makers will have access to trends to help make more informed decisions about the performance of health systems. Research and innovation organisations, including industry, will have access to large-scale data sets for analysis via national bodies supported by decentralised infrastructure. These data sets will provide insights to support the development of new innovative products and therapies, ultimately with the aim of enhancing European competitiveness.

“The European Health Data Space is a fundamental game changer for the digital transformation of healthcare in the EU,” revealed Stella Kyriakides, Commissioner for Health and Food Safety, who went on to say that “This data, accessed under strong safeguards for security and privacy, will also be a treasure trove for scientists, researchers, innovators and policymakers working on the next life-saving treatment.”

Ibec, under its ‘Where Digital Health Thrives’ campaign, was delighted to collaborate with EIT Health Ireland to support roundtables, which took place in May of this year at our inaugural Digital Health Conference. Andrzej Ryś, European Commission, Principal Scientific Advisor at DG Sante and Chair of the EHDS Steering Committee, was a special keynote speaker, while the roundtables helped inform the development of research on successful implementation of the Health Data Space in Ireland.

The report was launched in November of this year with representatives from right across the ecosystem. The report makes a number of recommendations, including: • The importance of multi-stakeholder alignment with clear definitions of health data and oversight of its use, along with harmonisation nationally and in the EU; • Investment in the health system to support successful implementation, bolstered by new training to develop skills in data and cybersecurity; • The importance of standardising data collection to ensure quality data and to facilitate data-interoperability and allow post-market publication of clinical trial data; • The secondary use of data is particularity important for industry.

With better connectivity in the health system to bridge the gap with healthcare professionals, specified characteristics for data from secondary use will be shared and reported, with reuse of clinical trial data.

From an industry perspective, it’s important that the EHDS set forth clear definitions, and can intersect with other legal frameworks such as the AI Act, the Data Act and GDPR. The EHDS should specify the scope of electronic health data categories for secondary use, as well as make all measures necessary to preserve the confidentiality of IP rights and

Ireland Where Digital Health Thrives

An Ibec Campaign

Ibec’s ‘Where Digital Health Thrives’ is a cross-sectoral campaign with BioPharmaChem Ireland, the Irish Medtech Association and Technology Ireland, to enable Ireland to become a recognised global hub for Digital Health.

trade secrets that might subsist in a dataset. To ensure the EHDS works as intended, and doesn’t stifle innovation, we must have clarity and assurance that the rights of data holders are securely protected.

Future skills needs in Digital Health The Connected Health Skillnet is an enterprise-led learning and development network, founded in 2017 to address the current and future skills needs arising from the convergence of health tech sectors in Digital Health, explains Jennifer McCormack, Network Manager. The Skillnet collaborates with industry to deliver grant-funded training and crosssectoral knowledge sharing/networking events focused on Digital Health to help facilitate collaboration and innovation between sectors.

It’s well known that Ireland is an attractive location for inward investment and Ireland has the potential to establish itself as a global hub for the next digital- and AI-powered evolution in healthtech, but that potential may go unrealised if we fail to develop the skills required to compete.

The Connected Health Skillnet recently launched the Future Skill Needs Analysis for Digital Health report, which showed that 87% of companies surveyed here are planning to increase their Digital Health activity over the next four years, and they intend to invest. 87% confirmed that their Irish operation will play a key role in their planned Digital Health activities and 82% of companies have partnered with other businesses to develop Digital Health solutions; this trend is also reflected globally. AI was identified by 52% of companies as a top current and future

“To ensure the European Health

Data Space works as intended, and doesn’t stifle innovation, we must have clarity and assurance that the rights of data holders are securely protected.”

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Irish PharmaChem | Industry Buyers Guide 2024

Cara Partners

40 Years and Growing

A leaf from Ginkgo Biloba , believed to be the oldest living species of tree. The seeds and leaves of Ginkgo Biloba have been used in Chinese traditional medicine for over 800 years

Cara Partners manufactures a quantified extract of Ginkgo Biloba for the EU and Chinese market Ginkgo Biloba extract products are used to treat a variety of conditions associated with blood circulation disorders

Little Island Industrial Estate, Wallingstown, Cork Telephone : +353 21 4520500 www.carapartners.ie31

Irish PharmaChem | Industry Buyers Guide 2024

DIGITAL HEALTH

Many of the world’s leading biopharma companies are exploring AI for use in drug discovery, clinical trials, diagnosing diseases and manufacturing. skills need. According to Galen Growth global research, there were 247 partnerships in Digital Health announced last year, up from 59 is 2018, and 90% of these partnerships are using AI. Last month, the Network supported a joint event with BPCI and EY on how Generative AI can enhance manufacturing, with 50+ pharma and biopharma companies participating. The session offered an opportunity to share real insights on how AI-powered solutions are driving innovation, streamlining processes and accelerating breakthroughs in Life Science manufacturing, and the opportunity for data-driven intelligence to support the future of this industry. These discussions highlighted the collaborative efforts driving advancements,

showcasing the power of partnership between industry leaders and technology innovators to pave the way for groundbreaking discoveries.

The Network is upskilling talent to navigate the growing complexities across the value chain, with a strong emphasis on regulation and R&D. In the EU alone, having the skills to navigate the evolving regulatory landscape, including the AI Act, Cyber Resilience Act and European Health Data Space Regulation, will be key, as well as ensuring we continue to build innovation capability. The Network recently launched a needs-led innovation programme in Digital Health with Enterprise Ireland’s dConnect to underpin R&D in this niche area.

To find out more, visit https://connectedhealthskillnet.ie.

Visit https://connectedhealthskillnet.ie for more information on the Connected Health Skillnet.

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Irish PharmaChem | Industry Buyers Guide 2024

Irish PharmaChem | Industry Buyers Guide 2024

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IDA IRELAND

Ireland continues to punch above its weight Rory Mullen, Head of BioPharma and Food at IDA Ireland, reflects on another positive year for Foreign Direct Investment, as Ireland continues to attract the world’s top biopharma companies thanks to our highly educated and talented workforce and stable, pro-business environment.

Rory Mullen, Head of BioPharma and Food at IDA Ireland.

economic recovery, grew to €315.5 billion in 2021 and the biopharmaceutical sector was a key driver of this. In addition to expenditure in the Irish economy, IDA Ireland clients make a considerable contribution to the public finances. Sectors dominated by IDA Ireland client companies account for an estimated 70% of corporation tax receipts and also make a significant contribution to income tax receipts.

The biopharma industry has continued to thrive in Ireland during 2023. Following the supply chain challenges during Covid-19, many

biopharmaceutical companies are ensuring the resilience of their global supply chains and this has resulted in the improvement of Europe’s attractiveness for specific manufacturing projects. Direct employment in the biopharmaceutical sector in Ireland is continuing to grow and is approaching 50,000 direct employees in IDA’s biopharmaceutical clients. In the last year, total investment of over €3 billion has been announced. These new investments have been all over the country and they will ensure that the recent growth in employment will continue.

IDA has continued to see improvement in the global economy and investment climate during 2023, despite the economic volatility brought about by supply chain challenges and the uncertainty around inflation, interest rates and energy costs, themselves the result of geopolitical events such as the ongoing war in Ukraine and recent developments in the Middle East. Despite these headwinds, the international investment landscape has continued to stabilise and evolve, particularly regarding national industrial strategies in strategic sectors, including biopharmaceuticals.

In Ireland, the number of Foreign Direct Investment (FDI) projects continued to hold up in the first half of 2023. There were strong levels of investment by both new and existing investors in Ireland. A total of 139 investments were won, with associated employment potential of over 12,000 jobs. 52 of these were new investors in Ireland, and 48% of the 139 investments won went to regional locations.

This performance underlines the country’s ongoing reputation as a competitive, stable and resilient place in which to do business.

Ireland continues to win international investment due to our highly educated and talented workforce and because of our stable, pro-business environment. We have a welcoming environment for FDI in all parts of the country and we will continue to work with all our client companies to ensure that they progress on the paths of digitalisation and decarbonisation that are essential to ensuring future competitiveness.

A vital national asset Ireland’s existing base of Foreign Direct Investment is a vital national asset that we must continue to nurture and develop. Exports by IDA’s multinational client companies, a key factor in Ireland’s

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Pictured at the official opening of the €38 million expansion at the BioMarin Pharmaceutical Inc. facility in Shanbally, Co. Cork, are (l-r): Michael Lohan, CEO, IDA Ireland; Jim Lennertz, Senior VP, Europe and Canada Commercial Operations, BioMarin; Geraldine Cregan, Executive Director and Quality Site Head, BioMarin; Mark Redmond, CEO, American Chamber of Commerce; Conor Delaney, VP, Shanbally Operations and Site Leader, BioMarin; Taoiseach Leo Varadkar TD; Eric Davis, Chief Legal Officer, BioMarin; Liz O’Mahony, Sr Director, People, Ireland, BioMarin; Minister for Finance, Michael McGrath TD; and Bruce Bickle, Senior VP, Global Manufacturing, BioMarin. The expansion at the facility will enable end-to-end manufacturing for a number of the company’s commercial products and has the capacity to produce additional clinical and commercial products, including gene therapies, as the company grows its pipeline.

Irish PharmaChem | Industry Buyers Guide 2024

IDA IRELAND 2023 highlights Highlights over the last 12 months include the announcement by Pfizer to invest more than €1.2 billion to build a new facility to double the biological drug substance manufacturing capacity of their Grange Castle campus. This expansion will also increase the manufacturing and laboratory capacity and add new oligonucleotide technologies to the campus.

In September 2023, MSD Ireland announced the official opening of their new, state-of-theart biologics site in Dunboyne, in addition to a significant expansion at their Carlow vaccine site. The projects represent a recent investment of over €1 billion across both facilities. The expansion projects have led to the creation of 670 new jobs across both sites, bringing total employee numbers in Ireland to over 3,100 people.

Astellas, the global Japanese pharmaceutical company specialising in transplant, kidney, bladder and cancer drugs, announced in September that they plan to invest more than €330 million in a new fill finish facility on a 45-acre site in Tralee, Co. Kerry.

This will complement their existing facility in Killorglin and demonstrates their commitment both to the region and the country.

Eli Lilly announced an additional €500 million investment in their new drug substance facility in Limerick and expansions were also announced during the year by Charles River in Ballina, Thermo Fisher and BioMarin in Cork and AbbVie in Dublin.

An investment location for ATMPs

Eva Gallagher, Site Lead at MSD Dunboyne with David Maraldo of MSD, Michael Kress of MSD, Taoiseach Leo Varadkar TD, Sanat Chattopadhyay, President, Manufacturing Division at MSD, Michael Lohan, IDA CEO, and Marie Martin, Site Lead at MSD, pictured as it was revealed that MSD’s new state-of-the-art site in Dunboyne is bringing together their research and manufacturing teams for the first time to support stronger collaboration during the development and manufacturing of clinical supplies.

Whilst we are continuing to win investment across both the small molecule and biologics manufacturing sectors, we need to ensure that we continue to be attractive as an investment location for the new modalities and Advanced Therapeutic Medicinal Products (ATMPs) that are currently being developed by the industry. These new advanced therapies will continue to transform the ways in which we can help patients, and the Advanced Therapies expansion at NIBRT that was completed this year will ensure that Ireland remains at the forefront of manufacturing training and research in these areas.

Pictured as Charles River Laboratories completes a €10 million site expansion in Ballina to facilitate batch release testing are (l-r) Rory Mullen, IDA Ireland, Head of Biopharma; Minister of State Dara Calleary TD; and Liam McHale B.Sc., Charles River Site Director.

Irish PharmaChem | Industry Buyers Guide 2024

The Irish Government is fully committed to the continued development of the biopharma sector in Ireland. The recently announced government-funded Digital Manufacturing Ireland Centre (DMI) in Limerick has already started to work with companies in the sector and the Government’s Expert Group on Future Skills Needs is currently completing its recommendations to ensure that Ireland continues to be able to meet the industry’s talent requirements. The Department of Health is taking the lead on Ireland’s input to the EU Pharma strategy and has brought together a cross departmental group to ensure that the Government takes a holistic view of the strategy.

IDA Ireland will, of course, also continue to collaborate closely with global biopharma companies to ensure that their activities in Ireland continue to excel. I am always impressed by the culture I see in our biopharma clients which is so focused on the delivery of innovative medicines that can transform people’s lives. I believe that Ireland has a strong future in biopharma and will continue to be a global leader in manufacturing and process development for many years to come. In addition, I believe that the advanced services activities that our client companies are increasingly establishing in Ireland will continue to grow and develop.

IDA was pleased to be able to host the 2023 BPCI conference in our offices on Hatch Street in September and I would like to extend my congratulations to Sinead Keogh on her appointment as Director of Biopharmachem Ireland and to thank Matt Moran for his contribution to the sector over many years. I wish Biopharmachem Ireland and its members every success in 2024 and I look forward to working together to ensure that we have all the building blocks in place for the continued success of the biopharma sector.

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MERCK

Merck: expanding globally and locally

Merck continues to grow its presence globally and here in Ireland, with the company currently investing over €440 million in its Cork site, which will lead to 370 new jobs.

Merck is a vibrant science and technology company with over 64,000 employees in 66 countries, spread across three businesses: Life Science, healthcare and electronics.

Merck are there for people at every step of their lives, helping to create, improve and prolong life. They deliver personalised treatments for serious diseases and enable people to achieve their dream of becoming parents. Merck’s tools, services and digital platforms make research simpler, more exact and help deliver breakthroughs more quickly. Their solutions accelerate access to health by ensuring tests are accurate and the medicines we take can be trusted.

Merck is the company behind the companies advancing digital living. Their science sits inside technologies that are changing the way we access, store, process and display information. Indeed, Merck’s innovations are unlocking the power and potential of data to open new possibilities to transform life as we know it.

Membrane: Membranes are incorporated into filtration devices to remove harmful bacteria and viruses from life-saving medicines. Often, this membrane is the last component a treatment will touch before being administered to a patient.

Media: Merck are proud to be a world leader in affinity chromatography resin manufacture. For example, their ProSep Chromatography media is part of a product used to treat breast cancer and is on the World Health Organisation’s list of essential medicines.

“Together with our colleagues, customers and stakeholders, we impact life and health with science,” sums up Mattias Heinzel, CEO of Merck Life Science.

Merck in Ireland Here in Ireland, Merck’s Cork site is part of the company’s Life Science business, which aims to impact life and health with science. The Merck Life Science Centre in Cork is a unique manufacturing facility within the company’s global network of 55 manufacturing and testing sites.

A dedicated team of more than 700 scientists, engineers and technical experts are involved in manufacturing critical products - including key components of Covid-19 rapid antigen tests.

Their Cork site continues to grow and increase its manufacturing capacity and last year announced an outlay of over €440 million in Merck’s largest ever single site investment; this will also lead to the creation of more than 370 permanent jobs in Cork by 2027.

From working on virus filters and UF filters for DNA sample preparation to diagnostics products such as Covid-19 lateral flow membranes, pregnancy, HIV and Dengue fever tests, Cork focuses on three areas of expertise: Biotools: The Biotools department makes filtration and medical devices, manufacturing 120 million devices annually for the pharmaceutical industry.

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Pictured as Merck announced a €440 million investment in their Cork site are (l-r): Cllr Gillian Coughlan, Cork Mayor; Martin McAuliffe, Managing Director and Head of Cork Operations, Merck; then Taoiseach, Micheál Martin TD; Matthias Heinzel, Member of the Executive Board of Merck and CEO Life Science; and Michael Lohan, CEO, IDA Ireland.

Irish PharmaChem | Industry Buyers Guide 2024

We are a

ProuD ParTner

of the Irish PharmaChem Yearbook 2024

Irish PharmaChem | Industry Buyers Guide 2024

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MEDICAL DEVICE REGULATION

MDR: the unexpected challenges for combination products

Dr Emer Sherry, Senior Executive, Irish Medtech Association, and Karina Cassidy, Senior Executive, BioPharmaChem Ireland, assess the impact of the Medical Device Regulation (EU) 2017/745 (MDR) on the regulatory pathways for drug-devices and combination products.

Drug-device products or combination products are used to describe a category of therapeutic and diagnostic products that combine medicinal products, including biologics, with a medical device.

Combination products range from inhalers, insulin syringes, auto injectors, drug eluting stents, antimicrobial catheters and bone cements containing antibiotics to smart wearable devices that deliver medicines directly to the patient.

Dating back to the 1950s, when the first metered dose inhaler was developed, combination products have since seen rapid advancements and developments over the decades. The integration of innovative technologies with pharmaceuticals is delivering improved patient outcomes and helping to address the increasing pressures from the rise in the level of chronic diseases and ageing demographics on health systems. These factors are driving the demand for an increase in the supply and availability of drug-device combination products worldwide.

The global drug-device combination products market was valued at US$109.17 billion in 2022 and is estimated to be worth around US$117.93 billion by the end of 2023. Furthermore, it is expected to reach US$236.36 billion by 2033 at a CAGR of 7.2% (Source: outsourcedpharma.com).

Ireland has a strong drug-device manufacturing base with all the

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key players based here, including 17 of the top 20 medtech companies and all of the top 10 biopharma companies, creating an ecosystem with significant expertise and a collaborative approach across these sectors from which to build further alliance.

However, the regulatory pathways for launching combination products in Europe is increasingly complex and slow, which is in sharp contrast to the US regulatory framework (21 Code of Federal Regulations Part 4) for drug-device combination products. The US has a well-established, transparent and streamlined regulatory framework with one specific office, the Office of Combination Products, which oversees and coordinates the regulation of all combination products in that jurisdiction.

In this article, we explore the various routes to market for combination products in the EU, their associated challenges, and how the Irish Medtech Association, together with BioPharmaChem Ireland, are supporting our member companies in addressing these challenges.

EU Regulatory Pathway of Drug/Device Combination Products to Market The European regulations do not officially define the term ‘combination product’ and there is no specific regulatory category for drug and medical device combination products. In Europe, the Irish PharmaChem | Industry Buyers Guide 2024

MEDICAL DEVICE REGULATION FIGURE 1: Integral Combination Pathway

regulatory pathway for combination products concerns the Medical Device Regulation (EU) 2017/745 (MDR) and the Medicinal Products Directive 2001/83/EC (MPD). The regulatory pathway for combination products depends firstly on whether the product is an integral (e.g. pre-filled syringe) or a non-integral combination product (e.g. oral medication and its administrating syringe).

For integral products, manufacturers must determine the Principal Mode of Action (PMOA) and based on this, the product is regulated as a medical device or a medicinal product (see Figure 1).

However, the pathway for combination products is different from individual medical devices or medicinal products requiring application of some aspects of the medical device and medicinal products regulations as appropriate.

A single article within the MDR, Article 117 that amends the MPD, establishes the inter-relationship between the two separate regulatory frameworks. This single article, however, has a substantial impact on the regulatory framework and associated stakeholder responsibilities, that remain largely undefined as there is no substantive guidance available.

Integral combination products Consider the first case, when the PMOA of integral products is considered a medicinal Irish PharmaChem | Industry Buyers Guide 2024

product, it is then regulated under MPD, but the device component is still subject to Article 117 of MDR requiring the medical device to be either CE marked or, where applicable, receive a Notified Body Opinion (NBO) on its conformity with the relevant General Safety and Performance Requirements (GSPRs) of the MDR where applicable (NBOP required for device constituent parts which would otherwise

Dr Emer Sherry, Senior Executive, Irish Medtech Association.

require the involvement of a Notified Body if placed on the market as a ‘standalone’ medical device in accordance with the MDR - i.e. device classifications of Class I - sterile and/or measuring function, IIa, IIb and III).

This requirement under MDR did not previously exist under the predecessor to MDR, the Medical Device Directive (MDD) 93/42/EEC. In the second instance, where the

Karina Cassidy, Senior Executive, BioPharmaChem Ireland.

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MEDICAL DEVICE REGULATION PMOA is a medical device (e.g. via mechanical and physical means), the product is regulated as a medical device under MDR (e.g. drug eluting stents), and must obtain CE marking. For these products, the medicinal product is an ancillary action to that of the medical device.

The quality, safety and efficacy of the medicinal product must be verified by equivalence with the methods specified in Annex I of the MPD. Accordingly, as part of the NBO’s CE conformity assessment, a scientific opinion from a medicinal product competent authority or the European Medicines Agency (EMA) must be sought. This is a similar requirement as previously set out in the Medical Device Directive (MDD) 93/42/EE; however, unlike the MDD, the MDR states that the medical device may not be approved if the scientific opinion received is unfavourable.

Non-integral combination products For non-integral combination products that typically consist of either a co-packaged medical device and medicinal product (e.g. oral medication and syringe), or a cross-referenced medical device and medicinal product (e.g. aero chamber), the requirements of both the MPD and MDR apply, in full, to the medicinal product and medical device constituent parts respectively, see Figure 2. Specifically, in relation to the medical device, CE marking is required by a notified body (NB).

FIGURE 2: Co-packed Combination Pathway

product. Previously, these device components were generally categorised as packaging components by the EMA and therefore were included as part of the overall review of the medicinal product application.

The new collaboration now required between pharmaceutical companies and NBs is resulting in several challenges and obstacles to market. In the first instance, many of the impacted pharmaceutical companies do not have an existing relationship with an NB and have difficulty gaining access to NBs, in part because not all designated NBs under the MDR are providing these services, as well as current resource constraints within the NB. Given the relatively recent implementation of MDR in Europe, there is also a deficiency in the number of experienced industry professionals, particularly impacting pharmaceutical companies. The requirement for an NB opinion under the MDR applies to both EMA centrally approved products and to products approved by the relevant individual competent authorities. Apart from the administrative burden of managing NB opinions with multiple Marketing Authorisation Holder’s (MAH), typically one per country, it is not yet fully understood how these reviews are being addressed by each competent authority.

NB opinions are also required to support any significant changes to device components of existing integral combination products.

It is up to the relevant MAH to justify its reasoning for a change not being significant and this is then reviewed by the EMA, but there is

Non-Integral Product Regulatory Path Individual Regulatory Paths 2001/83/EC (MPD)

Medicinal Product

MAA

Immunological Metabolic Pharmacological

Co-packed Evidence of Conformity with MDR

Medical Device

Mechanical Physical

(EU) 2017/745 (MDR)

Implementation challenges currently faced by integral combination product manufacturers in Europe The MDR implementation process for individual medical devices is considered by the industry as overly complex, unpredictable, costly and slow, but its negative impact on combination products is particularly acute. What is clear is that the requirements of Article 117 are also having a significant effect on pharmaceutical companies, the full extent of which is only beginning to become apparent. The scope in Article 1, section 8 and 9 of the MDR and the requirements of Article 117, which amends the MPD, have an impact on any medicinal product with an integral device used for the delivery of a pharmaceutical

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CE

no EMA guidance on what is considered a significant change or if the EMA has the necessary expertise to make this determination. There is no formal methodology if manufacturers have to defer to the device expertise of NBs or competent authorities when making these types of assessments.

The unpredictable timelines for the NB opinion process are resulting in lengthy delays and causing significant planning challenges for an EMA submission and a subsequent product launch.

The MDR states relevant GSPRs shall apply to the device part of a single integral product. There is no guidance on what is considered appropriate for the different types of combination products and Irish PharmaChem | Industry Buyers Guide 2024

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MEDICAL DEVICE REGULATION exactly how the relevant manufacturers/ MAH must determine and document an appropriate justification. If the NB disagrees with the MAH justification, there is no formal appeals process, and the MAH is required to comply with the requirements, further challenging the predictability of approval timelines.

Implementation challenges for nonintegral combination products Co-packaged and referenced combination products fall under the first subparagraph of Article 1 (9) of the MDR and, as such, copackaged and referenced medical devices are required to be CE marked in accordance with the MDR. Taken in isolation, and in lieu of specific guidance, the regulatory process should be the same as that required for standalone medical devices. However, in practice, several regulatory challenges arise for co-packaged medical devices, as they are subject to two largely separated, multifaceted regulatory frameworks. These challenges are perhaps most prominent when a device manufacturer and a medicinal product manufacturer co-develop and co-package a combination product.

Co-packaged combination product clinical studies of medicinal products and medical devices utilise the same investigational sites, investigators and study participants etc. However, the approval of such studies is required to undergo what are essentially mutually exclusive and independent regulatory approval processes: the medicinal product clinical trial approval process and the medical device clinical investigation approval process.

Consequently, the efficiencies made under the Clinical Trials Regulation (CTR, Regulation (EU) No 536/2014) are negated by the current clinical investigation review and approval process for the medical device part, resulting in a prolonged approval process for studies of co-packaged combination products.

Furthermore, there can be significant overlap in the information submitted in the dossiers to support the respective approvals.

There appears to be no formal mechanism allowing for collaborative reviews of medicinal product clinical trials and medical device clinical investigation applications.

The absence of such collaboration can lead to not only duplication of effort but also the potential risk of diverging reviews and requests to sponsors.

Both the co-packaged medicinal product and the medical device are required to meet the labelling requirements of their respective regulatory frameworks, with the respective labelling being reviewed and approved independently of each other.

However, this may result in scenarios where conflicting or contradicting information is

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provided on the device labelling and the medicinal product labelling.

It is often the case that the legal manufacturer of a medical device component is located in a different legal entity from the pharmaceutical company that co-packages the component with its medicinal product.

Therefore, difficulties arise when the medical device manufacturer is based in a third country, the pharmaceutical company placing the co-packaged combination product on the European market might meet the definition of an importer and its associated obligations or other entities in the supply chain deemed to meet the definition of a distributor and its obligations.

This is notwithstanding the fact that the co-packaged combination product would be placed on the market as a medicinal product, meeting all relevant regulatory requirements in accordance with the MPD and the associated Good Distribution Practice Guidelines.

Both the medicinal product and the medical device parts of a co-packaged combination product are required to undergo separate and independent regulatory approvals. Review durations for such combination products also differ.

The marketing authorisation processes for medicinal products follow a well-defined regulatory timeline, whereas the regulatory timeline for the conformity assessment process of medical devices is undefined and can differ between NBs. Consequently, the approval and/or the launch of a medicinal product, co-packaged with a medical device, can be delayed until the CE certification has been acquired for the device, further emphasising the crucial need for continued further collaboration and communication between notified bodies and the EMA and the Competent Authorities when reviewing such products.

Supporting Ibec member companies in navigating the complexity of the combination products regulatory pathways The Irish Medtech Association (IMA) together with BioPharmaChem Ireland (BPCI) have established a cross-sectoral working group to promote awareness of the new obligations for combination products, to provide a forum for knowledge sharing between both sectors and to identify the key industry recommendations that are needed to address some of the implementation challenges as described above.

This working group leverages the comprehensive support and expertise of the IMA’s dedicated workstreams on MDR. A joint position has been developed setting out the key challenges of the regulatory frameworks and requesting

significant improvement in the level of guidance and clarity on the implementation of the regulatory requirements, responsibility of the respective agencies and collaboration of same in the review and approval of combination products. The IMA and BPCI are currently engaging with key stakeholders, both at national and European level, and collaborating with the relevant European trade associations on this pan-European issue.

In the years ahead, with the emergence of digital health, the majority of products are expected to involve a combination of drugs, device and digital, and so it is imperative for greater co-ordination and engagement across regulatory bodies so that manufacturers are not subject to multiple horizontal regulations.

Early engagement with regulatory bodies throughout the development of the product could alleviate much of the administrative burden and duplication of workload. By developing a better process and engagement model for current combination products, it could serve as a template for future combination products that will have even more regulatory complexity.

Our vision is to enable Ireland to become a recognised global hub for digital health, where companies can develop and commercialise products, as well as attract projects and investments. One of the pillars of the Ibec’s cross-sectoral ‘Where Digital Health Thrives’ campaign is to represent the sector by engaging policymakers. At a European level there is a lot of legislation in development affecting the industry, such as the Artificial Intelligence Act, Data Act, Cyber Resilience Act and European Health Data Space, with the group collaborating on a white paper on the European Health Data Space with the European Institute of Innovation and Technology Health Ireland-UK. It is important to note that industry fully supports the goals of MDR to develop a robust, transparent, predictable and sustainable regulatory framework that ensures a high level of safety and health, while supporting innovation, for the benefit of European patients, health systems and society. Article 117 is only one example of where there are significant challenges associated with the implementation of MDR, signifying the urgent need for system level reform of the medical device regulatory system.

This forms part of Irish Medtech Association’s wider advocacy campaign calling for the comprehensive structural reform of MDR and seeking an efficient, innovation-focused and well-governed regulatory framework in Europe. For more information or to get involved in the cross sectoral working group, please contact Dr Emer Sherry, Senior Executive, Irish Medtech Association, and Karina Cassidy, Senior Executive, BioPharmaChem Ireland.

Irish PharmaChem | Industry Buyers Guide 2024

RECRUITMENT

Cpl: your partner in talent acquisition

manufacturers and specialised biotech firms.

The Future of Work Institute employs best and next practices, independent research, and creative engagement to develop world-class frameworks and approaches for innovative people and workforce strategies.

Expert recruitment teams Cpl’s expert recruitment teams, specialised Talent Evolution Group, and FOWI are committed to fulfilling BPCI's mission of: • Identifying talent needs aligned with BPCI's national GBS strategy; • Assisting clients in acquiring digital talent and skills; • Providing a skilled workforce to maintain labour-intensive assets in Ireland.

Cpl Group’s Talent Evolution Group and Life Sciences recruitment division have been instrumental in fostering the industry's growth from its inception to the billion-dollar powerhouse it is today.

As Ireland solidifies its position as a global hub for innovation and sustainable manufacturing in biopharmaceuticals, pharmaceuticals and chemicals, Cpl proudly stands alongside the industry, providing unwavering support.

Their Life Sciences division guides companies across growth stages, from startups to fully operational manufacturing sites, excelling in talent acquisition and fostering a culture of retention.

Whether companies are rapidly scaling, optimising manufacturing or ensuring compliance, Cpl’s Talent Evolution Group offers customised RPO and MSP solutions for diverse clients, including multinational pharmaceutical companies, medical device

When it comes to your Life Science talent needs, reach out to Cpl. We are here to support your journey.

For over three decades, the Cpl Group has been a trusted partner to Ireland’s thriving life science industry.

Our Talent Evolution Group and Life Sciences recruitment division have been instrumental in fostering the industry’s growth from its inception to the billiondollar powerhouse it is today.

When it comes to your life science talent needs, reach out to Cpl. We are here to support your journey. www.cpl.com

Irish PharmaChem | Industry Buyers Guide 2024

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ACCESS TO TALENT

Crafting excellence:

nurturing talent development for future success.

Siobhán Dean, BioPharmaChem Ireland.

Siobhán Dean, BioPharmaChem Ireland, stresses the importance of addressing skill needs and gaps in the biopharma sector, as companies revolutionise their acquisition strategies to attract and retain staff.

The biopharma sector in Ireland and globally is expected to continue to grow both in scale and in diversity. International analysts predict the scale of global pharmaceutical sector growth to be in the range of 5-9% per annum. To support this growth, the sector depends on a strong pipeline of multi-disciplinary skills. Changes in manufacturing technologies, alongside a parallel growth in the digitalisation of processes and systems, create a need for staff with data management and digital skills, in addition to the core manufacturing skills.

Data from the 2021 Global Biopharma Resilience index (https:// www.ft.com/cytiva) revealed that from a survey of 1,165 biopharma executives from 20 countries, 15% of executives state that sourcing digital, manufacturing and R&D talent has become increasingly difficult and access to talent was associated as the primary weakness in the growth and resilience of the global biopharma industry.

A critical component of Ireland’s success in the Life Sciences sector is its highly skilled workforce and the deep commitment to education and skills development. We have a well-educated workforce with a strong focus on STEM disciplines, coupled with robust collaborations

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between academia and industry, to develop and provide specialised courses in Life Sciences, thus ensuring the continuous provision of qualified professionals to continue to support the growth of the sector.

A significant 67% of companies cited the attraction and retention of talent as their top priorities in a recent Ibec Manufacturing report.

The availability of skills remains a challenge in the context of wage pressures, shortages in housing and infrastructure availability. In response to the demand for top talent, companies are revolutionising their talent acquisition strategies, piloting technologies and recruitment/retention strategies.

Expert Group on Future Skills Needs report In 2022, the Expert Group on Future Skills Needs (EGFSN) established the Biopharmachem Steering Group to embark on a skills analysis and development of key recommendations to ensure a strong pipeline of skills for the biopharmachem sector in Ireland. The group was chaired by Patricia Quane (Formerly Astellas Pharma) and made up of representatives from industry, academia, education Irish PharmaChem | Industry Buyers Guide 2024

ACCESS TO TALENT and training providers, along with relevant Government departments and state agencies. The objective of the study was to review the supply and demand of skills required to meet the needs of the biopharma sector in Ireland up until 2027. The report is due to be launched in January 2024 and thoroughly evaluates the current and future skills requirements, offering insights into the scale and nature of future needs.

An Implementation Group will be established to oversee and coordinate the recommendations from the report, which are likely to include the some of the following:

“It is not enough to invest in training and mentorship programmes; companies also need to develop a strong and adaptable learning culture, which in turn develops a more agile workforce.”

• Strengthening STEM outreach and education; • Collaboration between industry and academia; • Supporting the expansion of apprenticeships; • Development of digital skills and skills for ATMPs; • Development of skills competency framework and further skills mapping promoting careers opportunities in biopharma.

Investing in education and training The Human Capital Initiative fund, which was launched in 2019 under the National Training Fund, plays a pivotal role in driving innovation in skills development under its three strategic pillars:

• Pillar 1: Graduate conversion and specialisation courses; • Pillar 2: Additional places on undergraduate provision; • Pillar 3: Innovation and agility.

It allows for partnership between biopharma companies and academic institutions. These collaborations can lead to joint initiatives, internships and real-world projects that bridge the gap between theoretical knowledge and practical application. Since 2019, over 700 learners have gained qualifications in a range of courses developed for the biopharma sector The ‘Enabling Future Pharma –Beyond the Pill’ project led by RCSI School of Pharmacy and Biomolecular Science under the Human Capital Initiative Pillar 3, is developing a suite of innovative and agile programmes focusing on advanced therapies, genomics, precision medicine, big data and connected health, underpinned by innovation and leadership.

In response to the demand for top talent, companies are revolutionising their talent acquisition strategies, piloting technologies and recruitment/ retention strategies (image from rawpixel.com).

Irish PharmaChem | Industry Buyers Guide 2024

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ACCESS TO TALENT

Addressing skill needs and gaps in the biopharmachem sector is crucial for sustained growth and innovation (image from rawpixel.com).

The iEd Hub, led by UCC and MTU, aims to co-design and deliver a suite of new postgraduate programmes for the health and Life Sciences sectors, including indigenous and multinational companies. iEd education targets both technical, non-technical and innovation skill sets, with students dividing their time between industry sites and academic campuses. In September, UCC launched their new M.Sc. Industrial Pharmaceutical Sciences, Operation & Management and MTU are due to Launch their MSc. Regulated Tech. Transfer & New Product Introduction (60 Credits) programme, again developed in collaboration with industry.

Micro-credentials, bite-sized accredited courses, are revolutionising education by offering targeted and flexible learning opportunities, allowing professionals to acquire specific skills quickly, precisely addressing skill gaps in real-time. Many Universities and HEIs in Ireland are now offering a range of such courses, delivering a more flexible and transformative learning experience. Embracing microcredentials promotes a lifelong learning agenda, enabling individuals to continuously adapt and upskill, empowering them to advance their careers, whilst providing employers with a knowledgeable and agile workforce.

Apprenticeships shaping the future talent Apprenticeships are emerging as a transformative pathway into the Life Sciences sector, with companies embedding them in their talent recruitment strategies. Apprenticeship offers a blend of hands-on experience with theoretical knowledge, providing a unique learning experience to bridge the gap between academic teaching and practical applications, offering new opportunities for individuals to enter the sector.

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In 2018, the Lab Apprenticeship was developed by industry in parentship with TU Dublin to address the emerging skills gap in the quality function in Life Science companies. The programme is now in its fifth year, supporting over 48 Life Science companies in their talent recruitment, with 127 apprentices currently enrolled in the TU Dublin, SETU Waterford and MTU Cork campuses. For more information, visit: www.ibec.ie/connect-and-learn/industries/lifesciences-and-healthcare/laboratory-apprenticeship.

Over the past four years, we have seen an expansion of apprenticeship programmes relevant to the biopharma sector in engineering, logistics and ICT disciplines. The sector is currently developing a new Biotech/Pharma Technician Apprenticeship for Operators, which is awaiting funding approval from the National Apprenticeship Office.

Leverage the National Training Fund In the ever-evolving landscape of the Irish biopharma sector, acquiring and improving the right set of skills is paramount for individuals and industry alike. We need to ensure that funding is available to create a supportive and collaborative ecosystem for educational institutions and industry. Partnerships can help establish internship and apprenticeship opportunities, provide access to state-of-theart facilities and resources, and bridge the gap between academic knowledge and industry requirements.

Springboard+, the Human Capital Initiative (HCI) apprenticeships, vocational training, work-based learning, and lifelong learning programmes are all funded under the National Training Fund (NTF).

Ibec has been calling for the Government to utilise the €855 million surplus in the NTF. Employers contribute 1% of their payroll to Irish PharmaChem | Industry Buyers Guide 2024

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ACCESS TO TALENT the NTF to support access to training and education for individuals in employment and seeking employment. This year, the surplus in the NTF will increase by a further €150 million. By 2025, it is projected to rise to between €1.4 billion and €1.9 billion.

Refining our approach to talent and inclusivity According to Eurostat figures, 44% of Ireland’s 287,500 scientists and engineers were female in 2021 (Source: https://ec.europa.eu/eurostat/ web/products-eurostat-news/w/ddn-20230210-1). This is a little above the EU average of 41%. While progress has been made in recent years to improve gender balance in STEM, it is crucial to continue promoting and encouraging more women to pursue STEM careers.

One of the primary challenges hindering women’s entry into STEM is the persistence of gender stereotypes. Societal expectations and biases can discourage young females from pursuing scientific and technical interests from an early age. It is vital to challenge these stereotypes by providing diverse role models and highlighting the achievements of women in STEM. This can be achieved through targeted awareness campaigns, mentorship programmes and showcasing successful female professionals as inspirations — for example, the IMI/30% Club Network Mentor Programme (www.imi.ie/ imi-30-club-network-mentor-programme/) and Iwish (www.iwish.ie).

Creating more educational opportunities to promote STEM careers Encouraging young people to pursue STEM subjects throughout their academic journey is crucial. Industry outreach programmes can introduce students to STEM concepts, emphasising their practical applications and their potential to make a positive impact on society, such as SciFest, STEM Teacher Internship (STInt), and Amgen’s Biotech Experience.

STInt, the STEM Teacher Internship (stemteacherinternships.ie), provides paid summer internships in STEM roles for teachers in industry settings, including with industry partners in the biopharma sector. The programme is co-ordinated by Dublin City University (DCU) and since 2026, a total of 177 STInt internships have been awarded to pre-service and early career teachers from 32 degree programmes in DCU, MU, TCD, UCC, UCD, UG and UL.

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Amgen’s Biotech Experience, delivered in collaboration with NIBRT, provides free training to secondary school teachers in molecular biology. For more information, visit www.amgenbiotechexperience.com.

The SciFest programme consists of a series of one-day STEM fairs for primary and second-level students (scifest.ie).

The STEM Transition Year Challenge is a hybrid event, where a consortium of Cork Life Science companies provide STEM mentors to work with student groups on STEM-related projects, facilitating immersive and practical learnings and insights into the many possibilities that exist within STEM. The project work culminates in the creation of a ‘Day in the Life of STEM’ video by each of the student groups. This year, the STEM TY Challenge concluded with a showcase event at Cork City Hall in November celebrating the efforts of 83 students from 10 Cork schools. The project is sponsored by Pfizer, Thermo Fisher Scientific, Hovione, Alcon, Sterling Pharma Solutions, PepsiCo, Gilead, Boston Scientific and BPCI. For more information, see www.activepeers.ai/stemtychallenge.

Strong equity and inclusion culture.

Research indicates that an organisation’s D&I culture and policies significantly influence job seekers, particularly among millennial and Generation Z employees, who increasingly dominate the workforce.

Job seekers are on the lookout for diverse workplaces that not only hire diverse people but strive to create a safe and inclusive environment for their employees. In fact, a survey from Glassdoor reveals that 76% of those actively looking for jobs say that a diverse workforce is an important factor when considering job listings and offers (Source: www.glassdoor.com/blog/glassdoors-diversityand-inclusion-workplace-survey).

While diversity may have always been core in companies’ recruitment and people management policies and procedures, events in recent years have reinforced the importance of developing and promoting a strong equity and inclusion culture.

Retention is a key issue across all sectors, with research showing that many employees are rethinking their careers and work-life balance.

One upshot to this new zeitgeist is the increased awareness placed on the value of staff, inspiring companies to develop workplace initiatives such as wellbeing programmes, professional development and mentorship programmes. Investment in these types of programmes can play a vital role in staff retention when they are of relevance to employees and their needs. Communication and collaboration with employees during the process of designing such programmes can enhance their effectiveness. It is far more prudent financially and strategically to invest within the existing talent pool than to only look externally, especially given the current very competitive environment.

Empowering employees to drive their own career development and creating pathways for their skills development is an excellent tool to develop one’s brand and to invest in exciting talent. It is not enough to invest in training and mentorship programmes; companies also need to develop a strong and adaptable learning culture, which in turn develops a more agile workforce.

In conclusion, addressing skill needs and gaps in the biopharmachem sector is crucial for sustained growth and innovation. By implementing targeted solutions, the industry can foster a skilled workforce capable of navigating the complexities of the pharmaceutical research and development sector.

Irish PharmaChem | Industry Buyers Guide 2024

Amneal Ireland Ltd is part of Amneal Pharmaceuticals, inc. (NYSE:AMRX) a fully integrated global essential medicines company powered by a robust U.S generics business and a growing branded business as well as deepening portfolios in institutional injectables, biosimilars and select international markets. Together, we’re rapidly becoming one of the most dynamic, purpose driven pharmaceutical companies delivering more affordable access to essential medicines.

Amneal Ireland is located in Cashel, County Tipperary. Our state of the art 200,000 ft2 facility is dedicated to the development and production of metered dose (MDI) and dry powder (DPI) inhalation products.

We are Amneal and we make healthy possible. Together, we can do more to improve health.

That’s a powerful reason to come to work.

2024 will see significant growth in our Cashel team. If you’re excited about joining a company with a purpose that believes in, encourages and invests in the growth of its people, let’s talk!

We are looking for people within the following disciplines: • • •

Manufacturing/Operations Engineering/Maintenance Quality Assurance

• • •

Quality Control Warehouse HR

To share your interest in joining our Amneal Cashel team, please reference the appropriate role and email CV to careers.cashel@amneal.com

Irish PharmaChem | Industry Buyers Guide 2024

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CONCEPT AT NIBRT

CONCEPT is the new core facility for early-stage biotherapy development at the National Institute for Bioprocessing Research and Training (NIBRT).

Dr Fiona C. Killard-Lynch, CSO & Director of Research and Innovation, NIBRT.

CONCEPT at NIBRT is a cutting-edge core facility for early-stage biotherapy development, which underscores Ireland's commitment to fostering innovation in the biopharmaceutical sector, writes Dr Fiona C. Killard-Lynch, CSO & Director of Research and Innovation, NIBRT. December 8, 2023, saw the official opening of CONCEPT at NIBRT, providing a dedicated, state-of-the-art resource for the rapid generation of optimised cell lines and biological materials.

Central to its mission is ensuring that CONCEPT’s resources are accessible to a broad base of academic research scientists, but its impact spans research, innovation and industry, as it effectively addresses infrastructure gaps in the research ecosystem, enabling the holistic development of advanced therapies. This will empower researchers to transform concepts into tangible outputs.

Through strategic collaborations with both national and international partners, CONCEPT is poised to shape the future of advanced therapies, solidifying Ireland’s leading role in the development of Advanced Biotherapies.

Ireland’s pioneering role in biopharmaceutical innovation Ireland has firmly established itself as a global leader in pharmaceutical biomanufacturing, currently ranking as the third-largest exporter of pharmaceuticals worldwide. As of now, Ireland’s advanced

50

manufacturing sector boasts exports worth approximately €140 billion and employs 261,400 people. This sector’s significance is underscored by its contribution to Ireland’s economy and its potential to lead in the rapidly evolving field of biopharmaceuticals.

Recently, the dynamic landscape of the biopharmaceutical sector has witnessed a shift in innovation focus from traditional proteinbased medicines to more advanced therapies, including Cell and Gene Therapies. Projections indicate that the global Cell and Gene Therapy market is set to reach $240 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 29%. These therapies target a diverse range of conditions, from cancer and blood disorders to cardiovascular diseases, autoimmune disorders and immunodeficiencies to neurodegenerative disorders.

Despite the transformative potential of Cell and Gene Therapies, significant challenges persist for their widespread clinical application.

These challenges include identifying robust and stable cell sources, ensuring reliable therapeutic action, achieving predictable and defined levels of therapeutic potency, matching pharmacokinetic/ Irish PharmaChem | Industry Buyers Guide 2024

CONCEPT AT NIBRT pharmacodynamic properties with therapeutic requirements, addressing safety and immunogenicity concerns, establishing scalable manufacturing processes, and enhancing patient accessibility and affordability.

The emergence of advanced Cell and Gene Therapeutics Advanced cellular therapeutics involve the minimal manipulation or genetic engineering of immune cells (autologous or allogeneic) to deliver groundbreaking treatments. This technological evolution is epitomised by the rise of innovative therapies such as mRNA lipid nanoparticle treatments, which gained prominence during the Covid-19 pandemic.

Advanced gene therapy involves the precise introduction, alteration, or replacement of genetic material within cells to treat or prevent diseases. Key techniques include CRISPR gene editing, RNA interference, viral vector delivery systems like AAVs and lentiviruses, epigenome editing, modifying epigenetic markers for reversible changes in gene activity, and synthetic biology.

Advanced gene therapy represents a frontier of medical innovation, promising highly targeted, precise and personalised treatments, with expanding therapeutic possibilities as research progresses.

The biopharmaceutical landscape is dynamic and even before the onset of Covid-19, the pace of development of Advanced Therapeutic Medicinal Products

Darrin Morrissey, CEO of NIBRT, pictured at the launch of CONCEPT. (ATMPs), including viral vector-based gene therapies and autologous cell therapies, was rapidly increasing. Since the pandemic, the industry has developed, assessed and brought new technologies such as mRNA lipid nanoparticles to market at incredible speed.

Recognising the need for cutting-edge infrastructure and expertise to enable such advancements in Cell and Gene Therapy

research, development, and translational activities, the National Institute for Bioprocessing Research and Training (NIBRT) launched its new core facility for early-stage biotherapy development, named CONCEPT, on December 8, 2023. This facility, a first of its kind in Ireland and unique on a global scale, represents an investment of €7 million in funding from Science Foundation Ireland (SFI),

Pictured at the official opening of CONCEPT are (l-r): Professor Jonathan Bones, lead-PI on CONCEPT; Dr Clair Gallagher, manager of the CONCEPT facility; Dr Ruth Freeman, Director, Science for Society, SFI; Dr Darrin Morrissey, CEO, NIBRT; Dr Fiona Killard-Lynch, CSO, NIBRT; and Declan McAree, Business Development Manager, Biopharma & Food Division, IDA Ireland.

Irish PharmaChem | Industry Buyers Guide 2024

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CONCEPT AT NIBRT

Providing circular side stream solutions the Industrial Development Agency Ireland (IDA), and key industry stakeholders.

Talent development

The CONCEPT facility is based in a recently added extension to the NIBRT building, incorporating seven new laboratories. These Purifying water and recovering state-of-the-art laboratories are equipped Award-winning concept for API materials with mobile & modular with cutting-edge technology, specifically removal & metal recovery designed to support research in the InOpSys offers solutions to treat installations development and production of advanced InOpSys is committed to water and solvent streams, for: therapies. providing circular waste or side • Active Pharmaceutical Ingredient The expanded space has played a crucial (API) removal & recovery stream the chemical role insolutions establishingfor CONCEPT’s high-tech andlaboratories, pharmaceutical industry, by • Metal removal & recovery (e.g. tailored for specific workflows that replicate capabilitiesmobile and facilities precious metals) building and the operating & found inpurification the industry. Such research • Micropollutant removal modular installations infrastructure is vital for Ireland to continue on fostering the customer site.

Using an innovative start-up culture a trainand for of theselective technology ongoing development of the Awards: Irish biotech ecosystem.

Theefficiently expansion will • Imagine Chemistry Challenge combinations, InOpSys also accommodate other newly recruited AkzoNobel (2017) closes water and material loops world-renowned researchers and their teams and thus helps the industry • Belgian Business awards for the conducting research in the Cell and Gene Environment (2018): first prize reach their sustainability goals Therapy space.

This strategic co-location by with reducing waste and CO2 the CONCEPT facility will enhance and • Solar impulse foundation (2021):

emissions.

Selective and very high rate of removal InOpSys uses a decentralized model, creating installations on-site, close to the side stream source. This allows working with unmixed and welldefined side streams, and avoids transport as a plus.

InOpSys is a one-stop shop, because we do not focus on one single technology, but on a hybrid combination of different technologies. Thanks to this “relay team” of technologies, very high removal rates can be achieved in a more efficient way compared efficient solution label to monotechnology solutions. This also allows InOpSys to remove CONCEPT represents an investment of €7 million in funding Science Foundation Ireland, the pollutants infrom a selective way, leaving Industrial Development Agency Ireland (IDA), and key industry stakeholders. easily biodegradable components untouched.

“CONCEPT is not just a facility; it’s a driving force propelling CAPEX-free service

The customersin arethe unburdened as collaboration, innovation and advancements biotech InOpSys takes ownership from start landscape on a national and global scale. to finish,”and offers its service in a CAPEX-free way. InOpSys finances the installation via a pay-per-use model, spares customers investment has a diversity of skills secured from both whichAddressing a gap inan research industry and academia. whichinfrastructure is not interesting enough Professor Jonathan Bones is leading CONCEPT a significant gapon in according to addresses their internal return CONCEPT, using his NIBRT Characterisation research infrastructure, not only within investment guidelines.

cir ca

complement their activities, creating a truly dynamic environment for the development of future research leaders in this field.

In addition, the extension incorporates two exclusive training suites dedicated to and Comparability Laboratory for downstream Ireland but also across Europe, by bridging Advanced Biotherapy training, with the goal work, including liquid chromatography-mass divides in resources and expertise, enhancing Contact details and efficiency in advanced of educating and upskilling professionals in spectrometry and other purification and accessibility One of the running on-site installations which recovers valuable Palladium, used as a this innovative field - an essential contribution characterisation processes for antibodies.

The therapeutics research.

With such access to www.inopsys.eu • info@inopsys.eu homogeneous catalyst by the customer, and purifies the waste water, closing the loops to the growth of this industry in Ireland. facility is managed by Dr Clair Gallagher, who+32 (0)495 emerging technology platforms, CONCEPT 653 821 has a track record of working with clinicians, fosters innovation in the biopharmaceutical NIBRT, renowned for its excellence as academics and industry to bring novel and advanced therapeutics fields. This a world-class training facility, anticipates Alternative linearfrom destruction approaches from the research bench through represents a significant opportunity, both attractingfor trainees across the globe The with costs associated wastemix and defined regulatory frameworks to clinicians in in the translation of research outputs and in these new suites.with This diverse of advantages. the field. assisting biopharma sites diversify as they participants to create a distinct emissions canpromises thus be reduced andand • Reach sustainability goals • Reduce wastemature. and associated costs enriching learning environment.

The team also includes individuals with value can be created by the recovery • Create value by recovery metals like Pd, flexibility Pt, …) significant experience, includingofamaterial pioneer in(e.g. precious The facility also provides of materials • Reduce handling transport hazardous An expert(e.g. teamprecious metals like CAR-T therapeutics and&an expert inof CAR-T by material enabling researchers and companies Pd, Pt, and T-cell therapies.

The CONCEPT team also The…).

CONCEPT facility is underpinned by to select individual or small clusters of • Reduce CO2 emissions works closely with principal investigators a skilled team of expert personnel. These instrumentation. Researchers can also access from the wider NIBRT institute, harnessing scientists are dedicated developing comprehensive end-to-end workflows that InOpSys wants to do tobetter than we offer.

NIBRT’s collective knowledge. This range and innovative and effective solutions, cover all necessary steps in their therapeutics linear destruction (e.g. research incineration) • Circular economy solution • CAPEX-free concept • One-stop shop depth of expertise positions the CONCEPT whether the focus is on biologics, cell development.

This level of customisation of hazardous side or waste streams in • Selective removal ofthe pollutants • Ownership from to finishprocess is tailored team to effectively meet needs of clients therapies, gene therapies or RNA therapies. ensures thatstart the research times of member water and material scarcity. and enables them to customise workflows Each of the CONCEPT team brings to specific needs. Researchers and the for individual requirements. experience across a range of disciplines and biopharmaceutical industry can then leverage

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Irish PharmaChem | Industry Buyers Guide 2024

circular chemistry can save the world. we believe in circles.

we believe in circles.

rcular chemistry an save the world. advantages.

advantages.

circular chem can save the

SELECTIVE REMOVAL

Irish PharmaChem | Industry Buyers Guide 2024 www.inopsys.eu

Don’t accept the status quo53

CONCEPT AT NIBRT these resources to explore new ideas, develop novel treatments and ultimately bring new or optimised products to market more quickly.

Empowering research excellence The funding secured for CONCEPT from SFI, IDA Ireland, and EI has been transformative, allowing NIBRT to broaden its focus from industry-focused research to curiosity-driven initiatives that benefit the entire research community.

Designed to ‘think it, make it, use it’, CONCEPT enables users with an idea to rapidly generate biological reagents to facilitate their research through access to technology and capabilities not currently available anywhere else. The facility’s resources significantly enhance the speed and efficiency of optimised cell line generation, which is an indispensable step in the development of biopharmaceuticals, cell therapies, gene therapies and RNA therapeutics.

CONCEPT also serves as a catalyst for innovation in molecule research, breaking conventional boundaries and empowering researchers to explore various facets of cell therapy. This includes assessing cytokine release and mapping multiple cytokines in individual cells in culture. The most significant aspect of CONCEPT, however, lies in its ability to leverage excellent research within the Life Sciences ecosystem, providing a platform for scientists to explore the translational potential of their discoveries.

Driving collaboration Collaboration lies at the heart of CONCEPT’s mission. NIBRT’s open research institute approach, coupled with CONCEPT’s modular infrastructure, ensures accessibility for a broad spectrum of stakeholders. This inclusivity spans academics, spin-out companies, and

industry groups. The facility’s capabilities extend from validating genetic sequences to delivering tangible therapeutic products, providing end-to-end workflows to meet diverse needs.

In essence, CONCEPT is not just a facility; it’s a driving force propelling collaboration, innovation and advancements in the biotech landscape on a national and global scale. With an anticipation of collaboration extending across academic, clinical, and commercial realms - from Ireland to the UK, Europe and beyond - CONCEPT is poised to become a cornerstone in advancing research and development within the biotech landscape.

A core facility for biotherapeutics CONCEPT’s ultimate goal is to become a renowned core facility for advanced therapeutics, providing a collaborative space that brings together both local and international stakeholders.

Central to CONCEPT’s mission is ensuring that the facility is accessible to a broad base of academic research scientists, in addition to industry partners. NIBRT’s open research institute approach, coupled with CONCEPT’s modular infrastructure, ensures accessibility for a broad spectrum of stakeholders, including academics, spin-out companies, and industry groups.

Its capabilities range from validating genetic sequences to delivering researchgrade therapeutic products, offering end-to-end workflows to meet diverse needs. This collective effort aims to drive biopharmaceutical development and manufacturing to elevated levels of technology readiness, commercialisation and investability. By engaging with researchers and industry players, CONCEPT ensures that cutting-edge science is not

confined to laboratories but is brought to the mainstream.

A commitment to fostering innovation The CONCEPT Facility at NIBRT stands as testament to Ireland’s unwavering commitment to fostering innovation in the biopharmaceutical sector. CONCEPT is committed to developing biotherapies of the future by providing access to the nextgeneration instrumentation and expertise required to deliver these innovative medicines.

By providing a unique space for translating ideas into impactful outcomes, NIBRT aims to empower Ireland as a global hub for biotechnological innovation, shaping the future of advanced therapies in collaboration with national and international partners. By enhancing the efficiency of research and development processes, CONCEPT plays a crucial role in expediting the entire product development cycle.

CONCEPT’s existence and its alignment with international standards and practices enhance Ireland’s reputation as a hub for biopharmaceutical research and development.

This can attract talent and investment to the country and strengthen its position in the global biopharmaceutical industry.

The transformative funding received from the IDA and SFI that enabled CONCEPT is pivotal in placing Ireland at the forefront of advancements in Cell and Gene Therapy.

While CONCEPT will primarily support local academics and industry, its aim is to bring science to the mainstream, facilitating the development of therapies for those who truly need them. This not only shapes a future where people will live longer and healthier lives, but also demonstrates the potential of a small institute in Ireland to have a global impact.

Through strategic collaborations with both national and international partners, CONCEPT is poised to shape the future of advanced therapies.

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Irish PharmaChem | Industry Buyers Guide 2024

Our Ringaskiddy facility offers API development and manufacturing services Differentiated partnership model with true scientific collaboration at its core.

Emerging technologies including flow chemistry, peptides, high potency API, biocatalysis, and more.

World-class facilities in Ringaskiddy, Ireland (EU), Cramlington (UK), Newcastle (UK), Deeside (Wales), North Carolina and Wisconsin (US).

1350+ passionate team members with expertise in hazardous chemistry and complex, multi-stage processes.

50+ years of leadership in API development and manufacturing.

Impeccable compliance record and commitment to environmental responsibility.

www.sterlingpharmasolutions.com Ringaskiddy, Raheens East, County Cork, P43 FR63, Ireland Service | Passion | Science

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ELLAB

Ellab:

dedication to innovation

Since its formation in Denmark in 1949, Ellab has always taken an innovative approach to product development, allied to a dedication to performance and quality, which combine to ensure its range exceeds customer expectations, including the company’s Irish customer base.

When Ellab recently sought highly skilled personnel to bolster its product development, the company took an unconventional path by recruiting from an unexpected profession: watchmakers. Despite a diminishing demand for professional watchmakers, Ellab's team recognised the unique detail-focused skillset these individuals bring to the table. While this decision might seem out of the ordinary, it underscores Ellab's unwavering commitment to innovation, precision and quality.

Innovation and a dedication to precision and detail have long been core principles at Ellab. Established in 1949, and headquartered in Hillerod, north of Copenhagen, Ellab's mission is to reduce time-to-market and mitigate product loss risks for global biotech and pharma companies. This mission is achieved through a comprehensive offering, including onsite validation and calibration management, monitoring systems, consulting, and a continually expanding portfolio of leading products.

Exceeding industry standards Ellab emphasises an unwavering dedication

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to performance, ensuring their products not only meet but exceed industry standards.

Since introducing their first thermometers in the 1950s, they have developed an extensive product range, from wireless data loggers to thermocouple systems designed for thermal validation processes and environmental wireless monitoring solutions.

In recent years, on-site services have gained increasing importance for the company. “We’re always focused on innovation and creating more and more value for our customers and we are currently developing an innovative operating model for global field services while we continue to heavily invest in equipment, software, tools and systems to ensure accuracy and compliance in biotech and pharmaceutical processes,” reveals Ludvig Enlund, Ellab CEO.

Commitment to quality The commitment to quality at Ellab is steadfast. Jacob Kristoffersen, the VP of Global Field Services, explains: “Our global field service team has grown tremendously over the last number of years, going from a team of 16 in 2016 to almost 400 in 2023.” The

ambition is to grow even more. Harmonising the way they work is crucial to ensuring consistent, high-quality services, regardless of the client's location, be it in the USA, Asia or Ireland. There's a significant effort to align how their people collaborate and work together in groups across borders, emphasising Ireland as a crucial market where Ellab believe they can truly make a difference for their clients.

Ellab's slogan, ‘Global Knowledge with Local Reach’, perfectly encapsulates its strategy of establishing a direct presence in key markets through successful mergers and acquisitions (M&As). This has positioned Ellab as a trusted partner to the top 40 pharma companies globally.

Ellab in Ireland The company began establishing its presence in Ireland in 2020 with the acquisition of Co. Meath-based instrumentation products and services supplier, Instrument Technology Ltd, and Cork-based thermal qualification and validation service provider, QualUs. Its presence was further expanded in 2022 Irish PharmaChem | Industry Buyers Guide 2024

ELLAB Ireland: “We have plans to substantially expand our operations in Ireland over the coming years, with a number of significant developments in the pipeline here.”

Amidst this growth, however, the commitment to maintaining the highest quality standards remains unwavering.

Ellab continues to offer top-tier equipment, employs the best engineers and technicians, and prioritises continuous training and development for its teams, ensuring clients receive the best possible service, both onsite and from support teams.

Against the backdrop of Ireland’s flourishing biotech and pharmaceutical market, Ellab’s focus on innovation and quality is perfectly timed.

For more information, visit www.ellab.com.

Innovation and a dedication to precision and detail have long been core principles at Ellab.

with the acquisitions of Autocal, a Dublinbased validation services provider, and CalX, a calibration services provider, based in Co. Meath.

“2023 was a very busy year for us,” remarks Paul O’Hare, Managing Director of Ellab Ireland. “We saw tremendous growth within the Irish market, and we successfully merged four separate companies into one cohesive unit.”

The fact that the owners of the four previous companies - Peter Keane, Gerard Collins, Paul O’Hare, Kevin Davis, Claire McMahon, and Willie McMahon - stayed on in leadership roles helped to both ensure a smooth transition and retain decades of industry experience and knowledge.

Ellab's standout offering in the Irish market lies in being a complete solutions provider, covering both products and services, with an emphasis on managed services where they go beyond just performing required tasks. For example, in the area of calibrations, Ellab don’t just perform calibrations as required, they also manage the entire process, from notifying the client when calibrations are due to ensuring all necessary documentation is uploaded and available online at the touch of a button before their team even leave the site.

Looking to the future Looking ahead to 2024, Paul O'Hare anticipates even more activity for Ellab

Ellab’s standout offering in the Irish market lies in being a complete solutions provider, covering both products and services.

Ellab’s global field service leadership team from the US and Europe met last November in Ireland to strategise plans to optimise and develop Ellab’s field service offering globally.

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SHORLA ONCOLOGY

Shorla Oncology growing from strength to strength Pictured are Orlaith Ryan and Sharon Cunningham, founders of Shorla Oncology.

Tipperary-based Shorla Oncology recently secured $35 million in series B funding to advance its oncology product portfolio.

Shorla Oncology, based in Clonmel, Co. Tipperary, recently announced that it has raised $35 million (approximately €32 million) in Series B funding, led by Kurma Partners’ Growth Opportunities Fund, with participation from existing investors Seroba Life Sciences and Irish, US and Canada based family offices and Enterprise Ireland. The funding will enable Shorla to accelerate the growth of its oncology portfolio by advancing its pipeline, bringing therapies to market that will address drug shortages, and improving the preparation and application of oncology medication.

“We are thrilled to announce the successful conclusion of our Series B funding round,” stated Sharon Cunningham, CEO and co-founder of Shorla Oncology. “The investment will underpin the advancement and commercialisation of our oncology drugs, ensuring we continue to deliver on our mission of bringing promising treatments to patients around the globe.”

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Addressing gaps in patient care Established in 2018 by Sharon Cunningham and Orlaith Ryan, Shorla Oncology is a privately held, Ireland- and US-based pharmaceutical company with an advanced pipeline of innovative oncology drugs for orphan and paediatric cancers. The company concentrates on indications where existing treatments are limited, in shortage or the drug applications are inadequate for the target population.

Backed by a dedicated team of scientists and clinicians, the company is advancing a differentiated portfolio of oncology treatments aimed at addressing significant gaps in patient care. Shorla recently announced the FDA approval and market launch of Nelarabine Injection, marking its first approval in the US. Shorla aims to continuously bring further products to market with a significant and growing portfolio of late-stage assets. These products are improving efficiencies by providing more convenient formulations to clinicians and enabling easier application for patients.

Life-changing medications “Shorla’s recent FDA approval is a testament to its capabilities for bringing differentiated formulations of life-changing medications to the market,” commented Daniel Parera, MD, Partner, Kurma Partners. “We are excited to support Shorla’s growth as an integrated specialty pharma company to address shortcomings in patient care and improve outcomes. In particular, the team has shown impressive agility in identifying unmet needs and in operational execution. This matches very well with our focus and expertise as a growth fund to support the scale-up of emerging champions of the European healthcare and Life Science ecosystem.”

Kurma Partners is a key European venture capital firm specialised in healthcare, with more than €700 million under management, with three dedicated franchises: Kurma Biofund is focused on venture investments in therapeutics (current active fund KBIII); Kurma Diagnostics is focused on venture investments in diagnostics and digital health (current active fund Kurma Dx2); and its recently launched first Growth Opportunities Fund is focused on late-stage growth investments in therapeutics, diagnostics, digital health and medtech, with six investments to date including Shorla. Kurma Partners is part of the Eurazeo Group.

At the end of October 2023, Shorla announced an agreement to acquire Jylamvo, an oncology and autoimmune drug, for the US market, from Therakind Ltd, a UK-based company. The therapy has been approved by the FDA. Jylamvo is an easy-to-administer oral methotrexate solution that eliminates the need for crushing or splitting pills or compounding into a liquid formulation, and is an alternative solution for patients who have difficulty swallowing pills.Earlier in the year, in July 2023, Shorla entered into a licensing agreement and strategic partnership with another UK-based company, to register and commercialise PIP-101, an oral solution treatment that slows or stops the growth of certain forms of leukaemia, such as acute lymphoblastic leukaemia and chronic myeloid leukaemia.

For more information, visit shorlaoncology.com.

Irish PharmaChem | Industry Buyers Guide 2024

ENSURING UNINTERRUPTED PATIENT SUPPLY • • • •

Global distribution of investigational medicines and finished products Time critical, temperature sensitive patient supply Supporting the needs of Irish Manufacturing Plants Expanding GDP & GMP capacity in Dublin to help futureproof your supply chain

Learn more about how our expertise and resilience can help you with your supply chain needs: John Halpin, Business Development john.halpin@dhl.com + 353(0)86 0665865 DHL Supply Chain – Excellence. Simply delivered. www.dhl.com/gb-en/home/our-divisions/supply-chain.html

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LOGISTICS & TRANSPORT: DHL SUPPLY CHAIN DHL Quantum is a new carbon neutral site, opening in January 2024, located close to the existing Life Sciences and Healthcare site at Dublin airport, which is ideal for global and European export, while supporting Irish manufacturing plants.

DHL Supply Chain expands Life Sciences footprint in Ireland DHL Supply Chain has become a key strategic partner to pharmaceutical manufacturers in Ireland and around the world, specialising in supporting biologics customers with their time-critical temperature sensitive needs.

As the Life Sciences sector in Ireland continues to grow with confidence on the back of major investment announcements in 2023 by companies such as Pfizer, MSD, Eli Lilly and Astellas, DHL Supply Chain is at the forefront of expanding the support infrastructure landscape to meet the increasing demand for best-in-class, end-toend supply chain services.

DHL Supply Chain has made its mark on both the Irish and global Life Sciences sectors within a short space of time. Since opening the doors of its Global Export Centre in the Horizon Logistics Park, Dublin Airport, in 2016, it has become an established strategic partner to key pharmaceutical manufacturers in Ireland and around the world. Whether in R&D, clinical trials, manufacturing or finished goods supply chains, DHL has specialised in supporting biologics customers with their time-critical temperature sensitive needs.

Across the whole team, their passion and competency has ensured a patient-focused service geared to attain customer satisfaction, whilst achieving almost flawless KPIs. “Our business, which forms part of a network of 43 depots globally, is compliant with the most rigorous regulatory and security standards, with certification being successfully renewed following reinspections,” explains John Halpin, Business Development Manager - Life Sciences

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& Healthcare Ireland, DHL Supply Chain Ireland.

The DHL Supply Chain Ireland team can also count on the support of two other DHL divisions, DHL Global Forwarding and DHL Express, connecting customers to their customers and patients through a comprehensive multi-temperature shipment and medical parcel distribution network globally.

Expanding capacity Looking to the future, DHL Supply Chain’s new carbon neutral site, opening in January 2024, will elevate the Horizon experience and high-quality service to a much larger scale, allowing them to extend their support across multiple temperature regimes, to the thriving biopharmaceutical industry in Ireland, and support the needs of the rapidly emerging Advanced Therapeutics industry.

Quantum, a 200,000 square feet facility located close to the existing Life Sciences and Healthcare site at Dublin airport, is ideal for global and European export, while supporting Irish manufacturing plants. It will offer full sprinkler protection in an all humidity-controlled ambient chilled and frozen environment, designed to provide storage pick-and-pack and conditioning services under stringent GDP and GMP conditions.

This state-of-the-art facility is an LEED gold and BREEAM excellence rated site, equipped with full range of levers to maximise the energy efficiency of the building and its operations: intelligent business monitoring, rainwater harvesting, heat pumps and solar panels. “Such features support our work to enable a more sustainable future whilst delivering excellence across the globe to our customers’ patients,” notes John Halpin.

A sustainable sector that drives innovation DHL Supply Chain Ireland is aiming to fulfil the group’s long-term strategy, with a particular focus on further investment in key sectors, such as Life Sciences and healthcare, by continuing to develop the innovative services that their customers need. As a global logistics leader, DHL has played a key role in the delivery of 1.5 billion doses of Covid vaccines around the world, significantly enhancing their global capacity and capability in cold chain and deeper frozen storage and distribution activities.

“DHL invests heavily in innovation, with four dedicated innovation centres located around the world, and with our innovation efforts driven by our logistics trend radar which sets the priorities for investments,” John Halpin states proudly.

Irish PharmaChem | Industry Buyers Guide 2024

LOGISTICS & TRANSPORT: DHL SUPPLY CHAIN Within the industry in Ireland, the DHL Life Sciences team leverages these global initiatives and develops the solutions which will enhance their customers’ business. Most recently, they completed the extension of services into the deeper frozen -40 and -70, to support R&D in biologics, and they have upgraded their warehouse management system, providing enhanced functionality and enabling easier adoption of digital tools, and end-to-end supply chain visibility via their MySupplyChain platform.

MySupplyChain MySupplyChain gives DHL customers full operational visibility of your supply chain at your fingertips, anytime, anywhere, on any device, so you have the ability to make quick, informed decisions by identifying supply chain issues in real-time, giving those who use it a competitive advantage.

The web portal provides realJohn Halpin, Business Development Manager - Life Sciences & Healthcare Ireland, DHL Supply Chain Ireland. time visibility of your warehouse and transport operations and allows you to track inventory remotely and securely. Users can also benefit from tailored DHL is fundamentally decarbonising a 2050 to ensure a sustainable future. We want dashboards, which provide operational significant proportion of the retail transport to achieve this for, and together with, our performance and newly available data which sector in Ireland, and the company intends customers,” stresses John Halpin. “As part of helps with business analytics. to continue to roll this out to all the other this, DHL Supply Chain Ireland aims to have

Biomethane: for a sustainable future DHL is committed to playing its part in decarbonising the logistics industry and has demonstrated this with its multi-million euro investment in biomethane to fuel customers’ transport requirements.

The company invested €80 million in a dedicated biomethane production facility in Cork, run by Stream BioEnergy. The new facility will provide fuel for up to 150 trucks, resulting in an annual carbon reduction of 15,000 tonnes, the equivalent of more than 38 million miles driven by an average petrolpowered passenger vehicle.

Irish PharmaChem | Industry Buyers Guide 2024

sectors in which they operate, including consumer, technology, aviation, Life Sciences and healthcare.

The biomethane production site at Little Island, Cork, will process 90,000 tonnes of industry and consumer food waste per annum which could otherwise have been sent to landfill. The deployment of biomethane at scale requires no infrastructural upgrades to Ireland’s existing gas grid, and given its capacity to be carbon neutral, biomethane is a flexible, costeffective way to decarbonise commercial road transport.

“DHL is aiming for zero emissions by

the first carbon neutral fleet in Ireland and all our new facilities will be carbon neutral, starting with the new Quantum Life Sciences facility in January 2024.”

The group also aims to become a leader in sustainable aviation using sustainable aviation fuel (SAF) by 2030 and investing in the latest technology with the most fuel efficient, SAF capable, and alternative power solution assets available. “In the industry, these programmes will enable DHL Supply Chain to make our contribution to Ireland’s goal of sustainability manufacturing and supplying new medicines to patients globally,” concludes John Halpin.

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SSPC

SSPC: 15 years of impact The SSPC research centre, headquartered in University of Limerick, is celebrating 15 years of providing world-leading pharma research and talent development via unique academic-industry partnerships.

SSPC, the Science Foundation Ireland (SFI) Research Centre for Pharmaceuticals, is widely regarded as a world leader in pharma research and talent development. SSPC has established a globally unique academic-industry partnership. Through advanced technical expertise in pharmaceuticals and bio pharmaceutical related topics, SSPC can inform and advance multiple stages of the development journey of small molecule, biologics and advanced therapies. Now in its fifteenth year, SSPC is committed to providing a platform for collaboration among all stakeholders and is truly a global organisation, with 41% of all collaborative industry research through global sites.

SSPC’s Scientific Director Professor Damien Thompson, a world leader in molecular modelling of sustainable materials, says that the centre’s agility and pioneering research in data-driven materials and process development are key to its success.

“Our goal is to ensure that Ireland remains a leader in pharmaceutical research and development by delivering new science that addresses patient needs,” he notes. “Our researchers are providing new opportunities for patient treatment utilising digital health, AIdriven materials development, precision medicine and nanomedicine.”

The centre has achieved remarkable success in helping to develop innovative medicines, deliver new treatments to patients, and creating PhD researchers for the Irish pharmaceutical industry. It has also made significant strides in understanding and addressing many diseases.

SSPC has more than 80 investigators and over 120 PhD researchers

based across Ireland in nine higher-education institutes (HEIs) and its host University of Limerick (UL). Its industry-guided platform has to date led to collaborative projects with 46 companies globally. SSPC has welcomed no fewer than 10 new partners in the last year, bringing the total current membership to 52 industry members. The funding value of NE-NC this year is €9.8 million. SSPC shows participation in 45 NENC collaborative research applications, involving 90 HEIs, 30 research organisations, 65 industry partners (SMEs and MNCs) and 25 societal partners. These partnerships span 25 countries within the EU and beyond (USA, UK, and Norway etc.). Its industrial collaborative research projects have significant global reach, with 41% of active projects through global sites, and 40% of SSPC industry members engaging through their global sites and Irish sites.

SSPC launch phase two of project to innovate Protein A Resin Reuse SSPC and partners Pfizer, Eli Lilly, Janssen, BMS and MSD are working together on phase two of a partnership to address the growth in the protein A resin market, led by Professor Sarah Hudson, University of Limerick. The project addresses challenges that are shared across the biopharmaceutical manufacturing sector, including the rising need for early diagnosis of chronic diseases, the growing demand for drugs in the development of vaccines and therapeutics (specifically proteins called antibodies), and an increase in R&D investments in pharmaceutical companies. For more information, visit: sspc.ie/sspc-launch-phase-two-project-addressing-the-growthof-protein-a-resin-market/.

Societal impact By addressing societal pharmaceutical impacts, SSPC requires a multifaceted approach that encompasses safe medicines, accessibility, participatory health research and a disease-agnostic perspective.

By prioritising these aspects collectively, SSPC is working towards building healthier communities worldwide, while tackling global health challenges effectively.

An example is the recently funded project called OptiViVax: To Optimise a Vaccine for Plasmodium Vivax Malaria. Dr Anne Moore and Dr Sonja Vucen, University College Cork, are partnering with an international consortium for OptiViVax. Plasmodium vivax is the most widespread human malaria-causing pathogen, with 2.5 billion people living at risk in Africa, South America, Oceania and Asia. Over the next five years, OptiViVax, a newly created consortium across academia and industry, will build on exciting breakthroughs in malaria research to integrate state-of-the-art advances in parasite immunology, vaccine design and innovative pre-clinical and clinical studies, to develop next-generation vaccines with increased efficacy against the P. vivax parasite. For more information, visit: sspc.ie/optivivax-optimising-ahigh-efficacy-vaccine-for-plasmodium-vivax-malaria/.

Advancing talent

Professor Damien Thompson, SSPC Director.

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SSPC is the largest producer of PhD graduates for the biopharma sector in Ireland and one of the top ranked producers globally. SSPC has graduated over 120 researchers to date, with 69% of the PhD cohort now employed by industry. One of the key drivers facilitating the high number of transitions to industry is the SSPC PhD industry placement Irish PharmaChem | Industry Buyers Guide 2024

SSPC

Dr Sarah Hayes, COO, SSPC.

programme, which bring students into the industrial environment for a three-month placement aligned with their research area.

“Our research impacts society by improving and advancing the sustainable production and the availability of medicines globally,” explains Dr Sarah Hayes, SSPC COO. “Talent is a particular focus point and with a dedicated team of highly skilled professionals, we are nurturing and developing the brightest minds in pharmaceutical research.

SSPC has many training networks, and one outstanding example is the award winning EPSRC-SFI Centre for Doctoral Training (CDT) in Transformative Pharmaceutical Technologies, led in Ireland

by Professor Anne Marie Healy at Trinity College Dublin.

Future pharmaceutical skills requirements are becoming increasingly demanding, requiring a flexible and agile workforce.

The CDT aims to develop the holistic skill-set required for our graduates to be future research and industry leaders in both research-intensive and manufacturing industry environments. The CDT equips doctoral scientists in Ireland and the UK to drive innovation in the pharmaceutical and

healthcare sectors. For more information, visit: sspc.ie/epsrc-sfi-centre-for-doctoraltraining-cdt-in-transformativepharmaceutical-technologies/.

Ireland is one of the leading countries in the world when it comes to pharmaceuticals.

With a high number of PhD-level professionals, Ireland has been able to develop innovative products and services that have helped the country become an industry leader. 25% of all PhDs nationally are employed in the biopharmaceutical sector and SSPC is the largest producer of PhD graduates in this sector in Ireland. SSPC’s alumni network is a testament to the exceptional education and opportunities provided by the centre. SSPC graduates have gone on to make significant contributions in various corners of the world.

With a high number of PhD-level professionals, Ireland has been able to develop innovative products and services that have helped the country become an industry leader.

SSPC stands out through its focus on advancing talent, pushing beyond state-of-the-art science, impactful industry partnerships, international engagement, and societal impact.

Pictured at the launch of the second phase of an SSPC resin project at the BPCI Conference, are (l-r): Aisling Arthur, SSPC Industry Engagement Manager; Matt Moran, retired Director of BioPharmaChem Ireland; Dr Sarah Hayes, SSPC COO; Professor Damien Thompson, SSPC Director; and (seated); Professor Sarah Hudson, project lead, and Professor Philip Nolan, Director General, Science Foundation Ireland.

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PMTC

PMTC: innovation through collaboration Dr Rabah Mouras, Interim Director of the Pharmaceutical Manufacturing Technology Centre, highlights the valuable work the PMTC carries out across its key research areas, how industry needs are at the heart of everything PMTC does and the growing importance of sustainability and digitalisation.

Since its formation in 2013, Pharmaceutical Manufacturing Technology Centre (PMTC) has established itself as a progressive, agile, industry-led applied research and innovation centre. At PMTC, we act as a focal point around which companies in the sector come together and address common challenges collaboratively.

Leveraging our indigenous SME network, academic expertise and world class facilities available at PMTC centre and across Ireland’s extensive third-level institutions, PMTC focuses on delivering value and addressing real world challenges within the pharmaceutical manufacturing sector.

Situated within the Bernal Institute at the University of Limerick, PMTC has a wide range of capabilities and extensive domain experience, ensuring we can remain relevant, agile and highly responsive to the unique and growing needs of our member companies.

Our team of experienced post-doctoral researchers support companies across the pharmaceutical manufacturing sector in optimising their manufacturing facilities within the framework of our three core research areas:

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1. Pharmaceutical Plant Cleaning including containment, changeover, and verification; 2. Process Control and Optimisation; 3. Data Analytics and Utilisation.

As the PMTC centre transitions into Phase 3 of the Centre’s operations, in addition to the above core research areas, PMTC will expand its expertise and research in the areas of digitalisation and sustainability to support and response to the evolving needs of industry.

PMTC has a number of affiliated research performing organisations and research centres to assure we can place the industry need with the best academic talent and capabilities nationally.

The importance of pharmaceutical manufacturing to the Irish economy cannot be understated. Ireland is the largest net exporter of medicines in the EU, with over €90 billion worth of products being exported each year.

This accounts for over 40% of the country’s total exports. The industry directly employs ca. 43,000 people, with comparable numbers employed in the provision of services to the

sector. This critical sector is ever expanding and developing and PMTC’s objective is to support continued growth and competitiveness of the sector in Ireland through excellent research and development outputs.

With an emphasis on collaborative engagement with our industrial partners, PMTC is strategically positioned to address realworld challenges within the pharmaceutical manufacturing sector, ensuring that the needs of this important sector are supported into the future. Sitting at the interface of industry and academia, PMTC supports the pharmaceutical manufacturing industry and its supply chain to solve problems, while differentiating itself by focusing on industry informed research, where programmes are driven by real market needs defined by pharma multinational operations in Ireland.

Training and upskilling In Phase 3, PMTC would target supporting skills needs for pharmaceutical manufacturing operations, including data analytics, which supports the digital journey leveraging our deep domain knowledge Irish PharmaChem | Industry Buyers Guide 2024

PMTC Sustainability

Since its formation in 2013, Pharmaceutical Manufacturing Technology Centre has established itself as a progressive, agile, industry-led applied research and innovation centre. and our growing digitally enabled infrastructure towards a testbed environment to provide opportunities to learn and develop or adapt technologies to meet the growing needs of the sector.

As we plan forward to a future Phase 3 of PMTC, we aim to provide access to companies to get hands-on learning and development opportunities in a testbed environment to promote innovation opportunities, such as digital transformation and continuous manufacturing, at Irish sites.

PMTC will work together with its members to design training that relevant to the industry and delivered by world-class experts.

PMTC is also offering the micro-credential towards higher education certification in collaboration with the host University. In addition, the centre will offer access to Lab 5.0 infrastructure.

PMTC is well placed to support companies across the sector on their sustainability journey. The importance of sustainability in the pharmaceutical industry has become more apparent in recent years as global concerns about climate change and environmental degradation grow. To making a significant improvement in overall sustainability, pharma manufacturing needs to incorporate ‘sustainability by design’ concepts into the design of pharmaceutical facilities, medicinal products and manufacturing processes.

Sustainability in pharma is more than just adopting environmentally responsible practices. It encompasses the entire product lifecycle, from drug development to disposal. PMTC’s team will develop models and tools to facilitate integration of sustainability concepts across the entire life cycle of pharma products. By collaborating with advanced manufacturing pillars, PMTC will ensure that crucial aspects of sustainability by design are integrated by leveraging cutting-edge technologies like digitalisation, 3D printing and automation.

Some of PMTC’s high-impact research projects already being delivered for pharma sites in Ireland have sustainability at their core, such as reduction in solvent volumes, reduction in downtime and faster cycle times. Research outcomes so far have enabled companies to save on costs of materials, reduce downtime and improve process robustness, as well as helping to strengthen the competence of their site team through a deeper understanding of manufacturing technologies. One such example is the implementation of PMTC’s unique ATEX rated cleaning facility.

Lab 5.0 Digitalisation transformation in laboratories focuses on streamlining processes, improving data accuracy, and fostering greater collaboration. Automation, AI, and data analytics have revolutionised research and analysis, accelerating results, which in turn increases productivity, while simultaneously reducing errors.

The transition to Factory 5.0 necessarily needs the laboratory to first adapt industry 5.0 principles before moving to manufacturing. The PMTC initiative to implement Lab 5.0 is part of the Centre’s mandate to provide access to talents and skills and to prepare the future skills for the sector.

Access to Lab 5.0 will offer the members a great opportunity to gain insight into new technologies and explore how Industry 5.0 principles can enhance lab efficiency. To build the knowledge and expertise required to set up a Lab 5.0, the Centre is involved in the BPCI/ISPE/ Lab 5.0 by being an active member, as well as leveraging the shared knowledge in the ISPE/ Lab 5.0 meeting and working groups.

Digitalisation As pharma sites across Ireland embark on their digital transformation, we at PMTC are leveraging our deep domain knowledge and our growing digitally enabled infrastructure to support pharmaceutical manufacturing operations in identifying skills needs in data analytics.

Looking forward to Phase 3 of PMTC operations, we aim to provide access to companies to get hands-on learning and development opportunities in a testbed environment to promote innovation opportunities, such as digital transformation and continuous manufacturing, at Irish sites.

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ATEX rated Cleaning Rig Technology in PMTC exemplifies the capabilities of the centre in tackling process challenges for pharma manufacturing.

Cleaning has a significant impact on pharma plant efficiency, utilities and resources. Based on client testimonials and some recent survey data, it is estimated that some sites spent 50% of time on plant cleaning, severely impacting operations with excessive downtime, costs and delays across the supply chain.

PMTC’s industry-designed cleaning facility will have a transformative impact by allowing offline development and transfer of right first-time cleaning processes to pharma plants, enabling better utilisation of their high value fixed assets, while maximising processing time to achieve optimal productivity. The facility was funded through Enterprise Ireland and endorsed by PMTC’s member companies.

This unique capability within PMTC presents many opportunities for delivering competitive advantage to companies, including: • Replicating plant operations to develop new cleaning methodologies for new entities and supporting new product introductions at Irish sites; • De-risk and prove the use of PAT tools for real time monitoring and verification of cleaning;

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PMTC • Reduction in time, cost and volumes of cleaning agents; • Development of greener and sustainable processes by reducing waste and energy usage; • Supporting tailored training to industry members in the areas of cleaning and cleaning validation, driving compliance and process robustness.

PMTC has an excellent track record in cleaning by developing methodologies to optimise cleaning processes toward more efficient and sustainable processes.

In addition to addressing real world problems in the pharmaceutical industry, PMTC offers industry-wide access to a range of case studies, white papers and reports, with core research outputs available to members only and selected publications and guides available at a cost to non-members.

One such example is the Publication of the Good Cleaning Validation Practice guide. The second edition of PMTC’s CVGP guide, covering the science of cleaning and cleaning validation and the communication of cleaning validation, was published in June 2023, offering industry wide access to this valuable research publication.

solutions to MNCs in Ireland and beyond.

In essence, the Centre provides a focal point for innovation and demonstration of new technologies and services for SME members, facilitating direct engagement and showcasing indigenous capabilities to MNCs. This is a key enabler for those indigenous companies, as well as providing a rich ground for understanding the end user needs, which helps in product development, whilst allowing MNCs to influence how best these technologies can be applied in a pharmaceutical manufacturing context.

PMTC also recognises there are valuable synergies amongst the multinationals’ needs and the skills, services and products of SMEs nationally. Acting as the enabler to foster collaborations across these sectors is just one of the ways PMTC delivers value across the wider ecosystem of companies.

PMTC, with support from IDA Ireland and Enterprise Ireland, recently surveyed industry stakeholders on their current position and future needs. The study, titled ‘Delivering for Ireland’s Pharmaceutical Industry’, identified clear trends and challenges, while also pinpointing how supports can be matched to meet these challenges.

The results of the study paint a positive picture of a pharmaceutical manufacturing ecosystem that is expanding and building on its strong track record, reputation and innovative culture. The findings of this work give us a solid basis for further industry engagement and collaboration, while ensuring PMTC stays relevant to the future needs of the industry. The study has been distributed to PMTC industry members and is available to the public at www.pmtc.ie.

Innovation through collaboration

PMTC Good Cleaning Validation Practice guide, published June 2023, is available through PMTC.ie.

Collaborative engagement is core to PMTC. Our focus towards industry-led, highly engaged collaborative research strongly translates to the delivery of real impact for member companies through the research

outputs delivered by the Centre.

Membership of PMTC is open to all companies involved in the (bio) pharmaceutical manufacturing sector in Ireland. PMTC welcomes multinational pharma companies, together with indigenous technology and service providers, supporting the industry to help advance technology innovation and application in pharma manufacturing processes.

This strong emphasis on collaboration within PMTC is not limited to the relationship between the Centre and its members, but importantly, supports company-to-company engagement and collaboration across the Irish pharmaceutical manufacturing sector as a whole, thus enriching the eco-system in Ireland.

In recognising this strong need for industry engagement, PMTC provides opportunities for companies to network and stay abreast of new technology developments through events such as the PMTC Knowledge Day, as well as technical workshops, communities of practice and training events.

Through our knowledge-sharing across the PMTC community and acknowledging that talent and capacity development across the pharmaceutical sector in Ireland is a key success factor for the industry, PMTC supports member companies in the continued professional development of technical personnel in member companies and always seeks new ways to strengthen the talent pipeline in Ireland. To get involved or learn more, visit www.pmtc.ie or contact pmtc@ul.ie.

Focus on industry Having built up a strong membership base of pharma multinationals since the establishment of the centre in 2013, now entering the final chapter of Stage 2 funding, PMTC has an ever-increasing focus on broadening its SME membership base. Our goal is to provide Enterprise Ireland clients with unrivalled interaction with pharma multinationals, enabling SMEs to grow through delivery of new technologies and

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PMTC is an award-winning research centre: Pharma Research Centre of the Year 2022 and Pharma Project of the Year – Small 2022.

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Over the past 50 years we have grown to service most of the leading global biopharma clients on their critical production, research and development facilities throughout Europe.

We are proud of our reputation for assisting clients in bringing innovative and life improving medicines to market.

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ASTELLAS

Astellas invests more than €330 million in Tralee Astellas Pharma is set to invest over €330 million in a new stateof-the-art facility in Tralee, Co. Kerry, which will build capabilities to supply the Astellas global market and accelerate the development and commercialisation of innovative medicines.

Astellas Pharma Inc. recently announced its intention to submit a planning application to build a new state-of-the-art facility, at an approximate cost of €330 million in Tralee, Co. Kerry.

This investment by Astellas in Ireland will expand its capacity and capabilities for aseptic drug products, reinforce stable production for global supply and accelerate the development and commercialisation of innovative antibody drugs and other new products.

The facility will be based on the Industrial Development Authority’s greenfield site in Kerry Technology Park, Tralee, bringing highly specialised engineering, science and

technology roles to the region and helping to further the Astellas vision to “be on the forefront of healthcare change to turn innovative science into value for patients.”

Strengthening in-house production capacity “Astellas is developing innovative drugs and technologies based on our Focus Area research and development approach, placing patients at the forefront of everything we do,” noted Hideki Shima, Chief Manufacturing Officer at Astellas. “With the new facility, Astellas will aim to strengthen our in-house production capacity and capabilities and

ensure a stable supply of high-quality Astellas medicines to patients around the world.”

Michael Lohan, CEO at IDA Ireland, described the announcement as “excellent news for the South West region and indeed Ireland. Astellas already has a presence in both Kerry and Dublin and this significant investment of approximately €330 million, adding a new state-of-the-art aseptic drug product facility, underscores the strategic importance Ireland plays in Astellas’ global operations. The new facility in Tralee will be built with sustainability at its core and will showcase Ireland and our regional attractiveness as a location for investment.”

Sustainability targets The new facility in Tralee will be built in line with Astellas’ ambitious sustainability targets and values, incorporating the highest national and international best practice in energy and environmental design. The project aims to cut water use by about half, reduce operational energy intensity by more than one-third and produce zero waste to landfill (compared with LEED baseline). These measures, along with onsite renewable technology, including solar PV panels and biomass boiler, underpin Astellas’ efforts in the mitigation of climate change.

The new Tralee facility will cover a site area of approximately 44.7 acres, consisting of a three-storey building, with a total floor area of 17,000 square metres, while the building footprint will stretch to approximately 7,300 square metres. Subject to planning permission, construction will commence in 2024, with the site expected to be operational by 2028.

Astellas’ new €330 million facility in Tralee is expected to be operational by 2028.

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Irish PharmaChem | Industry Buyers Guide 2024

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

Irish PharmaChem | Industry Buyers Guide 2024

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SPECIALIST INTEGRATED CDMO

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

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

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

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

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

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

Irish PharmaChem | Industry Buyers Guide 2024

BIOPHARMACHEM SKILLNET

Learning that delivers real results

Susan Costello, Network Director, BioPharmaChem Skillnet, reflects on an extremely busy but rewarding year, the evolution of the steering group and how the organisation continues to create and deliver effective learning and development courses for the biopharma sector in Ireland.

The BioPharmaChem Skillnet steering group plays a pivotal role in leveraging a wealth of knowledge from diverse corners of the biopharmaceutical sector. Comprised of experts with extensive experience and deep insights, this group serves as the compass, guiding strategic decisions within the industry.

The steering group fosters innovation, facilitates collaborative problem-solving, and ensures a comprehensive understanding of the dynamic challenges and opportunities within the biopharmaceutical landscape. This diversity in expertise not only enriches the decision-making process but also contributes to the development of sustainable solutions that address the intricate needs of the sector.

Throughout 2022 and 2023, the critical cohort of business contacts shaping the priorities and initiatives of the Network has undergone significant changes. During this period, we witnessed the retirement of several committee members from Eli Lilly (GBS), Pfizer (API) and Hovione (CDMO). Concurrently, we welcomed new members from Takeda (API/ FFF), APC/VLE (biopharmachem), Alexion (biopharma), Abbvie (biopharma) and Sterling Pharma (CDMO), Our steering group remains fortified with representatives from ThermoFisher (CDMO), Eli Lilly (biopharmachem), Janssen (biopharma), J&J (API), BioMarin (biopharma), and our promoting organisation BioPharmaChem Ireland.

There is no doubt that being associated with the biopharmachem sector at this time is exciting – though challenging. The sector has developed its capabilities in the transition to biopharma manufacturing over the past 1015 years, demonstrated by its global impact in producing over 11 billion doses of Covid-19 vaccine through the pandemic years. But a new industry transition is under way, driven by new medicine technology advances such as Cell and Gene Technology (CGT), new Irish PharmaChem | Industry Buyers Guide 2024

manufacturing technologies in biopharma and API continuous manufacturing.

These challenges are in addition to the global skills shortage, sustainability goals, digitalisation, and Factory 5.0 facing high-tech manufacturing globally. Established almost 20 years ago, the BioPharmaChem Skillnet, with the promotion of BioPharmaChem Ireland (BPCI), is in a unique position to support businesses in the sector in their efforts to address these challenges.

Consistent with Skillnet Ireland’s strategic goals and the BPCI strategy to support the sector, BioPharmaChem Skillnet has demonstrated its connection with businesses by: • Sourcing and subsidising learning required by member businesses; • Developing innovative training programmes to provide skilling and reskilling of new entrants; • Collaborating with third level institutions and training sector providers to develop new programmes as businesses develop their workforces.

Making real strides for equality In February 2023, the BioPharmaChem Skillnet in collaboration with Skillnet Ireland and BPCI launched the first Equality, Diversity and Inclusion report for the BioPharmaChem sector in Ireland. The research has outlined

specific measures to facilitate workforce development within the industry and attract and retain diverse talent. The research will empower the sector’s businesses to devise effective solutions to support diversity and inclusion for both leaders and the broader workforce. One of the findings in the report was the lack of gender balance in the industry when we reach senior leadership level.

BioPharmaChem Skillnet in conjunction with CareerVision and Kennedy Insights worked to hone a programme to encourage and prepare women to assume leadership roles within businesses in the sector.

Women in Leadership Development (WiLD) is a six-month career advancement programme specifically adapted for female leaders in Science, Technology, Engineering, and Mathematics (STEM) organisations in Ireland.

It aims to support and accelerate the career trajectories of women in the biopharmachem and wider Life Sciences sector.

The programme is designed to shift the participants’ view of themselves as individuals and the broader definition of leadership. It moves participants away from a traditional, often male-dominated vision of leadership, and encourages them to understand, develop and embrace their unique leadership styles and strengths. This initiative won the 2023 Pharma Industry Award in the Pharma Education and Training category.

Susan Costello, Network Director (second from left), is pictured accepting the Pharma Education & Training Award 2023 for the WiLD programme in partnership with CareerVision and Kennedy Insights!

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BIOPHARMACHEM SKILLNET Biopharmaceuticals and Advanced Personalised Therapies Launched in November 2023, the Certificate in Continuing Professional Development: An Introduction to Biopharmaceuticals and Advanced Personalised Therapies is a Micro-credential at NFQ Level 8 with a goal of providing a deep understanding of the technologies related to Advanced Personalised Therapies, a potential growth area for the sector.

This programme has been developed by the BioPharmaChem Skillnet in collaboration with UCC to address some of the talent shortages being experienced by industry. It aims to provide students with an introduction to the molecular and cellular basis of disease and how this informs the design and manufacture of biological therapies.

There will be a focus on protein and vaccine based therapeutic approaches, as well as emerging gene and cell therapies, and the personalised treatment of disease.

Embracing Virtual Reality The BioPharmaChem Skillnet, in conjunction with representatives from businesses in the API and formulation manufacturing sectors and TU Dublin, have developed a training and learning programme on Powder-Handling in Chemical Manufacturing in Virtual Reality (VR). This is the second true interactive VR training course aimed at the biopharmachem manufacturing sector, the first being the Aseptic Technique for Bio-Pharma Manufacturing in VR. The course gives a detailed, immersive, and engaging training and learning experience in the core competencies of powder-handling techniques and standards. Users are guided by the VR environment through the learning material, which includes interactive 3D models and animations, preparing them for three practical tasks in the virtual manufacturing environment. This programme was a finalist in the 2023 Learning and Development Institute Awards in the Best Digital Learning Initiative category.

training providers, the BioPharmaChem Skillnet secured funding from Skillnet Ireland to develop a programme, which has been scoped and will commence development in late 2023.

In 2024, BioPharmaChem Skillnet will continue to play a pivotal role in advancing the learning and development needs of the biopharmaceutical, pharmaceutical, chemical and medical device sectors. With a commitment to excellence, the BioPharmaChem Skillnet programmes offer support to organisations, ensuring they stay at the forefront of industry advancements.

Through strategic initiatives, comprehensive training modules, and collaborative partnerships, BioPharmaChem Skillnet actively contributes to the enhancement of skills and competencies crucial for success in this dynamic sector. As it evolves alongside the rapidly changing landscape of biopharmaceuticals and chemicals, BioPharmaChem Skillnet remains a steadfast resource, empowering the workforce with the knowledge and expertise needed to navigate the complexities of the industry and drive innovation.

Meet the team!

Over the past year, BioPharmaChem Skillnet’s dynamic and dedicated group has continuously demonstrated its commitment to fostering growth and excellence within the biopharmachem sector. Their collaborative spirit and adaptability have not only empowered individual team members but have also contributed significantly to the overall success of the network.

In December 2023, the BioPharmaChem Skillnet and TU Dublin launched their third VR training programme, focused on Health and Safety Orientation for new entrants to the sector.

In December 2023, the BioPharmaChem Skillnet with partner TU Dublin launched their third VR training programme. This programme focuses on Health and Safety Orientation for new entrants to the sector. Often, these smaller businesses lack the internal specialist resources to design and deliver the full breadth of this training.

Specifically, this programme was created to support the indigenous businesses in the sector; although the content will also be applicable to the larger multinationals too.

The BioPharmaChem Skillnet team (l-r): Brendan Kellett, Learning & Development Project Adviser; Lorraine O’Toole, Project Lead; Breda O’Sullivan, Operations Lead; Susan Costello, Network Director; Aoife O’Reilly, Project Lead.

Sourcing operator level training The manner in which the BioPharmaChem Skillnet can respond to sector needs is demonstrated through the request by a network member business to source operator level training. Having been unable to source a programme that addressed the needs of the business amongst educational institutions and private

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Irish PharmaChem | Industry Buyers Guide 2024

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ENTERPRISE IRELAND

Ireland’s Life Sciences continue to grow The indigenous Life Sciences sector in Ireland continues to scale, writes Garrett Murray, Head of Life Sciences, Enterprise Ireland.

Despite the economic issues, geopolitical complexity and challenges facing businesses globally, Irish enterprises have scaled and have grown from strength to strength in every sector in recent years.

Companies supported by Enterprise Ireland in the wider indigenous Life Sciences sector, inclusive of biopharma and the chemicals sectors, last year posted gains in net job creation and export growth.

Employment increased in this portfolio of companies by over 10% in 2022 to over 11,000 across all regions of Ireland. Sales in the sector increased last year to over €4 billion, of which circa €3 billion were exports.

Over the period of our strategy, ‘Leading in a Changing World’ (2022-2024), we have continued to see world-class Irish companies achieve leading positions in global markets.

This success has been achieved by new High Potential Start-Ups (HPSUs), SMEs and large companies with the support and collaboration of many actors in our innovation and research eco-system.

It is not always recognised that the wider sector is not just made up of own product companies but that there are also many Irish companies contributing to the supply chains of those on the front-lines of drug discovery and production. This is true across services, equipment supply, facility construction and digital platforms. 2023 was a very busy and exciting time for the sector.

Commercialisation Enterprise Ireland operates a dedicated team of commercialisation specialists who work directly with ambitious research teams to assist in the generation of commercialisation opportunities in all sectors, including the Life Sciences sector. In the period 2019-2022, Enterprise Ireland has invested €60 million in 132 disruptive technologies and teams in our Research Performing Organisations via the Commercialisation Fund, priming the next wave of deep-tech start-ups.

Over 1,200 researchers are funded Irish PharmaChem | Industry Buyers Guide 2024

Garrett Murray, Head of Life Sciences, Enterprise Ireland. through R&I Commercialisation and Collaboration Supports per annum. Since 2007, Enterprise Ireland has supported almost 200 deep tech High Potential Start-Ups emerging from the Irish research system. Of these, around 80% received EI Commercialisation Funding.

This success at home has been replicated in the European context, with Ireland’s overall success with European Innovation Council Accelerator. Ireland is one of the strongest EU performers in Europe and Life Sciences spinouts feature disproportionately.

the Clinical Industry Liaison Office (CILO) at the National Clinical Trials Office (NCTO) is central to this agenda. This role is funded by Enterprise Ireland. The CILO supports entrepreneurs to navigate the clinical research landscape and the many supports available in Ireland.

Collaboration Enterprise Ireland continues to support the biopharma industry through our funding of the Pharmaceutical Manufacturing Technology Centre (PMTC). PMTC is focused on the delivery of high impact, industry relevant applied research solutions to critical process challenges within the pharmaceutical manufacturing sector.

Linking enterprise and the Irish health system is essential to our strategy. The role of

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ENTERPRISE IRELAND

Furthermore, since 2020, Enterprise Ireland has supported 47 Life Sciences Innovation Partner Programme (IPP) projects, with 55 companies and Research Performing Organisations (RPOs), with a total co-funding of €7.69 million, which represents an average €164K per project and €140K per company involved. This form of collaboration is complemented by the challenge-based Disruptive Technology Innovation Fund (DTIF); it has the objective of supporting enterprises in Ireland to collaborate in order to engage with and be prepared for challenges associated with new “disruptive technologies” that will have a transformative impact on the way we work and live in the future.

Innovators and entrepreneurs As we move into the last year of our current strategy, we will continue to prioritise working with established companies to innovate and scale and support innovative start-ups, with a particular focus on increasing the total number of High Potential Start-Ups in medtech and pharma.

Innovators and entrepreneurs are competing and excelling in terms of innovation, product and service development in Ireland. For example, Enterprise Irelandsupported Genicity recently won the Life Sciences Award at the 2023 Irish Times Innovation Awards. The company, led by Muhammad Yassin and Muneer Sawaied, has developed a cancer treatment platform to deliver a safe, affordable and off-the-shelf allogenic cell therapy.

European biopharma comes to Dublin Bio€quity is a key annual gathering of the corporate investment communities for the European Life Sciences Ecosystem. In May

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2023, it came to Dublin with more than 800 delegates from over 30 countries. Enterprise Ireland was a member of the Regional Host Committee, alongside others including Avectas, ICON, Fountain Healthcare Partners and Seroba. Hosting this event was a unique opportunity to showcase the depth and diversity of the biopharma sector in Ireland.

One Irish focused session featured six spinouts, including Probmet, LEP Biomedical, Renovate Pharma, Vzarii Therapeutics and AilseVax. The Trinity College Dublin (TCD) spin-out Parvalis Tx, focused on drug discovery, funded by Lightstone Ventures, Atlantic Bridge and Enterprise Ireland, also presented to the international audience.

Also, at Bio€quity, Mary Martin, Chair of Avectas, led a panel discussion entitled, ‘Spolight on Irish Biotech’. In this session, key Irish stakeholders, including Mark Barrett of APC, Daniel Crowley of Remedy Biologics and Therese Kinsella of ATXA, discussed the Irish ecosystem and debated how to further accelerate the growth of Irish biotech.

Bio€quity was a key highlight for the sector in 2023.

and the implementation of the European Union Chemicals Strategy for Sustainability: Towards a Toxic Free Environment. It will be important that enterprise continues to input into these processes to ensure we enhance our regulatory frameworks, ensuring we have an appropriate, and competitive set of regulations that support innovation, while having the patient and the citizen at the centre.

The more we work together as stakeholders the greater the impact that can be achieved in terms of the number of successful HPSUs, the success of our established companies, economic growth and enhanced outcomes for patients.

What comes next As we move into the last year of Enterprise Ireland’s strategy ‘Leading in a Changing World’ (2022-2024), it is a time to reflect and think about what comes next. The sector has much to celebrate and continues to scale, despite the challenge around early-stage funding. We continue to live through a period of uncertainty and change.

Amongst other things, the regulatory environment is shifting with the implementation of the European Union Pharmaceutical Strategy and the related reform of the EU pharmaceutical legislation Irish PharmaChem | Industry Buyers Guide 2024

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Micro-Bio’s cGMP, multi-compendial products include: cGMP Sodium Hydroxide Hydrochloric Acid Sodium Hypochlorite Sodium Chloride Solutions Customised blends If you would like more information, please contact any of the following: Peter McNamara, Managing Director Tom Tobin, Sales Director Denis O’Brien, Technical Director

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SCIENCE FOUNDATION IRELAND AWARDS

Some of Ireland’s most outstanding researchers were recognised at the 2023 Science Foundation Ireland Awards, with a broad range of categories honouring research excellence.

The winners of the Science Foundation Ireland (SFI) Awards for 2023 were announced recently at the Research Summit, a joint Summit hosted by SFI and the Irish Research Council (IRC).

“Through their innovation, creativity and tireless work, these researchers have striven to improve the world around them,” noted Professor Philip Nolan, Director General, Science Foundation Ireland. “SFI is delighted to recognise their efforts and achievements with these prestigious accolades. I want to offer my sincere congratulations to all the award recipients.”

Professor Nolan singled out the winner of the 2023 SFI Researcher of the Year, Professor Paul Ross from University College Cork, for special mention: “Paul Ross has been an outstanding researcher in the field of food health and gut health for many years, both in previous roles and in his current position as Director of the SFI Research Centre APC Microbiome Ireland.”

The SFI Awards featured 10 categories, including an inaugural award for Supporting Green Transition.

SFI Researcher of the Year 2023 Recipient: Professor Paul Ross, University College Cork Professor Paul Ross is Director of APC Microbiome Ireland since 2019.

He is a widely recognised researcher who has received international acclaim for research on antibacterial compounds. He is a current European Research Council (ERC) Advanced Awardee. His research is in the field of food microbiology, with a focus on physiology and genetics of LAB and their applications in food and pharma.

Commenting on receiving the award, Professor Ross stated: “I am truly honoured and humbled to receive this prestigious research award; it is great acknowledgement of the significance of microbiome research as we are about to celebrate our landmark 20th year here at APC. For me, it’s always about the people. I have been just so fortunate to have worked with really brilliant scientists down through the years – great collaborators, researchers and students – and it is really on their behalf that I accept this award.

Rewarding excellence in research the trillions of bacteria that live in our gut. Our research strives to find microbiome-based solutions to address some of the grand challenges society is facing right now. One example is the build-up of antimicrobial resistance in harmful bacteria; to this end, our lab has had some success in finding antibiotic alternatives. There is huge excitement in our ranks, as we can see that we are at the precipice for what microbes and microbiomes can offer in this huge challenge.

Our lab is currently working on a €2.5 million European Research Council project exploring the potential for naturally occurring antimicrobial peptide, specifically bacteriocins, for the development of new therapies to tackle infectious disease.”

SFI Early Career Researcher of the Year 2023 Recipient: Dr Sarah Guerin, University of Limerick Dr Guerin is a lecturer in the Department of Physics and a member of the SSPC Research Centre, University of Limerick. Her research focuses on modelling and growing crystals for use in areas such as eco-friendly sensing and pharmaceuticals. Dr Guerin’s research has led to significant breakthroughs with potential for use in medical implants and drug delivery devices.

“I have always been fascinated by the microbial world in which we live and depend on so much,” he continued.

“Most of this world is inhabited by diverse communities of microorganisms or microbiomes, as exemplified by SFI Researcher of the Year, Professor Paul Ross from University College Cork.

Irish PharmaChem | Industry Buyers Guide 2024

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SCIENCE FOUNDATION IRELAND AWARDS SFI Engaged Research of the Year Award 2023 Recipients: Professor Andy Way & the SignON project

Winner of the SFI Early Career Researcher of the Year 2023, Dr Sarah Guerin, researcher at the SSPC SFI Research Centre based at University Limerick, pictured with Professor Philip Nolan, Director General, Science Foundation Ireland, and Professor Norelee Kennedy, Vice President Research at University Limerick.

SFI Commercialisation Award 2023 Recipient: Professor Steve Kerrigan, RCSI University of Medicine and Health Sciences Professor Steve Kerrigan is the Deputy Head of the School of Pharmacy in RCSI University of Medicine and Health Sciences.

In 2021, Professor Kerrigan founded Inthelia Therapeutics, a spin-out, clinical-stage pharmaceutical company which aims to develop personalised therapeutic approaches to treat patients with sepsis. Sepsis is the leading cause of death worldwide, causing over 15 million deaths globally per year.

SFI Best International Engagement Award 2023 Recipient: Professor Edward Curry, University of Galway Professor Edward Curry is the Established Professor of Data Science and Director of the Insight SFI Research Centre for Data Analytics, University of Galway. Along with his research activities, Professor Curry has shown leadership in developing the European Date and AI Ecosystem. He was a key architect in designing and creating two triple-helix European Partnerships between industry, research/ academia and the European Commission on Big Data and AI, Data and Robotics, providing the roadmap for the EU over the last decade.

SFI Outstanding Contribution to STEM Communication Award 2023 Recipient: MTU Blackrock Castle Observatory Munster Technological University’s (MTU) Blackrock Castle Observatory has been championing scientific literacy, communicating STEM through the inspirational themes of astronomy and space for 16 years. Over that time, more than 1.3 million people have visited BCO.

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SFI Award for Supporting Green Transition 2023 Recipient: Dr Una Fitzgerald, University of Galway Dr Una Fitzgerald, School of Natural Science, University of Galway and an Investigator in CÚRAM, the SFI Research Centre for Medical Devices, is a leading voice in the national movement of ‘greening’ research laboratories, and her laboratory was the first in Europe to be Green Lab-certified. She also led the Galway Green Labs initiative and is the chairperson for Irish Green Labs, a network of Irish labs that share case studies and best practice in lab sustainability.

SFI Industry Partnership Award 2023 Recipient: Professor Frank Peters, IPIC, in partnership with Rockley Photonics, University College Cork & Tyndall National Institute

The SignON project aims to bridge the communication gap between Deaf, Hard of Hearing (DHH) and hearing people. The project focuses on development of the SignON communication service that uses machine translation to translate between Sign and spoken languages. It represents a shift in the field of sign language technologies, offering an inclusive, cocreated and ethically responsible solution to the historical challenge of communication between signers and non-signers. Its innovative approach ensures that DHH communities are not just subjects of, but also active participants in the research and development process. This project is based in the ADAPT SFI Research Centre for AIdriven Digital Content Technology and led

by Professor Andy Way. SFI Research Image of the Year Award 2023 Image title: I C You Recipient: Elin Strachan, PhD student, University College Dublin The winning image displays the head, and specifically the eye, of a five-day-old zebrafish larva. The blue stain shows the cell nuclei, whilst the green labelling are the mitochondria within the animal’s optic nerve, which relays information from the eye to the brain. In this lab, fish are used to better understand inherited diseases of the eye, due to how well developed the visual system is in such early stages of fish development and how closely their eyes resemble our own.

Professor Frank Peters has over 30 years’ experience in photonic research, including 12 years in industry, filing more than 80 patents. He has been part of three start-ups, including, most recently, Rockley Photonics and the creation of the Irish research division of Rockley.

SFI Mentorship Award 2023 Recipient: Professor Anne Marie Healy, Trinity College Dublin Professor Anne Marie Healy, School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, is a founding member and co-PI in SSPC - The SFI Research Centre for Pharmaceuticals. Professor Healy is one of the Co-Directors of the Centre for Doctoral Training in Transformative Pharmaceutical Technologies, run in partnership between SSPC, University College London and the University of Nottingham. She has graduated 23 PhD students and mentored 27 postdoctoral researchers.

Professor Anne Marie Healy, winner of the SFI Mentorship Award 2023 , from the School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, and one of the CoDirectors of the Centre for Doctoral Training in Transformative Pharmaceutical Technologies, is pictured with Professor Philip Nolan, Director General, Science Foundation Ireland.

Irish PharmaChem | Industry Buyers Guide 2024

LOGISTICS: KUEHNE+NAGEL

HealthChain: cutting-edge healthcare logistics Kuehne+Nagel’s HealthChain helps to set the gold standard in healthcare logistics.

The pharmaceutical industry in Ireland is booming: more and more oncology-related products and biopharmaceuticals are being developed. New challenges must be met when transporting these complex products.

Continuous cold chain and door-to-door visibility are essential to ensure that product integrity remains intact. For some cell and gene therapies, you need to go directly to the patient, collect their blood, ship the blood to the laboratory or the manufacturing environment, where the blood is manipulated to add the therapy, before being shipped back to the patient. This process, also known as veinto-vein, is truly circular. Success is dependent on meticulous attention to quality when shipping these therapies.

To meet this need for enhanced quality, at the beginning of this year, Kuehne+Nagel launched HealthChain, their very own quality label, providing you with cutting-edge healthcare logistics services built on, and exceeding, industry leading GxP standards.

Every one of the 250+ HealthChain certified locations in their network, spanning over 60 countries, operate to the same high standards, delivering your products to over 95% of the world’s population, prioritising product integrity and sustainable practices at every turn.

But quality is not everything; working hand-in-hand with QuickStat, a Kuehne+Nagel company, they recognise that in the dynamic world of healthcare, every second counts.

When it comes to new drugs, therapies or medical devices, reducing the time it takes for a new product to reach the market can be the difference between life and death for patients.

How can you achieve this acceleration? By partnering with a logistics service provider early in the product development phase of the product life cycle to ensure that when a product is ready for launch, all the systems are in place.

Transparency and continuous communication Despite uncertainties during the clinical stages, transparency and continuous communication enable a logistics service provider, which has been involved early in the R&D phase, to plan a successful supply chain that adapts to changing needs. For example, QuickStat plays an important role in the R&D phase of a product’s life cycle, supporting clinical trials by providing reliable transportation for trial supplies, ensuring that the right materials reach the right place as the right time. Once the product under investigation has been approved, the

Kuehne+Nagel help to support the entire product life cycle.

Irish PharmaChem | Industry Buyers Guide 2024

Seamus Keane, National Business Development Manager, Kuehne+Nagel. seamless cooperation between QuickStat and Kuehne+Nagel means that they are ready to step in at product launch and assist in creating efficient supply chains, designed to manage the distribution of the product throughout the market, adapting the logistics needs as they evolve.

Agile and evolving capabilities “In a sector filled with uncertainties, agility is paramount,” noted Seamus Keane, National Business Development Manager, Kuehne+Nagel. “We have honed our capabilities and remain responsive to change, working closely with healthcare companies to manage any evolving scenarios. As your product moves from product launch to market growth and finally into decline, we’re here for you, supporting you at each stage, creating efficient supply chains and managing the distribution of your product, adapting, and reducing costs for you and your patients.

Contact Kuehne+Nagel to discuss how we can support you across the full product life cycle.”

For more information, visit: ie.kuehne-nagel.com.

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Co. Dublin Dublin --Ireland Ireland Co.Co. Dublin -Supply, Ireland • • Supply, installation installation & & commissioning commissioning • Supply, installation & commissioning Cookstown, Cookstown, Tallaght, Tallaght, Dublin Dublin 24 Cookstown, Tallaght, Dublin 2424 • Site Site survey survey & & system system recommendation recommendation • Site survey & system recommendation Unit Unit 26, Cookstown Cookstown Industrial Industrial Estate Estate Unit 26,26, Cookstown Industrial Estate Tel (+353) 01 405 6777 Tel 01 01 405 405 6777 6777 TelTel 01Project 405 6777 Co. Dublin Dublin ‐‐Ireland Ireland Co.Co. Dublin ‐ Ireland ••Supply, Project management management •(+353) Project management •(+353) Supply, installation installation & commissioning commissioning •(+353) Supply, installation && commissioning Cookstown, Cookstown, Tallaght, Tallaght, Dublin Dublin 24 Cookstown, Tallaght, Dublin 2424 Fax (+353) 0101 413 6932 Fax (+353) (+353) 01 4136932 4136932 Cross Technical Solutions Ltd. FaxFax (+353) 01 4136932 Tel (+353) (+353) 01 01 405 405 6777 6777 TelTel (+353) 01 405 6777 • • Energy Energy Saving Saving Packages Packages • Energy Saving Packages Co. Co. Dublin Dublin ‐ ‐ Ireland Ireland Co. Dublin ‐ Ireland Project Project management management • ••Project management PRODUCTS & SERVICES jmcgrath@ctsolutions.org jmcgrath@crosstechnicalsolutions.ie jmcgrath@crosstechnicalsolutions.ie Broomhill Road, jmcgrath@crosstechnicalsolutions.ie Fax (+353) (+353) 01 4136932 4136932 FaxFax (+353) 0101 4136932 Cross Technical Ltd. QUALITY ••9/10 Monitoring Monitoring Systems Systems ••Energy Monitoring Systems Tel (+353) (+353) 01 01 405 405 6777 6777 TelTel (+353) 01Solutions 405 6777 • Energy Energy Saving Saving Packages Packages • Saving Packages PRODUCTS & SERVICES www.crosstechnicalsolutions.ie www.crosstechnicalsolutions.ie Tallaght, 24 www.crosstechnicalsolutions.ie • Dublin Site survey & system recommendation sales@crosstechnicalsolutions.ie sales@crosstechnicalsolutions.ie sales@crosstechnicalsolutions.ie NSAI Certified www.crosstechnicalsolutions.ie Unit 26, Cookstown Industrial Estate Cross Technical Solutions ••Plant Plant Plant service service and and maintenance maintenance service and maintenance Fax Fax (+353) (+353) 01 4136932 4136932 Ltd. Fax (+353) 0101 4136932 Monitoring Monitoring Systems Systems • •••Monitoring Co. - Systems Ireland www.crosstechnicalsolutions.ie www.crosstechnicalsolutions.ie www.crosstechnicalsolutions.ie • Site Supply, installation Cookstown, Tallaght,Industrial Dublin 24 Estate •Dublin survey & system& commissioning recommendation Unit 26, Cookstown sales@crosstechnicalsolutions.ie sales@crosstechnicalsolutions.ie sales@crosstechnicalsolutions.ie Tel 01 405 6777 Co. Dublin ‐ Ireland Plant Plant service and and maintenance maintenance • ••Plant service and maintenance •service Project management •(+353) Supply, installation & commissioning Cookstown, Tallaght, Dublin 24 www.crosstechnicalsolutions.ie www.crosstechnicalsolutions.ie www.crosstechnicalsolutions.ie Fax (+353) 01 4136932 Tel (+353)Co. 01 405 6777 • Energy Saving Packages Dublin ‐ Ireland • Project management PharmaChem | Industry Buyers Guide 2024 82 jmcgrath@crosstechnicalsolutions.ie FaxIrish (+353) 01 4136932 • Monitoring Systems Tel (+353) 01 405 6777 • Energy Saving Packages www.crosstechnicalsolutions.ie sales@crosstechnicalsolutions.ie • Plant service and maintenance Fax (+353) 01 4136932 • Monitoring Systems ISO 9001:2015

ABBVIE

AbbVie invests €23 million in North Dublin hub AbbVie’s new state-of-the-art European services hub in Clonshaugh, North Dublin, supports manufacturing plants and company operations in Ireland and across the continent.

AbbVie recently opened a new €23 million European services hub in Clonshaugh, North Dublin, the latest Irish investment from the global research-driven biopharmaceutical company, who already have a significant presence across six Irish locations.

The new state-of-the-art facility spans two sites within the IDA Business Park in Clonshaugh and serves as an international base for a range of supply chain, manufacturing and engineering services, supporting AbbVie’s global network.

The creation of the new hub, which will support Irish manufacturing plants and company operations in other European countries (including Germany, Italy and the Netherlands), is the latest confirmation of Ireland’s strategic importance within AbbVie’s footprint.

The company’s manufacturing presence in Ireland dates back to 1974 and now includes significant operations at six separate Irish locations in Cork, Sligo, Mayo and Dublin.

The expanded Clonshaugh site, which celebrates its 30th anniversary this year, now employs close to 400 people.

AbbVie, which was formed in 2013 following a separation from Abbott, has consistently and significantly invested in Ireland over the course of the past 11 years.

Activities have included the acquisition of Allergan and its significant Irish operations in 2020. The Clonshaugh opening follows a €60 million investment in Cork in 2022 and brings total AbbVie investments in Ireland over the past 11 years to more than €430 million.

Longstanding partnership with Irish Government “Ireland plays a critical role in supporting AbbVie’s international operations and I was delighted to join Minister Coveney, IDA leadership and AbbVie employees to officially open our redeveloped site in Clonshaugh,” noted Azita Saleki-Gerhardt, AbbVie EVP, Chief Operations Officer, at the official opening of

Pictured at the official launch of AbbVie’s new €23 million European manufacturing services hub in North Dublin are (l-r): Marco Froehlich, Site Director, AbbVie; Azita Saleki-Gerhardt, Chief Operations Officer, AbbVie; Simon Coveney TD, Minister for Enterprise, Trade and Employment; and Michael Lohan, CEO, IDA Ireland.

Irish PharmaChem | Industry Buyers Guide 2024

the Clonshaugh site. “Today’s grand opening represents one of AbbVie’s many investments in its Ireland-based operations and a continuation of our longstanding partnership with the Irish government. Our new AbbVie North Dublin (AND) facility will be a key node in AbbVie’s global operations network, serving as a European hub, bringing together our Dublin-based supply chain, engineering, quality assurance and manufacturing teams for the first time.

“Built with our employees and the future in mind, AbbVie North Dublin features new, improved collaboration spaces and amenities designed to significantly elevate our employees’ experiences and make this facility a great place to work for many years to come.”

Vote of confidence in Ireland Minister for Enterprise, Trade and Employment, Simon Coveney TD, said, “As a European hub, it serves as an enormous vote of confidence in the region – and the talent, skills and experience Ireland has to offer.

Manufacturing innovation and expertise is the foundation on which Ireland’s thriving health and Life Sciences sector is built on.

That’s shown in the continued investment in manufacturing facilities across the sector.

It’s also demonstrated by AbbVie’s ability to deliver international manufacturing services from North Dublin. Congratulations to the team involved and the very best of luck.”

CEO of IDA Ireland, Michael Lohan, described the opening of this new European Services hub as “a wonderful addition to the six locations across Ireland that AbbVie currently operate in. This is a continued endorsement in Ireland as a strategic location for biopharmaceutical investment and one we are very proud of. This new hub will place Ireland at the centre of the European supply chain. Since AbbVie arrived in Ireland in 1974, the country has continued to grow as a global hub for Life Sciences and be at the forefront of innovation.

IDA is delighted to be a longstanding partner with AbbVie now and into the future.”

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AUTOMATION AND ROBOTICS

Horan: masters of automation Horan Automation and Robotics are a local, family-owned business which was established in Cashel, County Tipperary, in 1996. Initially employing four people, their team has grown steadily to meet the demands of their developing client base. Today, the business employs a highly skilled team of 11 staff, including nine engineers across robotics, mechatronics, electrical, mechanical, design and software development. Their core business is the design, integration and commissioning of precision engineered bespoke solutions for the Irish manufacturing sector. For almost 30 years, they have proudly supported Irish industry across the dairy, food and beverage, automotive, medtech and pharma sectors, amongst others.

Leading global partnerships In 2020, as a part of their ongoing innovation programme, Horan Automation and Robotics evolved their product and service offering, leading to the development of a series of successful partnerships with global brands such as Fanuc Robotics, Global AGV, Robos Logistic Systems and Intecro robotic welding systems, while building on existing relationships with long established key partners such as Carlow Toolmaking Services, Keyence Vision and Horan’s own contract manufacturing agency, Hualian Machinery China.

“The development and deepening of these partnerships have given us a unique, innovation-based leading edge over many of the other integrators in the market today,” notes Gary Monks, Sales & Marketing Director. “Our 24-7 service team provides peace of mind and rapid action to ensure operational uptime is maximised.”

Favourable return on investment Changing dynamics in pharma and medtech in Ireland have led more and more companies to take a closer look at automation. Whether process driven or not, every business has its vulnerabilities. Ultimately, a key deciding factor in a lot of projects tends to be cost, but the ROI metrics are often far more favourable than might first be thought. In the past three years, Horan Automation and Robotics have successfully delivered several high value solutions to Ireland’s pharma, biorech and medtech sectors. These systems have ranged from sub component assembly, device assembly and checking, through to vision, validation, liquid dosing and capping, through to sterile area equipment upgrading. Automation has enabled their partners to maintain progress in a very fluid and often challenging market by removing the reliance on human operatives, all while increasing production throughput, accuracy and reducing defects and failures.

“We work with some of Ireland’s key businesses to design, specify and integrate systems and solutions which support their production, outputs and bottom-line profitability,” Monks stresses. “From assembly all the way through to palletising, Horan Automation and Robotics are your partners in automation.”

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Irish PharmaChem | Industry Buyers Guide 2024

IT SERVICES

Westbourne IT and Industry 5.0 Dennis Blanck, Business Development Manager, explains why Westbourne IT Global Solutions have the solutions and talent for your transformation journey.

What our clients have on their mind • “How to navigate the validation process for our upcoming product innovations?”

• “What can we do to implement digitalisation while ensuring GMP?” • “How do we ensure uptime while staying within budget?”

• “Where can we find qualified talent in light of changing FDA regulations?”

• “How can we maintain the integrity of our infrastructure while transitioning towards Industry 5.0?”

• “Who can train our team to ensure proficiency for HPLC and UPLC environments?”

These are just some of the questions that existing and potential clients come to us with.

The Westbourne portfolio • People and skillsets are at the core of our service portfolio.

• Your team will be enriched with our talent to deliver on projects short-, medium- and longterm.

• This includes compliance and validation topics for your laboratory, IT and Lab IT environment.

• We support your move towards simple digitisation and holistic digitalisation, based on your project and budget requirements.

• LIMS, CDS, CSV/CSA, data analytics, audits and surveys are just some examples of our expertise.

• We offer you the possibility to grow our talent in your organisation and have seen many individuals transition from entry-level IT technicians to Lab and Engineering Leads within our clients’ organisations.

• Additionally, we are able to add to your stack of applications through strategic partnerships with ticketing solutions, OS providers, cybersecurity and laboratory applications.

The “real” challenges However, with any enquiry we receive, it is not about the focus on what our solutions and talent can do. It is about the underlining challenges and requirements of our clients. Long-term partnerships with clients large and small Irish PharmaChem | Industry Buyers Guide 2024

have provided us insights into the changing infrastructure and project focus that especially clients in the Life Sciences sector have.

The EU framework that showcases Industry 5.0 translates more and more into Pharma 5.0 and eventually into Lab and Manufacturing 5.0. Topping the list of priorities is talent and how the industry can nurture the new generation of digital natives to navigate both an OT and IT environment. At the same time, we need to ensure that existing talent can be developed holistically to grow their own careers and be long-term contributors.

The specific landscape of Life Sciences In an industry that is both highly regulated as well as budget conscious, it is more often than not about expectation management and navigating both regulators / industry bodies, as well as the market.

Response times are critical Over the last three decades and with a Life Science focus for seven years, we have taken on an approach of flexibility when it comes to cost, project duration, solution requirements and talent mobility.

As an SME-sized partner, our team can react faster to changing priorities, new clients KPIs/SLAs and project outcomes.

Scalability is key

Validation via our PM and CSV resource reduced validation cost by 50%.

Biopharma client: CDS software uptime improved to support 24/7/365 operation via user roles, upgrades and back-up procedure.

Global manufacturing client: Over 99% SLA compliance for service desk tickets during a 12-month period including significant off- and onboarding event.

Global biopharma client: Strategic long-term staffing with Lab personnel to support growth and expansion phase.

Global chemical manufacturing client: Document Management and Workflow Automation via SaaS solution to consolidate data repositories, unlock data enrichment and improve analytics across business units.

If the above resonates with you, feel free to reach out to us at dennis.blanck@westbourneit.com or visit our website: https://westbourneit.com.

Westbourne IT, Rubicon Centre, MTU, Bishopstown, Cork, T12 Y275 About the author: Dennis Blanck is the Business Development Manager for Westbourne IT Global Solutions.

By showcasing that we can provide a service and solution portfolio to global organisations across multiple countries, we have risen to the challenge of scalability.

What does success look like?

The key question for our clients which is not always visible inside an RFP/RFQ document because it has a different meaning for the individuals involved.

Expectations can be vastly different between for example a Head of Quality, Head of Procurement and CIO. This is where we use flexibility and expertise to mitigate and be a resourceful partner.

Eventually, no matter what success looks like for you, it is a combined effort.

Recent client success stories Global biopharma client: CDS and LIMS software

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ELI LILLY

Sustainable manufacturing: the wave of the future

Eli Lilly is leading the way on sustainable manufacturing, with a whole-of-company approach delivering real results.

Sustainability is a key issue for the pharma sector and a journey that Eli Lilly and Company has been on since arriving in Ireland in 1978. With Government ambitions to achieve a 51% reduction in emissions by 2030 and carbon neutrality by 2050, the race is on for businesses in this industry to stay on target.

Eli Lilly and Company (Lilly), founded in 1876, is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. Today, with over 40,000 employees globally, and over 3,000 of those in Ireland, the company remains committed to making life better and doing so in a sustainable manner.

As the organisation grows its footprint in Ireland (earlier this year, they broke ground at Lilly Limerick, a Next Generation Biotech drug substance facility, and Lilly’s most technically advanced manufacturing site to date), it has never been more important to keep sustainability front and centre of development plans.

Key areas for sustainability efforts Lilly Kinsale has identified five key areas for sustainability efforts, with measurable deliverables in each area to stay on track. Gerard O’Shea, Director for Health, Safety and Environment at Kinsale, shared plastic waste reduction as an example: “Our employees are passionate about sustainability. They’ve spearheaded a plastic recycling initiative to repurpose recycled plastic into a raw material used for garden benches and planters. In the last 12 months, we have diverted a significant proportion of what would otherwise be waste plastic to make 570 garden benches and planters. It’s a real testament to the commitment of the team.”

Sustainable travel is another focus, and the company has put a lot of effort into finding alternative ways get people to work, instead of bringing cars. In early 2023, Lilly Kinsale introduced a bus service travelling to the rural site from Cork City, which has been so successful, they recently launched a second route.

Reducing energy usage is also a top priority. Paul O’Sullivan, Utilities Engineer at Lilly Kinsale, says, “Adjacent to our Kinsale site, we have one of Ireland’s largest solar farms, which can provide about 15% of the site’s electricity per annum. On a sunny day, the solar farm can generate about

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4.5MW, which is over 60% of the site’s daily demand.”

Sustainability is a priority for Lilly Limerick, and because it is a greenfield site, sustainability has been placed at the core of the entire campus design. Compared to a traditional pharma site, Lilly Limerick will have 35% lower energy intensity, use 40% less water and have 15% less waste.

The decarbonisation challenge Looking forward, Paul feels decarbonisation will be the next major challenge for the manufacturing industry: “Decarbonisation needs capital investment, and it requires replacing established technologies with low-carbon technologies.”

Gerard believes that everyone needs to play their part in making small efforts to become more sustainable. “Lilly has always looked at sustainability with a ‘continuous improvement’ focus,” he concludes. “If we continue to move that dial with a view to the future, and what it’s going to be like to manufacture in Ireland in 2030 or 2035, we’re on the right track. Once that spirit of continuous improvement is alive and well, I think we are in good shape.”

Pictured at the launch of Eli Lilly’s solar farm at Dunderrow, Co. Cork, are then Taoiseach, Micheál Martin TD, and David A. Ricks, Lilly’s Chairman and CEO. Irish PharmaChem | Industry Buyers Guide 2024

Ground Breaking Science.

Life Changing Medicine.

Find your place at Lilly

careers.lilly.com

Manufacturing Campus Kinsale, Co. Cork Global Business Solutions Centre Little Island, Co. Cork Manufacturing Campus Raheen, Co. Limerick Irish PharmaChem | Industry Buyers Guide 2024

Copyright © 2023 Eli Lilly and Company.

All rights reserved

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CHEMICAL SOLUTIONS/TECHNICAL SERVICES

Chemifloc: chemical solutions for industry The Chemifloc Group is a wholly Irish-owned company, dedicated to the supply of chemical solutions to industry. Water and wastewater treatment solutions are provided via its Chemifloc and Chemilab operations and industrial bulk chemical solutions via its GI Chemicals DAC operation.

Established 40 years ago, the Chemifloc Group has evolved from a water treatment chemical provider with five staff members to a highly experienced chemical solutions provider with over 70 personnel. Key to the company’s growth has been its staff, whose work ethic, safety culture and commitment has enabled expansion and new product offerings as needed to serve industry today.

The company is fully compliant with all Health and Safety, Environmental and Quality standards currently in place and, to this end, maintains all relevant ISO certifications for its business, including ISO 9001, ISO 14001 and ISO 45001.

The Group has facilities in both Shannon and Foynes Port. Both facilities continue to evolve, with an extensive capital programme of projects seeing over €10 million invested during the last four years in the automation of processes and increased storage capacities, as well as expanding and advancing its capability to continue to provide a safe working environment and meet the sustainability challenges of the future.

Logistics is also key to the success of Chemifloc Group. Investment in its fleet and drivers ensures the company can provide an excellent service to its customer base. With a dedicated tanker and rigid truck fleet, prompt deliveries to customers are guaranteed.

Chemilab (Analytical Services)

Chemilab provides technical expertise to support Chemifloc in the manufacture of chemical solutions that facilitate the delivery of potable drinking water to homes and businesses and enables wastewater to meet the stringent environmental standards in force today. Chemilab, with INAB accreditation for specific test criteria, can also provide services to enable continuous optimisation of current processes and have the capability to provide support services for Research and Development projects for the future.

Chemical solutions Chemifloc manufactures a full range of chemical solutions for the water and wastewater treatment process, including the following applications:

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Chemifloc Group provides specialist chemical solutions and technical services for multiple applications and use in industry.

• Coagulation/Flocculation - Aluminium Sulphate solutions (ALUM) - Polyaluminium Chloride (PACL) - Ferric Sulphate - Ferric Chloride - Ferric Aluminium Sulphate • Disinfection - Sodium Chlorite - Sodium Hypochlorite solutions • PH Correction - Sodium Hydroxide solutions - Sulphuric Acid Solutions • Odour and Septicity - Ferric Nitrate - Sodium Nitrate - Calcium Nitrate

Polyelectrolytes and specialist chemical solutions In addition, Chemifloc offers a full range of Polyelectrolytes and specialist chemical solutions for the treatment of foaming, sludge bulking and nutrient problems. These solutions are supported by its Chemilabs operation to ensure they are correctly applied. Chemilabs offers a full range of

technical services to support its chemical solutions offerings, as well as a range of laboratory services for customers that include: • Chemical analysis of water and wastewater streams; • Biological analysis of water and wastewater streams; • Jar testing to aid flocculation solutions; • HPLC testing to determine detailed chemical compositions; • R&D projects.

Industrial bulk chemical solutions GI Chemicals focuses on the supply of industrial bulk chemical solutions in road tanker format to Irish industry. Industrial chemical solutions provided include: • Sodium Hydroxide solutions; • Sulphuric acid solutions; • Caustic potash solutions; • Hydrochloric acid solutions.

Chemical storage is in Foynes Port, with large inventories maintained and a fully ADR compliant fleet available to meet all customer needs. Chemical supply is by ship ex-Europe direct to Foynes Port, with contracts in place with large European suppliers to ensure the security of supply.

The Chemifloc Group has the capability to develop chemical solutions to meet customers’ specific requirements. The combination of manufacturing capability, industry knowledge and technical expertise allows the Chemifloc Group to innovate and react to customer requirements.

For more information, visit www.chemifloc.ie.

Irish PharmaChem | Industry Buyers Guide 2024

The Chemifloc Group Irelands largest indigenous Chemical Solution provider to the Water, Wastewater Treatment and Manufacturing Industries

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

Supplying to industry the following: Flocculent and Coagulant aids for water and waste treatment processes Odour and Septicity control chemicals Disinfection chemicals PH correction chemicals

• • • •

Contact us at: info@chemifloc.ie

Supplying to industry the following: Chemical analysis Microbiological analysis Jar testing HPLC testing of solutions

• • • •

Contact us at: info@chemilab.ie

Supplying to industry the following: Caustic Soda solutions Sulphuric Acid solutions Hydrochloric Acid solutions Caustic Potash solutions All bulk formats catered for all industry sectors

• • • • •

Contact us at: info@gichemicals.ie

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

Irish PharmaChem | Industry Buyers Guide 2024

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SK PHARMTECO

SK pharmteco

expands in Ireland SK pharmteco is investing in the future with increased investments across the globe, including Ireland.

SK pharmteco’s Dublin-based pharma plant celebrates six years operating as a CDMO this year, with an integrated facility combining manufacturing plants, R&D and QC laboratories within the same footprint. In this short period of the facility’s almost 60year history, it has grown significantly, and an investment for more growth is underway.

This project provides an increase in manufacturing capacity and capabilities for its global customer base. It includes a new manufacturing building, an increase of 24m3 reactor volume capacity, along with filtration/ drying equipment, additional manufacturing lines and associated utilities. The new building will occupy a decommissioned building onsite, close to the other site facilities.

“As we continue to innovate in our core technologies, our entrepreneurial spirit guides us to look for new services and capabilities to enhance our offering to our customers,” noted Joyce Fitzharris, President of SK pharmteco’s Ireland operations. “With substantial growth in our business base, this expansion supports the Ireland site position as a key contributor to SK pharmteco’s EU and worldwide business.”

A proven track record Through the implementation of strong safety policies and compliance with the high-quality and safety standards required of the industry, SK pharmteco has a proven track record as a reliable supplier of HPAPIs to multiple customers. For the last 30+ years, the Swords campus has maintained its leadership in the development, scale-up and commercial manufacture of highly potent chemical intermediates and APIs. Today, it offers multi-scale plants (from grams to 100s of kg) capable of handling materials with Occupational Exposure Limit (OEL) ≤10ng/m³.

SK pharmteco is strengthening the role of the facility as a Centre of Excellence for particle engineering, small scale spray drying, and commercial scale micronization through additional $10 million investment in equipment.

The Ireland facility is a focus for the company’s continued growth in Antibody

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Drug Conjugates (ADC) linkers and payloads.

This leverages the existing capability to handle highly potent molecules with the established track record of the SK pharmteco Korea site in supplying commercial quantities of the key linker units. Further investment is underway in Ireland to allow broad scale assembly of ADC backbones.

Analytical Services Launched in 2022, the SK pharmteco Ireland site’s Analytical Services offers a broad range of innovative technology that supports both method development and product release.

The head of Analytical Services at the SK pharmteco Swords site, Dr Matthew Webberley, said, “Our model is flexible to allow customers access to our leading analytical capabilities without a wider commitment.

With our talented team of analytical scientists and the latest cutting-edge equipment, including XRD, NMR, LC-QToF and GC-MS, it makes perfect sense to have Analytical Services in the heart of Europe to complement the SK pharmteco location and gives our customers a global solution.”

SK pharmteco also has capabilities in Cell and Gene Therapy, including sites in France and in the United States. The French and US sites serve as one-stop-shops for viral vector development and manufacturing for gene therapy, offering comprehensive services for Lentiviral (LV) manufacturing for bulk drug substances (up to 1,000 litres), as well

Joyce Fitzharris, President of SK pharmteco’s Ireland operations. as final fill and finish for drug products. This significantly increases the speed-to-market.

The location also inaugurated an additional €60 million biomanufacturing site, which is now the largest Cell and Gene Therapy CDMO in Europe. Located just outside Philadelphia in what is known as Cellicon Valley, due to the significant number of biopharma research centres and companies in the area, the US location serves as a single-site advanced therapies facility offering a range of services, including process development, analytical testing, plasmid DNA manufacturing, as well as viral vector and cell therapy manufacturing.

Like its sister company in France, the US location is making significant investments in expansion and new technologies to become the largest single-site CGT CDMO in terms of capacity and capabilities, all in response to the critical shortage of cell therapies.

As Joerg Ahlgrimm, CEO of SK pharmteco, succinctly summarised: “Our commitment is unwavering in creating diverse opportunities for sustained growth, positioning us as a leading company with global top-tier competitiveness across the spectrum, from small molecule APIs to biopharmaceuticals.”

The SK pharmteco plant in Swords, Co. Dublin.

Irish PharmaChem | Industry Buyers Guide 2024

Your End-to-End CDMO

Your partner in…

Cell & Gene Therapy

Linkers & Payloads

HPAPI

Analytical Services

Antibody

Payload

Linker

Continuous Processing

Chromatography Batch & SMB

Particle Engineering

Spray Drying & Micronisation

Safety First, Quality Always!

US | Korea | Ireland | France skpharmteco@sk.com www.skpharmteco.com Irish PharmaChem | Industry Buyers Guide 2024

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INSTRUMENTATION

Smart support from Endress+Hauser

Save time and costs throughout the life cycle of your measurement devices with remote technical support from Endress+Hauser.

Endress+Hauser technical support provides timely remote guidance on service operations that enables you to increase your expertise, to reduce diagnostics, troubleshooting and maintenance time and costs, and to improve your process availability.

Technical Support from Endress+Hauser can help you: • Decrease process downtimes and rapidly restore operations;

application expertise with their technical knowledge base; • Register for the Endress+Hauser Service Portal for free and access their database of products and applications 24/7.

Smart Support packages from Endress+Hauser

Smart Support, technical support packages from Endress+Hauser with guaranteed response times, can provide the necessary • Reduce maintenance staff efforts with help from experts who address technical remote technical support; inquiries about instruments and processes in a timely manner. In the event of an • Save time and cost of unplanned field incident or unexpected downtime, service visits and reduce instrument Endress+Hauser are available to get you back returns; up and running quickly. They can perform • Enhance your instrumentation and remote diagnostics, troubleshoot your instrumentation and guide you through service operations. They can also offer live video transmission or screen sharing for efficient support sessions whenever needed.

You get dedicated access to a growing knowledge base on Endress+Hauser instruments, applications and Smart Support from Endress+Hauser is available in different support plans service operations for immediate designed to keep your instruments operating at optimal performance.

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self-service or to improve your skills. You can create, update and manage your support cases and track service incidents online.

Endress+Hauser have customised service level agreements with guaranteed availability, response times and remote connectivity options, to best fit and accommodate your needs. Obtain the most value out of your instruments and processes to maximise your business outcomes.

Benefits of Smart Support Smart Support from Endress+Hauser is available in different support plans designed to keep your instruments operating at optimal performance.

Smart Support plans allow you to: • Benefit from remote support phone or online or even visual remote support; • Get immediate remedy information from the extensive knowledge base on Endress+Hauser instruments and applications; • Get the most from expert support guidance via live video transmission or remote screen sharing; • Track support performance and benefit from guaranteed availability and priority call-back; • Log service tickets via the online Service Portal.

If you would like to learn more about the different Smart Support Plans, please visit: https://eh.digital/44dGfdm Irish PharmaChem | Industry Buyers Guide 2024

We understand how important it is to find the right expertise for your industry application needs.

KNOWLEDGE + KNOW-HOW You are assured to get the best-fit products, solutions and services for your specific requirements.

150,000 customer queries per year, treated and solved globally

by Endress+Hauser technical support organization

With Smart Support, Endress+Hauser delivers the expertise you need remotely to resolve and prevent technical issues on your measurement instruments.

• Shorten unexpected downtimes • Decrease the effort on maintenance staff • Save costs of field service visits and device returns • Increase expertise on instrumentation and application

Do you want to learn more? www.eh.digital/3OfCY6r Irish PharmaChem | Industry Buyers Guide 2024

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RENEWABLE ENERGY

Astatine: pioneering renewable heat and power Astatine’s ground-breaking renewable heat and power solutions are helping their clients to reduce energy costs, carbon emissions and overall environmental impacts.

Astatine stands at the forefront of the renewable heat and power sector, delivering tailored, sustainable solutions for diverse industries such as pharmaceuticals and the beverage sector.

Astatine’s services include: • Feasibility: Astatine provides customised detailed engineering sizing and modelling services for industrial heat pumps, solar photovoltaic (PV) systems, thermal storage and batteries, to meet your unique requirements.

• Turnkey solutions: Astatine offers full turnkey project delivery, including detailed design, planning, grants, installation, commissioning and operation & maintenance.

• Optimisation: Conducting a comprehensive renewable energy assessment of your facility, Astatine can optimise energy assets, renewable energy generation, heat pumps, electrical and thermal energy storage to maximise carbon and financial saving; • Fully funded solution: Astatine offer a zero capex financed solution for all projects.

Unlocking enhanced efficiency By implementing Astatine’s solutions, you can expect: • 30% increase in heat pump efficiency: Astatine’s advanced engineering techniques result in a significant increase in efficiency, translating into substantial energy saving.

• Enhanced grant eligibility: Astatine’s high-efficiency industrial heat pumps can potentially make you eligible for increased grant funding, further reducing the upfront cost of your investment.

• Reduced carbon emissions: Astatine’s technology solutions directly target and reduce reported carbon emissions under scope 1,2, and 3 of the EU Emissions Trading System (ETS).

• Doubled net Present Value (NPV): The amalgamation of energy savings, grant incentives and reduced operating costs leads to a remarkable doubling of the project’s NPV, maximising your financial returns.

At Ahascragh Distillery, Astatine designed and installed the first heat pump in Ireland and the UK capable of surpassing 100°C.

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Astatine facilitated Medentech’s green energy transition, reducing their carbon footprint by 46,030kg CO2 per annum through 508 Solar PV Panels.

Astatine’s solutions transcend mere heating, cooling and energy production; they represent a commitment to sustainability, innovation and financial prudence. By embracing their technology, you can achieve a cleaner, more efficient future, while reaping significant economic benefits.

Benefits of renewable power The benefits of renewable power for industrial companies include: • Cost savings: By providing a significant source of on-site renewable energy, this technology reduces electricity bills, cutting costs up to 50%, with a typical payback period of three years.

• Environmental impact: Astatine’s renewable energy technologies help companies significantly reduce carbon emissions, contributing to environmental sustainability goals. It also enhances a company’s profile, making them more innovative and forward-looking.

• Long-term investment: Solar panels and heat pumps have a lifespan of over 15-20 years.

Proven track record Astatine have successfully delivered renewable energy projects for industrial companies. In the pharmaceuticals industry, Astatine facilitated Medentech’s green energy transition, reducing their carbon footprint by 46,030kg CO2 per annum through 508 Solar PV Panels. They also have recently partnered with Viatris to deliver solar PV generation at their Dublin facility.

In the beverage sector, Astatine design solar and heat pump solutions, including the first fossil fuel free distillery in Ireland and the UK, Ahascragh Distillery. This system provides them with 120°C of heat.

Astatine also have ongoing projects with clients including Coca-Cola, Java Republic, Carlow Brewing and Wicklow Wolf.

Astatine are devoted to helping industrials businesses achieve cost savings and environmental impact reductions. To discover how they can assist you on your journey to lower energy costs, carbon emissions and overall environmental impacts, visit www.astatine.ie or email info@astatine.ie.

Irish PharmaChem | Industry Buyers Guide 2024

ASTATINE, RENEWABLE HEAT & POWER SPECIALISTS, CUT ENERGY COSTS BY 50% WHILE REDUCING CARBON EMISSIONS

BY OVER 70% We offer turnkey heat pump and solar PV

costs and decrease onsite CO2 emissions.

CONTACT Irish PharmaChem | Industry Buyers Guide 2024

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CLEANROOM SOLUTIONS SERVICES & MAINTENANCE

Asgard: at the vanguard of Cleanroom Solutions Asgard Cleanroom Solutions cover a wide range of professional cleanroom services, from the routine maintenance of your facility to a bespoke designed service.

Maintaining cleanrooms and controlled environments requires special maintenance provisions with respect to environment, people, equipment and process. Asgard Cleanroom Solutions’ in-house training programme guarantees highly trained members of staff, who are efficient and fully trained in cleanroom services and disciplines. They operate to ISO9001: 2015 Quality Standard and are totally committed to the principles and practice of Occupational Health & Safety. They have attained OHSAS 45001:2018 & 18001:2007 (NSAI) for their Safety Management System.

Understanding the need for speed and efficiency, Asgard Cleanroom Solutions cover a wide range of professional cleanroom services, from the routine maintenance of your facility to a bespoke designed service, depending on your business needs, carried out by professionals, and backed up with invaluable experience and industry-specific qualifications.

Understanding your business With their scheduled maintenance service, Asgard Cleanroom Solutions’ team will take the time to understand the unique characteristics of your cleanroom facility, allowing for faster diagnosis and rapid repairs, keeping you compliant, operational, and reducing the loss of profit. Their service is supported by an extensive range of in-house stock at Asgard’s premises, guaranteeing you a rapid response with the right product solution. “We have the latest methodologies and equipment, allowing us to carry out our services efficiently and to high standards, resulting in time and cost savings,” noted Jimmy Blaney, VP / Director of Business Development and Marketing. “Due to our extensive experience, we can offer our customers a one-stop solution for getting your new cleanroom up to specification or upgrading your existing cleanroom to ever changing industry standards.

“At Asgard, we strive to be the most strategic, innovative and professional service partner in our industry. The safety of your workers and the undisrupted flow of goods and people is our number one priority. We

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pride ourselves on our bespoke service solutions that ensure you have a partner that truly understands your challenges.”

Comprehensive service Asgard’s services include: A full retrofit service: Retrofitting existing live areas within cleanrooms to bring them back to a GMP standard without disruption to existing facilities.

Emphasis on the upgrading of existing areas within cleanrooms / live areas: Bringing existing areas back to a higher finish, more in line with Annex 1.

Original spare parts: As the original equipment manufacturer, Asgard always use genuine spare parts to keep your entrance solutions in perfect condition.

Technical documentation: Asgard have defined procedures and specifications for servicing all your PPM requirements and provide you with the full overview.

Asgard Cleanroom Solutions’ team will take the time to understand the unique characteristics of your cleanroom facility, allowing for faster diagnosis and rapid repairs, keeping you compliant, operational, and reducing the loss of profit.

Service agreements: Keep track of costs and experience true peace of mind with service agreements, which are customised to suit your business.

Flexible service packages: Their variety of service packages allows for a high degree of flexibility and tailored solutions to fit your needs. All packages include safety, compliance and quality control checks.

Local compliance: Local rules and regulations vary and change over time. Asgard’s service checks and maintenance programmes always follow the latest developments.

Budgeting: They offer a full service, enabling you to plan and budget your costs on an annual basis, with no surprises.

Training: Asgard offer several courses and sessions at no charge to ensure your team’s full functionality.

PPM elements include: • Antistatic Heavy Duty Polyurethane Floor Finish; • Retro fitting cleanroom walls / ceilings; • Manual Doors / Automatic Swing doors (Fire & non fire rated); • Automatic & Rapid Roll Doors; • Fire rated roller shutters – Fire drop test (bi-annual); • Airtight Doors; • Area modifications; • Interlocking inspection / service / philosophy changes; • FFU’s, General & Emergency Lights; • Cleanroom service pass through inspections / service / replacement.

For more information, visit asgardcleanrooms.com.

Irish PharmaChem | Industry Buyers Guide 2024

Cleanroom & Controlled Environment Design & Build Solutions Understanding the need for speed and efficiency, Asgard Cleanroom Solutions cover a wide range of professional cleanroom services, from the routine maintenance of your facility to a bespoke designed service, depending on your business needs, carried out by professionals and backed up with invaluable experience and industry specific qualifications

Asgard Cleanroom Solutions’ team will take the time to understand the unique characteristics of your cleanroom facility, allowing for faster diagnosis and rapid repairs, keeping you compliant, operational and reducing the loss of profit.

At Asgard, we strive to be the most strategic, innovative and professional service partner in our industry. The safety of your workers and the undisrupted flow of goods and people is our number one priority. We pride ourselves on our bespoke service solutions that ensure you have a partner that truly understands your challenges.

Contact us for more information: www.asgardcleanrooms.com Irish PharmaChem | Industry Buyers Guide 2024

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ANALYTICAL TESTING

Almac: your partner for analytical testing

Almac employs approximately 200 highly skilled analysts, working in GMP environments across the UK, Europe and US, with significant experience in the analysis of both small and large molecules. Their technical expertise, combined with a wide range of advanced analytical instrumentation, delivers fast and reliable results.

Almac’s laboratories are fully certified by appropriate authorities (FDA, MHRA, HPRA) and offer a full suite of analytical testing for a range of different product types, including small molecules, peptides, biologics, conjugates, highly potent and controlled substances.

Method development & validation Developing and validating over 400 drug substances and drug product methods each year, Almac has considerable experience which, coupled with advanced instrumentation, enables the development and validation of efficient, accurate, reliable and robust analytical methods. Almac’s scientists have acquired years of experience, working across many types of products, methods and analytical technologies to ensure a successful outcome.

Drug product release testing Almac’s extensive expertise in performing release testing includes API, drug product, medical devices and biologics, and provision is in place to handle highly potent and controlled substances. Almac has an extensive library of in-house methods, and significant experience working with pharmacopeial methods. They

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Almac’s state-of-the-art analytical testing labs support drug substance (API) and drug product (finished product) analytics across all phases of clinical development and into commercial release. routinely work on NCEs and set specifications in line with ICH guidelines.

Spectroscopy With a wide range of sophisticated MS and NMR instruments, Almac provides method development and validation of methods for identification of unknowns, bioanalysis, genotoxic impurities, elemental impurities and other requirements.

Almac’s scientists are highly experienced in the development of high-quality assays using state-of-the-art LC-MS/MS technology which incorporates the automated reporting of data. They excel in the development and validation of routine and non-routine methods in a very wide range of matrices and apply these methods in a GMP compliant environment.

Stability testing Almac’s UK, European and US state-ofthe-art, walk-in stability chambers provide 300m3 of ICH-compliant, climatic storage facilities to satisfy all requirements. Their dedicated team supervises over 350 stability programmes. From early phase material to validation and commercial batches, all conditions are continually monitored and employ back-up systems to ensure a secure and controlled environment.

Analytical solutions for biologics Almac offers a diverse suite of analytical methods with applications across the biologic development space, with extensive experience in the analysis of drug substance, drug product and reference material from pre-clinical phase through to commercial manufacture for: • Monoclonal • Biosimilars and antibodies and biobetters mAb-like molecules • Recombinant • Antibody drug proteins conjugates • Long peptides Key offerings: • State-of-the-art analytical methods to thoroughly assess and characterise critical quality attributes; • Science-driven analytical data and characterisation packages for demonstration of biosimilarity and establishing totality-of-evidence; • Phase-appropriate lifecycle approach to analytics for method development, optimisation and validation; • Release and stability testing to support clients’ successful product launch in regulated markets, including FDA, EMA and PMDA; • Global cGMP quality systems to support clinical and commercial biologics.

For more information, visit almacgroup.com.

Irish PharmaChem | Industry Buyers Guide 2024

Irish PharmaChem | Industry Buyers Guide 2024

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ROBOTICS

Rise of the Robots Robotics and automation have emerged as indispensable tools, empowering manufacturers within the cleanroom and pharmaceutical industries.

Robotics and automation are cutting-edge technologies which deliver a multitude of advantages, such as heightened efficiency, improved quality control, and enhanced safety measures. In this context, here are some key ways in which robotics and automation are reshaping these critical sectors: 1. Improved efficiency: Increased production rates: Robots and automated systems can work around the clock without fatigue or breaks, leading to higher production rates and reduced cycle times.

Streamlined workflows: Automation can assist in the optimisation of manufacturing processes, minimising downtime and delays in cleanroom and pharmaceutical operations, a key attribute when spikes in demand and seasonal trends impact throughput.

Precision and consistency: Robots can perform tasks with high precision and consistency, reducing errors, waste and avoiding costly product recalls.

2. Enhanced quality control: Reduced human error: Automation minimises the risk of human error in tasks such as drug formulation, packaging and quality control, leading to higher product quality and customer trust.

Data monitoring: Automated systems can continuously monitor and collect data on

In the cleanroom and pharmaceutical industries, robotics and automation offer a multitude of advantages.

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manufacturing processes, enabling real-time quality control and immediate response to deviations.

3. Contamination control in cleanrooms: Reduced contamination risk: Robots can operate in cleanroom environments with minimal human intervention, reducing the risk of contamination from human skin cells, particles or microbes.

Aseptic handling: Automated systems can handle sterile materials, drugs and equipment with aseptic techniques to maintain product integrity.

4. Flexibility and scalability: Easily reconfigurable: Robotic systems and automation can be reprogrammed or reconfigured for different tasks and products, making them adaptable to changing manufacturing needs.

Scalability: Manufacturers can scale production up or down more easily and cost-effectively with the use of automation, to align with changing operational dynamics.

5. Safety: Reduced exposure to hazardous materials: Robots can be employed to handle, mix and transport hazardous or toxic materials, protecting human workers from potential health risks.

Improved worker safety: By taking over repetitive or physically demanding tasks, automation can improve workplace safety and reduce the risk of injuries.

6. Cost savings: Reduced labour costs: Investing in automation can lead to long-term cost savings by reducing labour costs and increasing production efficiency, especially so at a time when many industries are struggling with skilled labour shortages.

Lower reject rates: Improved quality control and consistency lead to fewer product rejects and less waste, resulting in cost savings.

7. Regulatory compliance: Traceability: Automation allows for better tracking and traceability of materials and products, which can help in complying with regulatory requirements, such as good manufacturing practices, or GMP. Documentation and reporting: Automated systems can generate detailed records and reports, facilitating regulatory audits and inspections.

8. Improved Product Development: High-throughput screening: Robotics and automation can accelerate the drug discovery process by conducting high-throughput screening, leading to faster development of pharmaceuticals.

In the cleanroom and pharmaceutical industries, robotics and automation offer a multitude of advantages, encompassing heightened productivity, enhanced product quality, elevated safety and improved costeffectiveness. The potential returns on investment (ROI) are considerable.

Contact a robotics expert at KUKA Ireland today, and explore automation options that could make your mark in the pharmaceutical and cleanroom industry like never before. Embrace the future today for a more efficient, productive, and innovative tomorrow! For more information, call (042) 939 5034 or email sales.ie@kuka.com.

Automation can assist in the optimisation of manufacturing processes, minimising downtime and delays in cleanroom and pharmaceutical operations.

Irish PharmaChem | Industry Buyers Guide 2024

Automating the healthcare sector: robot-based solutions, shaping the medical technology of the future Robotic lab solutions optimise workflows and provide personnel with more time for highervalue tasks in their daily work. KUKA robots meet the specific technical requirememts of fast-paced, sterile environments, that demand highly-accurate, repetitive application delivery.

Featured: KR AGILUS HM (hygienic machine).

The design and material of this variant are absolutely hygienic. This enables use in applications with direct contact with food and pharmaceutical substances.

KUKA Ireland Ltd. T: 042 9395034 E: sales.ie@kuka.com

WASTE MANAGEMENT

Shaping tomorrow’s waste management Why the current market requires flexible planning in waste management.

party facilities, and it’s a puzzle that only grows more intricate when the global market shifts, due to geopolitical conflicts or energy supply disruptions.

Indaver faces challenges in its European waste treatment capacities. The pharmachem industry had to adjust their processes due to a shortage of essential chemicals, leading to altered waste streams that required different treatment methods. Volume fluctuations have also been witnessed, notably in the pharmaceutical industry, where sudden changes in production led to shifts in medical waste categorisation. A rapid response was and is still necessary.

Long-term vision & collaboration Short-term solutions are no real option. Thanks to a well-thought-out Sales and Operations Planning (S&OP), Indaver extends its reach into the medium-term realm, ensuring a six-week to three-month overview. This allows for the timely detection and correction of imbalances between demand and processing capacity, reducing the pressure on short-term planning departments.

We live in a world where we face climate unpredictability, geopolitical conflicts, an energy crisis, increasing pressure on our health systems, and our supply chains are becoming unpredictable and diversified. As a result, the Irish pharmaceutical industry faces unprecedented challenges.

Indaver, a leading European waste treatment company for that industry, has also had to adapt quickly to guarantee service continuity.

The stability of supply chains has become a thing of the past.

Indaver, specialising in waste treatment and management, finds its processes intrinsically linked to the pharmachem industry it serves.

Supply chain disruptions, production cycles and fast-evolving waste streams resulting in a daunting diversity of materials with sometimes hazardous properties, form an unpredictable jigsaw puzzle to solve.

To balance supply and demand and ensure continuous adaptability and treatment capacity, Indaver has embraced Sales & Operations Planning (S&OP). S&OP is the connective thread that commences with customers and extends through sales, supply, production and operations.

A jigsaw puzzle to solve, quickly Indaver handles a multitude of complex, often hazardous waste streams from industrial companies. It is Indaver’s mission to find safe and efficient ways to recycle, process, recover and convert them into valuable resources, such as energy and high-quality materials similar to that of virgin resources. This task involves a mix of in-house and third-

Indaver has embraced Sales & Operations Planning (S&OP), the connective thread that commences with customers and extends through sales, supply, production and operations.

The success of S&OP hinges on effective communication, especially with industrial clients operating production campaigns. Early notifications of waste streams allow Indaver to assess the necessary processing technology and available capacity. Changing regulations also introduce new waste materials to the market, such as Substance of Very High Concern-containing streams, which demand solid, safe and also innovative treatment solutions to minimise environmental impact.

The future challenges The Indaver team acknowledge that the future holds more puzzles to solve. Climate change, droughts and floods will bring their own set of challenges to waste management and the supply chain. However, Indaver’s robust S&OP process, combined with its expertise in the circular economy and local re-supply, a commitment to collaboration and an overall sustainable waste management system, mean that new uncertainties can be conquered.

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Recycling of precious metals & end-of-life plastics

Local and international waste treatment

Heat networks for industry & community

Solvent recovery

The circular economy

Together we make it happen It's all about Sustainable Partnership really. Constant Innovation comes with it. Discover how Indaver can contribute to a cost-effective, CO2-reducing and environmentally friendly waste management.

Contact us by email: info@indaver.ie or call +353 1 6972900. www.indaver.ie

LEADING THE FIELD IN SUSTAINABLE WASTE MANAGEMENT Irish PharmaChem | Industry Buyers Guide 2024

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NCC: HIGH-PURITY SOLVENTS

NCC:

your partner for highpurity solvents

The National Chemical Company understands the importance of high-purity solvents for pharmaceutical production.

In pharmaceutical and biopharmaceutical production, the significance of high-purity solvents cannot be overstated. Solvents play a pivotal role in the optimisation of manufacturing processes for Active Pharmaceutical Ingredients (APIs). Solvents, in fact, account for 80-90% of the volume throughput of raw materials in a typical fine chemical process.

As the pharmaceutical industry faces the ongoing challenges of quality control, regulatory compliance and, more recently, supply chain constraints, companies like NCC (the National Chemical Company) are at the forefront, providing indispensable solvents that ensure both quality continuity and a secure supply.

The foundation of pharma production At the heart of pharmaceutical synthesis, APIs are produced through chemical processes that demand precision and purity. High-purity pharmaceutical grade solvents, including but not limited to acetone, benzyl alcohol, ethanol, ethyl acetate, isopropyl alcohol (IPA) and propylene glycol (PG), form the essential building blocks.

NCC’s portfolio of REACH registered solvents includes: Acetonitrile, 1,3-Dimethyl-2-imidazolidinone, Anisole and Isopropyl Chloride. These solvents contribute not only to the efficacy of the final pharmaceutical products but also to the adherence to stringent quality standards required by regulatory bodies.

Slight impurities in a small sample might seem inconsequential but their impact becomes catastrophic when scaling up production.

The presence of impurities has the potential to completely transform a formulation, resulting in an entirely different substance due to variations in chemical reactions. A notable example is the introduction of incorrect chemical components into a drug formulation, rendering the drug hazardous for human consumption.

When an active pharmaceutical ingredient carries impurities, it can lead to significant issues for a pharmaceutical manufacturer.

Creating unexpected end results, this can result in huge costs, as well as wasted resources and time.

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NCC’s commitment to excellence NCC is an established and highly reliable sourcing and chemical distributor partner, addressing the industry’s core needs. Their commitment to excellence is reflected in the fact that NCC have longstanding working relationships with many major pharmaceutical manufacturers. NCC’s role extends beyond being a supplier; they serve as a strategic partner, providing accurate, on-time services, robust customer support and unmatched supply chain expertise.

Ensuring supply chain security and continuity Though it is commonplace for sourcing partners to have a fully integrated supply chain, there are significant differences when it comes to approaches and the actual management of the supply chain. It is not enough to ensure that the right product is delivered at the right time. It is important that a sourcing partner understands their customers’ goals and has the ability to deliver the right product at any time. This can only be achieved by analysing the vulnerabilities associated with specific supply chains and working towards solutions that ensure a reduced impact to production when something unexpected goes wrong. It’s moving from the risks of ‘just in time’ to the comfort of ‘just in case’.

How NCC can help Regardless of whether your organisation requires a solvent, intermediate or another type of raw material, NCC can assist.

They have established relationships with trusted manufacturing partners, as well as market expertise of the specific requirements of relevant manufacturing. Working closely with customers, NCC act as an extension of their team at every stage. With strong technical backgrounds and a deep understanding of the challenges that their customers face, solving their unique supply challenges is NCC’s primary goal. For further information call (01) 6131400 or email hello@ncc.ie.

Irish PharmaChem | Industry Buyers Guide 2024

A sourcing partner you can rely on

Solvents account for 80-90% of the volume throughput of raw materials in a typical fine chemical process. That’s why it is essential to use a trusted sourcing partner like NCC. We are the provider of solvents to some of the largest and most reputable pharmaceutical companies. With in-house sourcing expertise as well as our Quality and Compliance Team, we ensure continuity of supply and purity.

To learn more about NCC and our approach to sourcing: Irish PharmaChem | Industry Buyers Guide 2024

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ACTYLIS

A hybrid of global manufacturing and sourcing Actylis’ unique offering of both manufactured and sourced raw materials and performance ingredients provides unparalleled choice for customers’ supply chains.

Actylis is a leading global manufacturer and sourcing expert of critical raw materials and performance ingredients for the Life Sciences market. Actylis’ hybrid approach provides key benefits to its customers in the pharmaceutical and biopharmaceutical industries.

Its key products include: • Water for injection; • Excipients; • APIs and PIs; • Process and cleaning solutions; • Buffers; • Cell culture ingredients; • Amino acids; • Critical raw materials.

“ Actylis’ deep understanding of its customers’ needs, industry regulations and market requirements enables the company to manufacture or source materials with a strong record for on-time/infull deliveries.”

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Global operations include R&D facilities, GMP manufacturing, sourcing hubs, GMP warehousing and sales offices across 10 countries, including Ireland. Actylis’ GMP manufacturing facilities, renowned for high-quality standards, hold all the major certifications and applicable licenses from the main accreditation bodies and agencies, including ISO 9001:2015 and EXCiPACT (GMP and GDP), and are Drug Establishment Licensed for the manufacture of APIs.

Unparalleled choice

Actylis Ireland specialises in all of the above services for downstream liquid and buffer manufacturing and is poised to meet customer demand either by manufacturing critical starting materials or sourcing them through its extensive global network. All products are backed by world-class quality, regulatory expertise and transparency for confidence in the finished drug product.

For more information, visit www.actylis.com or email biopharma@actylis.com

The unique offering of both manufactured and sourced materials provides unparalleled choice for customers’ supply chains. Actylis offers over 4,000 critical raw materials to customers globally, with full supply chain transparency and supporting regulatory and quality documentation.

Actylis’ deep understanding of its customers’ needs, industry regulations and market requirements enables the company to manufacture or source materials with a strong record for on-time/in-full deliveries.

Key services Actylis’ key services include: • GMP manufacturing; • Contract R&D and scale-up; • Custom manufacturing; • Custom ingredient development; • GMP custom packaging & downpacking; • Analytical services; • Sourcing and distribution; • Regulatory support.

Actylis offers over 4,000 critical raw materials to customers globally, with full supply chain transparency and supporting regulatory and quality documentation.

Irish PharmaChem | Industry Buyers Guide 2024

Our Hybrid model delivers more choice and flexibility

Hybrid of Global Manufacturing & Sourcing Irish PharmaChem | Industry Buyers Guide 2024

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MODULAR BUILDING SOLUTIONS

The power of modular building solutions Christian Visser of Dawsongroup TCS Ireland explores the benefits that modular construction brings to the table for pharma and biotech companies, challenging the status of traditional methods.

In the ever evolving landscape of construction, where innovation meets necessity, the shift towards modular building is undeniable. At Dawsongroup TCS Ireland, we specialise in providing cutting-edge solutions, From walkin stability chambers to ATEX units, spanning temperature ranges from +60°C to -70°C, cleanrooms, test chambers and blast freezers, our focus extends to the transformative power enabled in modular construction.

in construction, and modular building excels in this regard. Factorybased manufacturing allows for meticulous oversight, ensuring that each component meets the highest standards. This not only enhances the overall quality of the build but also minimises on-site safety risks, aligning with Dawsongroup TCS Ireland’s commitment to delivering excellence without compromise.

In a world increasingly conscious of its environmental impact, modular construction emerges as a sustainability champion. Approximately 67% less energy is used, and up to 50% less time is spent onsite compared to traditional methods, marking a significant stride towards a greener, more eco-friendly future. Also keep in mind that our modular buildings have a reusable nature; once built, they can be sold, hired, rebought and refurbished for new needs.

Speed and cost-efficiency redefined One of the most compelling advantages of modular construction is its unmatched efficiency. In a world where time is money, the streamlined nature of modular building stands out. With up to 50% faster construction times, projects are not only completed swiftly but also with significant cost savings. This efficiency aligns seamlessly with the ethos of Dawsongroup TCS Ireland, where precision and timeliness are paramount.

Traditional construction often falls victim to weather related delays, impacting timelines and escalating costs. Modular building, by contrast, is impervious to such setbacks. With 90% of manufacturing conducted in a controlled factory environment, adverse weather conditions become a nonissue. This resilience ensures that our clients at Dawsongroup TCS Ireland receive premium solutions.

Quality assurance and safety: a factory-crafted environmental standard Dawsongroup TCS Ireland emphasise the importance of quality control

Quality adaptability with a visionary tomorrow Perhaps one of the most overlooked advantages of modular construction is its adaptability. At Dawsongroup TCS Ireland, we recognise the need for tailored solutions. Our modular application allows for seamless expansion, offering the flexibility to meet evolving requirements. Whether it’s adding an extra room or expanding an existing facility, modular construction is the answer.

Dawsongroup TCS Ireland leads the charge and advocates for modular construction resonates. The benefits extend far beyond the speed and costeffectiveness, including quality assurance, environmental sustainability and design versatility. It’s a shift that not only aligns with the present needs of the construction industry but paves the way for a visionary tomorrow, one built with efficiency, sustainability and innovation at its core.

Ready to buy or rent? For more information, call (045) 448810 or visit dawsongroup.ie.

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DATA ACQUISITION AND CONNECTIVITY

Harnessing the power of data acquisition and connectivity with Bonner In today’s increasingly interconnected world, the forward momentum of smart technology has transformed various aspects of our lives, including industrial processing for Life Sciences and manufacturing industries. However, many factories continue to rely on outdated equipment and processes that fail to generate usable data from multiple sources. Thankfully, embracing a modern system that collects, analyses and presents process data in actionable formats can lead to significant time and cost savings for businesses.

By harnessing the power of data acquisition and control applications, process information can be converted into a valuable asset. This transformation enables factories to optimise production, identify nonperforming processes and enhance the Overall Equipment Effectiveness (OEE) by boosting equipment and area efficiency.

Leveraging your data effectively Bonner specialise in providing tailor-made, comprehensive systems that empower customers to leverage their data effectively. Whether it’s energy monitoring, condition monitoring, predictive maintenance or remote asset monitoring, their team designs solutions that perfectly align with each plant’s unique requirements. The Bonner approach for clients lies in its flexibility, as their systems can seamlessly integrate with both new and legacy equipment, catering to a wide range of traditional and cutting-edge processes. ai165849213027_Bonner_FI2022_180x131_04.pdf 1 22/07/2022 In addition to offering expertise in data-driven solutions, Bonner also specialise in providing advanced SCADA (Supervisory Control and

Harnessing the power of data acquisition and control applications allows process information to be converted into a valuable asset.

Data Acquisition) and also DCS or MES, depending on the complexity, scale of operation or if specific challenges need to be overcome.

These sophisticated technologies play a crucial role in enhancing the efficiency, safety and quality of food processing and dairy operations.

For over 45 years, Bonner have worked with clients to ensure 13:15 compliance and they seek to help their clients in pursuing efficiency, quality and digitalisation for their modern factory.

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EDUCATION & TRAINING: UCC & MTU

iEd Hub:

education & knowledge for enterprise, with enterprise

The iEd Hub at UCC and MTU is a Life Science industry-focused knowledge and education provider, where pharma, biopharma and medtech companies are directly involved in the design and delivery of the courses.

“There’s a difference between training someone for a job and training someone for a career,” says Dr Michael Kilkelly of the iEd Hub at University College Cork.

Simultaneously developing both technical and business skills sets employees and companies up for accelerated success, both in the near-term and long-term.

Based at UCC and MTU (Munster Technological University), the iEd Hub is a Life Science industry-focused knowledge and education provider. This novel entity represents a consortium of the region’s key stakeholders in this sector, featuring leaders from pharma, biopharma and medtech companies (from multinational through to start-up), relevant agencies and the Cork universities.

Unique to the iEd Hub is that a large proportion of the staff were recently recruited from local companies, who possess decades of experience in senior management in this sector. Michael Kilkelly was Plant Manager and Director at Recordati before joining the hub.

“Along with these iEd Hub staff, companies are directly involved in both the design and delivery of these courses” says Dr Kilkelly. “Our lecturers in UCC and MTU have collectively spent a lot of years working in the sector and span multiple teaching disciplines, ranging from management and entrepreneurship to pharmacy and manufacturing sciences, anatomy and regulations, to name a few.’’

The iEd Hub has benefited from an €8.7 million grant from the Higher Education Irish PharmaChem | Industry Buyers Guide 2024

Authority’s Human Capital Initiative. “This funding has facilitated us to build a unique industry-experienced course design team,” says Professor Mark Tangney, Head of the iEd Hub. “It has provided us with focused time to analyse the market, build an extensive network, design multiple courses and source appropriate infrastructure and equipment to help deliver them.”

MSc Industrial Pharmaceutical Sciences, Operation & Management 2023 saw the launch of the new MSc in Industrial Pharmaceutical Sciences, Operation & Management (IPSOM). From the outset, students are immersed in a learning environment that simulates the Life Sciences workplace, followed by an eight-month industry placement. Delivered by former industry personnel in the School of Pharmacy and UCC’s business school, the course is a blend of technical and soft skills learning. This is augmented by guest lecturers from the local pharma sector.

An example of this blended learning approach is the use of capacity planning case studies, which the students present to a team of senior leaders from the industry. Laboratory practicals include qualifying equipment in the aseptic suite in UCC, working in GMP conditions and being examined in audit situations.

Students have a hands-on practical session in the BioPharma Training Centre, as well as access to detailed tours of local

manufacturing facilities. From 2024, students will have access to 3D virtual tours of local manufacturing facilities.

Accessibility to life-long-learning The iEd Hub also broadens access to employee upskilling through micro-credentials. This is a flexible approach to learning, whereby, for example, an employee on shift work can chose several short courses over their chosen period.

Recent examples include micro-credentials in anatomy delivered to medtech engineers.

Registration will soon open for the new joint MTU/UCC MSc Medical Device Design, which can be taken part-time or full-time.

Rapidly changing skills needs Overall, the iEd Hub can respond rapidly to the changing skills needs of the Life Sciences sector and produce graduates that have the skills relevant to the modern workplace. For more information, visit https://iedhub.ie/.

The Human Capital Initiative Pillar 3 (HCI Pillar 3), is a €300 million programme of 24 projects across Ireland’s Higher Education (HE) institutions, using innovation & agility to increase capacity in higher education to provide skills-focused programmes All 24 projects are collaborative between HE and Enterprise partners, and funded by the National Training Fund (NTF) to meet existing and future industry skills needs. For more information, visit https://hea.ie/skillsengagement/human-capital-initiativepillars-1-2-and-3/.

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INGREDIENTS

Barentz: a broad portfolio to suit all applications Ingredients distributor Barentz offers pharmaceutical manufacturers a range of ingredients to suit every application, including challenging formulations.

Barentz is a global life science ingredients distributor specialising in human nutrition, pharmaceuticals, personal care and animal nutrition, creating unique synergies across all fields of expertise.

Founded in 1953, Barentz is now present in over 65 countries, with a global team of more than 2,000 local experts, dedicated to 22,000 customers and with a turnover of €2.1 billion. Driven by the powerful blend of entrepreneurship, partnership and knowledge, Barentz is known as the global life sciences ingredients distributor and create and delivers “Always a better solution”.

Barentz acquired Forum Products in 2011 and rebranded it as Barentz Ireland in 2019.

Barentz’s success lies in building long-lasting relationships with suppliers and customers, based on trust, transparency and reliability, where going the extra mile to provide customer satisfaction is part of the company’s DNA.

High quality ingredients and technical expertise

A broad portfolio of premium quality and high-performance ingredients

Barentz offers clients: • In-house technical scientists, providing specialist advice on ingredient choices and functionality; • Local sales office, staffed with technical sales managers and support staff; • Local, regional & central (HUB) warehousing; • Combined order management and sampling service with harmonised ERP/ CRM systems; • Fully implemented QA systems, ISO9001:2015 and GDP certified.

EXCIPIENTS Fillers

Taste masking

Excipients for Nutraceuticals

Binders

Flavours

Oils, fats, and waxes

Diluents

Sweeteners

Preservatives

Disintegrants

Solubilisers

Emulsifiers

Glidants

Sugars

Permeation enhancers

Lubricants

Controlled release

APIs Antihypertensives

Anthelmintics

Antiarrhythmics

Diuretics

Sedatives

Mineral salts for Atypical & Speciality APIs

Why Barentz is the right business partner for you

For more information, contact Barentz Ireland Ltd, Block S, Grants View, Greenogue Business Park, Rathcoole, Co. Dublin, D24 XN60

BIOPHARMA INGREDIENTS

Tel: (01) 4039518

Mineral salts – low in endotoxin grades

Amino Acids

Mannitol

Sorbitol

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Barentz has a skilled team of technical sales managers offering a broad portfolio of ingredients to suit every application. They are on hand to select the optimum combination of ingredients to assist with solving the formulation challenges and manufacturing demands of customers.

Barentz represents some of the world’s foremost producers of excipients, APIs, nutraceutical and biopharma ingredients, including Roquette, Meggle, Dr Paul Lohmann, IFF, Ajinomoto, Abitec, Ashland, Asahi Kasei, Sandoz & Moehs. Barentz supplies a range of customers producing specialist pharma, generics, OTC, CMOs/ CDMOs, biopharma, medical devices, nutraceutical and healthcare supplements.

Dextrose

E-mail: pharmaireland@barentz.com Web: www.barentz.com Irish PharmaChem | Industry Buyers Guide 2024

Always a better solution.

At Barentz, we have made it our business to excel in delivering premium quality and high performance excipients, APIs & nutraceutical ingredients – sourced and provided by our partnered suppliers.

Customers greatly value our deep technical knowledge and extensive product portfolio, our capability to manage quality throughout the entire supply chain and our local presence.

Contact our Dublin sales office at pharmaireland@barentz.com or call us at + 353 1 4039518.

www.barentz.com

Irish PharmaChem | Industry Buyers Guide 2024

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SCIENTIFIC EQUIPMENT/TECHNICAL SOLUTIONS

Mason Technology:

your partner in scientific equipment Established in 1780, Mason Technology is a trusted provider of high-quality scientific equipment and technical solutions to the pharma and biopharma sectors.

Supplying the scientific solutions you need Partnering with 50+ leading manufacturers including Mettler Toledo, Eppendorf, Edwards Vacuum, Evident (formerly Olympus), Buchi, Shimadzu, and Don Whitley Scientific, Mason Technology specify and supply chromatography, weighing, microscopy, spectroscopy, biotechnology, general laboratory and software products and solutions. Their sales teams, with a background in science, can design tailored solutions to meet your specific needs.

Ensuring your scientific equipment operates effectively Mason Technology’s highly skilled service engineers, well-versed in regulated environments, provide comprehensive technical services throughout your equipment’s lifecycle.

From installation and commissioning Mason Technology’s highly skilled service services that are aligned engineers provide comprehensive technical with manufacturer services throughout your equipment’s lifecycle. recommendations to

Mason Technology partners with more than 50 leading manufacturers worldwide. tailored Validation Services (IQ, OQ, PQ, RQ) and INAB accredited Calibration Services, they ensure your equipment supports you in your scientific work.

Additionally, their dedicated team of software specialists offer software support services, including consultation and CSV (Computer System Validation), guaranteeing compliance with Data Integrity & 21 CFR 11 for GxP environments.

A safe pair of hands At Mason Technology, their commitment to quality is evident through their continuous certification to ISO standards since 1994. Today, they are certified to ISO 9001, ISO 14001, ISO 45001, and ISO 17025, making Mason Technology the ideal partner for anyone looking for a safe pair of hands.

For more information, visit www.masontechnology.ie.

Your Trusted Partner Leading provider of high-quality scientific equipment, innovative solutions, and technical services to the pharmaceutical, biopharma, chemical manufacturing, and medical device sectors.

Your Safe Pair of Hands Recognising the importance of quality to our customers, we take pride in our continuous certification to ISO standards since 1994.

T: +353 1 4534422 114 Pharma BioChem.indd 1

E: info@masontec.ie

masontechnology.ie 01/12/2023 Irish PharmaChem | Industry Buyers07:31:20 Guide 2024

CONTRAST MEDIA: GE HEALTHCARE GE HealthCare celebrated 30 years at its Irish campus in Carrigtohill, Co. Cork.

GE HealthCare celebrates 30 years in Ireland GE HealthCare has been supporting patients across the globe for three decades from its Irish base in Carrigtohill, Co. Cork.

In 2023, GE HealthCare’s pharmaceutical imaging agent manufacturing facility at its Ireland Campus in Carrigtohill, Co. Cork, celebrated 30 years. During that time, the site has seen significant growth – it started production in 1993 with 43 employees, producing three million doses annually for customers in western Europe. Today, more than 760 employees work at the site, producing over 32 million doses annually for customers and their patients across the globe.

The site manufactures injectable diagnostic imaging agents (contrast media) used in X-ray and Computed Tomography (CT) procedures around the world. Contrast media helps improve the visibility of specific organs, blood vessels or tissues during imaging procedures. This aids clinicians in making better informed decisions regarding monitoring and treatment of patients.

Increasing demand The company estimates that demand for its iodinated contrast media products will increase significantly over the coming years, largely due to an increase in the use of CT imaging procedures. To help address this increasing demand, GE HealthCare invested $30 million into additional production capacity at the Carrigtohill site to support the company’s ambition to produce an additional 30 million patient doses per year by the end of 2025, compared to 2022.

Eugene Barrett, GE Healthcare Ireland Site Leader, who leads the team at the Cork facility, said: “We know that our products play an important role in helping clinicians diagnose patients and put in place the most appropriate treatment options available. As a team, we’re driven by that purpose to deliver on our promises to our customer because patients rely on us each and every day to have Irish PharmaChem | Industry Buyers Guide 2024

their scheduled X-ray and CT procedures.

“The opening of our newest production line has been a great success and means that our products can help even more customers and patients. That’s only possible because of the commitment of everyone on the team,” Eugene continued. “We’ve come a long way over the last 30 years and we’re looking forward to the next 30 years and the opportunities there will be for us to make an even bigger impact for our customers and their patients but also for our local community, as an employer seeking to grow further.”

A global leader in imaging agents The Carrigtohill site is part of GE HealthCare’s Pharmaceutical Diagnostics segment, a global leader in imaging agents used to support around 100 million procedures per year globally, equivalent to three patient procedures every second. For more than 40 years, GE HealthCare imaging agents have been routinely used across MRI, X-ray/ CT and ultrasound to enhance clinical images and support diagnosis.

GE HealthCare is a leading global medical technology, pharmaceutical diagnostics and digital solutions innovator, dedicated to providing integrated solutions, services and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise and patients healthier and happier. Serving patients and providers for more than 100 years, GE HealthCare is advancing personalised, connected and compassionate care, while simplifying the patient’s journey across the care pathway.

For more information about roles currently open at GE HealthCare, visit: https://jobs.gecareers.com/healthcare/global/en/.

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HUBBCAT: ERT COMMUNICATION

Hubbcat:

communication for ERT Within the pharmaceutical industry, you need to have the most up-to-date communication, along with the ability to know when your team members are in difficulty and they need support. Hubbcat can provide just that.

Many ERT members will be familiar with Two Way Radio, paging systems, fire panel alerts and lone worker systems. They are critical tools but often operate independently of each other and are based on technology which remains largely unchanged for the past 20 years. This is despite high levels of on-site infrastructure investment in data connectivity in terms of Wi-Fi, enhanced mobile/cellular coverage and even private LTE. Today’s pharmaceutical plants operate like connected cities rather than a one-building factory or production line. Better team collaboration, process compliance and duty of care to the workforce have never been more important. Automation is everywhere across the factory floor; machines talk to machines, production is 24-hours, with people and goods constantly on the move. For all this to work efficiently, we need to think differently about how we communicate and collaborate at speed and securely across our functional teams.

Technological advances in on-site connectivity mean that it is now possible to converge many of the legacy single technologies into one easy-to-use, cost efficient digital device. This greatly enhances communication effectiveness whilst providing the necessary compliance measures in one package.

Hubbcat’s Push-to-Talk platform includes best-in-class secure voice communications, along with integrated lone worker/man down alarms, GPS location services, fire panel integration, secure instant message, short video and much more.

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Push-to-Talk Hubbcat offers a range of cutting-edge Business Critical Solutions to the pharmaceutical sector. Their Push-to-Talk platform not only includes best-in-class secure voice communications but also integrated lone worker/man down alarms, GPS location services, fire panel integration, secure instant message, short video and much more. All this comes in one dedicated device, which is ATEX rated for all working environments.

Alarms and emergencies happen. When they do, Hubbcat’s system can track, log and control the situation. Users can trigger an alarm via dedicated assistance buttons on the device or if the sensors on the device sense a drop, fall or inactivity. Alarms can be handled locally on their proprietary dispatch console or handed off to 24-hour dedicated monitoring teams. Colleagues’ location can be determined instantly on a map and the ERT team can react at speed and in a coordinated manner to any ongoing event.

Hubbcat devices use clever technology to utilise the network coverage of all the mobile phone operators based on signal strength.

This is great for operations with large campuses or indeed multiple geographically disperse facilities. They can also connect to local Wi-Fi networks. This is designed to eliminate the coverage blackspots we often find using traditional two-way radio systems.

EHS/ERT teams’ core mission is to provide a safe and productive environment for their colleagues across the workplace. Using Hubbcat can bring the following core benefits: • Fast, secure and reliable 1-2-1 and team communications; • Maximum site coverage and reduced communications blackspots; • Integrated alarms and fire panels; • Lone worker protection; • ATEX certified device range; • Converged services and ease of deployment; • 30% cost savings over legacy systems; • Fully encrypted GDPR compliant communications; • Unlimited geographic reach and range.

Hubbcat is a trusted partner to a number of leading pharmaceutical companies by providing best in class communications to ERT Teams in some of Ireland’s newest and most modern facilities.

“It is time on-site ERT comms came out of the dark ages,” stressed a company spokesperson. “When the communication counts, you can count on Hubbcat.”

To learn more about how Hubbcat can help your ERT team modernise and get maximum utility from their on-site infrastructure, visit www.hubbcat.com or email enquiries@hubbcat.com.

Irish PharmaChem | Industry Buyers Guide 2024

Modernize Your Emergency Response Communications • Consolidate systems on to one reliable platform • Eliminate poor coverage areas • Better collaboration between EHS teams • Lone Worker & Fire Panel integration • Improve Audit compliance

Effective team communication with Hubbcat

Email enquiries@hubbcat.com for more information and a free trail.

Irish PharmaChem | Industry Buyers Guide 2024

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LOGISTICS: KWE IRELAND

KWE Ireland: your logistics partner

KWE Ireland was established in 1998 as a subsidiary of Kintetsu World Express, Inc. and is now a major contributor and trusted partner in the Irish freight and logistics industry.

Long established in the Top 5 Forwarders in Ireland, KWE have developed a well-earned reputation for the provision of quality, tailormade, cost effective logistics solutions.

Temperature-controlled, GDP-certified warehousing KWE Ireland offer full temperature-controlled, WDA/GDP-certified warehousing, and are considered experts in this field, offering a full advisory service and storage solutions to the pharmaceutical industry, including:

• Fully validated pharmaceutical WDA/GDP

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

Management System is consistently reviewed both internally and externally, to allow them to go beyond industry standards of quality.

KWE are continually and independently audited by internationally renowned and recognised standards authorities and governing bodies.

Exceptionally high standards “Our goal is to make life easier for our clients by taking their headaches and effectively, making them ours,” explains Karl O’Reilly, Sales Manager,

KWE. “We have built up a large and impressive client base by making their lives easier.”

Kora Healthcare is one such satisfied customer, as Niall Jones, Global Supply Chain Manager, explains: “We started working with KWE more than four years ago and they are a most professional company. We have been hugely impressed by their exceptionally high standards and levels of service throughout this period. They are highly recommended.”

“As a customer of KWE Ireland, you will come to know us as a trusted partner that is always there for you,” O’Reilly concludes. “That’s the level of service we have built our reputation on.”

certified temperature-controlled facility;

• Bespoke end-to-end logistics solutions; • Expert in-house commissioning and validation team;

• All staff are trained to the highest industry

standards, and pride themselves on exceeding customers’ expectations through the quality of service they provide; • RP & Deputy RP on-site.

Always looking to the future and ever seeking to improve, KWE Ireland’s Quality

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KWE Ireland are currently offering capacity for both long-term and short-term customers. For all enquiries, please contact their Sales Team by emailing dubsls@kwe.com or phone (01) 8239600.

Irish PharmaChem | Industry Buyers Guide 2024

Your search is over!

KWE WDA/GDP approved Temperature Controlled facility close to Dublin Airport

Your trusted Global Logistics Partner

Dublin Head Office & Temperature Controlled Warehouse Facility at Harristown, Swords, Co. Dublin.

Tel: (01) 823 9600 Fax: (01) 836 1111 Email: kwedub@kwe.com www.kwe.com Irish PharmaChem | Industry Buyers Guide 2024 119 Cork Regional Office & Warehouse Facility, Tel: (021) 497 5722 Email: kweork@kwe.com

INTELLIGENT AUTHORING

Intelligent authoring: enhancing manufacturing efficiency in the age of Industry 5.0 Industry 4.0 has revolutionised manufacturing with automation and digitisation. Now, Industry 5.0 refines this, emphasising human-AI collaboration. To keep pace with this shift, companies in medtech and Life Sciences must transition from traditional documents to data-driven approaches. Whether you work with paper-based or digital content, such as SOPs, intelligent authoring holds the key to accelerating manufacturing, reducing errors, enhancing quality compliance and speeding up time to market.

Revolutionising content creation and review Intelligent authoring, tailored for regulated industries such as pharma, biopharma, and medical devices, will revolutionise the content creation and review process. Current authoring processes involve long creation times and laborious reviews. While reviews are vital, intelligent authoring offers faster, more cost-effective and reliable outcomes.

Why? Because it involves creating machine-readable content in small, reuseable XML-tagged chunks. This approach allows for swift and accurate content updates, while adhering to Change Control processes.

How? Editability features simplify quality control and rules and parameters automatically assemble complete documents. What’s more, conditional and variable content is accommodated, which enhances flexibility.

Intelligent authoring aligns with Industry 5.0, blending mass production efficiency with human intuition and vision. For medtech and Life Sciences companies, it improves product delivery, while embracing hyperautomation and advanced analytics. This technology offers high-quality, adaptable documentation from a single source.

Intelligent authoring aligns with Industry 5.0, blending mass production efficiency with human intuition and vision.

Intelligent content is agile, cost-effective and accessible. It simplifies taxonomy-based searching and provides a rich audit trail.

As Industry 5.0 bridges the gap between humans and machines, intelligent authoring sets the standard for content creation.

About TWi TWi, a global content services company based in Cork, supports technologyenabled manufacturing teams with intelligent information solutions, empowering businesses to meet their objectives in the evolving landscape of Industry 5.0.

Revolutionise Your Manufacturing Process with Intelligent Authoring The Power of Intelligent Authoring for Life Sciences: Accelerated Manufacturing: Reusable content chunks reduce the time needed for procedural content updates.

Enhanced Efficiency: Improved overall efficiency by streamlining content creation with small, reusable content segments and automated document assembly.

Error Reduction: Structured, rule-based authoring minimises errors in critical documentation.

Quality Assurance: High-quality, consistent documentation derived from a single source.

Adaptability and Cost Savings: Content quickly adapts to changes and is cost-effective to maintain.

technicallywriteit.com Bring Technological Innovation to Your Documentation.

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Irish PharmaChem | Industry Buyers Guide 2024

CHEMICAL SUPPLIERS ACIDS & ALKALIS AQS Environmental Solutions Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Chemifloc Ltd Corcoran Chemicals Ltd Fisher Scientific Ireland Ltd GI Chemicals Greenfield Global Heterochem Dist Ltd Micro-Bio Ireland Ltd National Chemical Company Q1 Scientific Solv-Echem Ireland Ltd Univar

ACTIVATED CARBONS Associated Chemicals Ltd Brenntag Ireland Chemco Ireland Ltd Fisher Scientific Ireland Ltd National Chemical Company Univar

ACTIVE PHARMACEUTICAL INGREDIENTS AbsorboPak Barentz Corcoran Chemicals Ltd Mallinckrodt Pharmaceuticals Mason Technology SK Pharmteco

BIOCHEMICALS Alexion Arran Chemical Company Associated Chemicals Ltd Camida Ltd Carbon Group Corcoran Chemicals Ltd Fisher Scientific Ireland Ltd GI Chemicals Mason Technology Pharmalex Univar

BIOCIDES Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Corcoran Chemicals Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd Mason Technology Univar

CATALYSTS Arran Chemical Company Associated Chemicals Ltd Camida Ltd Fisher Scientific Ireland Ltd Ortec Inc. National Chemical Company SK Pharmteco

CHIRAL COMPOUNDS Arran Chemical Company Associated Chemicals Ltd Camida Ltd Fisher Scientific Ireland Ltd Hovione Ltd National Chemical Company SK Pharmteco

EXCIPIENTS A&C Your Global GMP Partner Associated Chemicals Ltd Azelis Barentz Brenntag Ireland

Irish PharmaChem | Industry Buyers Guide 2024

Camida Ltd Chemco Ireland Ltd Corcoran Chemicals Limited Greenfield Global Heterochem Dist Ltd Mason Technology Micro-Bio Ireland Ltd National Chemical Company Ortec Inc. Univar

FINE CHEMICALS Actylis AbsorboPak Arran Chemical Company Associated Chemicals Ltd Azelis Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Greenfield Global Heterochem Dist Ltd IDA Ireland Micro-Bio Ireland Ltd National Chemical Company Ortec Inc. SK Pharmteco Solv-Echem Ireland Ltd

GASES National Chemical Company

HETEROCYCLICS Arran Chemical Company Associated Chemicals Ltd Camida Ltd Corcoran Chemicals Ltd National Chemical Company

INDUSTRIAL CHEMICALS Corcoran Chemicals Ltd GI Chemicals Mason Technology

INORGANIC CHEMICALS Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Chemifloc Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd GI Chemicals Heterochem Dist Ltd Micro-Bio Ireland Ltd National Chemical Company Ortec Inc. Solv-Echem Ireland Ltd Univar

LABORATORY REAGENTS Associated Chemicals Ltd Bonner Corcoran Chemicals Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd IDA Ireland Mason Technology Solv-Echem Ireland Ltd

MISC. CHEMICALS

AbsorboPak Arran Chemical Company Associated Chemicals Ltd Azelis Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Chemifloc Ltd Corcoran Chemicals Limited

Fisher Scientific Ireland Ltd Greenfield Global Heterochem Dist Ltd Mason Technology National Chemical Company Solv-Echem Ireland Ltd Univar

OILS, FATS AND WAXES

Associated Chemicals Ltd Brenntag Ireland Carbon Group Corcoran Chemicals Limited Heterochem Dist Ltd Mason Technology

ORGANIC INTERMEDIATES Arran Chemical Company Associated Chemicals Ltd Camida Ltd Corcoran Chemicals Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd Hovione Ltd IDA Ireland Mason Technology National Chemical Company Ortec Inc. SK Pharmteco Univar

ORGANOMETALLICS Arran Chemical Company Associated Chemicals Ltd Camida Ltd Mason Technology National Chemical Company

REAGENTS Associated Chemicals Ltd Camida Ltd Corcoran Chemicals Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd IDA Ireland Mason Technology National Chemical Company Source BioScience

SILANES Arran Chemical Company Associated Chemicals Ltd Brenntag Ireland Camida Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd Ortec Inc. Univar

SOLVENTS Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Greenfield Global Heterochem Dist Ltd National Chemical Company Univar

SURFACTANTS Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Greenfield Global Heterochem Dist Ltd

TREATMENT CHEMICALS Corcoran Chemicals Ltd GI Chemicals Micro-Bio Ireland Ltd

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GENERAL SUPPLIERS AGITATORS CPI Technology Ltd Quitmann O’Neill

AIR / ROAD / OCEAN FREIGHT AbsorboPak Dawsongroup | TCS Ireland Hazchem Training Ltd Kuehne + Nagel Portakabin Ireland UPS Healthcare

AIR FILTRATION / MONITORING / INGREDIENTS

Holfeld Graphics Horan Automation Tekpak Automation Ltd

BARCODING / LABELLING / TRACEABILITY Corcoran Products Ltd GS1 Ireland Holfeld Graphics Horan Automation Tekpak Automation Ltd

BURSTING / RUPTURE DISCS Horan Automation

CABINETS Dawsongroup | TCS Ireland Fisher Scientific Ireland Ltd Foltech Engineering Ltd Horan Automation Mason Technology Source BioScience

BIOINTERACTION ANALYSIS

CAD

ATG Scientific Ltd

Horan Automation

CMS Chemstore Engineering Ltd

BIOLOGICS

CALIBRATION

ALUMINIUM PRODUCTS

Mason Technology MSD Ireland

Ballinlough Pharma Solutions Bonner Dawsongroup | TCS Ireland Labplan LotusWorks Mason Technology

Foltech Engineering Ltd Quitmann O’Neill

ANALYSIS SERVICES Almac Sciences Ltd ATG Scientific Ltd Charles River Laboratories Ireland Ltd Charles River Microbial Solutions Corcoran Products Ltd Eurofins Biopharma Product Testing GI Chemicals IDA Ireland Particular Sciences Ltd Reading Scientific Services Ltd SK Pharmteco

ANALYTICAL EQUIPMENT ATG Scientific Ltd Endress & Hauser (Ireland) Ltd Fisher Scientific Ireland Ltd LABPLAN Mason Technology Particular Sciences Ltd Scientific Instruments Ireland

ASSOCIATIONS GS1 Ireland

AUTOCLAVES Fisher Scientific Ireland Ltd Scientific Instruments Ireland Mason Technology

AUTOMATION Bonner Endress & Hauser (Ireland) Ltd LABPLAN O’Flynn Medical Ltd Portakabin Ireland ProSys Containment and Sampling Technology Tekpak Automation Ltd

BALANCES Bonner Fisher Scientific Ireland Ltd Mason Technology Scientific Instruments Ireland

BARCODE VERIFICATION GS1 Ireland

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BIOPHARMACEUTICALS AbsorboPak Alexion Alkermes Pharma Ireland Limited Almac Sciences Ltd Barentz BS&B Safety Systems Ltd Charles River Laboratories Ireland Ltd Charles River Microbial Solutions Eurofins Biopharma Product Testing Horan Automation IDA Ireland Janssen Mason Technology Micro-Bio Ireland Ltd MSD Ireland Pharmalex Portakabin Ireland Reading Scientific Services Ltd

BIOPHARMA / BIOTECH SUPPLIERS BS&B Safety Systems Ltd Mason Technology

BIOPHARMA / BIOTECH SUPPORTS Flexachem Manufacturing Ltd

BIOTECHNOLOGY Almac Sciences Ltd Charles River Microbial Solutions DHL Supply Chain IDA Ireland Labplan Mallinckrodt Pharmaceuticals Mason Technology Micro-Bio Ireland Ltd MSD Ireland Particular Sciences Ltd Pharmalex

BLENDERS Fisher Scientific Ireland Ltd Ortec Inc.

BLISTERING / DE-BLISTERING Holfeld Graphics Horan Automation

BPRV BS&B Safety Systems Ltd CPI Technology Ltd

CARTONING SYSTEMS Tekpak Automation Ltd

CASE ERECTING / PACKING Horan Automation Tekpak Automation Ltd

CASE SEALING Horan Automation

CENTRIFUGES AQS Environmental Solutions CPI Technology Ltd Fisher Scientific Ireland Ltd Labplan Mason Technology

CHEMICAL CONSULTANTS Corcoran Chemicals Limited Hazchem Training Ltd Mason Technology

CHILLED WATER Astatine Cross Technical Solutions

CHROMATOGRAPHY Charles River Microbial Solutions Fisher Scientific Ireland Ltd Labplan Mason Technology SK Pharmteco

CLEANROOMS Charles River Microbial Solutions Cross Technical Solutions Dawsongroup | TCS Ireland Fisher Scientific Ireland Ltd Horan Automation KUKA Robotics Ireland Ltd Mason Technology Ortec Inc. Portakabin Ireland

Irish PharmaChem | Industry Buyers Guide 2024

GENERAL SUPPLIERS CLEANING SERVICES / EQUIPMENT AQS Environmental Solutions Portakabin Ireland

CLINICAL RESEARCH ORGANISATION Charles River Microbial Solutions

COLD CHAIN CONSULTATION DHL Supply Chain

COLD CHAIN PACKAGING Alexion CRS Pharma Solutions DHL Supply Chain Horan Automation Kuehne + Nagel Quitmann O’Neill UPS Healthcare

COMPRESSED AIR / COMPRESSORS Ballinlough Pharma Solutions

COMPUTER SYSTEMS Charles River Microbial Solutions Chemishield Westbourne IT Global Services

CONDENSORS Ballinlough Pharma Solutions CPI Technology Ltd Cross Technical Solutions Dawsongroup | TCS Ireland Flexachem Manufacturing Ltd Mason Technology

CONDITION MONITORING AbsorboPak Bonner Charles River Microbial Solutions Flexachem Manufacturing Ltd Foltech Engineering Ltd LotusWorks Q1 Scientific

CONSTRUCTION MANAGEMENT Astatine Dawsongroup | TCS Ireland Portakabin Ireland Tandem Project Management Ltd.

CONSULTANCY Astatine Dawsongroup | TCS Ireland Hazchem Training Ltd Horan Automation Reading Scientific Services Ltd Tandem Project Management Ltd

CONTENT STRATEGY TWi

CONTRACT DEVELOPMENT & MANUFACTURING Hovione Ortec Inc. SK Pharmteco

CONTRACT DEVELOPMENT & MARKETING Charles River Microbial Solutions Hovione

CONTRACT PHARMA SERVICES Alkermes Pharma Ireland Limited Charles River Laboratories Ireland Ltd Charles River Microbial Solutions Eurofins Biopharma Product Testing Hovione Mason Technology Ortec Inc. Pharmalex Reading Scientific Services Ltd Irish PharmaChem | Industry Buyers Guide 2024

CONTROL SUBSTANCES CONVEYORS Horan Automation Tekpak Automation Ltd

COOLING SYSTEMS Astatine Ballinlough Pharma Solutions CPI Technology Ltd Cross Technical Solutions CRS Pharma Solutions Dawsongroup | TCS Ireland Mason Technology

DATA ACQUISITION Bonner Charles River Microbial Solutions IDA Ireland Labplan

DEHUMIDIFIERS Cross Technical Solutions CRS Pharma Solutions Dawsongroup | TCS Ireland Mason Technology

DESIGN Ballinlough Pharma Solutions Horan Automation Nelipak Healthcare Packaging Pharmalex Quitmann O’Neill Tandem Project Management ltd Tekpak Automation Ltd

DISPERSERS Fisher Scientific Ireland Ltd Horan Automation

DISTILLATION Fisher Scientific Ireland Ltd Labplan Mason Technology

ELECTRONIC COMPONENTS Horan Automation

ENERGY EFFICIENCY / MANAGEMENT Astatine Horan Automation Sustainable Energy Authority of Ireland

ENGINEERING SERVICES Astatine Bonner Charles River Microbial Solutions Chemishield Dawsongroup | TCS Ireland Endress & Hauser (Ireland) Ltd Horan Automation LotusWorks Mason Technology Tandem Project Management ltd Tekpak Automation Ltd

ENVIRONMENTAL CONSULTING Charles River Microbial Solutions CMS Chemstore Engineering Ltd Mason Technology Quitmann O’Neill

ENVIRONMENTAL MONITORING Bonner Charles River Microbial Solutions Mason Technology

ENVIRONMENTAL SERVICES / EQUIPMENT AQS Environmental Solutions Charles River Microbial Solutions CMS Chemstore Engineering Ltd GI Chemicals Mason Technology O’Flynn Medical Ltd Portakabin Ireland Quitmann O’Neill Source BioScience

DOCUMENTATION SOLUTIONS

EVAPORATORS

Charles River Microbial Solutions Kuehne + Nagel TWi

Cross Technical Solutions Dawsongroup | TCS Ireland Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Labplan Mason Technology

DRAINS AQS Environmental Solutions Foltech Engineering Ltd

DRUMS / CONTAINERS AbsorboPak CMS Chemstore Engineering Ltd Complas Packaging Ltd Corcoran Products Ltd Interpac National Chemical Company Quitmann O’Neill

ECONOMIC DEVELOPMENT AGENCY IDA Ireland

EDUCATION & TRAINING Charles River Microbial Solutions GS1 Ireland Mason Technology Pharmalex Reading Scientific Services Ltd Science Foundation Ireland (SFI) TWi Westbourne IT Global Services

EFFLUENT MONITORING / TREATMENT Carbon Group Mason Technology

ELECTRICAL Portakabin Ireland Tandem Project Management ltd.

EXPLOSION PROOFING CMS Chemstore Engineering Ltd Henley Forklift Group Limited Mason Technology

EXPLOSION PROTECTION / PANELS BS&B Safety Systems Ltd CMS Chemstore Engineering Ltd Henley Forklift Group Limited

EXTRUDERS BS&B Safety Systems Ltd

FACILITY DESIGN ATG Scientific Ltd Dawsongroup | TCS Ireland Pharmalex Tekpak Automation Ltd

FACILITIES MANAGEMENT AbsorboPak AQS Environmental Solutions Foltech Engineering Ltd O’Flynn Medical Ltd Quitmann O’Neill

FILLING EQUIPMENT Horan Automation Ortec Inc. Quitmann O’Neill Tekpak Automation Ltd

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GENERAL SUPPLIERS FILTERS

HEALTHCARE LOGISTICS

ISOLATORS

Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Mason Technology

Kuehne + Nagel

Foltech Engineering Ltd ProSys Containment and Sampling Technology

FILTRATION Associated Chemicals Ltd Fisher Scientific Ireland Ltd Mason Technology

FIRE DETECTION / PREVENTION / PROTECTION BS&B Safety Systems Ltd

FLAME ARRESTERS

HEALTH & SAFETY / FIRST AID Charles River Microbial Solutions Hazchem Training Ltd Tandem Project Management ltd.

HEAT EXCHANGERS BS&B Safety Systems Ltd Cross Technical Solutions Flexachem Manufacturing Ltd Labplan

HEATERS

BS&B Safety Systems Ltd Flexachem Manufacturing Ltd

Ballinlough Pharma Solutions CMS Chemstore Engineering Ltd Mason Technology

FLEXCO PLATES

HOMOGENISERS

Holfeld Graphics

FLOW CONTROL Bonner Endress & Hauser (Ireland) Ltd Flexachem Manufacturing Ltd Horan Automation Mason Technology

FLUID HANDLING Horan Automation Interpac Labplan ProSys Containment and Sampling Technology Quitmann O’Neill

FUME CUPBOARDS Fisher Scientific Ireland Ltd Foltech Engineering Ltd Mason Technology

FURNACES Fisher Scientific Ireland Ltd Mason Technology Scientific Instruments Ireland

GAS DETECTION Bonner CMS Chemstore Engineering Ltd Fisher Scientific Ireland Ltd

GAS SUPPLY Corcoran Products Ltd Scientific Instruments Ireland

GAUGES BS&B Safety Systems Ltd Fisher Scientific Ireland Ltd

GENERATORS Dawsongroup | TCS Ireland Mason Technology Scientific Instruments Ireland

GLASSWARE

Associated Chemicals Ltd Fisher Scientific Ireland Ltd Mason Technology Quitmann O’Neill

GRINDING Fisher Scientific Ireland Ltd

HAZARDOUS WASTE DISPOSAL INGREDIENTS

Chemishield Indaver Ireland Interpac Quitmann O’Neill

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Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd

HOSES Mason Technology

HUMIDITY / HUMIDIFIERS AbsorboPak Ballinlough Pharma Solutions Cross Technical Solutions Dawsongroup | TCS Ireland Interpac Mason Technology Source BioScience

HYGIENIC DIAPHRAGM VALVES

LABELLING CMS Chemstore Engineering Ltd DHL Supply Chain Horan Automation Tekpak Automation Ltd

LAB IT Mason Technology Westbourne Global IT ServicesS

UPPLIERS LABORATORY EQUIPMENT / SUPPLIERS

ATG Scientific Ltd Charles River Microbial Solutions Chemishield CMS Chemstore Engineering Ltd Fisher Scientific Ireland Ltd Labplan Mason Technology Micro-Bio Ireland Ltd O’Flynn Medical Ltd Particular Sciences Ltd Portakabin Ireland ProSys Containment and Sampling Technology Scientific Instruments Ireland Solv-Echem Ireland Ltd

LABORATORY MOBILE BENCHES ATG Scientific Ltd

Flexachem Manufacturing Ltd

LABORATORY SERVICES

INCUBATORS

Charles River Laboratories Ireland Ltd CMS Chemstore Engineering Ltd Eurofins Biopharma Product Testing GI Chemicals Mason Technology Nelipak Healthcare Packaging Reading Scientific Services Ltd Westbourne Global IT Services

Ballinlough Pharma Solutions Charles River Microbial Solutions Cross Technical Solutions Dawsongroup | TCS Ireland Fisher Scientific Ireland Ltd Mason Technology ProSys Containment and Sampling Technology

INJECTION MOULDING Horan Automation Quitmann O’Neill

INSPECTION EQUIPMENT Holfeld Graphics Horan Automation Mason Technology O’Flynn Medical Ltd Tekpak Automation Ltd

INSTRUMENTATION ATG Scientific Ltd BS&B Safety Systems Ltd Charles River Microbial Solutions Endress & Hauser (Ireland) Ltd Horan Automation Labplan LotusWorks Mason Technology Scientific Instruments Ireland

IT Charles River Microbial Solutions Westbourne Global IT Services

INVESTMENT IDA Ireland

INVESTMENT PROMOTION AGENCY IDA Ireland

LIFT TABLES Horan Automation

LIQUID FILLING & CAPPING ATG Scientific Ltd Horan Automation Tekpak Automation Ltd

LOGISTICS AbsorboPak AQS Environmental Solutions Ballinlough Pharma Solutions Charles River Laboratories Ireland Ltd Chemco Ireland Ltd Dawsongroup | TCS Ireland DHL Supply Chain Kuehne + Nagel Portakabin Ireland Quitmann O’Neill Solv-Echem Ireland Ltd UPS Healthcare

MACHINE TOOLS Horan Automation Lister Machine Tools Ltd

MAINTENANCE AQS Environmental Solutions Bonner Cross Technical Solutions Endress & Hauser (Ireland) Ltd Irish PharmaChem | Industry Buyers Guide 2024

GENERAL SUPPLIERS Horan Automation LotusWorks Mason Technology Particular Sciences Ltd Source BioScience

MANUFACTURERS Abbvie Amneal BS&B Safety Systems Ltd Horan Automation Hovione IDA Ireland Micro-Bio Ireland Ltd Portakabin Ireland Ltd Quitmann O’Neill Source BioScience Tekpak Automation Ltd

MATERIALS HANDLING / FORKLFTS / PALLET TRUCKS AbsorboPak Ballinlough Pharma Solutions Henley Forklift Group Limited Horan Automation Interpac Portakabin Ireland Toyota Material Handling Ireland Ltd

Scientific Instruments Ireland

PARTICLE SIZING SURFACE AREA

MILLING

Particular Sciences Ltd Reading Scientific Services Ltd

Fisher Scientific Ireland Ltd Mason Technology SK Pharmteco

MIXERS Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Mason Technology

NOISE / ODOUR CONTROL AbsorboPak Associated Chemicals Ltd ATG Scientific Ltd Flexachem Manufacturing Ltd

NON-HAZARDOUS WASTE DISPOSAL/RECOVERY

PHARMACEUTICAL FABRICATION Charles River Microbial Solutions IDA Ireland ProSys Containment and Sampling Technology

PHARMACEUTICAL MANUFACTURE Abbvie Amneal LotusWorks Mallinckrodt Pharmaceuticals Mason Technology SK Pharmteco

PICK & PLACE MACHINES Tekpak Automation Ltd

Indaver Ireland

PIPES / CORES

NON-HAZARDOUS WASTE MANAGEMENT

Mason Technology Quitmann O’Neill Smurfit Kappa Ireland

Indaver Ireland

PLASTIC CONTAINERS

MECHANICAL ENGINEERING SERVICES

NON-HAZARDOUS WASTE TREATMENT

Foltech Engineering Ltd LotusWorks Portakabin Ireland Tandem Project Management ltd Tekpak Automation Ltd

Indaver Ireland

Mason Technology Interpac Nelipak Healthcare Packaging PrimePac Ltd Quitmann O’Neill

MECHANICAL & PROCESS ENGINEERING Endress & Hauser (Ireland) Ltd Foltech Engineering Ltd Horan Automation LotusWorks Tandem Project Management ltd.

MEDICAL DEVICE MANUFACTURE B. Braun Medical Charles River Microbial Solutions Horan Automation LotusWorks Mallinckrodt Pharmaceuticals Mason Technology Ortec Inc. Tekpak Automation Ltd

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

METERS Fisher Scientific Ireland Ltd Mason Technology

MICRO QC Charles River Microbial Solutions Mason Technology Reading Scientific Services Ltd

MICROSCOPES Fisher Scientific Ireland Ltd Mason Technology Particular Sciences Ltd

OEM MANUFACTURING B. Braun Medical Foltech Engineering Ltd IDA Ireland Mason Technology

Quitmann O’Neill Smurfit Kappa Ireland

PACKAGING / BLENDING UNDER GMP

PNEUMATICS

National Chemical Company

PACKAGING / DESIGN Charles Tennant & Co Ltd Complas Packaging Ltd Holfeld Graphics IDA Ireland Interpac Kuehne + Nagel Limerick Packaging Nelipak Healthcare Packaging Quitmann O’Neill Tekpak Automation Ltd UPS Healthcare

PACKAGING / MACHINERY AbsorboPak Horan Automation IDA Ireland Interpac NPP Group Ltd Limerick Packaging Nelipak Healthcare Packaging Quitmann O’Neill Smurfit Kappa Ireland Tekpak Automation Ltd

PALLETS Ballinlough Pharma Solutions Interpac Quitmann O’Neill Tekpak Automation Ltd

MICROWAVE TECHNOLOGY

PALLETISING / DEPALLETISING

Mason Technology

Tekpak Automation Ltd

Irish PharmaChem | Industry Buyers Guide 2024

PLASTIC CORES / TUBES

Flexachem Manufacturing Ltd Horan Automation Mason Technology

POWDER HANDLING AQS Environmental Solutions Dawsongroup | TCS Ireland Foltech Engineering Ltd Interpac Mason Technology ProSys Containment and Sampling Technology Quitmann O’Neill

PRESSURE MEASUREMENT / SWITCHES / VESSELS

BS&B Safety Systems Ltd Flexachem Manufacturing Ltd Horan Automation Mason Technology

PRESSURE RELIEF BS&B Safety Systems Ltd Flexachem Manufacturing Ltd

PRINT PACKAGING Horan Automation Limerick Packaging Quitmann O’Neill

PROCESS CONTROL Bonner BS&B Safety Systems Ltd Charles River Microbial Solutions Dawsongroup | TCS Ireland Horan Automation Mason Technology

125

GENERAL SUPPLIERS O’Flynn Medical Ltd Scientific Instruments Ireland

PROCESS DESIGN Bonner BS&B Safety Systems Ltd Pharmalex Tandem Project Management ltd.

PROCESS & MECHANICAL ENGINEERING CONTRACTORS Bonner

Q1 Scientific Source BioScience

RENEWABLE ENERGY Astatine Dawsongroup | TCS Ireland Sustainable Energy Authority of Ireland

RESEARCH FUNDING Pharmaceutical Manufacturing Technology Centre (PMTC) Science Foundation Ireland (SFI)

PROJECT MANAGEMENT

RESPIRATORY PHARMACEUTICALS

Astatine Chemishield Horan Automation Pharmalex Reading Scientific Services Ltd Tandem Project Management Ltd

Mason Technology Reading Scientific Services Ltd Teva Pharmaceuticals Ireland

PROTECTIVE CLOTHING / APPARATUS O’Flynn Medical Ltd ProSys Containment and Sampling Technology

ROBOTICS Charles River Microbial Solutions KUKA Robotics Ireland Ltd Labplan Tekpak Automation Ltd

SANITARY TUBING

PUMPS

Flexachem Manufacturing Ltd

Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Horan Automation Mason Technology Quitmann O’Neill

SCADA /DCS / MIS

QC RELEASE TESTING

Bonner Horan Automation ProSys Containment and Sampling Technology Tekpak Automation Ltd

Charles River Laboratories Ireland Ltd

SCREENS

QUALITY & COMPLIANCE

Horan Automation

AbsorboPak Charles River Microbial Solutions Chemifloc Ltd LotusWorks Mason Technology Pharmalex ProSys Containment and Sampling Technology Reading Scientific Services Ltd SK Pharmteco Westbourne Global IT Services

R&D Almac Sciences Ltd ATG Scientific Ltd Charles River Microbial Solutions Chemifloc Ltd IDA Ireland Mason Technology Pharmaceutical Manufacturing Technology Centre (PMTC) ProSys Containment and Sampling Technology Reading Scientific Services Ltd SK Pharmteco Synthesis and Solid State Pharmaceutical Centre

REACTORS Flexachem Manufacturing Ltd Mason Technology

RECRUITMENT Chemishield ICDS Recruitment Consultants Tandem Project Management ltd.

REFRIGERATION / FREEZING Ballinlough Pharma Solutions Cross Technical Solutions CRS Pharma Solutions Dawsongroup | TCS Ireland Fisher Scientific Ireland Ltd Mason Technology

126

SCRUBBERS Dawsongroup | TCS Ireland Flexachem Manufacturing Ltd

SEALS & GASKETS Flexachem Manufacturing Ltd Mason Technology

SIEVING Fisher Scientific Ireland Ltd Particular Sciences Ltd

SLEEVE / STRETCH WRAPPING Horan Automation

SOFTWARE Ballinlough Pharma Solutions Charles River Microbial Solutions Chemishield CMS Chemstore Engineering Ltd Mason Technology Westbourne Global IT Services

SOLVENT RECOVERY / SERVICES Carbon Group

STABILITY STORAGE Almac Sciences Ltd ATG Scientific Ltd Ballinlough Pharma Solutions Charles River Laboratories Ireland Ltd Charles River Microbial Solutions CMS Chemstore Engineering Ltd Corcoran Products Ltd Cross Technical Solutions CRS Pharma Solutions Dawsongroup | TCS Ireland Eurofins Biopharma Product Testing

Kuehne + Nagel Mason Technology Q1 Scientific Reading Scientific Services Ltd SK Pharmteco Source BioScience

STABILITY TESTS Charles River Laboratories Ireland Ltd Eurofins Biopharma Product Testing Mason Technology Ortec Inc. Particular Sciences Ltd Reading Scientific Services Ltd SK Pharmteco

STAINLESS STEEL / FITTINGS / PRODUCTS CMS Chemstore Engineering Ltd Flexachem Manufacturing Ltd Foltech Engineering Ltd Henley Forklift Group Limited Interpac Mason Technology ProSys Containment and Sampling Technology Quitmann O’Neill

STEAM EQUIPMENT BS&B Safety Systems Ltd Flexachem Manufacturing Ltd Foltech Engineering Ltd

STERILITY TESTING Charles River Laboratories Ireland Ltd Charles River Microbial Solutions Eurofins Biopharma Product Testing Reading Scientific Services Ltd Source BioScience

STORAGE / BUNDING Ballinlough Pharma Solutions CMS Chemstore Engineering Ltd Charles River Microbial Solutions CRS Pharma Solutions Dawsongroup | TCS Ireland Interpac Kuehne + Nagel Quitmann O’Neill

STORAGE OF HAZARDOUS MATERIALS CMS Chemstore Engineering Ltd Corcoran Products Ltd CRS Pharma Solutions Dawsongroup | TCS Ireland Hazchem Training Ltd Indaver Ireland Kuehne + Nagel

STRAPPING EQUIPMENT AbsorboPak Horan Automation

SUPPLY CHAIN MANAGEMENT AbsorboPak Alexion Ballinlough Pharma Solutions Chemco Ireland Ltd DHL Supply Chain GS1 Ireland IDA Ireland Kuehne + Nagel KWE (Ireland) Ltd Limerick Packaging National Chemical Company Portakabin Ireland Quitmann O’Neill Solv-Echem Ireland Ltd Irish PharmaChem | Industry Buyers Guide 2024

GENERAL SUPPLIERS SURFACE PLASOMON RESONANCE

TUBE SETS / DISPOSABLES

WATER TREATMENT

ATG Scientific Ltd

Mason Technology Quitmann O’Neill

BS&B Safety Systems Ltd Charles River Microbial Solutions Chemco Ireland Ltd Chemifloc Ltd Flexachem Manufacturing Ltd GI Chemicals InOpSys Mason Technology Portakabin Ireland

TABLETING EQUIPMENT ATG Scientific Ltd Flexachem Manufacturing Ltd Horan Automation

TANKS Complas Packaging Ltd Flexachem Manufacturing Ltd Mason Technology Quitmann O’Neill

TEMPERATURE CONTROL Ballinlough Pharma Solutions Bonner CMS Chemstore Engineering Ltd Corcoran Products Ltd Cross Technical Solutions CRS Pharma Solutions Dawsongroup | TCS Ireland DHL Supply Chain Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd KWE (Ireland) Ltd Labplan LotusWorks Mason Technology Q1 Scientific Source BioScience

VACCINES Ballinlough Pharma Solutions Mason Technology MSD Ireland

VACUUM SYSTEMS BS&B Safety Systems Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Horan Automation Mason Technology Particular Sciences Ltd

VALVES Bonner BS&B Safety Systems Ltd Flexachem Manufacturing Ltd Foltech Engineering Ltd Horan Automation Mason Technology

VALIDATION

Almac Sciences Ltd ATG Scientific Ltd Bonner Charles River Laboratories Ireland Ltd Charles River Microbial Solutions Chemifloc Ltd CMS Chemstore Engineering Ltd Eurofins Biopharma Product Testing Mason Technology Reading Scientific Services Ltd SK Pharmteco

Almac Sciences Ltd Bonner Charles River Microbial Solutions Chemishield CRS Pharma Solutions Dawsongroup | TCS Ireland Horan Automation LotusWorks Mason Technology Pharmalex Reading Scientific Services Ltd SK Pharmteco Source BioScience Tandem Project Management ltd Tekpak Automation Ltd Westbourne IT Global Services

THERMAL IMAGING / THERMOGRAPHY

Cross Technical Solutions

TESTING SERVICES

Ballinlough Pharma Solutions Reading Scientific Services Ltd

TOOLS Charles River Microbial Solutions

TRAINING Hazchem Training Ltd Reading Scientific Services Ltd TWi

TRANSPORT & LOGISTICS AbsorboPak AQS Environmental Solutions Ballinlough Pharma Solutions CRS Pharma Solutions Dachser Ireland Ltd Dawsongroup | TCS Ireland DHL Supply Chain Hazchem Training Ltd Kuehne + Nagel KWE (Ireland) Ltd Quitmann O’Neill Skycell AG UPS Healthcare

TRAY HEAT SEALER Nelipak Healthcare Packaging Irish PharmaChem | Industry Buyers Guide 2024

WEIGHING Bonner Fisher Scientific Ireland Ltd Horan Automation Mason Technology Tekpak Automation Ltd

WORKWEAR O’Flynn Medical Ltd

WORKWEAR MANAGEMENT DISPENSING MACHINE O’Flynn Medical Ltd

VENTILATION VISION SYSTEMS Bonner Horan Automation KUKA Robotics Ireland Ltd Particular Sciences Ltd Tekpak Automation Ltd

WAREHOUSE MANAGEMENT CMS Chemstore Engineering Ltd Complas Packaging Ltd DHL Supply Chain Horan Automation Henley Forklift Group Limited Kuehne + Nagel Portakabin Ireland UPS Healthcare

WASTE MANAGEMENT / BALERS / RECYCLING AQS Environmental Solutions Indaver Ireland Quitmann O’Neill

WATER FOR INJECTION Mason Technology National Chemical Company

127

COMPANY LISTINGS A

arran

ABBVIE

Address: Tel: Address:

Tel: Business:

ABBVIE Sligo – Manorhamilton Road.

(071) 913 6600 14 Riverwalk, Citywest Business Campus, D24 XN32.

(01) 428 7900 Pharmaceutical.

ABSORBOPAK LTD

Address:

Tel: Email: Web: Business: Contact:

6 Main Street, Howth, Dublin, D13P2C1, Ireland. +353 (1) 6978733 info@absorbopak.com www.absorbopak.ie With our range of desiccants, we help clients all over the world prevent moisture damage.

Sé O'Leary, Sales / Technical Support

ALMAC SCIENCES LTD.

(FORMERLY BIOCLIN RESEARCH LABORATORIES) Address:

Tel: Fax: Email: Web: Business:

Contact:

IDA Technology & Business Park, Garrycastle, Athlone, Ireland, N37 X061. +353 (0)90 646 0200 +353 (0)90 646 0210 almacanalytical@almacgroup.com www.almacgroup.com Analytical services provider in GMP / GLP environments across UK, Europe and US with significant experience in the analysis of small, large and bio logic molecules. Our state of the art labs support drug substance (API), drug product (finished product) analytics across all phases of clinical development and into commercial release.

Business Development: Chris Merrick

ARRAN CHEMICAL COMPANY Address: Monksland Industrial Estate, Athlone, Co. Roscommon, N37 DN24, Ireland.

Tel: +353 (0) 90 644 5700 Email: info@arranchemical.ie Web: www.arranchemical.ie Business: Fine chemical company specialising in the manufacture of products for Pharma, Healthcare, Flavour/ Fragrance & other specialised chemicals & industrial applications.

Contact: Business Development Manager: Gareth Maguire.

ACTYLIS

Address:

Grange Business Park, Skule Hill, Fedamore, Co. Limerick Tel: (061) 574 404 biopharma@actylis.com Email: Web: www.actylis.com Business: Actylis is a global GMP manufacturer of Excipients, APIs and PIs, Process and Cleaning Solutions, Buffers, Cell Culture Ingredients, Amino Acids & Cell and Gene Therapy Ingredients.

Contact: biopharma@actylis.com

ASGARD CLEANING SOLUTIONS

AMNEAL IRELAND LIMITED Address: Cashel Road, Cashel, Co. Tipperary.

Tel: +353 (0) 62 27000 Email: careers.cashel@amneal.com Web: www.amneal.com/cashel Business: Pharmaceutical Manufacture.

Contact: VP Operations, Ireland: Niall Prendergast

Address: 2E Purcellsinch Industrial Estate, Dublin Road, Kilkenny, R95 D882.

Tel: +353 56 7771771 Email: enquiries@asgardcleanrooms.com Web: www.asgardcleanrooms.com Business: Cleanroom Design & Construction.

Contact: Group VP / Director Business Development & Marketing: Jimmy Blaney

ASSOCIATED CHEMICALS LTD ALEXION, ASTRAZENECA RARE DISEASE

Address:

College Business & Technology Park, Blanchardstown, Dublin 15, D15 R925.

Tel: (01) 254 6400 julie.carney@alexion.com Email: Web: www.alexion.com Business: Pharmaceutical.

Contact: Site Operations Coordinator: Julie Carney

128

AQS ENVIRONMENTAL SOLUTIONS

Address: Castletown, Galmoy (via Thurles), Co. Kilkenny.

Tel: +353 (0)504 57800 Email: info@aqssolutions.ie Web: www.aqssolutions.ie Business: Provider of drainage, industrial cleaning, waste management and processing services.

Contact: Commercial Director: Stan O’Reilly

Address: 16D Euro Business Park, Little Island, Co. Cork, Ireland.

Tel: +353 (0) 21 4351014 Email: info@acl.ie Web: www.associatedchemical.wixsite.com Business: Chemical Suppliers.

Contact: Managing Director: Sylvester Cotter

Irish PharmaChem | Industry Buyers Guide 2024

COMPANY LISTINGS

BARENTZ IRELAND LTD

ASTATINE Address: Suite 301, Guinness Enterprise Centre, Dublin 8, D08 T1WY. Tel: (01) 525 3006 Email: anthony.glynn@astatine.ie Web: www.astatine.ie Main Products & Services: Solar PV and High Temperature Heat Pump Installation.

Contact: Sales and Marketing Director: Anthony Glynn

ATG SCIENTIFIC LTD

Address: Oxford Centre for Innovation, New Road, Oxford, OX1 1BY, United Kingdom.

Tel: +44 (0) 1865 261423 Email: enquiries@atgscientific.co.uk Web: www.atgscientific.co.uk Business: Supply of Laboratory Products and Equipment Solutions.

Contact: Andrew Graham

AZELIS IRELAND LIMITED

Address:

Tel: Fax: Email: Business: Contact:

Unit 23, Sandyford Office Park, Blackthorn Avenue, Sandyford Industrial Estate, Foxrock, Dublin D18 X9X7.

(01) 295 6977 (01) 295 8338 graeme.locke@azelis.ie Chemical Distributor.

Managing Director: Graeme Locke

Address: Block S, Grants View, Greenogue Business Park, Rathcoole, Co. Dublin.

Tel: +353 1 4039518 Fax: +353 1 4039519 Email: pharmaireland@barentz.com Web: www.barentz.com Business: Distributor of excipients, amino acids and APIs to the Pharmaceutical, Nutraceutical & Biopharma industries in Ireland.

Contact: Sales Manager: Storme Delaney

Email: Web:

Singapore, London & Dubai.

(01) 872 4666 (021) 428 9600 info@Berkley-group.com www.berkeley-group.com

Email: Web: Business:

Contact:

Irish PharmaChem | Industry Buyers Guide 2024

Contact:

+353 (0) 1 401 3500

dublin.sales@brenntag.ie www.brenntag.ie Chemical Suppliers & Distributors.

Evelyn O'Connor: evelyn.o'connor@brenntag.ie Cole Carroll: colman.carroll@brenntag.ie

BONNER

BS&B SAFETY SYSTEMS LTD Address: Tel: Fax: Email: Web: Business:

INSTRUMENTATION, CALIBRATION AND AUTOMATION SOLUTIONS Address: Tel: Fax: Email: Web: Business:

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

(01) 450 5050 (01) 450 5183 contact@bonner.ie www.bonner.ie Instrumentation, Calibration and Automation Solutions including calibration, maintenance, temperature mapping and automation systems including SCADA, DCS and MES. Instrumentation product sales from international manufacturers.

Managing Director: Patrick M Bonner Service Manager: Roddy Jefferson Automation Solutions: Darren Roche

BALLINLOUGH PHARMA SOLUTIONS

Tel:

Tel: Email: Web: Business:

Unit 405, Greenogue Business Park, Rathcoole, Dublin 24.

Dublin: 20 Harcourt Street, Dublin 2.

Cork: 3 Watergold, Douglas, Cork.

International Offices: Tel:

Contact:

Clondalkin, Dublin, Annacarton Bridge, Co. Cork & Ballinlough, Co. Roscommon.

Dublin (01) 460 0322 Cork (021) 488 2077 Roscommon (094) 964 0045 info@brltd.ie www.brltd.ie Suppliers of Thermo King Pharma Transport Refrigeration.

Sales - Service - Parts Joe Malone

Address:

BERKLEY GROUP Address:

B

Address:

BRENNTAG IRELAND

Contact:

Raheen Business Park, Limerick, Ireland V94 N4V2.

(061) 484 700 (061) 304 774 sales@bsb.ie www.bsbsafety.com Design, manufacture and supply of Pressure Relief Devices such as rupture disks, safety heads, custom engineered products, explosion vents, flame arresters, breather valves, safety valves and more.

Regional Sales Manager: Patrick Murphy

C

CALLAGHAN | RED ENGINEERING B. BRAUN MEDICAL Address: 3 Naas Road Industrial Park, Dublin 12.

Tel: (01) 709 1800 Email: robert.bannon@bbraun.com Web: www.bbraun.ie Business: OEM manufacturing.

Contact: Sales Consultant: Robert Bannon

Address:

Tel: Email: Web: Business: Contact:

Sobo Works, 2 Windmill Lane, Sir John Rogerson's Quay,

Dublin Docklands, Dublin 2, D02 K156.

(01) 661 4420 dublin@red-eng.com www.calleng.ie Engineering & Project Management Company.

Director: Killian O'Neill

129

COMPANY LISTINGS

CAMIDA LTD Address: Tel: Email: Web: Contact:

New Quay, Clonmel, Co. Tipperary, E91 YV66, Ireland. +353 52 6125455 info@camida.com www.camida.com Company Secretary: Deirdre McGrath

CERTIFICATION EUROPE LIMITED Address:

Tel: Web: Business:

Contact:

Block 20A, Beckett Way, Park West Business Park, Dublin 12, D12 P8R2.

(01) 270 7973 www.certificationeurope.com ISO Management Standards Certification body for ISO 9001, 14001, 45001, 50001, 27001, 22301 and 20000-1.

Holly Fitzpatrick, Sales and Marketing Manager

CHEMCO IRELAND LIMITED Address:

Tel: Email: Web:

Unit 2, Stadium Business Park, Ballycoolin, Cappagh, Dublin 11, D11 X205. +353 (0)1 829 3600 info@chemco.ie www.chemco.ie

CARA PARTNERS Address: Tel: Email: Business: Contact:

Little Island Industrial Estate, County Cork.

(021) 4520500 mkirk@carapartners.ie Pharmaceuticals.

Site Head: Michael Kirk

CHARLES RIVER LABORATORIES IRELAND LTD Address:

Email: Web: Business:

Carrentrila, Ballina, Co. Mayo, F26 D786, Ireland. askcharlesriver@crl.com criver.com/biologics Biologics Testing Solutions.

CHEMIFLOC GROUP: CHEMIFLOC, GI CHEMICALS, CHEMILABS Address: Tel: Fax: Email: Web: Business:

CARBON GROUP Address: Tel: Mobile: Fax: Email: Web: Business: Contact:

Ringaskiddy, Co. Cork, P43 R772. +353 (0)21 437 8988 +353 (0) 86 2612 485 +353 (0)21 437 8950 carol.deegan@carbon.ie sales@carbon.ie www.carbon.ie Pharma/biopharma chemicals.

Area Sales Manager: Carol Deegan

CHARLES RIVER MICROBIAL SOLUTIONS INTERNATIONAL LTD Address:

Email: Web: Business:

49, Greenogue Business Park, Jordanstown Ave, Jordanstown, Rathcoole, Co. Dublin, D24 NF21, Ireland. askcharlesriver@crl.com criver.com/microbial Micro QC.

Contact:

CHEMISHIELD Address: Tel: Email: Web: Business: Contact:

CENTRAL PUMP SUPPLIES

Address:

Tel: Email: Web: Business: Contact:

Unit 21, Primeside Park, Kilshane Way, Ballycoolin, Dublin15.

(01) 861 2326 info@centralpumpsupplies.com www.centralpumpsupplies.com Appliances, Electrical, and Electronics Manufacturing.

Sales/Digital Marketing Assistant: Beatriz Baldiviezo

CHARLES TENNANT & CO LTD Address: Tel: Email: Web: Business:

Unit J, Aerodrome Business Park, Co. Dublin.

(01) 451 4099 info@ctennant.ie www.charlestennant.com Chemical and Packaging supplier.

Arc Labs, Carriganore, Waterford. +353 (0)51 576 025 sales@chemishield.com www.chemishield.com Software & Life Sciences Consultancy.

Commerical Director: Kevin Walsh

CMS CHEMSTORE ENGINEERING LTD. Address:

Tel: Email: Web: Business:

130

Smithstown Ind Est, Shannon, Foynes Port, Limerick.

061 708699; 069 65318 (GI) +353 61 708653 info@chemifloc.ie info@gichemicals.ie chemifloc.ie; gichemicals.ie Chemifloc: Water Treatment GI: Industrial Chemicals Chemilab: Technical Services Gary Palmer, Business Development

Clondrinagh Industrial Estate, Ennis Road, Limerick, V94 XT27.

(061) 327 792 sales@chemstore.ie www.chemstore.ie Solutions provider for the safe storage and management of Hazardous Materials.

Irish PharmaChem | Industry Buyers Guide 2024

COMPANY LISTINGS COM-PLAS INTERNATIONAL Address: Tel: Email: Web:

Southern Link Business Park, Naas, Co. Kildare.

(045) 874 088/9 sales@complas.ie www.complas.ie

D

CROSS TECHNICAL SOLUTIONS Address:

CORCORAN CHEMICALS LTD

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

17 Parkgate Street, D08 NRP2.

(01) 633 0400 (01) 679 3521 info@corcoran-group.com www.corcoran-group.com Distributors of raw materials for the food, pharmaceutical, polymer & chemical industry.

Sales

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

9/10 Broomhill Road, Tallaght, Dublin 24.

(01) 405 6777 (01) 413 6932 sales@ctsolutions.org www.crosstechnicalsolutions.ie Refrigeration.

Technical Director: Jonathan McGrath General Manager: Jason Keating

DACHSER IRELAND LTD

Address:

Tel: Email: Web: Business:

CORCORAN PRODUCTS (IRL) LTD

Address:

Tel: Email: Web: Business: Contact:

Unit 12, Northern Cross Business Park, Finglas, D11 DC67.

(01) 864 4422 info@corcoran-group.com www.corcoran-group.com Suppliers of packaging to the food, pharmaceutical and chemical industry.

Derek Lennon

CPI TECHNOLOGY LTD

Address:

Tel: Email: Web: Business: Contact:

CPL

Address:

Tel: Email: Web: Business:

1-5 Eastgate Drive, Eastgate Retail Park, Little Island, Co. Cork, T45 A433.

(021) 435 4690 info@cpitechnology.com www.cpitechnology.com Providers of Process Equipment.

Managing Director: Adrian Giltinan

Ground Floor, One Haddington Buildings, Haddington Road, Dublin 4, D04 X4C9.

(01) 614 6000 hello@talentevolutiongroup.com www.cpl.com/ie Specialised talent and recruitment solutions company.

CRS PHARMA SOLUTIONS Address:

Tel:

Email: Web: Business:

Contact:

Ireland HQ: Summerhill Enterprise Centre, Summerhill, Co. Meath, A83 XE40.

UK HQ: Unit 3, Thornton Park, North Road, Ellesmere Port, CH65 1AB. Ireland: +353 (0) 46 943 5000 UK: 0800 085 2298 info@crspharmasolutions.ie www.crspharmasolutions.ie Climate controlled storage specialists. Internal coldroom and freezer installations with temperatures ranging from -65°C to +60°C. Close control temperature and humidity stores, stability chambers, incubators, Atex cold stores, dual redundant cooling systems with integral back-up generators, blast freezers, freezers for fast freezing of phase change materials (Eutetic plates and gel packs).

Technical Director: Patrick Tyrrell

DAWSON GROUP | TCS IRELAND Address: Tel: Email: Web: Business:

Contact:

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

(045) 448 810 christianvisser@dawsongroup.ie www.dawsongroup.ie Temperature Controlled Solutions. Clean rooms, Stability chambers -70c to +60c, ATEX Modular Solutions, Humidity control, Test Chambers, Blast Freezers (gel packs / Eutectic plates), Hybrid Generators.

Business Development: Christian Visser

DHL SUPPLY CHAIN Address:

Tel: Email: Web:

Business: Contact:

Irish PharmaChem | Industry Buyers Guide 2024

Blackchurch Business Park, Rathcoole, Co. Dublin, D24 C796. +353 1 401 3333 dachser.ireland@dachser.com www.dachser.ie Founded in 1930, DACHSER is a global market leader in logistic services with a revenue of €7.1 billion. With our comprehensive European road transport network of system and charter service, as well as a homogeneous structure of branches, subsidiaries and partner companies, we will support you in fulfilling your logistics requirements reliably, cost-effectively and on time.

We transport your groupage, your full or partial loads and manage your procurement and distribution, both Europe-wide and national, to the highest level.

Unit 1 Quantum Distribution Park, Kilshane Cross, Dublin, D11 KV1W, Ireland. & Unit B1 Horizon Logistics Park, Harristown, Co. Dublin, K67 N5C3, Ireland.

086 0665865 john.halpin@dhl.com http://www.dhl.com/globalen/home/our-divisions/ supply-chain/sectors-overview/ life-sciences-and-healthcare.html Supply Chain & Logistics.

Business Development Manager, Life Sciences: John Halpin

131

COMPANY LISTINGS

DORNAN ENGINEERING LTD Address: Tel: Email: Web: Business:

Contact:

10 Eastgate Ave, Eastgate, Little Island, Cork, T45 PC63.

00353 212 330 900 alyson.murphy@dornangroup.com www.dornan.ie Dornan Group is a wellestablished mechanical, electrical and HVAC engineering and construction company, with major project experience across a wide range of sectors in Europe.

Business Development Coordinator: Alyson Murphy

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

Address:

Tel: Email: Web:

Clogherane, Dungarvan, Co. Waterford, X35 T628, Ireland. +353 (0) 58 48300 EurofinsBPT-IE@eurofins.ie www.eurofins.ie/biopharma-services

ELI LILLY KINSALE Address:

Dunderrow, Kinsale,

Tel: Email: Web: Business: Contact:

Co. Cork 085 878 3827 ezara.ahern@network.lilly.com www.lilly.co/ie Pharmaceutical.

External Communications: Ezara Ahern

Address:

Tel: Email: Web: Business:

Contact:

Tel: Email: Web: Business: Contact:

GRAHAM HART (PROCESS TECHNOLOGY) LTD Tel: Email: Web:

FISHER SCIENTIFIC IRELAND LTD Address:

Address: Tel: Email: Web: Business:

Contact:

132

Unit 6, Dunboyne Business Park, Dunboyne, Co. Meath, W86 WP74 (01) 801 3770

Tel: Email: Web: Business:

ireland@ellab.com

www.ellab.com Complete solutions provider to the Biotech and Pharma sectors offering validation & calibration services, monitoring solutions & product sales.

Sales Director: Peter Keane

Friars Industrial Estate, Bradford Road, Idle, Bradford, BD10 8SX, UK. (0044) 1274 617021 post@graham-hart.com www.graham-hart.com

GREENFIELD GLOBAL Address:

ELLAB

The Store House, Charleston Maltings, Midleton, Co. Cork.

(021) 463 9592 info@foltech.ie www.foltech.ie Mechanical Engineering.

Director: John Foley

G

Address:

F

Donnybrook Commercial Centre, Douglas, Cork, T12 X68Y. (021) 461 7200 sales@flexachem.com www.flexachem.com Mechanical Process Equipment Supplier - Pumps, Seals, Valves, Process Equipment, Biotech and Pharma Equipment and Technical Support.

Commercial Manager: Michael Bradley

FOLTECH ENGINEERING LTD

Address:

EUROFINS BIOPHARMA PRODUCT TESTING

E

FLEXACHEM MANUFACTURING LTD

Contact:

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64.

(01) 885 5854 fsie.sales@thermofisher.com www.ie.fishersci.com Laboratory supplies, Chemicals, Consumables, Reagents, Equipment & Instruments.

Portfolio Manager: Gerry Fitzmaurice

Tel: Email: Web: Business: Contact:

IDA Business & Technology Park, Mountrath Road, Portlaoise, Co. Laois.

+353 (0) 57 8671400 Portlaoise.info@greenfield.com www.greenfield.com Excipients, Buffer Solutions and CIP Solutions producer.

Business Development Manager: Johnny Geraghty

GS1 IRELAND

Address:

Tel: Email: Web: Business:

Second Floor, The Merrion Centre, Nutley Lane, Donnybrook, Dublin 4.

(01) 208 0660 healthcare@gs1ie.org www.gs1ie.org/healthcare Global Supply Chain Standards Body.

Irish PharmaChem | Industry Buyers Guide 2024

COMPANY LISTINGS H

HOVIONE LTD Address:

HALEON

Address:

Tel: Email: Web: Business: Contact:

Clogherane, Knockbrack, Dungarvan, Co. Waterford

086 4081878 gillian.m.power@haleon.com www.haleon.com Healthcare manufacturer.

Business Manager/Comms & Engagement Lead: Gillian Power

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

Tel: Fax: Email: Web: Contact:

INDAVER IRELAND Address:

The Highline, 1st Floor, Bakers Point, Pottery Road, Dun Laoghaire, Co. Dublin, A96 KW29.

Tel: (01) 697 2900 Fax: (01) 633 5464 Email: info@indaver.ie Web: www.indaver.ie Business: Hazardous & nonhazardous waste disposal and recovery ensuring full compliance.

HUBBCAT HAZCHEM TRAINING LTD

Address:

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

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

Manager: Michelle Cleere

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

HENLEY FORKLIFT GROUP LIMITED Address: Tel: Web: Business:

Address:

Tel: Email: Business: Contact:

Block 2, Newtown & Business Enterprise Park, Newtownmountkennedy, Co. Wicklow.

+353 89 700 3476 niall.otoole@hubbcat.com Telecommunications.

COO: Niall O'Toole

I

Henley Industrial Park, Killeen Road, Dublin 10.

(01) 620 9200 www.henley.ie/pharma Forklift and warehousing equipment, sales, service, hire, parts, driver training, thorough examinations.

Address:

Tel: Email: Web: Business:

Connacht House, 24 Upper Fitzwilliam Street, Dublin 2. +353 1 632 1200 info@icds.ie www.icds.ie Specialist Recruitment Consultants to the Pharmaceutical, Life Science, Chemical, Medical Device, Food and Technology sectors.

AUTOMATION & ROBOTICS OF

COMPLETE

SOLUTIONS

HORAN AUTOMATION AND ROBOTICS LIMITED

Address:

Tel: Email: Web: Business:

Contact:

Drangan, Thurles, Co Tipperary, E41 DA36.

(052) 915 2208 sales@horan.ie www.horan.ie Automation, Integration, Service, Packing, Palletising, Filling machinery, Robotics, Consulting, Design, Prototyping, Medical device assembly, Sub Component assembly.

Sales & Marketing Director: Gary Monks

Irish PharmaChem | Industry Buyers Guide 2024

Maanstraat 9B, 2800 Mechelen, Belgium.

Tel: +32495653821 Email: thomas.windels@inopsys.eu Web: www.inopsys.eu Business: Providing circular side stream solutions. Purifying water and recovering materials with mobile & modular installations.

Contact: Sales Manager: Thomas Windels

ICDS RECRUITMENT CONSULTANTS

HORAN SUPPLIERS

INOPSYS NV Address:

IDA IRELAND Address:

Three Park Place, Hatch Street Upper, Dublin 2.

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

INTERPAC Address:

67E Heather Road, Sandyford Industrial Estate, Sandyford, Dublin D18 NV90.

Tel: (01) 294 0600 Fax: (01) 294 0602 Email: ian@interpac.ie Web: www.interpac.ie Business: Supplier of packaging to the pharmaceutical, hazardous waste, food and dairy industries.

Contact: Director: Ian Sutton

INVEST NORTHERN IRELAND Address: Tel: Web: Business:

Bedford Square, Bedford Street, Belfast, BT2 7ES. (0044) 800 181 4422 www.investni.com Economic development agency.

133

COMPANY LISTINGS K

L

LABPLAN

Address:

KUEHNE + NAGEL IRELAND Address: Tel: Email: Web: Business: Contact:

Unit D2 Horizon Logistics Park, Harristown, Swords, Co. Dublin, K67 A5W6.

(01) 823 9777 Seamus.keane@kuehne-nagel.com ie.kuehne-nagel.com Global Freight Forwarding & Supply Chain Management.

Seamus Keane, National Business Development Manager - Healthcare Mob: +353 85 8666646

Tel: Email: Web: Business:

M

Allenwood Enterprise Park, Allenwood, Naas, Co Kildare.

(045) 870 560 info@labplan.ie www.labplan.ie Lab supplier of analytical instrumentation, services, technical support.

MACLACHLAN & DONALDSON Address: Tel: Email: Web: Business: Contact:

Unit 10, 4075 Kingswood Road, Citywest Business Campus, D24 (01) 676 3465 mail@maclachlan.ie www.maclachlan.ie Intellectual Property Attorneys.

Dr. Yvonne McKeown

LENNOX LABORATORY SUPPLIES LTD Address: Tel: Email: Web: Contact:

John F. Kennedy Drive, Naas Road, Dublin, D12FP79.

(01) 460 7600 customerservice@lennox.ie www.lennox.ie Padraig Callan, Head of Business Development

MASON TECHNOLOGY KUKA ROBOTICS IRELAND LTD. Address:

Unit 16, Brewery Business Park, Ardee Rd, Cambrickville, Dundalk, Co. Louth, A91 ATX4, Ireland.

Tel: Email: Web: Business: Contact:

(042) 939 5034 sales.ie@kuka.com www.kuka.com Industrial robotics & automation.

Managing Director KUKA IE: Brian Cooney

Your trusted Global Logistics Partner

KWE (Ireland) Ltd

GDP Wholesale Licence Holder Dublin Head Office & Temperature Controlled Warehouse Facility Address: Horizon Logistics Park, Harristown, Swords, Co. Dublin.

Tel: (01) 823 9600 Fax: (01) 836 1111 Email: kwedub@kwe.com Web: www.kwe.com Cork Regional Office & Warehouse Facility Address: South Ring West Business Park, Tramore Road, Cork.

Tel: (021) 497 5722 Fax: (021) 497 5727 Email: kweork@kwe.com

LIMERICK PACKAGING

Address:

Tel: Email: Web: Business:

Contact:

Tel: Fax: Email: Web: Business:

Contact:

228 South Circular Road, Dublin, D08 DX8P (01) 453 4422 (01) 415 4492 info@masontec.ie www.masontechnology.ie Provider of scientific and laboratory equipment, and technical services including installation and calibration.

Strategic Marketing Manager: Eilish Sutton

LISTER MACHINE TOOLS LTD Address: Tel: Email: Web: Business: Contact:

PO Box 838, Bluebell Industrial Estate, Dublin 12.

(01) 450 8866 sales@listermachinetools.com www.listermachinetools.com Supply of machine tools and ancilliary equipment, service and support.

Sales: Ryan McGrath

MICRO-BIO IRELAND LTD

Address:

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

Industrial Estate, Fermoy, Co. Cork (025) 31388 (025) 32458 info@micro-bio.ie www.micro-bio.ie Chemical Manufacturer.

Sales Director: Tom Tobin

LOTUSWORKS

Address:

Tel: Email: Web: Business:

134

Eastlink Business Park, Ballysimon Rd., Limerick.

(061) 400 035 info@lmkpkg.ie www.limerickpackaging.ie Packaging manufacturers, Distributors, Designers and Auditors.

Sales Director: Mike Boland

Address:

Building 3, Finisklin Business Park, Sligo, F91 KAP2.

(071) 916 9783 contactus@lotusworks.com www.lotusworks.com Engineering & Technical Solutions Provider.

Irish PharmaChem | Industry Buyers Guide 2024

COMPANY LISTINGS

MSD IRELAND Address:

Tel: Email: Web: Business:

Contact:

Red Oak North, South County Business Park, Leopardstown, Dublin 18. +353 (0)1 299 8700 info@msd.ie www.msd.ie MSD Ireland is one of the country’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and diverse team of over 2,800 employees currently across six sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow and Dublin, and, in addition, operate substantial Human Health and Animal Health businesses. At MSD Ireland, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. With a long-standing footprint in Ireland, our Irish sites manufacture approximately half of MSD’s top twenty products, helping save and enhance lives in over sixty countries around the world.

Mairead McCaul MSD Ireland (Human Health) LTD

NELIPAK HEALTHCARE PACKAGING

Address:

Tel: Address: Tel: Address:

Tel: Email: Web: Business:

Contact:

Galway: Unit 6D, Mervue Business Park, Mervue, Galway, H91 C9D0, Ireland.

(091) 757 152 Offaly: Kilbeggan Road, Clara, Co. Offaly, R35 F583, Ireland.

(057) 933 1888 Derry: 1 Acorn Road, Campsie Industrial Estate, Derry, BT47 3GQ, Northern Ireland.

0044 28 7181 4000 info@nelipak.com www.nelipak.com Innovative packaging solutions and complementary products and services for the healthcare market serving the medical and pharmaceutical sectors.

Director of Global Marketing: Sean Egan

NPP GROUP LTD Address: Tel: Email: Web: Business:

ORTEC INC. Address:

Newcastle West Business Park, Station Road, Newcastle West, Limerick, V42 E765.

Tel: Email: Web: Business: Contact:

+353 87 7752914 jgeraghty@ortecinc.com www.ortecinc.com Contract Manufacturing.

Business Development Manager: John Geraghty

P

THE PACKAGING CENTRE LTD

Address: Tel: Email: Web: Contact:

Unit 2, Vantage Business Park, Coldwinters, Dublin 11.

(01) 880 9299 sales@npp.ie bmcmahon@npp.ie www.npp.ie Flexible packaging suppliers & distributors.

PARTICULAR SCIENCES LTD

O

Address:

OCON CHEMICALS LTD

N

Address: Tel: Email: Web:

Unit 3, M.F.T. Business Park, Doughcloyne Ind. Estate, Sarsfield Road, Co. Cork.

(021) 431 8555 info@oconchemicals.com www.oconchemicals.ie

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

NATIONAL CHEMICAL COMPANY Address: Tel: Fax: Email: Web: Business: Contact:

NCC House, 42 Lower Leeson St., Dublin 2, D02 FX39.

(01) 613 1400 (01) 634 0132 sales@ncc.ie www.ncc.ie Supply Chain PartnerLife Sciences Industry.

Product Manager: Christy Smith

2 Birch House, Rosemount Business Park, Ballycoolin Road, Finglas, Dublin D11 T327.

(01) 820 5395 (01) 822 8813 info@particular.ie www.particular.ie Supply, service and support of laboratory equipment.

Business Development Manager: Donnchadha Quilty

O’FLYNN MEDICAL LTD Address:

Tel: Email: Web: Business:

Contact: Irish PharmaChem | Industry Buyers Guide 2024

Fox & Geese House, Naas Road, Dublin 22.

(01) 450 8759 sales@thepackagingcentre.ie www.thepackagingcentre.ie Managing Director: Ivan Powell

Macroom Environmental Park, Bowl Road, Macroom Co. Cork, P12 YD92.

(029) 21 799 info@oflynnmedical.com www.oflynnmedical.com Distributor of OSL “Automated Protective Clothing Distributor”.

Conor O’Flynn

PBC BIOMED

Address:

Tel: Email: Business: Contact:

4D, Western Business Park, Shannon, Co. Clare, V14 RW92 +353 86 1280618 bronagh@pbcbiomed.ie Medical device consultancy Ms Bronagh O'Doherty

135

COMPANY LISTINGS S

PHARMACEUTICAL MANUFACTURING TECHNOLOGY CENTRE (PMTC)

Address:

Tel: Email: Web: Business: Contact:

Bernal Institute, University of Limerick, Co. Limerick, V94 T9PX. 086 8530310 marlo.kearney@ul.ie pmtc.ie Research and development.

Centre Director: Sarah Hayes

PROSYS CONTAINMENT AND SAMPLING TECHNOLOGY Address: IDA Business Park, Carrigtohill, Co. Cork, Ireland, T45 AP82.

Tel: +353 21 4853900 Email: info@prosysgroup.com Web: www.prosysgroup.com Contact: Head of Global Sales: Michael Hennessy

SCIENCE FOUNDATION IRELAND (SFI) Address: Tel: Email: Web: Business: Contact:

3 Park Place, Hatch Street Upper, Dublin 2.

(01) 607 3200 info@sfi.ie www.sfi.ie Government funding agency for research.

Director - Strategy and Communications: Dr. Ruth Freeman

PHARMALEX Address: Tel: Web: Business:

Contact:

Suite 2, Stafford House, Strand Road, Portmarnock, Co. Dublin, D13 H525. +353 1 846 4742 www.pharmalex.com/ireland An award winning EU and US Quality, Technical & Compliance consultancy to the life science industry.

Commercial Manager: Anne Marie Purcell

Q

SCIENTIFIC INSTRUMENTS IRELAND

Address:

Q1 SCIENTIFIC

Address:

PORTAKABIN IRELAND Address: Tel: Web: Business:

Roseville Business Park, Turvey Avenue, Donabate, Co. Dublin.

(01) 960 9033 www.portakabin.ie Portakabin is the pioneer of modular construction in Europe, delivering interim and permanent bespoke buildings, of any size and to fulfil almost any application, site and design.

Portakabin has provided award-winning off-site built environments of outstanding quality, with unrivalled on time and on budget performance, for over 50 years.

87 Westside Business Park, Co. Waterford.

Tel: (051) 355977 Email: info.cqw@cambrex.com Web: www.q1scientific.com Business: Stability Storage (ICH/GMP).

Contact: Stephen Delaney, MD

Tel: Web: Business:

Building C, Athlone Business & Technology Park, Garrycastle, Athlone, Co. Westmeath.

(0906) 460 300 www.ppd.com Contract Research Organisation.

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

St. Brendan’s Road, Portumna, Co. Galway, H53 HX51.

(090) 9741148 sales@quitmannoneill.com www.quitmannoneill.com Packaging Disributor and Stockist.

David O’Neill

SK PHARMTECO Address: Watery Lane, Swords, Co. Dublin.

Tel: (01) 813 9000 Email: skpharmteco@sk.com Web: www.skpharmteco.com Business: Contract Development Manufacturing Organisation.

Contact: Director Business Development & Marketing: Brian Fairley

R

READING SCIENTIFIC SERVICES LIMITED

Address:

Tel: Web: Business:

136

Contact:

QUITMANN O’NEILL PACKAGING LTD

PPD, INC. Address:

Tel: Email: Web: Business:

Oulart House, Cullagheerva, Clonsilla, Dublin 15.

086 833 1056 (Jenny) info@siireland.ie www.siireland.ie Distribution and Service Support of Sample Preparation and Analytical Equipment.

Jenny Egan

The Reading Science Centre, Whiteknights Campus, Pepper Lane, Reading, Berkshire, RG6 6LA, UK. +44 (0) 118 918 4076 www.rssl.com Analytical Testing Laboratory.

Irish PharmaChem | Industry Buyers Guide 2024

COMPANY LISTINGS

SKYCELL AG Address: Tel: Email: Web: Business: Contact:

Bahnhofplatz 6300, Zug, Switzerland.

00 4144 533 2300 info@skycell.ch skycell.ch Pharmaceutical Logistics & Supply Chain Solutions.

Sales Department: sales@skycell.ch

SSPC, SFI RESEARCH CENTRE FOR PHARMACEUTICALS Address:

Web: Business: Contact:

Bernal Institute, University of Limerick, Limerick, Ireland. www.sspc.ie Pharma Research Centre.

Chief Operating Officer, Dr. Sarah Hayes

TEKPAK AUTOMATION LTD. Address: Tel: Email: Web: Business:

SMURFIT KAPPA IRELAND Address: Tel: Email: Web: Business:

Ballymount Road, Walkinstown, Dublin 12.

(01) 409 0000 info@smurfitkappa.ie www.smurfitkappa.ie Packaging.

SUSTAINABLE ENERGY AUTHORITY OF IRELAND Address: Tel: Email: Web: Business:

3 Park Place, Hatch Street Upper, Dublin 2.

(01) 808 2100 info@seai.ie www.seai.ie Energy advice & information.

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

Zone C, Clonmore, Mullingar Business Park, Mullingar, Co. Westmeath.

(044) 933 5133 (044) 934 5248 info@soltec.ie www.soltec.ie Solvent Recovery and Hazardous Waste Management Managing Director: Michael Corcoran

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

Great Island Industrial Park, Ballincollig, Co. Cork.

(021) 487 7066 info@solvechem.com www.solvechem.com Chemical distribution, chemicals, solvents, water treatment, warehousing.

T

TANDEM PROJECT MANAGEMENT LTD. Address:

Tel: Email: Web: Business:

SOURCE BIOSCIENCE

Address: Tel: Web:

Riverstown 5 Complex, Tramore, Republic of Ireland. +353 (0) 51 338435 www.sourcebioscience.com

Irish PharmaChem | Industry Buyers Guide 2024

Contact:

11 Nessan House, Mahon Industrial Estate, Blackrock, Cork, T12 XN4V. (021) 2038130 info@tandempm.ie www.tandempm.ie Tandem is an expert project management and engineering design consultancy successfully delivering to life science clients in Ireland, the UK and Europe.

Tandem’s results orientated services include project management, project controls, multi-disciplined engineering design, construction management, energy & carbon reduction and CQV. Tandem also provide client representative teams, operational readiness consultancy and talent solutions.

Customer Relations Manager: Linda Nugent 0876897995 linda.nugent@tandempm.ie

Contact:

Whitemill Industrial Estate, Wexford, Y35 A620, Ireland.

+353 (0)53 9163033 info@tekpak.ie www.tekpakautomation.com End-of-Line Automated Packaging Line Design, Manufacture, and Integration for High-Speed Retail Packaged Products and Pharmaceuticals. Tekpak Automation is Focused on the Life Sciences Industry range of pharmaceutical, biomedical, medical device, biotechnology, and cosmeceutical products. With Clients across Ireland, the UK, Europe, North America, Asia and the Middle East, Tekpak Automation can produce customised packaging machinery for product manufactures at any size or scale.

Automated Applications include Robotic Pick and Place Systems, Vertical and Horizontal Cartoning, Brite Stock Loading/Unloading from Trays, Stacking, Nesting and Collating, Feeding Product to a Flow Wrapper Infeed, Labelling (TE, Print and Apply, or Thermal Transfer), Batch Data Printing with Camera Verification, Carton and Case Erectors/Closers, Case Packing and Palletising, Machine Linking Conveyors with Signal Exchange, Integration of Serialisation and Aggregation Systems, 21 CFR Part 11 Ready Machines, GAMP 5 Project Management, GMP Design Features and Full Validation Documentation.

Tekpak also offers a complete range of after-sales support and service packages to reduce machine downtime and disruptions to maximise the return on investment.

Contact us today to assist with your next end-of-line automated packaging project.

Managing Director: John Kehoe

THERMO FISHER SCIENTIFIC CORK LTD Address: Tel: Email: Web: Business:

Currabinny, Carrigaline, Co Cork, P43 AY66.

(021) 437 8800 contactcork@thermofisher.com thermofisher.com/patheon Active Pharmaceutical Ingredient Contract Development and Manufacuring.

137

COMPANY LISTINGS

TWi

UPS HEALTHCARE

Address:

Address:

Unit 3, Mygan Park, Jamestown Road, Finglas, Dublin 11.

Tel: Email: Web: Business: Contact:

+44 7979 704423 ukiehealthcare@ups.com www.ups.com/ie/en/healthcare/Home.page Transport & Logsitics.

Healthcare Marketing Manager: Paul Scott

West Building, Carrigaline Industrial Park, Carrigaline, Co. Cork, Ireland, P43 HK76.

Tel: +353 (0)21 242 8800 Email: info@technicallywriteit.com Web: www.technicallywriteit.com Business: TWi is a team of content creators and content strategists supporting leading technology and life sciences companies to create ideal end-user experiences.

Contact: Business Development Manager: Emmet Kearney

W

U

WESTBOURNE IT GLOBAL SERVICES Address:

UNIVAR SOLUTIONS

Address:

536 Grants Crescent, Greenogue Business Park, Rathcoole, Co. Dublin.

Tel: (01) 401 9800 Email: irelandsalesoffice@univarsolutions.com Web: www.univarsolutions.com/pharma Business: Chemical Distribution.

Contact: Key Account Manager: Carla Byrne

The Rubicon Centre, MTU, Bishopstown, Co. Cork.

Tel: (021) 431 4310 Email: dennis.blanck@westbourneit.com Web: www.westbourneit.com Business: General IT and Laboratory IT Service Provider to the pharmaceutical industry in Ireland.

Contact: Business Development Manager: Dennis Blanck

WRENTECH LTD

Address:

Tel: Email: Web:

138

Unit 3, Innovation Park, Carrigaline Ind. Estate, Kilnagleary, Co. Cork.

(021) 483 2644 mwren@wrentech.ie www.wrentech.ie Irish PharmaChem | Industry Buyers Guide 2024

Advancing Innovative Pharmaceutical Ingredient Solutions Univar Solutions brings you a premier portfolio, distribution and logistics excellence, and advanced technical solutions.

Pharmaceutical manufacturers who are seeking a global specialty pharmaceutical ingredient solutions partner are turning to Univar Solutions for innovation and technical support, plus insights into forthcoming regulations, trends, and market dynamics.

Whether you need high-purity solvents for API synthesis, or APIs, excipients, reactants and intermediates, we have a portfolio of the most specialized and in-demand brands from leading suppliers around the globe. Together with our application, regulatory, and quality experts, we can develop solutions for your manufacturing challenges, improving total costs of operations while supporting your supply chain.

Contact us for customized ingredient and distribution solutions: +353 1 4019800 or Irelandsalesoffice@univarsolutions.com univarsolutions.com/pharma

Irish PharmaChem | Industry Buyers Guide 2024

139

USEFUL REFERENCES ACADEMY OF CLINICAL

ELECTRICITY SUPPLY

INSTITUTE OF CHEMISTRY

IRISH PHARMACY UNION

SCIENCE AND LABORATORY

BOARD

OF IRELAND

Tel: (01) 493 6401

MEDICINE

Tel: (01) 676 5831

E-mail:

E-mail: info@ipu.ie

Tel: (01) 905 9730

E-mail: esbnetworks@esb.ie

secretary@instituteofchemistry.org

Web: www.ipu.ie

E-mail: mail@acslm.ie

Web: www.esb.ie

Web: chemistryireland.org

ENTERPRISE

INTELLECTUAL PROPERTY OFFICE

IRELAND

OF IRELAND

Tel: (01) 727 2000

Tel: (056) 772 0111

Web: www.enterprise-ireland.com

E-mail: ipinfo@ipoi.gov.ie

Web: www.acslm.ie AN BORD PLEANALA Tel: (01) 858 8100 E-mail: bord@pleanala.ie Web: www.pleanala.ie

Web: www.ivca.ie

ENVIRONMENTAL HEALTH INTERNATIONAL SOCIETY

BIOPHARMACHEM

Tel: (01) 276 1211

FOR PHARMACEUTICAL

IRELAND

Web: www.ehai.ie

ENGINERING (ISPE)

E-mail: info@ibec.ie

ENVIRONMENTAL

E-mail: ask@ispe.org

Web: www.biopharmachemireland.ie

PROTECTION AGENCY

Tel: (01) 605 1500

Web: www.epa.ie

Tel: (01) 400 4300 E-mail: info@chambers.ie Web: www.chambers.ie COMPANIES REGISTRATION OFFICE Tel: (01) 804 5200 LoCall: 0818 452 000

HEALTH AND SAFETY

Tel: (01) 874 6321 E-mail: mandate@mandate.ie Web: www.mandate.ie

Tel: +1 (813) 960 2105

NATIONAL INSTITUTE

Web: www.ispe.org

FOR TRANSPORT

LoCall: 0818 289 389 E-mail: contactus@hsa.ie Web: www.hsa.ie HEALTH PRODUCTS

E-mail: cro.info@enterprise.gov.ie

REGULATORY AUTHORITY

Web: www.cro.ie

Tel: (01) 676 4971 E-mail: info@hpra.ie

DEPARTMENT OF THE ENVIRONMENT,

Web: www.hpra.ie

CLIMATE ACTION AND COMMUNICATIONS

HEALTH RESEARCH

Tel: (01) 678 2000

BOARD

E-mail: customer.service@decc.gov.ie

Tel: (01) 234 5000

Web: gov.ie/decc

E-mail: hrb@hrb.ie Web: www.hrb.ie

DEPARTMENT OF ENTERPRISE, TRADE AND EMPLOYMENT Tel: (01) 631 2121 LoCall: 0818 302 121 E-mail: info@enterprise.gov.ie Web: enterprise.gov.ie

INVEST NORTHERN IRELAND

& LOGISTICS (NITL)

Tel: 0800 181 4422

Tel: (01) 402 3898

Web: www.investni.com

Web: www.nitl.ie

IRISH BUSINESS & EMPLOYERS

PARENTERAL DRUG

CONFEDERATION (IBEC)

ASSOCIATION (PDA)

Tel: (01) 605 1500

Tel: +1 (301) 656 5900

E-mail: info@ibec.ie

Web: www.pda.org

AUTHORITY Tel: (01) 614 7000

HIGHER EDUCATION AUTHORITY Tel: (01) 231 7100 E-mail: info@hea.ie Web: www.hea.ie IDA - INDUSTRIAL

Email: ciara@ivca.ie MANDATE TRADE UNION

Tel: (01) 268 0100 CHAMBERS IRELAND

ASSOCIATION Tel: (01) 276 4647

Web: https://www.ipoi.gov.ie/en/ ASSOCIATION OF IRELAND

IRISH VENTURE CAPITAL

Web: www.ibec.ie PHARMACEUTICAL IRISH CLEANROOM SOCIETY

SOCIETY OF IRELAND

Web: www.cleanrooms-ireland.ie

Tel: (01) 218 4000

IRISH COSMETICS, DETERGENT & ALLIED PRODUCTS ASSOCIATION Tel: (01) 605 1500

E-mail: info@psi.ie Web: www.thepsi.ie REPAK

E-mail: kevin.maher@ibec.ie

Tel: (01) 467 0190

Web: www.icda.ie

E-mail: info@repak.ie

IRISH EXPORTERS ASSOCIATION Tel: (01) 661 2182

Web: www.repak.ie

E-mail: contact@irishexporters.ie

SCIENCE FOUNDATION

Web: www.irishexporters.ie

IRELAND Tel: (01) 607 3200

IRISH MEDTECH ASSOCIATION

E-mail: info@sfi.ie

Tel: (01) 605 1500

Web: www.sfi.ie

E-mail: info@irishmedtechassoc.ie Web: www.irishmedtechassoc.ie

UCD SCHOOL OF CHEMICAL

DEPARTMENT OF HOUSING,

DEVELOPMENT AGENCY

LOCAL GOVERNMENT

IRISH NATIONAL

Tel: (01) 603 4000

AND HERITAGE

ACCREDITATION BOARD

E-mail: idaireland@ida.ie

Tel: (01) 614 7182

Tel: (01) 888 2000

Web: www.idaireland.com

E-mail: info@inab.ie

Tel: (01) 716 1825

Web: www.inab.ie

E-mail: SCBE.enquiries@ucd.ie

E-mail: qcsofficer@housing.gov.ie Web: www.housing.gov.ie

140

& BIOPROCESS ENGINEERING

Web: www.ucd.ie/chembioeng

Irish PharmaChem | Industry Buyers Guide 2024

2023 January Week 52 M T W T F S S

1

2023

February

1

2

3

4

Week 5

2 3 4 5 6 7 8

9 10 11 12 13 14 15

16 17 18 19 20 21 22

23 30 24 31 25 26 27 28 29

July

5

1 2 3 4 5

March

7

8

Week 9

6 7 8 9 10 11 12

13 14 15 16 17 18 19

20 27 21 28 22 23 24 25 26

2023 August

Week 26 27 28 29 30 31 M T W T F S S

M T W T F S S

2023 6

1 2

3 4 5 6 7 8 9

10 11 12 13 14 15 16

17 18 19 20 21 22 23

24 31 25 26 27 28 29 30

9

2023

Week 31 32 33 34 35 M T W T F S S

1 2 3 4 5 6

M T W T F S S

2023 6 7 8 9 10 11 12

1 2 3 4 5

13 14 15 16 17 18 19

September

20 21 22 23 24 25 26

27 28 29 30 31

2023

Week 35 36 37 38 39

7 8 9 10 11 12 13

14 15 16 17 18 19 20

21 22 23 24 25 26 27

2024

March

6

7

8

9

Week 9

5 6 7 8 9 10 11

12 13 14 15 16 17 18

19 20 21 22 23 24 25

26 27 28 29

28 29 30 31

10 11 12 13

M T W T F S S

4 5 6 7 8 9 10

1 2 3

11 12 13 14 15 16 17

18 19 20 21 22 23 24

25 26 27 28 29 30

April

2023

Week 13 14 15 16 17 M T W T F S S

1 2

3 4 5 6 7 8 9

10 11 12 13 14 15 16

17 18 19 20 21 22 23

October

24 25 26 27 28 29 30

May

2023

Week 18 19 20 21 22 M T W T F S S

1 2 3 4 5 6 7

8 9 10 11 12 13 14

15 16 17 18 19 20 21

22 29 23 30 24 31 25 26 27 28

2023 November

2023

Week 39 40 41 42 43 44 Week 44 45 46 47 48 M T W T F S S

1

2 3 4 5 6 7 8

9 10 11 12 13 14 15

16 17 18 19 20 21 22

23 30 24 31 25 26 27 28 29

M T W T F S S

6 7 8 9 10 11 12

1 2 3 4 5

13 14 15 16 17 18 19

20 21 22 23 24 25 26

27 28 29 30

June

2023

Week 22 23 24 25 26 M T W T F S S

5 6 7 8 9 10 11

1 2 3 4

12 13 14 15 16 17 18

December

19 20 21 22 23 24 25

26 27 28 29 30

2023

Week 48 49 50 51 52 M T W T F S S

4 5 6 7 8 9 10

1 2 3

11 12 13 14 15 16 17

18 19 20 21 22 23 24

25 26 27 28 29 30 31

2024 January Week 1 M T W T F S S

1 2 3 4 5 6 7

2024

February

5

Week 5

2

3

4

8 9 10 11 12 13 14

15 16 17 18 19 20 21

22 29 23 30 24 31 25 26 27 28

July

1 2 3 4

2024 August

Week 27 28 29 30 31 M T W T F S S

M T W T F S S

1 2 3 4 5 6 7

8 9 10 11 12 13 14

15 16 17 18 19 20 21

22 29 23 30 24 31 25 26 27 28

2024

Week 31 32 33 34 35 M T W T F S S

1 2 3 4

M T W T F S S

2024 4 5 6 7 8 9 10

1 2 3

11 12 13 14 15 16 17

September

April

2024

Week 14 15 16 17 18

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

M T W T F S S

2024

October

1 2 3 4 5 6 7

8 9 10 11 12 13 14

15 16 17 18 19 20 21

22 29 23 30 24 25 26 27 28

12 13 14 15 16 17 18

19 20 21 22 23 24 25

M T W T F S S

2025

March

6

7

8

9

Week 9

3 4 5 6 7 8 9

10 11 12 13 14 15 16

17 18 19 20 21 22 23

24 25 26 27 28

2 3 4 5 6 7 8

1

9 10 11 12 13 14 15

16 17 18 19 20 21 22

23 30 24 25 26 27 28 29

M T W T F S S

1 2 3 4 5 6

May

2024

Week 18 19 20 21 22 M T W T F S S

6 7 8 9 10 11 12

1 2 3 4 5

13 14 15 16 17 18 19

20 21 22 23 24 25 26

2024 November

Week 35 36 37 38 39 40 Week 40 41 42 43 44

5 6 7 8 9 10 11

26 27 28 29 30 31

10 11 12 13

7 8 9 10 11 12 13

14 15 16 17 18 19 20

21 22 23 24 25 26 27

28 29 30 31

27 28 29 30 31

2024

Week 44 45 46 47 48 M T W T F S S

4 5 6 7 8 9 10

1 2 3

11 12 13 14 15 16 17

18 19 20 21 22 23 24

25 26 27 28 29 30

June

2024

Week 22 23 24 25 26 M T W T F S S

3 4 5 6 7 8 9

1 2

10 11 12 13 14 15 16

December

17 18 19 20 21 22 23

24 25 26 27 28 29 30

2024

Week 48 49 50 51 52 M T W T F S S

1

2 3 4 5 6 7 8

9 10 11 12 13 14 15

16 17 18 19 20 21 22

1

23 30 24 31 25 26 27 28 29

2025 January Week 1 M T W T F S S

1 2 3 4 5

2025

February

2

3

4

5

Week 5

6 7 8 9 10 11 12

13 14 15 16 17 18 19

20 21 22 23 24 25 26

27 28 29 30 31

July

1 2

2025 August

Week 27 28 29 30 31 M T W T F S S

M T W T F S S

1 2 3 4 5 6

7 8 9 10 11 12 13

14 15 16 17 18 19 20

21 22 23 24 25 26 27

= Public Holiday

28 29 30 31

2025

Week 31 32 33 34 35 M T W T F S S

1 2 3

4 5 6 7 8 9 10

11 12 13 14 15 16 17

18 19 20 21 22 23 24

25 26 27 28 29 30 31

M T W T F S S

2025 3 4 5 6 7 8 9

1 2

10 11 12 13 14 15 16

September

17 18 19 20 21 22 23

24 31 25 26 27 28 29 30

2025

Week 36 37 38 39 40 M T W T F S S

1 2 3 4 5 6 7

April

2025

10 11 12 13 14 Week 14 15 16 17 18

8 9 10 11 12 13 14

15 16 17 18 19 20 21

22 29 23 30 24 25 26 27 28

M T W T F S S

1 2 3 4 5 6

7 8 9 10 11 12 13

14 15 16 17 18 19 20

21 28 22 29 23 30 24 25 26 27

October

2025

Week 40 41 42 43 44 M T W T F S S

1 2 3 4 5

6 7 8 9 10 11 12

13 14 15 16 17 18 19

20 21 22 23 24 25 26

27 28 29 30 31

May

2025

Week 18 19 20 21 22 M T W T F S S

1 2 3 4

5 6 7 8 9 10 11

November

12 13 14 15 16 17 18

19 20 21 22 23 24 25

26 27 28 29 30 31

2025

Week 44 45 46 47 48 M T W T F S S

1 2

3 4 5 6 7 8 9

10 17 11 18 12 19 13 20 14 21 15 22 16 23

24 25 26 27 28 29 30

June

2025

Week 22 23 24 25 26 27 M T W T F S S

1

2 3 4 5 6 7 8

9 10 11 12 13 14 15

December

16 17 18 19 20 21 22

2025

Week 49 50 51 52 M T W T F S S

1 2 3 4 5 6 7

23 30 24 25 26 27 28 29

8 9 10 11 12 13 14

15 16 17 18 19 20 21

1

22 29 23 30 24 31 25 26 27 28

Healthcare Logistics

For when it matters the most

No matter where along a product’s lifecycle you operate—from product discovery to patent expiry— choose a partner you can rely on to consistently apply the highest GxP compliant quality standards.

For all your shipping needs: ■ ■ ■ ■ ■ ■

Personalised medicines Medical devices

Pharmaceuticals Vaccines

Animal health products

Consumer healthcare products

Contact our Healthcare Logistics experts to learn more:

ireland.sales@kuehne-nagel.com healthcarelogistics.kuehne-nagel.com