Irish Pharmachem Summer 2022 Edition by Retail News

Summer 2022 Edition – Focus on Innovation

Source BioScience celebrates landmark anniversary of 15 years in Tramore Your trusted partner for stability storage services, because experience matters.

In Association with BioPharmaChem Ireland

Inventing for Life 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 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. Our Irish sites manufacture approximately half of MSD’s top twenty products, saving and enhancing lives in over sixty countries around the world. At MSD, we have and always will be Inventing for Life. These three powerful words reflect our commitment to inventing new medicines and vaccines that save lives by preventing and fighting disease. MSD has dedicated researchers trained in many different scientific disciplines who work tirelessly to find solutions for significant health challenges that still afflict millions around the world. As a team, we firmly believe that the most important thing we make is a difference – to patients, to our employees, to our communities and to the Irish healthcare landscape generally. We are 100% committed to putting the patient at the heart of everything we do. To find out more about our people and our work, visit www.msd.ie

CONTENTS

4 SECTOR OVERVIEW

16 FOCUS ON INNOVATION

2 Minister’s Foreword

Ireland has established itself as a place of global significance for the biopharmaceutical industry, growing rapidly to becoming the third largest exporter of pharmaceuticals globally, writes Tánaiste and Minister for Enterprise, Trade and Employment, Leo Varadkar TD.

4 SECTOR Overview

Matt Moran, Director, BioPharmaChem Ireland, charts the current performance of Ireland’s biopharma sector and examines the challenges we need to meet if our success is going to continue into the coming years.

8 MEDTECH

Dr Sinead Keogh, Head of Sectors, Director, Medtech & Engineering, Ibec, reports on the staggering level of innovation that sees Ireland cement its place as a global centre of excellence in the medtech sector.

12 ENTERPRISE IRELAND

Ireland’s indigenous life sciences sector is built on innovation and scaling globally, writes Garrett Murray, Head of Life Sciences, Enterprise Ireland.

16 FOCUS ON INNOVATION

With almost two decades of experience in biotech, including some of the most successful Irish start-ups of all time, Poolbeg Pharma CEO, Jeremy Skillington, explains what it takes to turn a scientific innovation into a viable business.

22 REGULATION

Ireland’s Health Products Regulatory Authority helps to create an ecosystem that supports science-based innovation, writes Dr Lorraine Nolan, Chief Executive, HPRA.

24 INDUSTRY 5.0

28 ADVANCED THERAPEUTICS

Paul McCabe, Chief Operating Officer, VLC Therapeutics, and Biopharmachem Ireland Chair, explains how APC & VLE Therapeutics are taking on global challenges for patients in Advanced Therapeutics with ‘The Medicine Accelerator’.

30 BIO INCUBATION

We are Pioneer Group (WAPG), in partnership with Spear Street Capital, are seeking to address gaps in Irish life sciences infrastructure and access to capital by establishing a 30,000 square feet bio incubation facility at The Campus, Cherrywood in Dublin. Irish PharmaChem – Summer 2022

34 NIBRT

Advanced Therapy Medicinal Products are set to provide the next wave of healthcare innovation. Darrin Morrissey, CEO, NIBRT, advises on how Ireland can ensure it is at the forefront of ATMP development and manufacture.

38 CAR-T CELL THERAPY

The first patients in Ireland have received groundbreaking CAR-T cell therapy for blood cancer at St James’ Hospital, Dublin.

40 TAKEDA IRELAND

Takeda Ireland have recently opened their commercialscale cell therapy production facility at their site in Grange Castle, Dublin, the first facility of its kind in Ireland.

42 STABILITY STORAGE

Source BioScience have been offering pharmaceutical and life science stability storage from their Tramore site for 15 years.

44 CHEMICAL TRANSFER PUMPING EQUIPMENT

Central Pump Supplies Ltd are experts in the supply of chemical pumping equipment to the pharma and biopharma industry in Ireland.

46 CELL & GENE THERAPY: AVECTAS

Avectas are actively recruiting engineers and scientists to join their growing team at the cutting edge of Cell and Gene Therapy via their SOLUPORE® delivery technology platform.

48 RAW MATERIALS

Greenfield Global offer reliable supply of pharmaceutical quality raw materials from their new cGMP production plant in Portlaoise.

54 PHARMACEUTICAL INGREDIENTS

Partnering with Univar Solutions Pharmaceutical Ingredients can help you to protect your business while driving innovation and growth.

46 Cell & GENE THERAPY: Avectas 56 CHEMICAL MANUFACTURING SK pharmteco have been enjoying significant market growth, including expansion at their SK biotek Ireland business, based in Swords, Co. Dublin.

60 LOGISTICS

Kuehne+Nagel are set to open a new Healthcare Logistics Facility in Ireland in Q3 2022.

62 LOTUSWORKS

LotusWorks have been a strategic partner of choice for some of the world’s leading biologics companies for three decades.

64 CHARLES RIVER LABORATORIES

A new GMP laboratory space is helping Charles River Laboratories Ireland to expand their analytical, cell culture, vaccine support and other specialised biologics services.

66 PHARMACEUTICAL RAW INGREDIENTS

Paul Power, Strategic Sourcing & Supply Chain Executive, NCC, discusses key considerations that a pharmaceutical organisation should consider when choosing a sourcing partner in 2022.

68 WASTE PROCESSING AND RECYCLING Indaver deliver processing capacity, high-quality recycling and a large-scale heat network for industry.

70 TOF MEASUREMENT INSTRUMENTS

The first cloud-connected radar level sensor from Endress+Hauser revolutionises measurement in storage tanks.

73 PROCESS DATA

A smarter approach to processing with Bonner.

75 PROCESS CONTROL SYSTEMS

PACIV continue to be industry leaders in the delivery of Process Control Systems and Systems Integration Services for the life sciences sectors.

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

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

Minister’s Foreword

Ireland: a home for biopharma innovation Ireland has established itself as a place of global significance for the biopharmaceutical industry, growing rapidly to becoming the third largest exporter of pharmaceuticals globally, writes Tánaiste and Minister for Enterprise, Trade and Employment, Leo Varadkar TD. The past couple of years have really demonstrated the strength and agility of the Irish life sciences sector. Covid-19 threw up many challenges and coupled with uncertainty around Brexit, it made for a formidable backdrop. The sector overcame every difficulty and indeed flourished. It adapted, found solutions to the new problems we faced as a nation and globally, and innovated. Thank you all for your hard work, determination and ingenuity. We are not out of the woods yet. The pandemic is not over. However, we have entered a new phase, one which I am confident we can continue to overcome together.

A remarkable success story Rising from modest beginnings in the 1960s, Ireland has established itself as a place of global significance for the biopharmaceutical industry, growing rapidly to becoming the third largest exporter of pharmaceuticals globally. That

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

is remarkable. We have a strong track record for excellence in design, development, and manufacture of biopharmaceutical products. I am really proud of how far we’ve come and our reputation. This edition of Irish PharmaChem is focused on innovation, showcasing some of the really exciting new developments that are happening around the country. As policy makers, we are constantly looking at ways we can foster and encourage innovation. The National Institute for Bioprocessing Research and Training (NIBRT) is an important part of that. NIBRT is a world class institute that provides training and research solutions for the bioprocessing industry in Ireland and globally, helping prepare our scientists, technicians and researchers for the jobs of tomorrow. The Institute is currently funding projects in new, cutting edge areas such as Cell & Gene Therapy, where it recently achieved funding through the Government’s

Irish PharmaChem – Summer 2022

Minister’s Foreword

Disruptive Technologies Innovation Fund. These treatments have the potential to be transformative for thousands of patients worldwide. Ireland is perfectly placed to deal with the complex data, quality, regulatory and supply chain considerations associated with the growing trend towards personalised medicines and increasing regulatory requirements.

Biopharma powering economic growth Foreign direct investment is an important part of Ireland’s economic model and a significant proportion of our recent growth is powered by the biopharmaceutical industry. There are now more than 40,000 people employed in the sector in over 85 biopharmaceutical manufacturing sites across Ireland. This includes nine of the top 10 global pharmaceutical companies and 13 of

Irish PharmaChem – Summer 2022

the top 15 medical technology companies. Our inward investment agency, the IDA, has plans to increase investment further, targeting 80 FDI investments and 5,000 new jobs over the next couple of years. We do not ever take this investment for granted and will be working hard to consolidate and sustain our existing partners during this growth. I wish BioPharmaChem Ireland and Irish PharmaChem every continued success in 2022. Thank you for all you have done over the past year. I’m excited to see what’s next and look forward to working with you over the coming period.

Leo Varadkar, Tánaiste & Minister for Enterprise, Trade & Employment

SECTOR Overview

A roadmap to a bright future

Matt Moran, Director, BioPharmaChem Ireland.

Irish PharmaChem – Summer 2022

SECTOR Overview

We are half-way through 2022 and the biopharma sector continues to perform strongly, with capital investment remaining robust. The first half of 2022 was peppered with a number of very positive announcements for the sector, some of which can be seen in Table 1 below. Taken in addition to ongoing significant investment programmes at MSD and Pfizer across most of their sites, this does indeed paint a very positive picture for the sector in Ireland, with foreign direct investment continuing to drive significant growth within the sector. Added to this is a decision by Spear Street Capital to invest in a bio incubator at Cherrywood, South Dublin. The 30,000 square feet facility will be run by We Are Pioneer Group (WAPG, formerly Biocity), a UK-based operator in incubating and accelerating life sciences businesses. The WAPG team will help potential start-ups in life sciences by coaching them and advising them of potential sources

Company Eli Lilly Merck Takeda Janssen Amgen Ipsen Eirgen

of finance to help them achieve critical mass. It is hoped that initiatives such as this will help to grow out a strong indigenous life sciences sector that can complement the already strong FDI sector. The recent opening of the cell therapy production unit by Takeda at Grange Castle represents another important milestone for the sector. This will be Ireland’s first stem cell therapy production facility and heralds a further step in the journey of innovation that the sector has been on since its establishment back in the 1960s. This journey has seen the sector evolve from the chemical synthesis of Active Pharmaceutical Ingredients (APIs), through final dosage forms, biotech manufacture right into the exiting new world of Advanced Therapeutics. The product being made at Grange Castle is designed to treat a side effect of irritable bowel syndrome and is an example of a family of products known as Cell and Gene Therapies – referenced in my last article.

Investment Potential Employment €400m 300 €440m 370 €36m 100 €150m 180 €100m €27m €12m

Location Limerick Cork Dublin Cork Dublin Dublin Waterford

Table 1: significant announcements in 2022 Irish PharmaChem – Summer 2022

SECTOR Overview

The evolution of Ireland’s biopharmachem sector from the 1960s to today.

The National Institute for Bioprocess Training and Research (NIBRT) has just commenced expansion of its Dublin campus to include a wing that will be dedicated to supporting training and research in the CGT field. This will add greatly to Ireland’s ability to compete for investment in this emerging area of therapeutic effect. As well as presenting an opportunity for new inwards investment, it is hoped that there will be opportunities for indigenous companies too. Maynooth-based company Avectas have demonstrated well that these can be converted into real commercial possibilities.

The right kind of talent

Above: Matt Moran, Director of BioPharmaChem Ireland, addresses the BPCI Annual Dinner in UCC. Below: Matt Moran, Director, BPCI; John O’Halloran, President of UCC; and Brian Killen, MSD, Vice Chair, BPCI, pictured at the BPCI Annual Dinner in UCC.

Naturally, as the sector continues to invest and expand its operations in Ireland, the demand for the right kind of talent becomes even more acute. BPCI is very happy that Government recognises this and has tasked the Expert Group on Future Skills Needs (EGFSN) with the job of preparing a report on the current skills scenario within the sector in the country. Even more importantly, the task force will seek to identify future trends and to make recommendations of where investment should be made to ensure that Ireland has the correct skills base in place to meet these future investment challenges. BPCI and its members will participate in the important work of the task force and look forward to working with Government to ensure that its recommendations are implemented. In my last piece, I spoke about the work that BPCI is conducting to prepare a fifth industry strategy for launch in October of this year. An important focus of this work will be to ensure that the sector stays both competitive and sustainable. BPCI hope to realise these twin goals through the work of its Pharma 5.0 Lighthouse Partnership, led by Johnson and Johnson’s Bryan O’Donnell. BPCI also see an opportunity for Ireland to take the lead within the European Union to ensure that pharmaceutical manufacturing is prioritised right the way across the Union. To this end, they have produced a White Paper in partnership with Innopharma. The White Paper has been presented to the European Commission and to Irish MEPs of the European Parliament in Brussels. BPCI feels that this project can aid a transition towards a climate-neutral society, while retaining industrial competitiveness. Industry 5.0 can help to drive this twin transition and involves the interpretation of Industry 4.0 technologies through a human-centric lens. This supports the European commission’s own Industry 5.0 policy brief, which emphasises the powerful role that industry can play in achieving societal goals through green and sustainable production.

Collaboration with Higher Education The country’s universities and technical universities play a vital role in supporting the

Irish PharmaChem – Summer 2022

SECTOR Overview ongoing development of the sector here. They achieve this through ensuring a high calibre of graduate students who go on to work in the sector. Of particular importance are graduates in Science Technology, Engineering and Maths – so called STEM subjects. Without these graduates, the industry will find it hard to continue to meet the many challenges that it will undoubtedly face in the coming years. The Higher Education sector also plays a crucial role in supporting R&D in the sector. I read recently that 90% of the roles we will create in the next 20 years do not exist yet. This only emphasises the need for strong collaboration between higher education and industry, also highlighting the need for Government investment in higher education. To this end, BPCI were particularly delighted that University College Cork allowed us the host our first Annual Dinner in three years at the wonderful Aula Max on their beautiful campus. The industry heard an inspiring address from University President John O’Halloran and we look forward to continuing a very productive collaboration with UCC and all the higher education sector.

White Paper Implementation of Industry 5.0 Practices in a Pan-European Setting - leveraging a proof of concept initiative within the Irish ecosystem

BPCI and Innopharma produced a White Paper on Implementation of Industry 5.0 Practices in a Pan-European Setting.

The BPCI Annual Dinner in the Aula Max at UCC proved an inspiring event.

Irish PharmaChem – Summer 2022

Medtech

A culture of collaboration and innovation Dr Sinead Keogh, Head of Sectors, Director, Medtech & Engineering, Ibec, pictured at the launch of the Irish Medtech Association strategy, ‘The Global Medtech Hub 2025: Dedication to the expected, the unexpected and everything in between’.

Irish PharmaChem – Summer 2022

Medtech The global medtech sector is evolving rapidly, and Ireland’s established medtech ecosystem continues to lead as a centre of excellence for advanced manufacturing, product development, and digital innovation.

Ireland’s incomparable global medtech hub Quite simply, Ireland’s unique ecosystem supports collaboration, connectivity and convergence in leveraging the necessary capabilities to develop and deliver new innovations today and ensures the required resilience to adapt to whatever happens tomorrow. Ireland’s medtech hub is over 100 years in the making and over time, we’ve developed a proven track record for next level product development, our resilient supply chains, our connections to strategic markets, and our ambitions for the future. Ireland’s ‘can do’ attitude and ability to collaborate helps create solutions and solve problems. Continued investment will ensure Ireland continues to be positioned to compete. Our unique mix of strategic stakeholders, from academia to large MNCs, supports convergence between life sciences, medtech and technology, enabling next generation innovation through collaboration. Such alchemy of skills and capability will prove a key differentiator.

Bausch + Lomb, Alcon, Abbott and Johnson & Johnson, to name but a few. In fact 75% of the FDI community are engaged and are continuing to invest in R&D right across the value chain. Boston Scientific recently unveiled a new €100 million expansion and 300 jobs at their operations in Galway. The expansion includes over 40,000 square feet of medical device research and manufacturing space that will be powered by renewable energy. 3M launched a new digital innovation centre in Dublin focusing on AI and computer assisted coding to measure the quality of healthcare delivery to improve clinical outcomes. Whether it’s acquisitions, IPO’s or scaling globally, the indigenous sector is grabbing international attention in its own right. SilverCloud Health, one of the world’s leading digital mental health companies, was acquired by the US telehealth giant Amwell. The digital therapeutics company, Health Beacon, recently went public, raising a total of €25 million. Athome diagnostics company, LetsGetChecked, gained ‘unicorn’ status with its USD$1 billion valuation, and acute care aerosol drug delivery company, Aerogen, the Medtech Company of the Year 2021 winner, are treating patients in over 75 countries. The Enterprise Ireland-backed BioInnovate programme continues to churn out investorready companies at pace, with Versono Medical, Symphysis Medical, Tympany Medical and One Projects recently raising capital.

Innovation with impact

Enabling technologies to stand out

The last five years have seen Irish medtech experience tremendous growth and develop even greater ambition. Ireland is already recognised as a global medtech hub, with 450 companies employing 42,000 people to deliver €12.6 billion in medtech exports, making an impact across the world. In fact, Ireland is the largest employer of medtech professionals in Europe per capita.

There are a number of enabling technologies driving innovation in healthcare. Artificial intelligence is being advanced by companies as a revolutionary tool which can inform early diagnosis, as well as support more sophisticated advanced manufacturing. Such is the importance of the area that the Irish Government has appointed an AI Ambassador who will champion the National AI strategy. Also, nanotechnology offers the potential to support better drug delivery, as well as reduce the quantity of drug needed, and has the potential to play a role in advancement of wearable technologies.

Globally, the medtech sector is defined by its strong history of research and innovation, with the average medtech worldwide R&I investment rate estimated to be approximately 8% in the sector. The sector is arguably the most innovative in Europe, with more than 14,200 patent applications filed with the EPO in 2020, representing a 2.6% growth compared with the previous year. The Irish medtech community has been a driver of this innovation, with patents granted to Irish companies almost doubling from 2017 to 2020, making it stand out as fifth in the world for medtech patents per capita.

Investment surging on foot of strong track record 17 of the top 20 global medtech companies are based here, many with centres of excellence in innovation, including Stryker, Medtronic, Irish PharmaChem – Summer 2022

Robotics has already transformed manufacturing and this sector is also making great strides in advanced surgery. The most recent Disruptive Innovation Fund will mobilise €500 million specifically to support collaborative research in advanced manufacturing, with the Government also establishing an Enterprise Digital Advisory Forum, which Ibec are represented on. The 3D printed medical device sector is expected to reach $4.9 billion by 2026, not only delivering bespoke implants, but surgeons are also cutting operating times for patients who had their surgery planned with a 3D model. Stryker have invested over €200 million in their 3D innovation centre in Cork, delivering

The last five years have seen Irish medtech experience tremendous growth and develop even greater ambition.

next generation products and services across their medical, surgical, orthopaedics, neurotechnology and spinal offerings. Personalised medical care and digital therapeutics are also on the rise, with greater adoption of digital health solutions, segments which have also garnered huge attention from investors. Data has the potential to improve healthcare radically, but there are challenges to tapping into this valuable resource; namely, data integration with technical and regulatory barriers, consumer attitude, and company cultures.

Partnerships for success What really sets Ireland apart from its competitors is the richness of its ecosystem, with 50% in the partnership space. Companies like BlueBridge Technologies and S3 Connected Health partner with global multinationals to enable connected devices and disease management solutions. There has been a clear trend towards greater use of contract manufacturers by medtech companies, with nearly 80% looking to improve collaboration, according to pre Covid-19 research. In parallel with increased

Medtech A new vision to maintain our leadership position

technological innovation and more complex business models, the Covid-19 pandemic has accelerated the demand for collaboration underscored by specialisation.

This year, we in the Irish Medtech Association launched our strategy, ‘The Global Medtech Hub 2025: Dedication to the expected, the unexpected and everything in between’. The report charts our strengths as a global medtech hub, and how we can use these to achieve our potential to transform healthcare across the world, while growing in Ireland.

Our globally respected research centres include the Insight Research Centre known for data analytics, while Tyndall National Institute is helping leading companies develop intelligent medical devices and systems. Additionally, the Regenerative Medicine Institute is leading our national stem cell manufacturing facility, with CÚRAM focusing on engineering smart medtech.

Convergence at the cutting edge As well as being home to nine of the world’s top 10 medtech companies, Ireland is home to all 10 of the world’s top 10 biopharma and technology companies. With sales of €15.7 billion forecast in digital health alone by 2024 and strong growth projections year on year, it’s an attractive area to drive competitive advantage for Ireland. As part of our Where Digital Health Thrives campaign, to raise awareness of the Ireland as a location of choice for Digital Health, we have already mapped out approximately 200 companies engaging in digital health, with particular strength across the indigenous sector, covering everything from connected medical devices to digital therapeutics.

Calls for a national strategy The value of adopting a more holistic approach

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Ireland is home to nine of the world’s top 10 medtech companies, as well as more than 200 indigenous companies engaging in digital health. to healthcare is accepted, with rising spending pressures and greater demand for international collaboration between both governments and businesses to provide access to vital care. To help Ireland achieve its potential, the Irish Medtech Association, along with Technology Ireland and BioPharmaChem Ireland, are advocating for the Government to develop a national healthtech strategy, led by the Department of Enterprise Trade and Employment. It needs an appropriate appointee put in place in the department to oversee and implement this strategy, which would operate in a similar fashion to Ireland’s Industry 4.0 Strategy 2020-2025.

We have developed a new vision for the industry in Ireland to be strongly positioned as a global leader in innovative patient-centred medical technology solutions, helping to set the future global healthcare agenda, with a proven ecosystem that is a major contributor to the economy. To ensure sustainable progress, not only do we need the right policies, but Ireland also needs world class talent that can stay ahead of both the latest technology and business trends. That is why the Connected Health Skillnet has led the development of a firstof-its-kind ‘Future Skills Needs Analysis of the Digital Health Sector in Ireland to 2025’, which will be launched later this year. We also partnered with the Irish Medtech Skillnet on the development of a ‘Realising your R&D Ambition Strategy’ to help build the level and sophistication of R&D taking place here amongst the FDI community and to support companies take full ownership of product portfolios. This programme will be rolled out again in 2022.

Irish PharmaChem – Summer 2022

Enterprise Ireland

Success founded on innovation Ireland’s indigenous life sciences sector is built on innovation and scaling globally, writes Garrett Murray, Head of Life Sciences, Enterprise Ireland. From exciting research projects in our Higher Education Institutions, through to highpotential start-ups (HPSUs) and established Enterprise Ireland clients, Irish researchers and companies are competing and excelling in terms of innovation and product and service development. Agile and ambitious by nature, the Irish life sciences sector responded to the Covid-19 pandemic, with companies supported by Enterprise Ireland at the forefront of meeting the challenges it posed through the application of their research and delivery of innovative solutions. Overall, according to our most recently published results, the Enterprise Ireland supported life sciences sector accounted for €2.4 billion in annual sales, with exports accounting for €1.9 billion in 2020. The figures for 2021 are forecast to be significantly higher. Most domestic sales go to multinational customers in Ireland and the interconnectivity of this eco-system is a key strength of the Irish economy. R&D investment as a percentage of sales is very high in this sector. The sector is long recognised on the global stage for its immense innovative capacity. It is important to note one in four graduates in Ireland is STEM, the highest per capita in Europe. These numbers and the internationally competitive nature of our research and innovation community are incredibly strong foundations on which to build future growth.

Recognising the importance of life sciences The importance of the life sciences sector, in terms of the positive impact it has on the citizens of the world, and the importance of collaboration and co-ordination in meeting the challenges humanity faces has never been more widely recognised. For instance, in June of this year, over 110

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delegates from healthcare systems around the world came to Ireland for the Enterprise Ireland Global Healthcare Forum to engage with Irish companies and the Irish innovation system. Increased investment has followed this recognition. Last year, The European Commission published a communication, ‘Drawing the Early Lessons from the Covid-19 Pandemic’ (EUR-Lex - 52021DC0380 - EN - EUR-Lex europa.eu). It highlights the importance of pandemic preparedness but also notes:

• The capacity to cope in a pandemic depends on continuous and increased investment in health systems;

• The need to set up a Health Important

Project of Common European Interest as soon as possible to enable breakthrough innovation in the health and pharmaceutical sector, making it more resilient;

• The requirement to establish a large-scale EU platform for multi-centre clinical trials;

• The reinforced importance of public-

private partnerships and that stronger supply chains are needed for critical equipment and medicines.

The European Commission also published a Pharmaceutical Strategy for Europe to underpin the need for, “well-functioning international supply chains and a well performing single market for pharmaceuticals, through an approach that covers the entire lifecycle of pharmaceutical products, from production to distribution, consumption and disposal” (A pharmaceutical strategy for Europe: europa.eu). These policy documents will underpin just some of the changes and create opportunities for companies operating in the sector on a European level.

Enterprise Ireland three-year strategy As we move into a new economic cycle, where global businesses are operating in an ever increasingly complex and changing world, it is a time to reflect and plan. Earlier this year, Enterprise Ireland launched our three-year strategy, Leading in a Changing World (2022-2024). The key areas of focus for our strategy include:

• Seeing Irish companies continue to deliver sustainable employment and economic growth at national and regional level. In

Irish PharmaChem – Summer 2022

Enterprise Ireland

The Disruptive Technology Innovation Fund, administered by Enterprise Ireland, provides a great opportunity for Irish companies to compete for funding and collaborate with other Irish enterprises and researchers.

this context, we are planning to assist with the creation of 45,000 new jobs over the period of the strategy.

• Targeting a significant increase in the

level of exports from Irish companies of all sizes and across all sectors to €30 billion, as well as increasing the overall number of Irish companies exporting.

• Fostering further entrepreneurship, leading

to increased start-up activity across the country. We will also put specific focus on scaling of companies, enabling Irish firms to grow faster and further in global markets. We’re targeting support to 450 early-stage companies over the next three years, growing our high potential start-up

Irish PharmaChem – Summer 2022

cohort by 20%.

• Supporting our clients to achieve increased productivity through higher levels of operational focus, more innovation and further digital adoption. We are targeting an R&D spend of €1.4 billion by Irish companies to support this activity.

The life sciences sector will be critical in achieving these employment targets, building on the more than 10,000 people already employed by companies across all regions of Ireland. We want to support clients at all stages in their scaling journey to innovate ahead of their competitors and contribute to achieving our ambitious R&D target. To achieve this aim, we will continue to support companies

through in-company and collaborative supports at all stages of their research and innovation journey. We do this because we know innovative companies are more productive, create more jobs and scale faster.

Indigenous success stories Ireland has so many global players in this sector that are exemplars for those commercialising their research or looking to scale their companies. ICON plc, a global provider of drug and device development and commercialisation services to pharmaceutical, biotechnology, medical device, and government

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Enterprise Ireland investment include AI-enhanced molecular modelling such as with BioSimulytics based in NovaUCD. This start-up focus is key to our strategy out to 2024 and beyond.

The importance of collaboration As the pandemic reaffirmed for many of us, little in life can be achieved without collaboration. The challenge-based Disruptive Technology Innovation Fund (DTIF), administered by Enterprise Ireland, provides a great opportunity for Irish companies to compete for funding and collaborate with other Irish enterprises and researchers.

Ireland’s life sciences sector accounted for €2.4 billion in annual sales, with exports accounting for €1.9 billion, in 2020. organisations, have been recognised with a number of prestigious business and industry awards, including Company of the Year at the 2021 Business & Finance Irish Business Awards. In September 2021, it was announced that the company has been awarded €4 million in R&D support administered by Enterprise Ireland to further enhance their data solutions and decentralised clinical trial technology. At the same awards ceremony, APC Ltd received the Elevation Award, sponsored by Enterprise Ireland. This award recognises Irish companies that are fast-growing and with significant potential to continue to scale globally, focused on Irish companies achieving up to €350 million in revenue. The company focuses on bringing new drugs to market at speed by designing, developing and implementing engineering platform technologies. In 2020, APC Ltd, through the combination of IP and customers, spun out VLE Therapeutics to drive scientific and digital-led manufacture of vaccines and Advanced Therapeutics. In April of this year, VLE Therapeutics opened their first GMP factory-of-the-future for the manufacture of advanced therapeutic medicines and vaccines in Cherrywood, Dublin, where a life sciences cluster is emerging. Enterprise Ireland has partnered with both companies to support their growth.

development and process intelligence technology using data analytics.

Enterprise Ireland Commercialisation Fund Increasing the number of researchers that take the exciting and rewarding road of commercialisation and leveraging the State’s investment in research and innovation is key to our strategy. The Enterprise Ireland Commercialisation Fund provides an avenue for Ireland’s brightest researchers to commercialise their work and bring their ideas to the market.

Two projects previously awarded funding include: Adjuvenate: a platform solution for improved subunit vaccines, led by Principal Investigator, Associate Professor Aisling Dunne, Trinity College Dublin; and Development of gene therapies for common retinal disorders, led by Principal Investigator, Professor Jane Farrar, Trinity College Dublin. Enterprise Ireland continues to prioritise supporting innovative start-ups with a particular focus on increasing the total number of HPSUs that spin-out of the research system. These have included drug development and gene therapy companies such as ATXA Therapeutics and Branca Bunús. Other interesting areas which have recently seen

To gain competitive advantage, Irish researchers and enterprises must also continue to look to Europe where there are a myriad of opportunities to seek mono beneficiary and collaborative funding. Irish companies, including Sirius XT and RemedyBio, to name just two, punched way above their weight in winning competitive funding under Horizon 2020. The current European Programme, Horizon Europe provides an even greater allocation of funding to healthcare across several pillars of the Programme, including the European Innovation Council, the Health Cluster and the Innovative Health Initiative (IHI). More information can be found at www.horizoneurope.ie. In April of this year, the Government published, ‘Impact 2030, Ireland’s Research and Innovation Strategy’. At its core is the objective of supporting Irish enterprises to innovate and scale. The importance of maximising the contribution to sustaining and furthering the health and wellbeing of the people of Ireland is also a key objective outlined in the strategy. I have no doubt that Irish researchers and companies will not only meet this challenge but that they will also increasingly bring their research and innovation to the global stage to improve patient outcomes and help humanity meet the challenges of today and beyond.

The importance of the life sciences sector, in terms of the positive impact it has on the citizens of the world, has never been more widely recognised.

Innopharma Education are another success story focused on the sector, providing educational and technology solutions to the pharmaceutical industry. The technology business is focused on the development of Process Analytical Technology (PAT) instrumentation and accelerated process

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Irish PharmaChem – Summer 2022

Mallinckrodt is building on our 155-year history of providing medicines that address 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.

www.mallinckrodt.com

Focus on innovation

The skills to succeed

When you talk about indigenous innovation in the Irish biopharma sector, a few companies spring immediately to mind, names like Elan, Inflazome, Avectas, Open Orphan, Genable Technologies and Poolbeg Pharma. One man who has played a key role in turning start-ups into big successes is Cork’s Jeremy Skillington, who was VP of Business Development at Inflazome and is the CEO of Poolbeg Pharma, which was spun-out of Open Orphan in 2021.

A biotech veteran, Jeremy has almost two decades’ worth of industry experience. A scientist by training, he spent some time in the University of California, San Francisco, as part of his PhD research, which turned out to be one of those “crossroads” in his life. “I stayed on in California doing Post-Doc research,” he recalls, “and the key factor was transitioning into biotech.” Jeremy began his biotech life in the Business Development group at Genentech Inc, a biopharma company now owned by Roche.

“I got great exposure to and experience of biotech there in terms of the business development side, the deal work, looking at companies’ pipelines and their products, licensing products that we liked and bringing them into Genentech for further development and commercialisation,” he explains. He ended up spending 11 years in California, where his two children were born. In 2009, Roche agreed to buy the remaining shares in Genentech, having been majority shareholders previously. At that point, both Jeremy and his Irish PharmaChem – Summer 2022

Focus on innovation

wife, Jennifer, were keen to move home to Ireland with their children and the buy-out by Roche provided the “perfect jumping off point to return to Ireland.” Back on home soil, he took up a role with Opsona Therapeutics. He had already come in contact with Professor Luke O’Neill when he led Genentech’s investment in Opsona in the very early days of the company. In 2009, Opsona raised a Series B round, involving companies like Seroba Life Sciences and Fountain Healthcare, and were looking to expand their management team, so he joined the management team on his return to Ireland. Together with Kingston Mills, one of the co-founders of Opsona, Jeremy was involved in spinning-out a company called TriMod Therapeutics, focused on immuno-oncology. “We raised seed capital for that but around that time in 2013, it was very hard to raise funds for biotech in Ireland,” Jeremy reveals. “One of the potential investors I presented to were based in Dusseldorf; they were interested in the company but wanted to see more data before they would consider an investment. They also said that if the investment didn’t come through, they had a role for me to join their fund and work with companies in their portfolio. While clearly disappointing at the time that we couldn’t raise the funds for TriMod to take us into the clinic, it was an interesting transition for me into a Germany-based VC fund, who had some very interesting companies in their portfolio which I worked with, such as such as mRNA company, Ethris GmbH.”

The Inflazome story Jeremy spent the following years between Ireland, Germany and “wherever I was needed at various conferences and events”. Then a call from Florent Gros, MD of Novartis Venture Fund (one of the original Opsona investors) proved too tempting to ignore, and so he joined the management team at the then fledgling startup called Inflazome, a biotech company leading the development of orally available drugs to address clinical unmet needs in inflammatory diseases by targeting inflammasomes. “I was employee number three, after Luke [O’Neill] and Matt [Cooper],” he smiles. It was a real start-up – finding an office, recruiting colleagues, getting the word out that Inflazome existed. From day one, we were talking to pharma companies about Inflazome and our NLRP3 inflammasome inhibitors. Many pharma companies were interested in NLRP3, a key driver of inflammatory diseases, so we were able to build relationships from the very beginning and they were closely monitoring our progress.” Inflazome raised an initial €15 million as part of their Series A funding from investors Fountain Healthcare Partners and Novartis Irish PharmaChem – Summer 2022

Venture Fund, with another €40 million following in the second round of investment in 2018, where US-based Longitude Capital and Forbion, who are based in the Netherlands, joined the original investors. “Discussions with pharma were ongoing; they were very keen to see the data from our clinical trials,” Jeremy recalls. “As the data came out, those conversations intensified and we had really deep discussions with Roche and some other pharma companies who were keen on that space and our programmes in particular.” September 2020 saw Inflazome bought by Roche in a deal worth an initial €380 million upfront, a seven-fold upturn, plus significant downstream milestone payments on further development of the products, which Jeremy modestly describes as “a great return for investors”. Jeremy stayed on board with Inflazome until the end of March 2021, as part of the transition period and was looking forward to a few months off, when another phone call brought him to yet another “crossroads”. This time it was Cathal Friel on the line, co-founder of Open Orphan, who made Jeremy another offer he couldn’t refuse, to head up Poolbeg Pharma, which was being spun-out from Open Orphan. “They were spinning out the pharma assets and going public from day one,” he explains.

The leadership team at Poolbeg Pharma (l-r): Professor Luke O’Neill, Ian O’Connell, Jeremy Skillington and Cathal Friel.

“Cathal was very convincing, and the fact that in the middle of a pandemic, Poolbeg as a new biotech company focused on infectious diseases, with its initial programme focused on severe influenza, I couldn’t resist. I’m a scientist by training and the fascination around the science lured me in. It was one of those times where if I had passed up on the opportunity, 12 months later I’d be kicking myself.”

Poolbeg Pharma: interesting, challenging and topical Poolbeg Pharma went public in July 2021, raising Stg£25 million. “Getting Poolbeg up and running over the last year has been very interesting, very challenging and very topical at times,” he admits. The company is now moving forward with running a Phase Ib human challenge trial this summer for its lead programme, POLB 001. “The holy grail for a young biotech company is to generate early human ‘Proof of Concept’ data” Jeremy admits, which adds significant value to the programme and decreases risk for future development. “We’re conducting a challenge study where we are going to

Focus on innovation

“Turning science into a business is doable, but it’s challenging and you need cash and expertise to get it there.” stimulate healthy volunteers’ immune systems and then monitor their response to POLB 001. We will learn a lot from that data-set, which will feed into the Phase 2 clinical trials with severe influenza patients. We intent to partner early so that pharma can apply their clinical expertise and fund future development and commercialisation – addressing the unmet medical need for effective treatments against severe influenza.” POLB 001 treats the body’s hyperinflammatory response to severe influenza and as such, is strain agnostic and offers potential for future stockpiling for both seasonal outbreaks and pandemic preparedness.

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Poolbeg are exactly where they hoped to be a year ago at IPO, which Jeremy is justifiably proud of: “A lot of work has gone into this from the Poolbeg team to advance POLB 001, not just from an intellectual property standpoint, but from a manufacturing standpoint, a formulation standpoint, including trial design and site selection etc. If it works in this challenges study, and we believe it will, then it should work in other diseases where ‘cytokine storms’ occur, so there is great potential for this product beyond severe influenza, which myself and the team are currently exploring.” He’s also excited about Poolbeg’s other programmes for respiratory viral diseases including a single dose, intranasal, dual action prophylactic & therapeutic which is targeting broad spectrum respiratory viral infections. Poolbeg is also collaborating with UCD on bacterial infections, is developing an Oral

Vaccine Delivery platform and pursuing a number of artificial intelligence programmes which he feels will identify new and novel targets for infectious diseases, making use of human challenge trial data which has “never before” been analysed using AI. “The company hit the ground running and has moved at a fast pace for the last 12 months,” he summarises. “We have lots to do but we are very motivated to bring our products forward to patients quickly and cost-effectively and partnering with pharma along the way.”

Funding our start-ups So given his vast experience at the cutting edge of innovative biotech, does Jeremy believe Ireland has a stronger innovation culture than when he started out in the industry? On one hand, he insists, Ireland is home to a host of Irish PharmaChem – Summer 2022

Focus on innovation

“We have done very well with Foreign Direct Investment. If we can turn it around and have a similar level of success with indigenous companies, that would be great. The technology is there, the appetite is there and I think the management is there.” academics who are being recognised for their innovations and scientific breakthroughs. “We have technology that is really innovative and could have huge potential for therapeutics,” he states. Jeremy is also hugely complimentary about the “fantastic work” of Enterprise Ireland in supporting HBSU’s (high potential start-ups) every year. The problem is the funding needed to take these innovations and turn them into real world companies is often hard to find in Ireland. “Maybe 20 years ago there was some naivety but now we realise that this is not easy, that the science is a starting point with maybe another 10 or 12 years of development, so there is a lot of money needed to fund that development,” he maintains. “If you are to run a pre-clinical study, you are looking at the guts of €30-40k,” he continues. “This is long-term work and it’s quite risky. I worry sometimes if Ireland has the appetite for that. If you look at where investors have been really successful, you’re looking at companies in the US biotech hubs around Boston and San Francisco where several million dollars are invested to see if the science works and if it works, then you get the bigger money to rapidly advance the technology and drive value. In Ireland, we sometimes don’t have the appetite to invest that €3, €4 or €5 million to validate a technology and I understand that. The technology is there but sometimes the funding for that early seed investment isn’t.” He cites the example of Boston-based Atlas Ventures, who frequently invest sums of up to $1 million in “these early risky “killer” experiments to see if they work. If it works, they will then invest many millions in a Series A round with a syndicate of other VC investors, then hope to either be acquired or go public and recoup their investment along with a sizeable profit. If it doesn’t work, they move on to the next one; they are willing to write that initial investment off.”He believes Irish PharmaChem – Summer 2022

that the perfect scenario is about providing potential investors with key, compelling data, partnering with them and knowing when, and planning for, an exit. “Without being cynical, for this kind of investment cycle, you need exits, so you need either companies or their products to be bought or they go public so investors can see a return on their investment and subsequently re-invest their money in new, emerging companies and the cycle continues,” he admits. In order to take an idea from the laboratory to market, you need an experienced management team, he insists. “You might have people in academia with interesting ideas and good data, but they don’t necessarily have the experience of translating that into a business. Turning science into a business is doable, but it’s challenging and you need cash and expertise to get it there.”

Nurturing our biotech innovators One can sense a nagging feeling of frustration that Ireland can do more to foster our biotech innovators. “I was in California when Elan really took off and I remember thinking it was fantastic; I was expecting that within 10 years, there would be three, four or five Elans in Ireland but that never happened,” he admits. “We have done very well with Foreign Direct Investment. If we can turn it around and have a similar level of success with indigenous companies, that would be great. The technology is there, the appetite is there and I think the management is there. There are a lot of Irish people who have worked abroad, worked for big pharma and medtech companies, have come back and are looking for programmes and projects in that early proof of concept stage that they can build companies around. This is a difficult industry with a lot of failures, but I think you have to accept that on the back of those failures, you are going to learn and you will have successes following that, i.e. important

medicines that will help patients, globally.” Ireland has a lot going for it, including the fact that the tax regime is conducive to business, it’s English-speaking and has strong links with the US, is based in Europe, with highly qualified and trained employees. NIBRT has to “take a lot of credit” for the latter point, having helped to train our future scientists and innovators since its formation.

Industry/academic collaboration Collaboration between industry and academia is vital for the industry’s future development, he believes, citing the example of the Karolinska Institute, a research-led medical university in Stockholm: “It’s an academic institute but they are very focused on therapeutics and filling that gap between innovation and company formation. I don’t think we have that in Ireland yet. “For many academics, their motivation is to publish papers and journals, and I understand that, but what about after publication; can that research help to form a drug? Can we commercialise the science, move it down the product development pipeline?” The barriers between industry and academia are, thankfully, breaking down, he admits: “A few years ago, it was either industry or academia; now there are great examples of academics going into industry and industry people going back into academia. Cross pollination of both is what is required to advance the science and the industry.” Traditionally, pharma manufacturing has been very strong in Ireland, but Jeremy insists that it is in the area of Research & Development where we can really excel on the world stage, given the right supports: “That’s where we need to improve, as that will add greater value in the long term and cement Ireland’s place as the ‘go-to’ country for drug discovery, development as well as manufacturing.”

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SkyCell Hybrid Containers: Safeguarding Sensitive Medicines With the rise of biologics, as well as stricter compliance and environmental regulations, pharma companies require a new solution to meet these challenges. At SkyCell, we have developed the next generation of hybrid container to ensure protection for an unbroken cold chain. The best of both worlds For over 20 years, the cold‑chain market has been divided into two worlds: active and passive. At SkyCell, our hybrid containers seamlessly combine and upgrade technologies of active and passive solutions, such as a longer runtime and hard exterior shell.

1500X: The next generation of hybrid The 1500X enables pharma shipments for products that need to be kept at +2°C to +8°C and has a tested market‑leading independent runtime of 270 hours at 20°C. The extended runtime ensures that the transportation of temperature‑sensitive goods remains unaffected even in the event of unforeseen circumstances such as flight delays, re‑routing, and delays at customs.

Our hybrid container’s average independent runtime of 270 hours is made possible through our patented phase changing material and Swiss precision engineered design, offering added security to any delivery destination worldwide.

In further enhancements to the safety and protection of goods within the 1500X, the container’s feet have been redesigned to improve shock and vibration protection from aircraft and trucks.

A fully audited and sustainable solution Safety is essential when it comes to life‑saving medicines. With temperature excursions contributing to over $34 billion in losses in the biopharma logistics market, audited, tested and approved solutions are vital. Through our data‑driven approach and annual quality audit by a global top auditor certifying a proven performance of less than 0.1%, we go above and beyond international standards with our hybrid containers.

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The 1500X is also the most space‑efficient container in SkyCell’s product portfolio. Four 1500X containers can be loaded onto one standard PMC pallet, while only a pallet jack is required to load the 1500X into a standard truck that can hold up to 18 containers. Included as standard with the 1500X, SkyCell’s proprietary SaaS platform, SECURE, offers customers real‑time visibility of shipments, closing supply chain visibility gaps and allowing corrective actions to be made via critical data gathered during transportation.

Hybrid not only safeguards medicines, but also the environment too. Through implementing the Circular Economy into our hybrid solution, we have stopped contributing to landfill waste. The efficient design also leads to a reduction of CO2 emissions by as much as half, as the containers are built from a recyclable multi‑layer material for a safe and sustainable delivery worldwide.

The 1500X sets the new standard by offering total cost savings and an unbroken cold chain; pharma companies can rely on us to safely ship their products without suffering temperature excursions and to optimise their supply chains. SkyCell SECURE acts like a ‘guardian angel’ by continuously monitoring the 1500X and helps to track its milestones to alert to delays or risks in the supply chain.

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Richard Ettl, SkyCell CEO

Safe. Secure. Sustainable. The future is hybrid. Globally available in over 25 service centres across North America, Latin America, Europe and APAC regions Up to 50% CO2 reduction and elimination of landfill Audited performance of less than 0.1% temperature excursions with an average runtime of 270 hours

REGULATION

Regulation supporting innovation Ireland’s Health Products Regulatory Authority helps to create an ecosystem that supports science-based innovation, writes Dr Lorraine Nolan, Chief Executive, HPRA. Life science and innovation can only thrive in an environment that provides the right support and guidance at appropriate times across the entire research spectrum to facilitate translation of promising discoveries into clinical practice. Similar to the highly globalised, complex and interconnected nature of modern science and innovation, which is typically dependent on experts from diverse fields, the range of stakeholders supporting scientific endeavours are equally diverse. Funding agencies, technology transfer offices, pharmaceutical companies, health technology assessment and other health system partners, all contribute in specific ways throughout the translational journey to facilitate the realisation of practical benefits for patients, health providers and the life sciences sector. Medicines and medical device regulatory agencies are very mindful of our role in creating

an ecosystem that supports science-based innovation. Recent examples of regulatory initiatives to enable life science innovation include the development of appropriate supports and access to guidance for priority medicines, mechanisms to enhance the conduct of clinical trials in the EU, and advances in the application of innovative evidence generation through real-world evidence and data (RWE and RWD, respectively) to support regulatory decision-making.

Access to support and guidance Given the pace of scientific and technological innovation, it is imperative that regulatory agencies adopt an agile approach to how we regulate innovative products. The pandemic has demonstrated in a very meaningful way the opportunities provided by, as well as the

feasibility of, safe and rapid acceleration in innovative product development. One of the main drivers supporting this incredible achievement was early access to scientific advice. Indeed, as outlined in the HPRA’s strategic plan 2021-2025, the organisation is committed to supporting Irish research through outreach and engagement. Experts from across the organisation are ready to provide advice and guidance for researchers throughout the development cycle using existing networks, while also establishing new relationships and mechanisms to support initiatives that facilitate the translation of research into clinical practice. In addition to supporting national life science innovation, the HPRA continues to contribute at European level to the development of regulatory science tools to facilitate priority medicines through the PRIME mechanism. Irish PharmaChem – Summer 2022

REGULATION significant step forward. It aims to ensure that the EU continues to be a focal point for clinical research, to further promote the development of high quality, safe and effective medicines, and to better integrate clinical research in the European health system. ACT EU builds on the application of the new Clinical Trials Regulations and the launch of the Clinical Trials Information System (CTIS) in January 2022 by providing key priorities for 2022-2023. Areas of focus include: enabling innovative trial methods, establishing a multistakeholder platform, and supporting the modernisation of good clinical practice.

Better use of existing and new sources of data

The recent publication of the PRIME Toolbox, for example, provides guidance on scientific elements and regulatory tools to support quality data packages. Specially, the guidance provides information to address common challenges faced by developers with meeting quality and manufacturing development data requirements, with specific reference to chemical, biological or biotechnologically derived substances and Advanced Therapy Medicinal Products (ATMPs).

Accelerating clinical trials in the EU (ACT EU)

Access and application of different sources of data to facilitate risk-based decision-making is an area of intense focus for regulators to support innovative evidence generation. As we embark on a digital revolution, we have already seen the routine application of RWE to inform regulatory decision-making. Approximately 40% of marketing authorisation applications to the EMA between 2018 and 2019, for example, contained some form of RWE/RWD (Source: Arlett P, et al. (2022) ‘Real-World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value’, Clinical Pharmacology & Therapeutics, vol. 111 number 1. DOI: 10.1002/ cpt.2479). New data sources can bring value to every stage of a drug’s life cycle. Although regulatory and health technology assessment (HTA) submissions are likely to remain focused on randomised controlled trials (RCTs) in the future, RCTs are also likely to be supplemented with RWD/RWE. As more technologically complex innovations progress through development, however, there will be increased need for early access routes that include robust

ways of measuring the actions of products under real world conditions. In recognition and support of the important role these data have on a range of issues, including, but not limited to, health care and regulation, the European Commission has proposed a European health data space to establish interoperable data access infrastructure, which will improve exchange, federated access and cross-border analysis of health data in the EU. Although RWE/RWD sources have obvious potential to complement more traditional forms of evidence, issues remain with regard to data quality, structure, standards, and other methodologic limitations. Therefore, significant work remains to fully leverage the potential opportunities afforded by novel forms of evidence generation to support innovation.

Conclusion: a delicate balance The core mission of the HPRA is to regulate medicines and devices for the benefit of people and animals through science, collaboration, and importantly, innovation. The HPRA, and indeed medicines and medical device regulatory agencies across Europe and beyond, have an important role in supporting life science innovation, from discovery through to regulatory approval. Allowing research discoveries to flourish and facilitate new treatment options for patients, while at the same time ensuring effective regulation of emerging therapies and technologies, is a delicate balance. As reflected in our strategic plan, the HPRA intends to continue to support health product innovation through our activities and contribution at national, European and international level, with a view to implementing new and adapted regulatory tools and approaches that mirror scientific and technological progress.

Given the multidisciplinary and globalised nature of modern science-biased innovation, it is imperative that regulators work collaboratively to contribute to a regional and global ecosystem that facilitates product development. Ready access to clinical trials reflects a progressive and modern healthcare system and provides a science-based approach to innovative patient care and clinical research. Clinical trials can serve to provide Irish patients access to advanced medicines and medical devices to treat sometimes rare and debilitating diseases. To further support science-based innovation in clinical trials in Ireland and indeed Europe, the HPRA’s and the European medicines regulatory network’s strategies, together with the European Commission’s Pharmaceutical Strategy, have put forward recommendations to enable innovation in clinical trials. The recent Accelerating Clinical Trials in the EU (ACT EU) initiative, for example, represents a Irish PharmaChem – Summer 2022

Industry 5.0

Industry 5.0: a data-led approach to Irelands’ manufacturing sector

Digital maturity and sustainability assessment is a critical first step for companies embracing Industry 5.0.

Innopharma Global have developed a digital maturity and sustainability assessment tool, based on Industry 5.0 best practice worldwide, to specifically assist organisations in formulating an evidence-based strategy that considers their unique technological and organisational direction, roadmap and destination, write Innopharma’s Noel Kelly and Ann Ryan. The two most significant challenges facing Ireland 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 human-centric 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 shown the importance for Europe to be more self-reliant and or flexible in manufacturing and supply to adapt to changing conditions. The European Commission’s Industry 5.0 Policy Brief emphasises the powerful role industry can play in achieving societal goals through green and sustainable production. Industry 5.0 provides an opportunity to reframe digitalisation and

the techno-economic vision of the Industry 4.0 revolution through a human-centric lens, moving the focus from solely shareholder value to value for all stakeholders. Not only do the industries within this sector save lives by developing muchneeded medicines, medical technologies and food products, they change lives by providing rewarding and exciting careers. To sustain and grow careers, we must successfully digitalise these operations. Irish PharmaChem – Summer 2022

Industry 5.0

Industry 5.0: industrial competitiveness and sustainability The European Commission’s Industry 5.0 Policy Brief emphasises the powerful role industry can play in achieving societal goals through green and sustainable production. Since its publication in January 2021, many of the elements are being implemented already. More recently, a brief on Industry 5.0 was prepared by the Commission’s Expert Group on the Economic and Societal Impact of Research (ESIR) and published in January this year. ‘Industry 5.0, a transformative vision for Europe | European Commission’ (europa. eu). Industry 5.0 provides an opportunity to reframe the digitalisation and techno-economic vision of the industry 4.0 revolution through the human-centric lens, considering all stakeholders. Key benefits are: ● Ensures a framework for industry that combines competitiveness and sustainability, allowing industry to realise its potential as one of the pillars of transformation; ● Emphasises impact of alternative modes of (technology) governance for sustainability and resilience; ● Empowers workers through the use of digital devices, endorsing a human-centric approach to technology; ● Builds transition pathways towards environmentally sustainable uses of technology; ● Expands the remit of corporation’s responsibility to their whole value chains; Irish PharmaChem – Summer 2022

The digital maturity and sustainability assessment provides clear insights into all areas of the company’s current industry 5.0 state, develops an understanding of their future state and facilitates the development of transformation roadmaps to get there.

Introduces indicators that show, for each industrial ecosystem, the progress achieved on the path to well-being, resilience and overall sustainability. The EU Commission’s ‘The European Green Deal’ states that ‘digital technologies and Industry 4.0 are critical enablers for attaining the sustainability goals of the Green deal in many different sectors. In order to facilitate the transformation European

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industry requires, pro-active re-skilling and upskilling are necessary to reap the benefits of the ecological transition. It is clear from these policy landscape that digitalisation, the Green Transition and the adoption of Industry 5.0 principles are a strategic priority within the European Commission.

The Lighthouse 5.0 Partnership The Lighthouse 5.0 Partnership is a cluster of Irish

Industry 5.0

Innopharma’s digital maturity and sustainability assessment is carried out in 10 business functions across three streams of the business: primary and secondary value chain and sustainability.

based high-tech manufacturers, service providers and Government agencies, formed with the goal of leveraging sectoral competencies and best practice experience to accelerate the transition of current operations towards Industry 5.0. The life science sector (including biopharma, medtech and agri/foodtech) is critical to the Irish economy, with exports close to €150 billion, over 100 manufacturing sites and employees in excess of 300,000 (direct and indirect). Based on global and European dynamics in this space, there is a real need and indeed opportunity for Ireland and more broadly Europe to grow this high-tech manufacturing base over the coming decades, while in parallel achieving our sustainability targets. The cluster involves benchmarking the current state, identifying best practise exemplars and areas of opportunity through a digital maturity and sustainability assessment exercise that will enable the development of a data-rich strategy that considers the unique technological and organisational direction, technology innovation and skills roadmap and destination. The cluster is a champion of change around the Industry 5.0 principles of human-centric, sustainable and resilient manufacturing. Initial focus is on small molecule chemical manufacturing, which is well positioned to benefit from ‘Factory of the Future’ advancements, with the intent to broaden scope to other sectors within the ecosystem such as biologics, chemicals, medtech, engineering and agri/foodtech. Lighthouse 5.0 members include life science leaders like Lilly, MSD, SK Biotek, J&J, Thermo Fisher Scientific, Pfizer, GE Healthcare, Merck. Key benefits of such an approach are: ● Provides all leaders and experts with a

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comprehensive awareness of Industry 5.0 in the context of their own organisation’s selfassessment; ● Effective supply chain resilience from increased visibility, improved vendor management and better understanding of all aspects of the endto-end value stream; ● Improved sustainability, resulting in less carbon footprint and climate impact; ● Provides a granular benchmark score against other life science companies; ● Provides a unique insight into people and culture and their critical role on your transformation journey; ● Provides recommendations of areas where initial transformation projects (both site-specific and cross-site projects) should focus; ● Provides the foundational inputs into developing a digital transformation roadmap (both technological and skills) to improve competitiveness and sustainability; ● Builds an ecosystem aligned with national, European and global goals and objectives.

Digital maturity and sustainability assessment tool Innopharma Global developed a digital maturity and sustainability assessment tool, based on Industry 5.0 best practice worldwide to specifically assist organisations in formulating an evidence-based strategy that considers their unique technological and organisational direction, roadmap and destination. With a greater understanding of where organisations sit in the adoption of advanced technologies, they are in a stronger position to set achievable targets and strategies for improvement.

Innopharma’s digital maturity and sustainability assessment is carried out in 10 business functions across three streams of the business: primary and secondary value chain and sustainability. Subject matter experts from the company are interviewed and guided through a series of questions relating to their business functions. Under each business function, the maturity and sustainability of the company is evaluated against Industry 5.0 concepts. The scores awarded are calculated to determine an overall percentage score for each concept (70 in total), each business function (10), across the three value streams and to calculate an overall business score. These scores are compared at each level with the company’s defined targets. The results of the survey combined with the inputs and rich discussion between Innopharma SMEs (subject matter experts) and the company SMEs lead to specific recommendations on potential next steps. Results are then benchmarked against other companies to identify internal opportunities for improvement, allowing comparison to be done at many levels, including concept by concept or area by area or value chain by value chain. The next steps for companies include developing/modifying their Industry 5.0 Roadmap, incorporating cost-benefit analysis and discrete implementation milestones. The potential improvement actions are then referenced against the company’s goals and strategy in order to determine priority of implementation. This is to ensure that time and effort spent on areas will address the company’s unique issues and deliver maximum benefit. The assisted and guided self-assessment covers the following areas: Irish PharmaChem – Summer 2022

Industry 5.0

Areas for assessment Primary Supply Chain Manufacturing and process automation: seven Industry 5.0 concepts and technologies; Lab, metrology and quality management: four Industry 5.0 concepts and technologies; Manufacturing support: six Industry 5.0 concepts and technologies; Production planning and supply chain: six Industry 5.0 concepts and technologies. Secondary Value Stream People, culture and skills: 10 Industry 5.0 concepts and technologies; Business insights and analytics: seven Industry 5.0 concepts and technologies; Systems interoperability, IT security and operations: nine Industry 5.0 concepts and technologies. Sustainability Energy management: seven Industry 5.0 concepts and technologies; Climate action: seven Industry 5.0 concepts and technologies; Resource management: six Industry 5.0 concepts and technologies. The digital maturity and sustainability assessment is a critical first step for companies embracing Industry 5.0. As a holistic assessment, it provides clear insights into all areas of the company’s current industry 5.0 state. It develops an understanding of their future state and facilitates the development of transformation roadmaps to get there.

Determining and developing current and future skills needs As a result of discussions and analysis conducted by industry colleagues that have participated in Innopharma’s digital maturity and sustainability assessment, workforce planning has emerged as a recurring theme. A key element identified within this theme is that of determining and developing the new skillsets required for an increasingly automated and digital environment. In addition, and from a wider viewpoint, many businesses from a variety of sectors are now witnessing an acceleration in the changing nature of work and employment, with systems and technologies advancing at an unprecedented rate. Facilitated by the internet and emerging technologies, Industry 4.0 has driven a paradigm shift in industrial production, transforming manufacturing environments from fully physical systems to highly automated cyber-physical systems. In fact, the primary focus of industry 4.0 is to improve the efficiency of processes and in doing so, it has inadvertently overlooked the human and/or environmental cost associated with increased automation. Industry 5.0 however, now requires us to think and act differently, with greater focus on sustainability and human-centricity in the Irish PharmaChem – Summer 2022

The DMSA process.

workforce. This places an onus on industries to move beyond driving efficiencies, which are aimed solely at increasing the profitability of their goods or services. Industry 5.0 builds on, and complements the technological advances of Industry 4.0, by now placing specific emphasis and focus on a transition to greater sustainability, human-centric and resilient industries. The industry 5.0 vision of the factories of the future, combines human operators and smart machines working in teams that are resilient and flexible, with the capacity to respond to dynamic changes within the production environment. Industry 5.0 has provided an opportunity to move from profit-centric strategies, to now integrate a human-centric approach to increasing automation, while enabling real valueadding synergies between human capital and autonomous machines. Through increased levels of autonomy, employees’ roles will ultimately shift from repetitive, hands-on, practical tasks to roles requiring higher level of analytical and cross functional competence, as the boundaries between disciplines become more fluid. As a result of the advances in technology affecting the nature of their employment, employees will now require training and education opportunities in order to reskill and learn a new sets of competencies to transition to a completely new role or to upskill and learn new competencies to stay abreast of changes in their current role. The operators, technicians and engineers, now and into the future, require advanced skills, not only in digital technologies which include AI, robotics, cloud technologies, and programming. These employees must also be competent to deal with the challenges of industrial data, including data management, statistics, data visualisation, data ethics and integrity. To quote the historian EH Carr, change is certain; however, success is not. Therefore, a key element of any organisation’s

industry 5.0 roadmap should plan for success and encompass a workforce planning strategy to address evolving and future skills needs, with a focus on talent flexibility and both upskilling and reskilling.

Conclusions & recommendations This article highlights the benefits of using a deep dive Industry 5.0 assessment process to define the maturity and to establish a transformation strategy for high-tech manufacturing companies across Ireland. The tool allows companies to understand the impact of Industry 5.0 technologies and concepts, their current state and what is required to significantly increase that level of maturity. The tool has facilitated industry ecosystem collaborations to accelerate the path to Industry 5.0 maturity. It provides data to facilitate the leveraging of sectoral competencies and best practice experience to accelerate the transition of current operations towards Industry 5.0 and build the necessary human capacity to enable this. The framework provides a unique methodology to assist companies and collaborative clusters to prioritise actions and develop meaningful data rich transformation roadmaps. Further rollout within Ireland has the potential to create a greater data-driven understanding of where Irish manufacturing organisations sit in the adoption of Industry 5.0. This in turn will assist Ireland to prioritise and focus supports to support the twin goals of transition towards a climate neutral society and the improvement of our industrial competitiveness. It is only through this approach that we will identify a robust and data-led research and innovation strategy and accelerate the adoption of Industry 5.0 in an Irish setting and indeed demonstrate leadership at a global level.

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Advanced Therapeutics

Introducing ‘The Medicine Accelerator’

The biopharma sector in Ireland continues to grow – it now contributes more than €100 billion in exports and accounts for approximately 67% of Ireland’s GDP. There are more than 60,000 highly skilled people directly and indirectly employed in the sector and we expect this to increase by more than 10,000 in the next five years. The sector in Ireland is also evolving and this is needed to ensure we create a broader and deeper ecosystem - a key objective to develop a sustainable industry for the future is to build out the indigenous biopharma sector; companies like APC and VLE Therapeutics are taking on the challenge of leading this change and hopefully more will follow. It has been very interesting, getting to see the challenges for biopharma SME’s in Ireland – the lack of a cohesive ecosystem connecting SMEs, multinationals and academia; a funding mechanism is required to evolve to support the sector (I could call out Enterprise Ireland specifically for their solid focus and support to SME’s) and an ask now is for policy to adapt to reflect the needs of the indigenous biopharma sector

Paul McCabe, Chief Operating Officer, VLC Therapeutics, and Biopharmachem Ireland Chair, explains how APC & VLE Therapeutics are taking on global challenges for patients in Advanced Therapeutics.

and enable it to grow like the multinational sector.

our employees, being part of this story is incredibly exciting and rewarding.

APC & VLE Therapeutics – a background

APC Ltd

We hear about the discovery of new therapies to treat illnesses but that’s only half the story. There are so many scientific, technical and engineering challenges required to translate these discoveries into robust processes that can then be manufactured for patients: that’s what we do at APC and VLE Therapeutics, ‘The Medicine Accelerator’.

Irish company APC Ltd was founded by Dr Mark Barrett and Professor Brian Glennon in 2011 in UCD School of Chemical and Bioprocess Engineering in Dublin, Ireland. Since 2015, the company has been based in our headquarters in Cherrywood, South County Dublin, and we are the largest biopharma company in this area.

Patients need innovation, they need speed, they need improvements to the cost of medicines. APC, through their miledeep process development capabilities, and VLE Therapeutics, through their science-led manufacturing, enable the Medicine Accelerator to take on these grand challenges. Our mission is to help pharmaceutical companies globally to accelerate the development, manufacturing and launch of these critical therapies for patients. For

APC were created out of a passion for science and research. Dr Barrett and Professor Glennon embarked on a mission to disrupt the pharma and biotech industries with a hyper-focused, accelerated approach to drug process development. APC have grown organically to become a global powerhouse in Process Development, partnering with biopharma and pharma companies, large and small, to bring medicines to market at unprecedented speed. Irish PharmaChem – Summer 2022

Advanced Therapeutics VLE Therapeutics Ltd VLE Therapeutics are a start-up GMP Manufacturing company based in Cherrywood, Co. Dublin. The company was launched in June 2021, spun out of the award-winning APC Process Development business. As an Irish pharma SME, we have ambitions to leverage the talent, experience, and track record in Ireland’s biopharma sector to become global trailblazers in the industry. We will be extending the value chain from clients to APC Process Development to VLE GMP Clinical Manufacturing, and thereby enabling clients to get their critical medicines to their clinical trials. As a result, we will reduce the non-value-added steps, thus accelerating the development of therapies, and so improve the time, cost and risk profile to market for these medicines. This is all about how we collaborate to get these medicines to patients more effectively & efficiently; this new model is what we call ‘The Medicine Accelerator’. Our vision is to create this premium and unique offering – The Medicine Accelerator – where, collaborating with APC’s Process Development team, we will be lifecycle partners for our clients, working intensively to solve their problems and supporting them getting their critical therapies to patients.

The cutting edge of science What attracted me to join APC and help launch the VLE Therapeutics business? The opportunity to work with an Irish company who have strong ambitions to be global pioneers. The opportunity to work with Advanced Therapeutics, the cutting edge of science; based on the quantum of molecules currently in clinical phase trials, we will expect to see these commercialise over the next five years. As a country, we have made very small steps in this area to date and we are way behind other countries already (UK, US, Israel, Belgium, Netherlands, Nordics etc.). There is a gap in the industry for Ireland to step into and I would love to help an Irish company take these steps and support the national agenda for the sector. The opportunity to work with a genuinely innovative company was fantastic. The investment in state-of-the-art technology, the constant look to the future, the real use of digitisation, offering first-in-class digital solutions for clients – all of these were soundbites in many other companies I have dealt with, but were the reality in APC. The opportunity to work with a company where people are empowered to make decisions, to be ambitious, to solve grand challenges, to find new ways in everything we do – after more than 30 years in business, this was so refreshing. The opportunity to work in a company with a strong and authentic culture; anyone who knows me knows that I am Irish PharmaChem – Summer 2022

passionate, actually obsessed with cultures in organisations. I’m a firm believer that ‘culture enables performance’; having partnered with APC for the previous 3-4 years with my previous company, I had interacted with their leadership and staff, and the sense of innovation, energy, collegiality and ambition was so evident to me.

Rewarding and exciting work So when the chance arose to join the company and to lead VLE Therapeutics, the chance to embed the best culture from the outset, to attract and recruit the best talent, the chance to create a process to work hand-in-hand with APC’s Process Development team, the chance to develop & deploy the strategy for GMP clinical manufacturing and as a result to fulfil the ambition of the company by developing something different and something special, ‘The Medicine Accelerator’ - which will aim to bring therapies to patients at speed, this is really rewarding and exciting for me. Overall, the chance to create something new, to create future opportunities for people and to create a potential for an Irish business to be a global player is absolutely incredible. We launched VLE Therapeutics in June 2021, with An Taoiseach, Micheál Martin TD and Leo Clancy (CEO, Enterprise Ireland) onsite to support the launch. Since then, we hired a talented team, went from concept to reality with our GMP clinical manufacturing suite in seven months, and implemented GMP and business processes to support our clients. We have so much potential ahead for ‘The Medicine Accelerator’ and such an opportunity to accelerate the development, manufacturing and launch of critical medicines to patients; what a compelling purpose that myself and our teams have to work for every day. I am so looking forward to continuing to move the business forward and watching the business and the team grow in the years ahead.

APC Ltd co-founders Professor Brian Glennon (left) and Dr Mark Barrett.

VLE Therapeutics launched in June 2021 and in April 2022 opened their GMP clinical manufacturing facility and are now looking forward to supporting clients & their patients.

BIO INCUBATION

Unlocking Irish life sciences innovation We are Pioneer Group (WAPG), in partnership with Spear Street Capital, are seeking to address gaps in Irish life sciences infrastructure and access to capital by establishing a 30,000 square feet bio incubation facility at The Campus, Cherrywood in Dublin. Innovation lies at the heart of the life sciences industry, fuelling the discovery of new technologies and therapies to treat, diagnose and manage human disease. This is the cycle that supports a highly significant and strategically important industry in Ireland. There are five core components required to build a successful life sciences innovation ecosystem: 1. Density of world-leading universities and

research institutes; 2. Access to a strong talent pool; 3. Proximity to industry; 4. Access to dedicated infrastructure; 5. Access to sufficient early-stage capital. Ireland has inherent strengths in the first three components that provide fertile ground for creating a sustainable life sciences ecosystem. The country enjoys a rich life sciences heritage,

The bio incubation facility, financed by Spear Street Capital and operated by WAPG, will provide wet and dry labs, flexible offices, and collaboration space.

with the sector exporting more than €52 billion annually and directly employing over 70,000 people across the country. Ireland is host to nine of the top 10 global pharma companies, while 14 of the world’s top 15 medical device companies have a base in Ireland, with a global reputation in highend manufacturing (Source: IDA). There are, however, current gaps in the Irish ecosystem around dedicated infrastructure to support early-stage innovation. This innovation is increasingly driven by life sciences start-ups, translating lab-based research and medical device prototypes into real world applications. These start-ups typically require a supportive business environment, skilled staff, and flexible laboratory and office space to increase their likelihood of success. Additionally, there remains a significant gap in access to seed and venture capital for earlystage Irish life science opportunities. This capital is often associated with accelerator programmes that provide commercial de-risking and access to investors capable of cultivating start-up activity. Such a dedicated life sciences accelerator programme has remained elusive in Ireland, stifling the opportunity to build a critical mass of Irish PharmaChem – Summer 2022

BIO INCUBATION life sciences start-ups that can be of interest to international capital.

New bio incubation facility We are Pioneer Group (WAPG), in partnership with Spear Street Capital, are seeking to address these gaps in infrastructure and capital by establishing a 30,000 square feet bio incubation facility opening in Q3 2022 at The Campus, Cherrywood in Dublin. The bespoke facility, financed by Spear Street Capital and operated by WAPG, will provide wet and dry labs, flexible offices, and collaboration space. Life sciences entrepreneurs will be able to use the facility to explore their ideas, test them, access mentorship and business support, as well as collaborate with industry veterans to grow their business. In addition, WAPG will run their signature venture building programmes to support company creation and generate a national pipeline of companies to catalyse ecosystem development. Each year, opportunities will be identified through extensive academic, clinical and industry networks. Scientific and commercial viability will be assessed through the accelerator programme and the most promising ventures will become attractive investment opportunities.

occupying 70,000 square feet on the Nottingham campus by 2021. The partnership between WAPG and Spear Street Capital to establish a dedicated acceleration and incubation platform for life science start-ups at The Campus, Cherrywood, presents a unique opportunity for Ireland’s life sciences innovation. For more information visit thecampus.ie/lifesciences.

Above: Life sciences start-ups typically require a supportive business environment, skilled staff, and flexible laboratory and office space to increase their likelihood of success. Below: The new 30,000 square feet bio incubation facility will open in Q3 2022 at The Campus, Cherrywood in Dublin.

Expert Mentor Network The programme is augmented by a 250-strong Expert Mentor Network to support companies, both in the accelerator phase and during incubation. The WAPG Expert Network comprises senior pharma and biotech industry figures, experienced life science entrepreneurs, dedicated life sciences investors and other key industry professionals. Additionally, WAPG will leverage international corporate partnerships with organisations such as AbbVie, Astellas and Walgreens Boots to provide further insights to companies and possible partnering opportunities. The Cherrywood facility and programme, as well as connection to the wider WAPG collection in the UK, can play a substantial role in filling the key gaps in infrastructure and access to capital, critical to establishing a sustainable life sciences ecosystem. This platform, coupled with the presence of leading life sciences companies already on site, such as APC, VLE Therapeutics, Genuity Science, Abbott, and Zoetis, has the potential to develop a cluster that can elevate Irish life sciences innovation onto global significance. This is a model WAPG has seen developed successfully in the past.

A strong culture of innovation WAPG originated as BioCity Group, which had been actively developing and incubating early-stage life science companies for nearly two decades. The impact of this is seen in the growth of the cluster in Nottingham compared to other cities, such as Leeds, Newcastle, and Birmingham. From humble beginnings, BioCity has developed into the preeminent bio incubation business in the UK. Core to each location was a holistic approach of venture building, incubation, and investment. Over nearly two decades, BioCity became home to more than 200 companies with a 91% survival rate. Examples include Sygnature Discovery, which was founded in 2004 with four people occupying 900 square feet, and had grown to over 500 people

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Life sciences start-ups translate lab-based research and medical device prototypes into real world applications.

Irish PharmaChem – Summer 2022

Your Ideal Partner for the Development and Manufacture of APIs Our team in Cork is expert in developing and manufacturing API for clinical and commercial supply Our campus in Cork is a state-of-theart contract API development and manufacturing facility, where our team support our customers in bringing medicines to patients through the relentless application of science in process and analytical development. We take chemistry from laboratory scale development through to large-scale commercial supply, made

possible by our driven and dedicated employees - a team of 500+ highly skilled chemists, engineers, analysts, operators and crafts personnel. Our facility meets with the most stringent production, compliance, safety and environmental standards. We take pride in our mission to enable our customers to make the world healthier, cleaner, and safer.

Learn more at https://www.patheon.com/sites/cork-ireland/ or email us at contactcork@thermofisher.com

NIBRT

Ireland can play a major role in ATMP manufacture It is not very often that we get the opportunity to welcome history-making visitors to NIBRT, but, earlier this year, that opportunity arrived as we greeted Emily Whitehead and her parents, Tom and Kari, at the NIBRT facility. The Whitehead family hail from western Pennsylvania, USA. In 2010, Emily was diagnosed with Acute Lymphoblastic Leukaemia (ALL) and initially responded very well to conventional therapies. However, her cancer came back in 2011 more aggressively

Advanced Therapy Medicinal Products (ATMPs) are set to provide the next wave of healthcare innovation. Darrin Morrissey, CEO, NIBRT, advises on how Ireland can ensure it is at the forefront of ATMP development and manufacture. than ever before and in early 2012 Emily’s doctors gave her very little chance of surviving more than a few months. Then, by a mixture of her family’s dogged perseverance and the good-fortune of being treated in a hospital

in Philadelphia with access to experimental treatments, Emily was offered a final chance and was accepted on to a compassionate use programme to receive autologous cell therapy CAR-T therapy, becoming the first paediatric patient in the world to be treated with a CAR-T. Amazingly, within a few weeks of receiving her re-engineered T-cells, Emily was cancer-free and 10 years later she is still cancer-free and living a normal life (Source: https://journals.lww. com/oncology-times/fulltext/2022/03200/ the_incredible_story_of_emily_whitehead___ car.1.aspx).

ATMPs: the next wave of biopharma

NIBRT delivers nearly 40,000 training days to 4,600 trainees and students annually.

The potential of cell-based therapies to offer substantial long-term benefits for patients is exemplified in Emily Whitehead’s story. Cell therapies are part of a category of novel biopharma known as Advanced Therapy Medicinal Products (ATMPs), that also includes gene-based therapies, engineered regenerative tissues and oligonucleotide-based (e.g. RNA) vaccines and therapies. Major investment has been made over several years in the discovery, development, clinical trialling and regulatory submissions of ATMPs Irish PharmaChem – Summer 2022

NIBRT capacity to deliver a sustained disease response or even a cure.

ATMP: opportunity for Ireland Over the last 20 years, Ireland has established itself as a global leader in biopharmaceutical manufacturing and we have experienced tremendous success in attracting multinational companies to establish monoclonal antibody and recombinant protein manufacturing operations across the country. Biopharma foreign direct investment (FDI) has topped €10 billion over the last decade, with the number of biopharma manufacturing facilities now standing at over 25 across the country, with over 40,000 people now directly employed, with the sector contributing over €40 billion in national exports annually (Source: https:// www.idaireland.com/doing-business-here/ industry-sectors/bio-pharmaceuticals).

and it is anticipated that this investment will bear fruit with a steady increase in the number of products in widespread use (Source: PhRMA, Innovation in the Biopharmaceutical Pipeline, December 2021). ATMPs treat diseases at a fundamentally molecular level and represent a potential step-change in the precision and personalised nature of treatment and in the

The manufacture of ATMPs, although in many ways similar to large protein-based manufacturing, is more complex and diverse, and the efficient and safe scaledup manufacture of cell-based and genebased therapies, in particular, presents unique challenges. Similar to the productivity challenges experienced with monoclonal manufacturing in the 1980s, process development and manufacturability is widely recognised as a critical success factor for ensuring that ATMPs can be affordable, safe and available for widespread patient access. Building on our successful track-record, our existing infrastructure, our experienced workforce and new investments, Ireland has a strong potential to play a major role in optimising and presenting solutions towards the efficient, cost-effective and safe manufacture of ATMPs.

In 2018, NIBRT took a leadership role in pulling together a group of like-minded stakeholders with interests in the advanced therapeutics area, under the banner of the Cell & Gene Therapy (CGT) Forum. The CGT Forum now includes over a hundred members, representing MNC and SME companies, engineering firms, consultancies, academic researchers, representative bodies like BPCI and IPHA, and government agencies, including IDA Ireland, Science Foundation Ireland, Enterprise Ireland and the Health Research Board. In 2019, the Forum published a white paper that recommended four focus areas for accelerated action to support Ireland’s move into ATMP development, manufacturing and supply. These were: 1. Infrastructure: Investment in the necessary ATMP infrastructural investments, including scale-up facilities, testbeds, incubators, training facilities, etc. 2. Talent development: Provision of national higher and further educational supports to ensure biopharma companies could source highly trained staff for ATMP manufacturing operations. 3. Research excellence: Ensure strong supports for scientific and engineering research in ATMP development and manufacturing within the broader Irish research system. 4. Public-Private sector alignment: Ensure a joined-up approach across government, state agencies and companies to advance the ATMP sector. Considerable progress is now being made across each of these four recommendation areas:

The manufacture of ATMPs for the supply of global markets represents a major opportunity for Ireland.

Irish PharmaChem – Summer 2022

NIBRT NIBRT was established in 2007 with the mission of supporting the biopharma manufacturing facilities in developing talent and skills through worldleading training and address complex manufacturing challenges through excellent research.

Investment in ATMP manufacturing and development infrastructure NIBRT has recently commenced an expansion of its training and research facility in Dublin. The expansion, which is funded by a capital investment from IDA Ireland / the Government of Ireland of €21 million over five years, will create around 1,800m2 of additional space, including an extra five laboratories and new training suites dedicated to cell and gene therapy training and research. The new facility is scheduled to open in the first half of 2023 and NIBRT is currently hiring additional principal investigators for its research team and additional training staff. In the private sector, a number of large-scale ATMP investments have also been announced over the last 12-18 months, including: Meira GTx’s announcement of Shannon as the site of their new cGMP viral vector manufacturing facility and cGMP plasmid production facility. The facilities will produce commercial-grade gene therapies in a fully integrated manner, creating 100 new jobs. Takeda’s €36 million expansion at their

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Grange Castle facility to support expansion of their cell therapy capacity. This expansion will create approximately 100 new jobs over three years. Pfizer’s expansion of their Grange Castle facility to the manufacture the Pfizer- BioNTech Covid-19 mRNA vaccine, with the addition of 75 new jobs. APC Pharma’s €25 million investment in a new global centre of excellence to accelerate the development and manufacture of vaccines and other medicines, as well as their €17 million spin-out of a CGT contract manufacturing company, VLE Therapeutics.

ATMP manufacturing skills and talent development The CGT Forum has established a ‘Training and Education’ working group to set direction and drive action in ATMP manufacturing skills development. This group, with representatives from across the sector, has developed a comprehensive set of priorities focused on developing specific ATMP-related technical skills, as well as important transferrable skills,

including process & analytical performance monitoring, logistics and cold-chain management. With these skills priorities now set, Ireland’s higher educational institutions and training institutes are developing tailored programmes to address them. NIBRT, as Ireland’s primary training institute for biopharma manufacturing, has launched a number of ATMP training programmes during in 2021/22 (available at www.nibrt.ie/wp-content/uploads/2020/11/ NIBRT-Training-Catalogue-2021-.pdf ). These include: ‘An Introduction to ATMPs/CGT’, ‘Advanced Cell Therapy Manufacture’ (in collaboration with Cytiva), ‘Fundamentals of Stem Cell Manufacture’ (with the Centre for Cell Manufacturing (CCMI), Galway), ‘Introduction to Gene Therapy Manufacturing’, ‘Manufacture of Viral Vectors’ and a range of NIBRT Online Academy modules.

Research and Development in ATMPs The highly diverse range of ATMPs are already presenting scaling, consistency, safety and affordability challenges for manufacturers. Therefore, the ability of the industry to access Irish PharmaChem – Summer 2022

NIBRT

research skills and expertise with the capacity to address process development, analytics and manufacturability issues close to their sites of manufacture will be critically important for future delivery. The CGT Forum is focused on identifying top ATMP manufacturing challenges and identifying where Ireland has complementary research strengths and skills across the academic and private sector research base to address these challenges. The ultimate aim is to produce an online directory of researchers, companies and infrastructures in Ireland into which the global biopharma industry can seamlessly tap, while availing of co-funding research supports from the state. Notably, 2021 and 2022 saw a significant increase in state and ‘above-state’ funding flowing into ATMP manufacturing research. The third round of Disruptive Technology Innovation Fund (DTIF) awards, announced in April 2021, resulted in funding with a combined value of over €20 million, from a total funding pot of €95 million, being awarded to five ATMP-related projects involving indigenous Irish biopharma companies, such as Remedy Bio, aCGT Vector, Valitacell, Avectas and BlueBridge Technologies, partnering with Irish research performing organisations. While on the European front, the European Innovation Council (EIC) recently ran a CGT manufacturingthemed Pathfinder Challenge call, in which a number of Irish research groups had success.

Joined-up ATMP approach across Government, state agencies and companies The work of the CGT Forum has already demonstrated the tremendous alignment that can happen between the state and private sector when there is a concerted effort to tackle an area of national strategic importance. In parallel, the Irish Pharmaceutical Irish PharmaChem – Summer 2022

Healthcare Association (IPHA) with PwC, have done excellent work on the patient access challenges associated with the growth in innovative medicines and vaccines, while BioPharmaChem Ireland (BPCI) and EY have established a working group that is exploring the digital and business services opportunities associated with advanced therapies.

In conclusion As we look forward to the next decade, the manufacture of ATMPs for the supply of global

NIBRT has recently commenced an expansion of its training and research facility in Dublin, including an extra five laboratories and new training suites dedicated to cell and gene therapy training and research. markets represents a major opportunity for Ireland. The foundations are already laid and NIBRT is committed to playing a leading role, along with our partners at IDA Ireland and the CGT Forum, in enabling Ireland to capitalise on this opportunity.

NIBRT, the National Institute for Bioprocessing Research and Training, was established in 2007 with the mission of supporting the biopharma manufacturing facilities in developing talent and skills through world-leading training and addressing complex manufacturing challenges through excellent research. Over the years, NIBRT has gone from strength to strength and the Institute now delivers nearly 40,000 training days to 4,600 trainees and students annually, as well as delivering a diverse range of research projects with funding from industry partners, state funders (SFI, EI, etc) and the European Commission.

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CAR-T Cell Therapy

CAR-T Centre opens at St James’ Hospital The first patients in Ireland have received ground-breaking CAR-T cell therapy for blood cancer at St James’ Hospital, Dublin. Professor Larry Bacon, Consultant Haematologist and Clinical Lead for the National Adult CAR-T Centre at St James’s Hospital, talks us through this important development. December 2021 saw the opening of Ireland’s National Adult CAR–T Cell Centre at St James’ Hospital, Dublin, which saw the first Irish patients receiving cell therapy treatment for lymphoma / acute lymphoblastic leukaemia in Ireland, the first time this leading medical technology was available within the country. Up until now, any patient who could benefit from this potentially life-saving personalised therapy had to travel to the UK to receive the treatment. Since December, however, the National Adult Allogeneic Bone Marrow Transplant unit, which has over 30 years’ experience in bone marrow transplantation, has been designated Ireland’s National Adult CAR–T Cell Centre. “CAR-T therapy is a lifeline for suitable blood cancer patients whose other treatment options have been exhausted,” explains Professor Larry Bacon, Consultant Haematologist and Clinical Lead for the National Adult CAR-T Centre at St James’ Hospital. “It is the most advanced immunotherapy currently available for patients with lymphoma. CAR-T therapy marks a huge breakthrough in the treatment of relapsed and refractory disease in particular, and St James’ Hospital is very pleased to be able to treat these patients in Ireland for the first time. This programme has been made possible through a massive collaborative effort between the Haematology, Oncology and

Palliative Care (HOPe) Directorate and medical, nursing, cryobiology laboratory, pharmacy and corporate teams, along with the Department of Health and the NCCP.”

A revolutionary treatment CAR-T therapy is at the cutting edge of healthcare innovation. A revolutionary development for blood cancer patients, Chimeric Antigen Receptor-T cell (CAR-T) therapy involves collecting a patient’s own T cells. The cells are cryopreserved and/or prepared for export in the hospital’s on-site Tissue Establishment, Stem Cell Facility, under the guidance of Dr Nicola Gardiner, Chief Medical Scientist. These cells are then sent overseas to a CAR-T manufacturing facility where they are re-engineered to express a receptor to target the cancer cells. Following a robust quality assessment, the cells, now deemed a medicinal product, are returned to the stem cell laboratory. At this stage, the pharmacy team and stem cell laboratory medical scientists perform a final quality check and verify the drug (frozen in liquid N2) is suitable for infusion. Prior to reinfusion, the patient receives three days of lymphodepleting chemotherapy, and then remains in hospital for two to three weeks to monitor for side effects. On the day of reinfusion, a medical scientist thaws the CAR-T product at the

bedside and transfers it to the specialist nurse in the bone marrow transplant unit for infusion. While awaiting manufacture of CAR-T cells, patients often receive “bridging therapy” to control their disease. This is a difficult and complex 4-6 weeks for patients. The CAR-T cell co-ordinator, Liz Higgins, is involved in coordinating the treatment pathway from initial referral to infusion and subsequent follow-up. The two main side effects of the process are Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), a form of systemic inflammatory response syndrome. CRS typically presents with high fevers, which can quickly progress to haemodynamic instability and multi-organ failure, requiring an ICU admission and ultimately death if untreated. ICANS presents initially with subtle neurological changes e.g disorientation/confusion, but can progress to the development of seizures and ultimately coma. Patients are regularly assessed for development of CRS and ICANS and with early intervention, significant complications can be avoided. Most patients are discharged by the third week in hospital and have regular follow-up in outpatients’ clinics to monitor for development of late side effects. In general, there is a 28-day timeline between the patient’s cells being harvested and the reengineered cells coming back for reinfusion. Irish PharmaChem – Summer 2022

CAR-T Cell Therapy Pictured left are Dee Byrne, CNM II, Clinical Facilitator, Denis Burkitt Ward, St James’ Hospital (foreground); and Catherine Blackwell, Senior Medical Scientist , Cryobiology Laboratory. Photo credit: Anthony Edwards, Medical Illustration, St James’ Hospital, Dublin 8.

Right: Catherine Blackwell, Senior Medical Scientist, Cryobiology Laboratory. Photo credit: Anthony Edwards, Medical Illustration, St James’ Hospital, Dublin 8.

“The processing is part of that, but because we are dealing with viral vectors, quality control is paramount, to ensure there are no mutagens,” Professor Bacon reveals.

Huge interdisciplinary collaboration While the treatment has around a 40% success rate, without it, most of these patients will face terminal illness. The HSE spent €8.18m on Irish patients receiving this therapy in the UK in 2019 and 2020, via the Treatment Abroad scheme. At the time of writing, seven patients in total have received the treatment at St James’. Four of those are in complete remission, two have “residual disease, but it is well controlled,” according to Professor Bacon, and unfortunately, one patient passed away. Professor Bacon and his team are also following up to 20 Irish patients, who had travelled to the UK for CAR-T therapy over the last three years but can now have their followup in Ireland. This cutting edge technology involves “huge interdisciplinary collaboration and activity,” Professor Bacon stresses, “not just here in Ireland but in other jurisdictions where the cells are sent to be re-engineered.” The multidisciplinary teams include the haematology transplant team supported by neurology, intensive care, radiation oncology, radiology, pharmacy, allied health, stem cell laboratory, quality, administration and input may be required from other specialist services. This new therapy is currently licensed to treat specific blood cancers, including Acute Lymphoblastic Leukaemia (ALL) and Diffuse Large B-Cell Lymphoma (DLBCL), a subtype of non-Hodgkin lymphoma (NHL). However, it is expected that use of CAR-T cell therapies Irish PharmaChem – Summer 2022

will grow exponentially and will include other diseases in coming years. In 2019, the American Society of Haematology described CAR-T therapy as “the next big thing” in blood cancers. CAR-T therapy is available in more than 15 EU countries, and has been publicly available in England through the NHS since 2018. The NCCP has designated St James’ Hospital as the initial National Adult CAR-T centre in Ireland and Children’s Health Ireland (CHI) in Crumlin as the National Paediatric CAR-T centre.

life limiting illnesses. “We should hopefully see a huge increase in the numbers of patients being treated with CAR-T therapy, particularly as new products and new innovations come on-stream,” concluded Professor Bacon.

Direct benefits for patients Minister for Health Stephen Donnelly TD, welcomed the CAR–T Cell Centre at St James’ Hospital: “This therapy had previously only been available overseas and it will make a huge difference to people to be able to access it in Ireland. I hope that CAR-T therapy will greatly improve treatment outcomes for many over the coming years. I provided €57 million this year for the development of cancer services, improvements in cancer screening and new cancer drugs. It is great to see the direct benefits that this funding is bringing to patients through new initiatives such as CAR-T therapy.” CAR-T cell therapy is in its infancy and is expected to grow exponentially and include other disease indications in the next decade, according to Professor Bacon. “Efficacy will be improved by using these products in first relapse or even as upfront therapies. In addition, other immune effector cells such as NK and dendritic cells are under investigation as potential CAR therapies, which will ultimately improve treatment outcomes for patients with

Pictured are (l-r): Professor Larry Bacon, Clinical Lead, CAR-T Programme; Olga Crehan, CAR-T Chief Pharmacist; Nicola Gardiner, Chief Medical Scientist, Cryobiology Laboratory; and Liz Higgins, CNMIII , CAR-T Co-ordinator. Photo credit: Anthony Edwards, Medical Illustration, St James’ Hospital, Dublin 8.

Takeda Ireland

Takeda open Ireland’s first commercial-scale cell therapy facility

Following a substantial investment over the last year, Takeda Ireland have recently opened their commercial-scale cell therapy production facility at their site in Grange Castle, Dublin, the first facility of its kind in Ireland. The opening follows an announcement in 2021 that Takeda would invest a further €36.4 million to support the expansion of the cell therapy facility at Grange Castle. The expansion, which is now complete, will allow the team to support the growing global demand.

Takeda Ireland, a subsidiary of Takeda Pharmaceutical Company Ltd, recently celebrated the official opening of their cell therapy production facility at their Grange Castle site in Dublin. The commercial-scale cell therapy production facility is the first of its kind in Ireland and will play an important role in supplying European, US and Canadian markets with a cell therapy treatment option for patients. “Congratulations to Takeda on the opening of this new, state-of-the-art facility, which already employs 100 people and will create 100 more jobs over the next three years,” noted An Tánaiste and Minister for Enterprise, Trade and Employment, Leo Varadkar TD, on the official opening. “Takeda are at the forefront of cutting-edge research and innovation and the company’s continued investment here underlines Ireland’s position as a global hub for the biopharma sector. The treatments developed at this centre will make a real difference to patients’ lives and I would like to thank the team for their commitment and wish them well in this new chapter.”

Highlighting Takeda’s innovation capabilities

Takeda Pharmaceutical’s Global Manufacturing & Supply Officer, Thomas Wozniewski and Takeda Grange Castle Site Head, Paul Keogh pictured at the official opening of Takeda Ireland’s newest cell therapy production facility at their Grange Castle site in Dublin.

Thomas Wozniewski, Takeda Global Manufacturing & Supply Officer, commented: “The opening of this state-of-the-art cell therapy facility at Grange Castle illustrates Takeda’s innovation capabilities and also underlines the importance of Ireland to the global Takeda manufacturing network. Cell therapy facilities require a specialised set of skills and the talent base in Ireland is as important as other frame conditions like proximity to partners and an international airport.” The facility will host drug product, drug substance and master cell stock. It will also play an important role in supplying drug substance to other Takeda manufacturing facilities. Due to the short shelf life of the treatment, the Irish PharmaChem – Summer 2022

Takeda Ireland facility has automated its supply chain and manufacturing processes, to create efficiencies and get the treatment to patients in need. The facility uses a number of rapid microbial test methods to ensure the release of product in a timely manner. It is the first facility in Ireland that is approved to release a cellular therapy product commercially using rapid test methods. “The Grange Castle site is growing from strength to strength thanks to a great team and strong investment in our people and technology,” noted Paul Keogh, Grange Castle Site Head. “The treatment produced here will be delivered to patients within 72 hours of being released from Grange Castle, which means we are closer to the patient than we have ever been and this brings a great sense of pride to our team.”

A vote of confidence in Ireland CEO of IDA Ireland, Martin Shanahan, said: “Takeda’s continued investment at their Grange Castle facility and the opening of this cell therapy production facility at the Grange Castle site is a huge vote of confidence in Ireland and our strong value proposition. Cell therapy is a core pillar in the emerging field of Advanced Therapy Medicinal Products (ATMPs), widely considered as the next generation of pharmaceutical therapies. These products require highly innovative approaches to manufacturing and offer unparalleled opportunities in the treatment of disease. This facility adds to Ireland’s reputation as a global location of excellence for next-generation biopharmaceutical products.”

Pictured are (l-r): Thomas Wozniewski, Global Manufacturing & Supply Officer, Takeda; and Paul Keogh, Site Head, Takeda Grange Castle; Mitsuru Kitano, Japanese Ambassador to Ireland; Professor Glen Doherty, Consultant Gastroenterologist at the Centre for Colorectal Disease, St Vincent’s University Hospital; and Michael Lohan, Head of Lifesciences & Talent, Transformation and Innovation at IDA Ireland. strength, thanks to substantial investment in people and industry-leading technology. Takeda currently operate across four locations in Ireland; Baggot Street, global operations

for biologics and small molecules; Bray, small molecule manufacturing; Citywest, commercial operations; and Grange Castle, small molecule and cell therapy manufacturing.

Takeda’s Grange Castle site has two additional production facilities, a bulk active pharmaceutical ingredient (API) production facility, and a dedicated oncology production facility, which houses all steps of the process (API, drug product, primary and secondary packaging) under one roof. The Takeda Grange Castle site uses 100% renewable electricity. The site is also one of the first pharmaceutical manufacturing sites in Ireland to achieve an international standard for energy management known as the ISO 50001:2018 standard. This is a voluntary standard for designing, implementing and maintaining an energy management system, which includes setting objectives for improving the efficient use of energy. These measures support Takeda’s wider commitment to being carbon zero in their own operations by 2040.

Substantial investment in people and technology Takeda’s presence in Ireland was established in 1997, and their Irish operations have played a key role in the company’s global leadership for 25 years. Since beginning commercial operations, Takeda Ireland have grown in Irish PharmaChem – Summer 2022

Takeda have invested €36.4 million to support the expansion of the cell therapy facility at Grange Castle, allowing the team to support the growing global demand.

Stability Storage

Source BioScience:

your trusted partners in Tramore Reasons to celebrate: Source BioScience have been offering pharmaceutical and life science stability storage from their Tramore site for 15 years. Source BioScience (‘Source’) are celebrating 15 years in business at their facility in Tramore. Formerly Vindon Scientific, the company has been in operation in the UK for more than 40 years. The Tramore facility opened in July 2007 and offers outsourced stability storage services to the pharma and biotech sectors and has fostered many partnerships with top 10 and top 20 pharmaceutical companies, as well as smaller healthcare organisations.

Ireland - a global life sciences precinct It is no secret that Ireland is endowed with a unique life sciences ecosystem. Awash with a talented, highly skilled and productive workforce, Ireland has great potential in next-generation and advanced therapeutics. Over the last decade, Ireland has earned its reputation as a global centre of excellence for the manufacture of medicinal products from

traditional solid dose, to medical devices and advanced therapeutics. At some stage in their development life-cycle, these products will undergo stability testing for the purposes of establishing shelf-life.

Source stability storage solutions Stability storage enables an evaluation of shelflife to be made by placing samples in storage, at controlled temperatures, for specified periods of time – conditions made possible by top of the range equipment, facilities and personnel. Source provide GxP compliant temperaturecontrolled storage solutions. Chamber temperatures range from -80°C to +50°C across a complete range of storage conditions in numerous climatic walk-in chambers and climatic cabinets, with a total storage capacity of more than 0.5 million litres of space. With over 100 walk-in rooms, cabinets and freezers, all ICH

climatic zones are catered for, and long-term and accelerated conditions are available. The storage chambers are fully controlled, with 24/7 monitoring and alert systems (21 CFR part 11 compliant). Also available are photostability testing facilities, biostorage capabilities, contingency storage for disaster recovery and facilities for the conservation of heritage items and other precious materials. Source have a world-wide reach, with operational bases in Rochdale, UK, and San Diego, California, USA. Their Director of Stability, Maureen Gilbert, predicts that the future looks bright. Given the high number of multinational pharmaceutical companies operating in Ireland, she sees significant opportunities to build on new and existing partnerships. Source Ireland’s business strategy is based on establishing strategic alliances with major biotech Irish PharmaChem – Summer 2022

Stability Storage customers to:

• • • •

Maintain compliance with regulations; Identify hot/cold spots and potential breaches; rend your data year-on-year to identify patterns; In conjunction with permanent monitoring, use mapping data to identify equipment failures.

Maureen advises customers that if they can answer yes to the following, then there is a good probability a partnership with Source would allow them to streamline their processes.

Source provide GxP compliant temperature-controlled storage solutions, with chamber temperatures ranging from -80°C to +50°C across a complete range of storage conditions in numerous climatic walk-in chambers and climatic cabinets. and pharmaceutical companies with operational facilities in the country. Maureen says Source can manage all storage of needs of clients, from palletised product down to an individual vial. “While stability storage is a regulatory requirement for pharmaceutical and life science firms, companies choose to outsource as in-house stability storage is expensive to build, involves ongoing costs, is large and takes up valuable production space,” Maureen notes.

Choosing the right industry partner The availability of ancillary services is a consideration for new companies looking to re-locate to Ireland. There are at least 220 pharmaceutical and life science companies in Ireland, which could potentially use outsourced services. Offering companies an outsourced solution for non-revenue generating activities represents an easy choice for those endeavouring to cut costs and deal with increased regulatory demands. Source have always offered a pay-peruse model and give companies the opportunity to control costs and to save on space.

• • •

Is there a need for temperature/ humidity-controlled spaces designated for the storage of temperature sensitive materials? Are temperature/humidity fluctuations likely? Are parameter fluctuations likely to impact negatively on the safety, efficacy and quality of products?

Guidelines note that in order to maintain regulatory compliance, any area used for the storage of products with a specified labelled storage requirement should be temperature mapped and a subsequent report generated to demonstrate the area is verified as fit for purpose. Product safety and efficacy are Source’s customers’ priority, as regulatory authorities and auditors will look for evidence that the customer understands the need to perform temperature mapping evaluation of areas used to store temperature sensitive goods. The HPRA notes that a risk-based strategy should be deployed when contemplating a mapping study, with consideration given to spatial conditions, equipment and product workflows. “The use of a risk assessment should be employed to identify suitable monitoring locations,” Maureen reveals. “Temperature mapping should be utilised

Quality underpins all outsourced activities. Customers expect more from their outsourced partner than they do from themselves, Maureen explains: “We tell our customers to treat us as an extension of their own operations and in order to do business, we expect to participate in audits by our customers. Our electronic Quality Management System is in place to manage documentation, CAPAs, deviations, nonconformances and to track relevant Standard Operating Procedures.”

In addition to outsourced stability services, source also provide qualification services, which allow Irish PharmaChem – Summer 2022

as part of the risk assessment to identify these locations.” Some areas requiring temperature mapping include temperature-controlled fridges, freezers, cold rooms, warehouses, incubators and ovens. Other areas include reefers and ambient warehouses with no active temperature control. The resulting data, showing the temperature distribution, will identify the hot/cold spots and provide assurance that products are being stored correctly. Source take a bespoke approach in every partnership, to establish your requirements and define your acceptance criteria and the critical mapping layout, which will be defined using a risk-based strategy, with consideration being given to the likely product workflow, HVAC equipment location and spatial distribution of doors, windows and other apertures. Simply put: the rules are to map in 3D and to monitor the openings and the extremes. Source’s fully trained engineers will install data measuring devices based on the approved plan and execute the study for the required time. Once the study is complete, the engineers will return to remove the devices. When the data is downloaded, you receive a full and detailed report, guaranteed to be compliant with current legislation.

Quality systems / accreditations

Qualification services

Stability storage enables an evaluation of shelf-life to be made by placing samples in storage, at controlled temperatures, for specified periods of time – conditions made possible by top of the range equipment, facilities and personnel.

Many solutions - one Source

Maureen Gilbert, Director of Stability, Source BioScience.

In addition to stability storage services and qualification activities, Source offer a complementary portfolio of services that share common technologies, lab processes, infrastructure and expertise. Source BioScience are your industry-leading partner in Sanger and Next Generation Sequencing, with labs in Dublin, Nottingham, UK, and San Diego, California. In addition to genomics services, Source provide market-leading histopathology services and precision medicine solutions, including molecular diagnostics for cancer and other diseases.

Chemical Transfer Pumping Equipment

Pumped for success Central Pump Supplies Ltd are all about providing chemical transfer pumping equipment to the Irish market. Since the company was established in 2010 as Ireland’s sole distributor of FTI Inc. products, they have become a leading supplier of chemical pumping equipment in Ireland.

Central Pump Supplies Ltd are experts in the supply of chemical pumping equipment to the pharma and biopharma industry in Ireland.

“We pride ourselves on our ability to provide quick response times to pricing, service and dispatch of products, offering a same day response time where possible,” explains Stephen McDowell, Director, Central Pump Supplies Ltd. “Due to the fact we only specialise in the supply and service of pumping equipment, this has resulted in us becoming experts and we have over 50 years’ combined experience to back it up.”

The Finish Thompson range Finish Thompson Inc., one of their main suppliers, have played a fundamental role in making the achievement of their goals possible. Finish Thompson were incorporated in 1951 as a designer and builder of custom decorating equipment, and have since evolved into their current position as a growing supplier of fluid transfer pumps and recycling systems for the fluid handling and environmental markets. Finish Thompson have proven to be highly intuitive in projecting and reacting to changing market demands, including the development of the mag drive pump, which derives its name from the magnets that are used to rotate the impeller. This innovative design creates a magnetic connection between the motor and the drive, enabling seal-less operation and helping improve productivity and enhance safety. “With most of our company’s growth coming from customer referrals, it is a sure indication that Central Pump Supplies Ltd are giving the customer what they need, a quality service at a competitive price,” notes Adrian Boehm, Director.

KC - Legacy Plastic Mag-Drive MSKC - Plastic Seal-less Multistage MSVKC - Vertical Plastic Seal-less Multistage SP - Plastic Mag Drive Self - Priming UC - ETFE-Lined Heavy Duty Mag Drive VKC - Plastic Vertical Seal-less

Drum Pump Series

Strong company portfolio

EF - Economy

The Central Pump Supplies portfolio includes:

PF - High Performance

Centrifugal Pumps Series

TT - Mid-Performance BT - Mid- to High Viscosity

AC - Sealed Stainless Steel

HVDP - High Viscosity

AK - Stainless Steel Cantilevered Vertical

TB - Mid-Performance

AV - Stainless Steel Vertical

TM - Drum Mixer

DB - Plastic Mag-Drive

For more information, visit centralpumpsupplies.com.

GP - Chemical Process, Corrosion Resistant

FTI Air, from Finish Thompson, expands the reach of the company’s expertise from centrifugal and barrel pumps to the markets of the versatile, portable, air-operated, double-diaphragm pumps.

Irish PharmaChem – Summer 2022

Cell & Gene Therapy: Avectas

Emily Whitehead and her parents, Tom and Kari, are pictured at Avectas, Maynooth, with Professor Bruce Levine and Dr Michael Maguire, Avectas CEO.

Avectas are actively recruiting engineers and scientists to join their growing team at the cutting edge of Cell and Gene Therapy via their SOLUPORE® delivery technology platform.

The Avectas laboratories are a hive of activity, with a steady hum of noise emanating from scientists and engineers who are criss-crossing between cell engineering R&D, international video calls, and collaborative projects with world renowned partners in the US and Europe. Cell and Gene Therapy is at the cutting edge of medicine and Avectas are playing a key role in this new field. The company are focused on developing a patented delivery technology platform called SOLUPORE® to enable the ex-vivo manufacture of complex gene modified cell therapy products, which will retain high in-vivo functionality.

CAR-T Cell Therapy in action

Avectas are developing a patented delivery technology platform called SOLUPORE® to enable the ex-vivo manufacture of complex gene modified cell therapy products, which will retain high in-vivo functionality.

It’s an exceptionally dynamic environment in a field with extraordinary potential. Just how extraordinary was made clear recently when Avectas hosted a visit from Emily Whitehead and her parents. A decade ago, at just seven years of age, Emily Whitehead was the first child in the world to be successfully treated for cancer using CAR-T Cell Therapy. The treatment took place in the Children’s Hospital of Philadelphia. It saw Emily’s own cells being removed from her body, engineered, and then returned to her body to fight her cancer. It was a ground-breaking procedure, and it heralded a whole new era in medicine. Emily, together with Professor Bruce Levine, who pioneered her treatment and who is a scientific advisor to Avectas, wanted to share her experience with the Avectas team and to better understand how the work being done in Maynooth might improve the treatment path which worked so well for her. A decade ago, Professor Levine engineered Emily’s cells using a virus. For Avectas, a key focus is how to develop a non-viral cell engineering technology which would have huge financial and operational benefits for autologous and allogeneic therapies.

Leading collaborations The Avectas work is attracting growing interest from both therapeutic companies internationally and the local growing CGT community. Avectas Irish PharmaChem – Summer 2022

Cell & Gene Therapy: Avectas

Avectas continue to grow at pace have engaged in collaborations with leading international research institutes, including The Simon Laboratory at UC Davis in California and the Karolinska Institutet in Stockholm. The Avectas team is relatively young, with an average age of 35.7, but there is plenty of solid experience also, with its founders Dr Michael Maguire and Dr Shirley O’ Dea, its board of directors that includes industry veterans, Dr Mary Martin, Eunan Maguire and Dr Ann Brady, and its international scientific advisory board. Michael Maguire, CEO, says the company is eager to recruit more team members: “We’re growing fast and we’re always on the lookout for dynamic, innovative people who can help steer and participate in that growth over the coming years.” For more information, visit: avectas.com.

The Avectas team are pictured celebrating being named Biotech Company of the Year at the Irish Pharma Industry Awards on April 26, 2022.

Avectas are on the lookout for dynamic, innovative people who can help steer and participate in their growth over the coming years. Irish PharmaChem – Summer 2022

Raw Materials

Reliable raw material supply from Greenfield Global One of the greatest challenges pharmaceutical companies face today is establishing a reliable supply of high-quality raw materials, at both global and regional levels. Travel restrictions, tight availability and other geopolitical factors have created challenges many in the industry could not have foreseen even three years ago. Greenfield Global, through a nimble and highly customisable structure, are uniquely situated to help customers address the challenges of the modern marketplace and serve customers in Ireland, the UK and beyond.

Greenfield Global offer reliable supply of pharmaceutical quality raw materials from their new cGMP production plant in Portlaoise.

Quality tested products Through Pharmco branded products, Greenfield Global offer a range of raw materials used in the production of oral, parenteral, transdermal and inhalation pharmaceutical products, as well as active pharmaceutical ingredients products for processes such as blood fractionation. Specific products include sodium hydroxide solutions, phosphoric acid solutions, citric acid solutions, USP ethanol, propylene glycol and ethylene glycol. Finished goods are produced using USP purified or Water for Injection (WFI) qualified water – and released from Greenfield Global analytical and microbials laboratories.

Greenfield Global offer easy access to product, lab resources and supply chain support on a global scale. Irish PharmaChem – Summer 2022

Raw Materials Global infrastructure and supply chain excellence With production, warehousing and R&D facilities in North America, Europe and Asia, Greenfield Global offer easy access to product, lab resources and supply chain support on a global scale. This helps manufacturers lower overhead and mitigate supply chain risk. Shipping quantities are available in sizes ranging from bottles to bulk. Products are monitored at multiple points in the process to ensure good manufacturing practice (GMP) compliance within a traceable supply chain. The result is high quality product delivered on time to help manufacturers develop the best possible product, backed up by access to a dedicate and experienced team of experts in the lab who can support when needed. Greenfield Global also implement meticulous documentation systems that meet regulatory needs and ensure transparency throughout the quality assurance process.

R&D and quality control Greenfield Global have a documented history of helping pharmaceutical manufacturers comply with the regulations and certifications critical to their business, including GMP, ISO, IPEC and EXCiPACT, by ensuring their own products meet regional and global multicompendial GMP standards. Every product is subjected to multiple stability and validation studies to ensure a level of quality and control, with testing methods ranging from simple wet chemistry to sophisticated metals testing using ICP-MS instruments.

Greenfield Global ensure that every product is subjected to multiple stability and validation studies to ensure a level of quality and control, with testing methods ranging from simple wet chemistry to sophisticated metals testing using ICP-MS instruments.

The company incorporates single use upstream large-volume liquids and downstream purification solutions to meet every step of the bioprocess workflow, again ensuring manufacturers access to the best possible product.

The latest addition to Greenfield Global: Portlaoise In 2021, Greenfield Global launched their newest cGMP production plant in Portlaoise, Ireland. This new facility is soon to be ISO and EXCiPACT certified later this year and follows IPEC guidelines, enabling the production of quality buffers for manufacturers globally. The site is an Irish Revenue approved warehouse keeper for alcohol products. The new 3,800 square metres facility features extensive warehousing, bioprocessing solution manufacturing and analytical and microbial laboratories. Products manufactured onsite are made using USP purified water and WFI generation in-house, ensuring greater quality control. Manufacturers interested in learning more should visit the company website at Greenfield.com or contact a representative at usasales@greenfield.com.

Greenfield Global offer a range of raw materials used in the production of oral, parenteral, transdermal and inhalation pharmaceutical products, as well as active pharmaceutical ingredients products for processes such as blood fractionation. Irish PharmaChem – Summer 2022

Providing circular side stream solutions Purifying water and recovering materials with mobile & modular installations InOpSys is committed to providing circular waste or side stream solutions for the chemical and pharmaceutical industry, by building and operating mobile & modular purification installations on the customer site. Using a train of selective technology combinations, InOpSys efficiently closes water and material loops and thus helps the industry reach their sustainability goals by reducing waste and CO2 emissions.

Award-winning concept for API removal & metal recovery InOpSys offers solutions to treat water and solvent streams, for: • Active Pharmaceutical Ingredient (API) removal & recovery • Metal removal & recovery (e.g. precious metals) • Micropollutant removal Awards: • Imagine Chemistry Challenge AkzoNobel (2017) • Belgian Business awards for the Environment (2018): first prize • Solar impulse foundation (2021): efficient solution label

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 to monotechnology solutions. This also allows InOpSys to remove pollutants in a selective way, leaving easily biodegradable components untouched. CAPEX-free service The customers are unburdened as InOpSys takes ownership from start to finish, and offers its service in a CAPEX-free way. InOpSys finances the installation via a pay-per-use model, which spares customers an investment which is not interesting enough according to their internal return on investment guidelines.

One of the running on-site installations which recovers valuable Palladium, used as a homogeneous catalyst by the customer, and purifies the waste water, closing the loops

Alternative for linear destruction The costs associated with waste and emissions can thus be reduced and value can be created by the recovery of materials (e.g. precious metals like Pd, Pt, …). InOpSys wants to do better than linear destruction (e.g. incineration) of hazardous side or waste streams in times of water and material scarcity.

Contact details www.inopsys.eu • info@inopsys.eu +32 (0)495 653 821

advantages.

• Reach sustainability goals • Reduce waste and associated costs • Create value by recovery of material (e.g. precious metals like Pd, Pt, …) • Reduce handling & transport of hazardous material • Reduce CO2 emissions

we offer.

• Circular economy solution • CAPEX-free concept • One-stop shop • Selective removal of pollutants • Ownership from start to finish

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

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SELECTIVE REMOVAL

www.inopsys.eu

Don’t accept the status quo

Pharmaceutical Ingredients

Addressing the challenges of today and tomorrow Partnering with Univar Solutions Pharmaceutical Ingredients can help you to protect your business while driving innovation and growth. As a member of the pharmaceutical industry, your goal is to create high quality products that treat or prohibit disease and illness. At the same time, your viability as an organisation depends upon vital research and development, meeting regulatory requirements, managing costs and optimising business operations. The pharmaceutical ingredients industry has been front and centre over the last two years with lifesaving vaccines and therapies, while also facing significant market challenges centred around: High profile ingredients for medicinal products such as titanium dioxide (TiO2) which faces scrutiny in Europe, with far-reaching implications potentially for manufacturers. The rising costs of doing business due to ingredient supply delays, labour and freight issues. Product development lead times and troubleshooting formulation issues. Productivity, efficiency and quality in product development in the face of disruptions like Covid-19. Businesses that don’t address these challenges face a myriad of risks, including product bans, a production shutdown and loss in profitability. Those risks can be minimised by optimising business operations and partnering

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with a trusted ally who can help you identify timely, reliable and innovative solutions.

Overcoming the obstacles – or what not to do We live in a global community with no shortage of information at our fingertips, but there is no one-size-fits-all solution that can be applied to optimising your pharmaceutical business. Don’t: Ask for advice from someone who isn’t an expert; Disregard regulatory compliance; Wait for circumstances to change; Delay planning for short- and long-term raw material needs; Sacrifice quality or integrity; Initiate knee-jerk strategies.

• • • • • •

Do: Partner with a reliable, reputable and forwardthinking partner like Univar Solutions, with nearly 100 years of experience and leadership, technical experts who support regulatory compliance and formulation needs, supply chain experts in raw material planning who optimise cost and can customise supply chain solutions, and quality assurance throughout their network of over 600 distribution centres across the globe.

industry foresight on regulations, trends, and market dynamics. Consider that a partner like Univar Solutions gives you access to:

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A global network of Pharmaceutical Laboratory Solution Centres. Pharmaceutical technical experts act as an extension of your team, responding to complex formulation challenges across the range of medicinal therapies and specialties and providing troubleshooting to meet new regulations, dosage goals, production needs and more.

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A dedicated team of experts who oversee the global supply chain of raw materials and transportation, monitoring market dynamics and offering solutions that avoid or minimise negative impact to your business. Their size and critical role in the global supply chain affords Univar Solutions first-hand insight, product accessibility and priority – advantages they use to augment their value to customers.

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Specialised pharmaceutical ingredients industry expertise, ranging from regulatory experts and innovative scientists to account and product managers. With pharmaceutical ingredient knowledge in excipients, APIs, high purity solvents and intermediates for drug synthesis, their global pharmaceutical ingredients team is solely dedicated to this market and your success.

The road ahead As supply chain shortages continue, companies must innovate to continue meeting demand. Increasingly, pharmaceutical manufacturers are turning to partners for innovation and technical support, supply chain guidance and Irish PharmaChem – Summer 2022

Advancing Innovative Pharmaceutical Ingredient Solutions Univar Solutions brings together a robust portfolio, distribution and logistics excellence, and advanced technical solutions. Univar Solutions is your premier specialty pharmaceutical ingredient solutions partner, offering customized solutions for ingredient supply and distribution. Whether you need high-purity solvents for API synthesis, or APIs, excipients, reactants and intermediates, we have a portfolio of the most specialized and demanded brands from around the globe. Together with our application, regulatory, and quality experts, we have the flexibility to develop solutions for your manufacturing challenges, improving total costs of operation while supporting your supply chain. We’re here to help with your pharmaceutical ingredient needs. Contact us at +353 1 4019800 or email us at Irelandsalesoffice@univarsolutions.com univarsolutions.com/pharma

000014017 Univar Pharma - EMEA - Chem Summer advert A4 - Q2 2022 V2.indd 1

25/05/2022 07:13

Chemical Manufacturing

SK pharmteco focus on Irish operation SK pharmteco may seem a relatively new name in the industry, when in fact they’ve been in the chemical manufacturing industry for 80 years, under different guises. SK pharmteco was formed in 2019 and they have been going from strength to strength in the intervening three years, adding broad ranging capability across their global network. Central to this strategic vision is the facility in Swords, Dublin, which is benefitting from this ambitious expansion with investment in both capacity and additional service offerings. SK pharmteco are the single market-facing

SK pharmteco have been enjoying significant market growth, including expansion at their SK biotek Ireland business, based in Swords, Co. Dublin. team comprised of SK biotek Korea, SK biotek Ireland, AMPAC Fine Chemicals, AMPAC Analytical and the Cell & Gene Therapy (CGT) business Yposkesi. In addition, in 2021, SK pharmteco took an equity position in the Philadelphia-based CGT company, the Center for Breakthrough Medicines, adding substantial capability and geographic diversity to their CGT

As a key business within the SK pharmteco family, SK biotek Ireland share in the overall growth ambition.

offering. Now with eight locations across three continents and a stated desire to expand further through organic growth and acquisitions, life in SK pharmteco moves at a fast pace.

Ambitious growth strategy As a key business within the SK pharmteco family, SK biotek Ireland are sharing in the overall growth ambition. Having already completed a recent expansion of their commercial cGMP trains – and now able to offer almost 100 cubic metres capacity - they are poised to add yet more large-scale capacity. In addition, they are strengthening their role as a centre of excellence for particle engineering, adding small scale spray drying capability and a commercial scale micronisation unit. Furthermore, the Swords facility will be a focus for the company’s continued investments supporting development of Antibody Drug Conjugates (ADC’s). It benefits from the existing capability to handle highly potent molecules and the established track record of its sister business, SK biotek Korea, in supplying commercial quantities of the key linker units. Further investment is planned in Ireland to allow broad scale assembly of ADC backbones. “Customers that have worked with our team Irish PharmaChem – Summer 2022

Chemical Manufacturing

SK biotek Ireland is responding to customer requests for the outsourcing of analytical services by replicating the offering already in place at their sister business, AMPAC Analytical.

in Ireland will have experienced the highest levels of communication and service during the delivery of API projects and this undoubtedly contributes to our high levels of repeat business,” explains Steve Barr, Vice President, Business Development. “But it’s important that we continue to invest in additional capability in order to further differentiate and offer customers further reasons to work with our business and help us to extend the strong growth path we have been on.” It’s an exciting time to be part of the SK biotek Ireland business and the changes are not limited to capacity and equipment. There has been a continued evolution of the business processes, as the site has transitioned from its Large Pharma heritage into a CDMO, with the differing demands this entails. “We are proud of what we have achieved in the last five years” explains Joyce Fitzharris, President of SK biotek Ireland. “We have refined our approach across a number of key areas in order to better compete in the CDMO space. The pace is different and business processes have had to accommodate this aspect. And whilst we must maintain the highest level of safety and quality, we continue to maximise the value proposition for our customers.”

Analytical services Another area where demand is proving strong in Europe is in the outsourcing of analytical

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services. SK biotek Ireland is responding to this need by replicating the offering already in place at their sister business, AMPAC Analytical. “There is already a highly capable, and successful analytical services business within the family, in the shape of AMPAC Analytical, a California-based standalone facility with

a broad range of services supporting both method development and product release,” Fitzharris explains. “We have established a distinct offering at our Swords facility which appeals directly to customers who may have established manufacture of API at another location but have gaps in their analytical needs. We are here to help.” The business has dedicated analytical personnel aligned to this offering and has access to state-of-the-art analytical equipment. “Although we feel our customers are best served by combining their analytical needs with our ability to develop and manufacture their products, we understand that this may not always be the preferred option at project conception,” Barr says. “Our model is flexible to allow access our leading analytical capability without a wider commitment. It’s about offering what the market is asking for and having a European base in this area is complementary to our US footprint.” Despite the global challenges that have been faced over the last two years, SK biotek Ireland have continued to thrive, and have established a key position within the overall SK pharmteco network. With the recent investment in capacity and in broadening their customer offering, they are well positioned to further support customers’ success. “We have seen a high demand for European manufacture and as a leading CDMO we are rising to this demand,” concludes Barr. “Ireland remains an attractive location for pharmaceutical manufacture, with access to highly skilled personnel and optimised transaction costs. We are confident in the future outlook of this key business.”

SK pharmteco are the single market-facing team comprised of SK biotek Korea, SK biotek Ireland, AMPAC Fine Chemicals, AMPAC Analytical and Yposkesi. Irish PharmaChem – Summer 2022

We are in the business of breakthroughs – the kind that transform patients’ lives. Dedicated to our mission of discovering, developing and delivering innovations that help patients prevail over serious diseases. We’ll never give up on our search for more hope, for more people, around the world.

Visit bms.com/ie to see how we’re driving meaningful change for patients, their loved ones and for the communities and societies we all share. © 2022 Bristol-Myers Squibb Company. All rights reserved. NO-IE-2200017 June 2022

Logistics

Kuehne+Nagel to open new Pharma & Healthcare warehouse

Kuehne+Nagel are set to open a new Healthcare Logistics Facility in Ireland in Q3 2022. Kuehne+Nagel Ireland will open their third pharma & healthcare building in Dublin, and their fourth in Ireland, during the third quarter of 2022. Kuehne+Nagel continue to invest and support the growing pharma & healthcare industry with a state-of-the-art temperature controlled facility, supporting their clients in delivering world class logistics services. The new facility, conveniently situated only five minutes from Dublin Airport and 10 minutes from Dublin Port, is the third healthcare facility for Kuehne+Nagel within their Healthcare Logistics Campus, located in Horizon Logistics Park, Harristown, Dublin. The facility will house 34,000 Euro Pallet positions. It will have segregated loading and unloading gates, direct access to temperature control storage areas and will be a highly secure site. The facility is HPRA-approved, with temperature control and humidity monitoring in place. Kuehne+Nagel now offer temperature

ranges of 15-25 and 2-8 (External Units) within the Healthcare Logistics Campus in Dublin. “This is a great addition to our healthcare logistics campus in Dublin,” explained Seamus Keane, Industry Champion – Healthcare, Ireland, Kuehne+Nagel. “We continue to invest in new facilities, technologies and people to serve our healthcare customers and their patients. We pride ourselves on our ability to develop advanced services for our customers to address global demands in handling temperature sensitive shipments.”

across the country. More recently, Ireland has expanded its global hub beyond commercialisation, to include innovation, digitalisation and next generation technologies. “Our commitment to the pharmaceutical and life sciences industries continues with the investment being made in Dublin in this new facility,” Seamus Keane concluded. “We at Kuehne+Nagel, are driving strategic innovation by supporting our customers and shaping the future of logistics.”

As a global logistics partner, Kuehne+Nagel are supporting Ireland‘s growing landscape within the pharma & healthcare industry.

Dedicated to success Ireland is one of the largest exporters of pharmaceutical products globally with 50 FDA-approved manufacturing plants

Seamus Keane, Industry Champion – Healthcare, Ireland, Kuehne+Nagel.

About Kuehne+Nagel

Kuehne+Nagel Ireland have invested in a new temperature controlled storage facility to meet the demands of an evolving critical healthcare logistics landscape.

With over 78,000 employees at almost 1,300 locations in over 100 countries, the Kuehne+Nagel Group are one of the world’s leading logistics companies. Their strong market position lies in sea logistics, air logistics, road logistics and contract logistics, with a clear focus on integrated logistics solutions. Irish PharmaChem – Summer 2022

KN PharmaChain GxP Compliant

CMYK Process Colour Dark blue C100, M66, K66 Light blue C80

For when it matters matters the themost most A partnerfocused focusedonon quality A partner quality and and service to: service to:    

Meet industry requirements

Meet industry requirements Offer product-specific E2E solutions Offer product-specific E2E solutions Leverage future digital solutions Leverage future digital solutions Make complexity simple Make complexity simple

...so you can focus on your patient/ ...so you can focus on your patient/ customer needs customer needs

LOTUSWORKS

LotusWorks: a biopharma partner for 30 years LotusWorks are a strategic partner of choice for some of the world’s leading biologic companies and have been for three decades. Many biologics organisations choose strategic partners to access capabilities and drive growth plans, so they can keep pace with their transforming business environment to maximise opportunities and maintain competitiveness. LotusWorks have been a partner of choice within the regulated manufacturing industry in Europe & North America for three decades. Within the biologics sector, the company holds long-standing successful partnerships with eight of the top 10 global manufacturers. LotusWorks have proven their ability to address the commercial, strategic, operational, cultural, and technical leading practices that together contribute to a win-win partnership. Working in collaboration with client engineering teams in facility new builds, the 600+ people strong company are reputed for supplying long-term value ability to their biopharma clients’ maintenance functions. Biologics clients outsource engineering and technical scopes of work to LotusWorks in the facility commissioning, calibration and maintenance areas. The ability to consistently deliver teams who can achieve measurable results and execute to the agreed regulatory compliance standards and safety requirements has rightly earned the company a powerful reputation as a valued strategic partner to the biopharma sector.

Partnership success In 2019, a leading biologics manufacturer in Ireland started their ambitious plans to build a state-of-the-art manufacturing biologics facility. It was the client’s first green-field project in Europe and following a successful tender process, LotusWorks partnered with the biologics client to implement initial calibrations during the project phase.

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Today, in close collaboration with the client’s engineering team at the facility, LotusWorks support the facility planners, process, and utility systems, and are responsible for the execution of the complete calibration programme. LotusWorks‘ engineering and technical teams typically aim to provide the client with increased value by setting standards, adhering to policies and principles, delivering results, and upholding the client’s reputation throughout the partnership duration. The LotusWorks teams have developed processes to build comprehensive data capture on integrated systems, ensuring traceability and real-time analysis, which qualifies decisionmaking on maintenance requirements on the client’s valuable equipment. The benefits for the client, as a result of the LotusWorks team’s analysis and execution, include cost savings, increased equipment availability and reduced equipment and machine downtime. The win-win relationship thrives on knowledge sharing; the partners continually adapt from lessons learned, ensuring objectives are met in an efficient and timely manner, while also maintaining the safety of the team and the quality of the product.

Perfect partnerships To achieve win-win partnership success, biologics manufacturers must choose partner organisations to match their culture and ambition. Biologics manufacturers acquire specialised technical skills and engineering knowledge on an ongoing basis to supplement their in-house expertise, and a partner must complement the manufacturers’ teams. The service organisation must understand and focus primarily on the manufacturers’ objectives and have the technical & engineering

problem-solving capability to achieve critical KPIs consistently. Transparency and open communication on the challenges faced and solutions found are required to build lasting, strong partnerships. Another vital quality is the ability to capture and interpret data to discuss regularly within an agreed, effective governance structure with all stakeholders. Today, companies are realising that the key to growth isn’t found in being all things to all people but in developing purposeful strategic partnerships that can help diversify and fulfil clients’ needs on-time, safely and better.

Agile and innovative Like all businesses, LotusWorks faced significant challenges during the recent pandemic. Most of the company’s talent are essential to biologics operations, so the challenge to uphold their work quality in an ever-changing environment was tested. The business could respond quickly, however, due to its agile business model and a strong culture of innovation. For LotusWorks, investing in a Continuous Improvement (CI) programme and creating a company-wide CI culture ensures that clients receive the best of value-added services through strategic partnerships. Working together and sharing knowledge is part of life at LotusWorks. The company’s expert technical and engineering talent work in major manufacturing facilities throughout Europe and North America, sharing process improvements and efficiencies, thereby accelerating operational excellence within client organisations and directly impacting the manufacturers’ ability to remain competitive, while ensuring the safe and compliant delivery of life-changing products to patients globally. For more information, visit lotusworks.com. Irish PharmaChem Irish PharmaChem – Special – Summer Edition 2022 2021

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“

Strategic partner to

eight of the top ten

biologics global manufacturers

”

600+ STAFF | EU & USA | EST. 1989 C

CMY

WINNER Pharma Supplier of the Year

CALIBRATION | COMMISSIONING | OPERATIONS & MAINTENANCE ENGINEERING & TECHNICAL EXPERTISE

Charles River Laboratories

Significant expansion at Charles River Charles River Laboratories Ireland are passionate about their role in improving the quality of people’s lives. The company’s mission, their excellent science and strong sense of purpose guides them in all that they do, and the team approach each day with the knowledge that their work helps improve the health and well-being of many across the globe. Charles River’s dedicated employees focus on providing clients with exactly what they need to improve and expedite the discovery, earlystage development and safe manufacture of new therapies for the patients who need them. The company, situated in Ballina, Co. Mayo, boast a diverse workforce from more than 20 nationalities across the globe and have experienced a doubling in their employee numbers to 200 over the last two years. Since 2020, Charles River Laboratories Ireland have played a key role in supporting the safe and timely rollout of many of the vaccines manufactured to combat the Covid pandemic, in particular AstraZeneca’s Covid-19 vaccine, Vaxzevira. Charles River Laboratories Ireland continue to expand their analytical, cell culture, vaccine support and other specialised biologics services, with the addition of a new €9 million, 15,000 square feet GMP laboratory space in 2022, as well as the creation of 90 new skilled roles over the next 18 months. Charles River Laboratories Ireland’s portfolio also includes

A new €9 million, 15,000 square feet GMP laboratory space is helping Charles River Laboratories Ireland to expand their analytical, cell culture, vaccine support and other specialised biologics services. Ireland’s only GMP compliant commercial Biosafety Level-3 (BSL-3) containment facility.

Supporting client programmes Charles River continually strive to stand out from their competitors, winning the Excellence in Business Life Science Company of the Year in 2021. Site Director Liam McHale explains: “The drug research and development process is highly complex, yet essential for delivering safe and effective therapies to patients. Even though the process is well defined, drug development programmes are fundamentally different for each product. Charles River are uniquely positioned to support client’s programmes. At our Ballina site specifically, Charles River offer a comprehensive package of Good Manufacturing Practice (GMP) services in support of recombinant biologics, vaccines, biosimilars, and medical devices. “We identify client needs and priorities through continued collaboration and partnership,” Liam continues. “By virtue of being embedded with our clients’ projects, we can gain continuous insight into what resources

and services they need to be successful. This allows us to assess our portfolio agilely and continuously and strategically, improve.”

Career opportunities Charles River Laboratories Ireland continue to evolve their capabilities to meet the growing global Cell & Gene Therapy market by adding innovative equipment such as Tecan Spark and Tecan Spark Cyto, plate readers with live cell imaging capabilities, ClarioStar and PheraStar plate readers, QuantStudion 7 qPCR quantitative real-time PCR (Applied Biosystems), Absolute Q digital PCR (dPCR) (Applied Biosystems) and Flow Cytometry - CytoFlexLX from Beckman Coulter, suited with six lasers and 21 colours analytical capability. To better serve their customers, they also offer same day sample delivery and/or collection when scheduled in advance (available to/from Ireland/UK). To enquire about opportunities to join the team at Ballina, please contact 096 20837 or view www.criver.com/careers. Irish PharmaChem – Summer 2022

Only .01% of all drug candidates entering clinical trials will reach the market. Budget. Capacity. Technical knowledge. These are just some of the obsticals that can stand in the way of your biologic’s market approval. Are you prepared for them? With Charles River supporting 85% of drugs approved by the FDA in 2019, leverage our experience and expedite your time to market. We can provide the services, capacity and know-how that can help you bring your therapies to those who need them most.

Improve your odds at criver.com/biologics.

Pharmaceutical Raw Ingredients

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, secondly, 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”.

In-house quality and compliance department As compliance and regulations become more complex, it is important that a sourcing partner not only has an in-house quality and compliance department but that it is consistently keeping up to date with all regulations, regardless of whether that is REACH or UK REACH. In addition, it is vital that an in-house quality and compliance department conducts background checks on all raw material manufacturers.

What to look for in a sourcing partner Paul Power, Strategic Sourcing & Supply Chain Executive, NCC, discusses key considerations that a pharmaceutical organisation should consider when choosing a sourcing partner in 2022. War, trade barriers and political instability, as well as rising inflation, have created a very challenging environment for global supply chains. More than ever, when it comes to sourcing raw materials for pharmaceutical manufacturing, it is essential for organisations to work with the most reliable and reputable partners. With that in mind, below are some key considerations that a pharmaceutical manufacturer should consider when choosing a raw material sourcing partner.

Safety stock buffer A safety stock buffer is a cushion to absorb the impact if there is a delay in the supply chain or a major disruption, such a regional lockdown or even war. For pharmaceutical manufacturers, it is now essential to avoid production downtime by having safety stock managed and always available. When choosing a sourcing partner, it is

vital that they provide a dedicated team to oversee and manage all aspects of the safety stock. This includes safety stock reports issued regularly, highlighting each material in stock, its quantity, or any material in transit and its current location. In addition, they should provide market information on each material supplied, as well as strategies to keep risk to a minimum. We can manage these buffers for you, in an accredited warehouse, freeing up storage space in your site, while keeping material close and accessible as it is required.

Integrated supply chain 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. To clarify further, it is not enough to ensure that the right product is delivered at the right

Built-in supply chain resilience as standard The world is a very different place than it was three years ago, and the market turbulence that currently exists is unfortunately the new normal for the foreseeable future. With that in mind, sourcing partners need to offer supply chain resilience as standard. When choosing a sourcing partner for your pharmaceutical materials, they should be able to provide supply chain strategies and approaches that lower the risks of bottlenecks and emerging logistical and supply challenges. With medium to high-risk materials, on the other hand, we improve resilience by having secondary sources lined up and additional managed stock to hand. Taking this perspective reduces the risk and most importantly, the associated costs.

Excellent sourcing expertise Utilising the right supplier for your pharmaceutical raw materials can make or break your business. In a recent NCC pharmaceutical customer survey (April 2022), 87% of customers either agreed or strongly agreed that NCC’s sourcing expertise is excellent and rates better than competitors. If you are looking for a reputable and reliable pharmaceutical raw material sourcing partner, then we can assist. We provide our customers with integrated end-to-end supply chain solutions that have resilience built-in as standard. By optimising the efficiency of your supply chain, we can save your organisation time, money, resources and remove the risk of production downtime. For more information, call (01) 6131400 or email hello@ncc.ie. Irish PharmaChem – Summer 2022

A sourcing partner you can rely on

In times of uncertainty, you need a pharmaceutical sourcing partner that not only has the know-how and in-house capability but will always go the extra mile. NCC is that partner. With over 50 years of sourcing excellence, we ensure that our customers receive consistently compliant products, solutions, and services. With full supply chain traceability and the highest global standards, NCC is that essential link in your supply chain.

To learn more about NCC and our approach to sourcing:

T. +353 1 613 1400 E. hello@ncc.ie W. ncc.ie

Waste Processing and Recycling

Indaver: making the circular economy a priority The Irish pharmaceutical and chemical industry want absolute certainty about the processing of their waste to safeguard production. In times of crisis, processing capacity is scarce and so Indaver continue to invest in new installations and technologies for waste processing and high-grade recycling. But energy supply is also under pressure today and here too, Indaver, as a waste company, play a crucial role in providing a new heat network for industry.

Indaver deliver processing capacity, high-quality recycling and a large-scale heat network for industry.

Investing in safe, processing capacity Through the increasing attention paid to the circular economy and the toxic-free environment, hazardous waste and the associated risks are regulated more stringently than ever before. Careful analyses of the composition of waste flows are crucial in this respect. Indaver have, therefore, developed a Waste Identity Card for certain critical flows, which lists all the critical parameters for both the customer and the waste treatment company in order to make safe, efficient and sustainable treatment possible. It is important to keep on investing in existing installations and new technologies. New turbines for better energy performance, and more storage capacity thanks to larger tank farms, are just a few examples of how Indaver invest in their broad processing portfolio in Europe. These investments pay off. By opting for sustainable, safe solutions for sensitive, complex waste, the industry can avoid future risks.

High-quality recycling from hazardous waste Understanding the needs of the industry is key to the solution. With IndaChlor, the recycling of chlorinated waste into hydrochloric acid, and Plastics-to-Chemicals, which converts post-consumer plastic packaging into basic chemicals for industry, Indaver are making the circular economy a reality in practice. But there is more. For example, a lot of precious metals still disappear in waste solvents from the pharmaceutical and chemical industries. These companies use precious metals, such as palladium and rhodium, as catalysts to make certain chemical reactions possible. Indaver recover these valuable and very expensive raw materials from the liquid waste. In this way, they offer a cost-efficient solution, help

to reduce the environmental footprint of the pharmaceutical industry and contribute to their sustainability objectives.

Local energy supply thanks to new large-scale heat network Antwerp North Heat Network, located in the port of Antwerp, is a brand new open access heat network, which provides a basic network to industry and also to residential energy users. It all starts with Indaver’s waste processing operations in Antwerp North, which release a great deal of heat used from their own business processes for electricity production. The residual heat that remains after electricity production is still suitable for heating applications. To make heat networks economically viable, however, requires customers. Boortmalt, the largest malt group in the world, who produce 470,000 tonnes per year, have their largest malting plant 8km from Indaver. In the future, when Boortmalt draw heat directly from the heat network, the company will save an amount of natural gas comparable to the annual consumption of approximately 10,000 families. The heat network will account for an annual CO2 saving of 80,000 tonnes. No less than 3,000

With IndaChlor, the recycling of chlorinated waste into hydrochloric acid, Indaver are making the circular economy a reality in practice.

households, seven schools and several public buildings will receive their heat from a heat network fed by residual heat from industry. For more information, visit www.indaver.ie or call +353 (0)1 6972900. Irish PharmaChem – Summer 2022

TOGETHER WE MEET YOUR CLIMATE

As an industry leader, you want to limit your environmental impact as much as possible. A reliable partner for your waste management can contribute to this. Thanks to our focus on the circular economy, recovering valuable materials and energy from your waste, we help you achieve your sustainability goals. Safe & circular.

INDAVER CONTRIBUTES TO YOUR CLIMATE OBJECTIVES. IN SUSTAINABLE PARTNERSHIP

THANKS TO 35 YEARS OF KNOW-HOW AND INNOVATION.

YOUR PARTNER IN THE CIRCULAR ECONOMY

O_INDAV_ADV_A4_APR_QJ12962.indd 1

Not yet a partner? Contact us: info@indaver.ie | +353 1 697 2900 | www.indaver.ie

21/04/22 10:29

ToF MEASUREment INSTRUMENTS

Access storage tank level from anywhere With more than 2.2 million installed applications and 50 years of experience, time-of-flight (ToF) measurement instruments are an important component of Endress+Hauser’s portfolio. ToF devices are used in a wide range of applications, and are a reliable solution, even under extreme process conditions, such as high pressure or temperatures and in corrosive or aggressive media. The new generation of Micropilot instruments offers compact design and maximum userfriendliness, as well as application-specific flexibility, to provide solutions for both mobile and stationary plastic tanks. The storage of liquids plays an important role in many industries. Liquid fertilisers or irrigation systems for agriculture, additives as well as cleaning agents for the food industry or liquefiers for the production of concrete are only a few examples. Usually, plastic tanks are used for this purpose. In order to ensure continuous production and prevent downtime, the liquids must always be available in sufficient quantities. This is where level measurement is used. As the number of tanks increase, so do the measurement requirements. The fact that plastic tanks are often located at remote sites and are widely dispersed geographically makes the process even more complex. In more than 80% of all production plants, level measurement is done manually. This type of manual monitoring is both time and cost intensive. So very often, this results in missing stocks only being registered when the tank has already run empty, and the production process has come to a halt. Even increased inventories are in most cases not an alternative due to the storage costs involved. Clearly, a better solution is needed.

to the distance. With a known vessel geometry, the level can be calculated. But the new Micropilot FWR30 offers considerably more. As the world’s first 80GHz wireless IIoT sensor, it combines high-end technology and user-friendly digital services in one costeffective device. The continuously recorded measurement data can be accessed at any time and from anywhere via the device’s cloud connection. Communication is made possible by an integrated SIM card.

The first cloud-connected radar level sensor from Endress+Hauser revolutionises measurement in storage tanks.

Field of application The Micropilot FWR30 can be used for level measurement and inventory management of mobile and stationary plastic tanks. In addition, the tracking of mobile storage tanks is also possible. The free radiating measuring device covers measuring ranges up to 15 metres (50 feet) and temperatures between -20 °C and 60 °C (-4°F and +140°F). Due to non-contact measurement, the Micropilot FWR30 can be used in all liquid media. It works where other measuring principles cannot be applied due to corrosion, abrasion, viscosity, or toxicity, and it can be employed in a variety of industries. For more information, visit www.endress.com/micropilot-fwr30.

Optimised inventory management: simple from scratch To meet these challenges, Endress+Hauser has developed a solution consisting of a level sensor and software. This solution considerably simplifies the management of stocks in stationary and mobile applications. As with conventional devices, the measurement is based on high-frequency radar pulses. These are emitted by an antenna and reflected by the surface of the stored medium. The travel time of the reflected radar pulse is directly proportional

For more information visit www. endress.com/micropilot-fwr30 Irish PharmaChem – Summer 2022

We understand how you are challenged every day to enhance your plant’s safety and performance.

MAXIMIZE + CAPITALIZE You gain more options to fit your needs, build up product quality, increase safety, reduce costs and minimize risks.

Micropilot FWR30 – The cloud connected radar level sensor • Transparency – full and secure access to information on asset and inventory status, from anywhere at any time • Simplicity – from procurement to operations, simplified commissioning, handling and processes • Flexibility – suitable digital services defined by user needs, scalable from Netilion Value via Netilion Inventory to SupplyCare Hosting • Reliability – precise measurements with wireless high-end 80Ghz sensor technology

Do you want to learn more? www.ie.endress.com/fwr30

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

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Dublin ‐ Ireland •Project • Packages Project Project management • Saving management •Monitoring • Monitoring Monitoring Systems Systems• Energy Saving Packages •management Systems Fax (+353) (+353) 01 014136932 4136932 from large capacity Fax Fax (+353) 01 4136932 equipment chillers to medical storage our our large large client client base base when when ititMonitoring comes comes to servicing, servicing, maintaining, maintaining, Equipment, Fire Rated Insulation our large client base when servicing, maintaining, •comes Monitoring Systems Systems • it•Monitoring Systems sales@crosstechnicalsolutions.ie sales@crosstechnicalsolutions.ie Tel Telsales@crosstechnicalsolutions.ie (+353) (+353) 01 01405 4056777 6777 Tel (+353) 01 405 6777 Fax (+353) 01 4136932 •Energy • to Energy Energy Saving Packages • to Saving •Packages • Packages Plant Plant service service and maintenance maintenance •Saving Plant service andand maintenance • Monitoring Systems sales@crosstechnicalsolutions.ie sales@crosstechnicalsolutions.ie sales@crosstechnicalsolutions.ie • • Plant Plant service service and and maintenance maintenance www.crosstechnicalsolutions.ie www.crosstechnicalsolutions.ie • Plant service and maintenance www.crosstechnicalsolutions.ie Fax Fax (+353) (+353) 01 01 4136932 4136932 Fax (+353) 01 4136932 sales@crosstechnicalsolutions.ie •Monitoring •knowledge Monitoring Monitoring Systems Systems • equipment Systems and and replacing replacing all all types types refrigeration equipment equipment from large large and aallwealth of refrigeration application tofrom our clients. and replacing types refrigeration from large cabinets and temperature control systems. www.crosstechnicalsolutions.ie www.crosstechnicalsolutions.ie www.crosstechnicalsolutions.ie • Plant service and maintenance PRODUCTS & SERVICES Cross Technical Solutions Ltd. sales@crosstechnicalsolutions.ie sales@crosstechnicalsolutions.ie sales@crosstechnicalsolutions.ie www.crosstechnicalsolutions.ie & SERVICES •Plant • Plant Plant service service and maintenance maintenance • PRODUCTS service andand maintenance Cross Technical Solutions Ltd. • Site survey & system recommendation Unit 26, Cookstown Industrial Estate capacity capacity chillers chillers tomedical medical storage storage cabinets cabinets and and temperature temperature capacity chillers to to medical storage cabinets and temperature www.crosstechnicalsolutions.ie www.crosstechnicalsolutions.ie www.crosstechnicalsolutions.ie • Site survey & system& recommendation Unit 26, Cookstown Industrial Estate PRODUCTS SERVICES • Supply, installation & commissioning Tallaght, Dublin 24 Cross TechnicalCookstown, Solutions Ltd. • Supply, installation &industry commissioning Cookstown, Tallaght, Dublin 24 control control systems. systems. 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legislative and environmental guidelines. We provide a With With aacomplete vast vast knowledge knowledge of the refrigeration refrigeration industry industry and andRated With a vast knowledge ofof the refrigeration industry and solution ofthe Mechanical Equipment, Fire the the Pharmaceutical Pharmaceutical sector sector in in particular, particular, we we are are the the first first Pharmaceutical sector in particular, we are the first SPECIALIST REFRIGERATION ENGINEERINGthe Insulation and a wealth of application knowledge to our SPECIALIST REFRIGERATION ENGINEERING choice choice choice for for our our large large client client base base when when it comes comes to servicing, servicing, for our large client base when it it comes toto servicing, clients. maintaining, maintaining, and and replacing replacing all types types refrigeration refrigeration maintaining, and replacing allall types refrigeration equipment equipment from from large large capacity capacity chillers chillers to medical medical storage storageand equipment from large capacity chillers toto medical storage With a vast knowledge of the refrigeration industry cabinets cabinets and and temperature temperature control control systems. systems. cabinets and temperature control systems. the Pharmaceutical sector in particular, we are the first

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capacity chillers medical storage cabinets and temperature www.crosstechnicalsolutions.ie PRODUCTS & & SERVICES SERVICES PRODUCTS & SERVICES Tallaght, Tallaght, Dublin Dublin 24 24 ••Dublin Site Site survey survey & &tosystem system recommendation recommendation Tallaght, 24 •PRODUCTS Site survey & system recommendation Unit Unit 26, Cookstown Cookstown Industrial Industrial Estate Estate Ltd. Unit 26,26, Cookstown Industrial Estate Cross Cross Technical Technical Solutions Solutions Ltd. Ltd. Cross Technical Solutions Tallaght, Dublin 24 control systems. 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. Dublin Dublin ‐‐Ireland Ireland Co.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 Monitoring Systems Tel (+353) (+353) 01 01 405 405 6777 6777 TelTel (+353) 01Solutions 405 6777 Energy Energy Saving Saving Packages Packages • •••Energy Packages PRODUCTS & SERVICES www.crosstechnicalsolutions.ie www.crosstechnicalsolutions.ie Tallaght, Dublin 24 www.crosstechnicalsolutions.ie •Saving Site survey & system recommendation sales@crosstechnicalsolutions.ie sales@crosstechnicalsolutions.ie sales@crosstechnicalsolutions.ie NSAI Certified www.crosstechnicalsolutions.ie Unit 26, Cookstown Industrial Estate Ltd. Cross Technical Solutions Plant Plant service service and and maintenance maintenance • ••Plant service and maintenance Fax Fax (+353) (+353) 01 4136932 4136932 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 jmcgrath@crosstechnicalsolutions.ie Fax (+353) 01 4136932 • Energy Monitoring Systems Tel (+353) 01 405 6777 • Saving Packages www.crosstechnicalsolutions.ie sales@crosstechnicalsolutions.ie Plant service and maintenance Fax (+353) 01 4136932 • • Monitoring Systems www.crosstechnicalsolutions.ie sales@crosstechnicalsolutions.ie ISO 9001:2015

Process Data

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Bonner helps customers to unlock the value within their process data. Equipment Effectiveness (OEE) by increasing the efficiency of the equipment or area.

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STANDARDS YOU CAN TRUST Irish PharmaChem – Summer 2022

WE LISTEN TO AND LEARN FROM PATIENTS EVERY DAY...

We are dedicated to improving patients’ lives through innovative medicines in Oncology, Neuroscience and Rare Diseases. Because patients can’t wait. www.ipsen.com

CR-IE-000003 May 2021 © Ipsen 03.2019 / PIERRE-OLIVIER / CAPA Pictures

Ipsen has been in Ireland for over 30 years, pioneering innovation across R&D, manufacturing and commercial activities at its site in Blanchardstown, Dublin

Process Control Systems

Cutting edge solutions leader PACIV turns 25 Founded in 1997, PACIV continue to be industry leaders in the delivery of Process Control Systems and Systems Integration Services for the life sciences sectors. The company also deliver Control Systems for other industries with automated manufacturing, such as food and beverage, general manufacturing or process controls for power, water and wastewater utility systems and distribution. “We recognise that being in business 25 years is a phenomenal milestone and it is thanks to the commitment and hard work of all our associates and team members, who have continued to add value and to deliver projects successfully and on time for our many clients around the world,” notes Denis Gorey, PACIV VP Operations Ireland. “Because our primary product is engineering service, client service is our business. We must come with cutting edge solutions for our clients’ processes and equipment control. We work integrally as part of their delivery teams for new projects, as well as on embedded teams for continued operational and maintenance of existing facilities.”

Denis Gorey, PACIV VP Operations Ireland. As part of their Compliance Services, PACIV also have a team of experts focused on Validation, CSV, C&Q, Data Integrity Assessments, Reporting and Remediation for gaps found in System Security and Data Integrity. In addition, PACIV have an experienced team dedicated to delivering their bespoke instrumentation service for clients’ projects, which includes instrument procurement, receipt verification/inspection, storage in controlled warehouse, generation of

regulatory compliance and turn over packs, and delivery to site or skid builder on a Just-In-Time (JIT) basis. The company was founded by Jorge L. Rodríguez, the company’s CEO and Chairman, in Puerto Rico in 1997, before expanding to the US mainland in 2003, to the UK in 2007 and to Ireland in 2011. PACIV are working on opening an office this year at Research Triangle Park in Raleigh, North Carolina, considered the largest research park in North America. PACIV’s clients include major multinational pharmaceutical, biotechnology, medical and diagnostic device companies, which make up a large share of the company’s portfolio. “We have the capability to serve and lead projects of any size,” explained Denis. “Nothing is too small for us to handle turnkey for our clients, and we have served as an integrator for two of the largest biotechnology sites in the world. We have also serviced several biotech start-up companies and facilities, including laboratories and manufacturing sites.” For more information, visit: paciv.com.

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Contact PACIV today to explore how we can design and support your automation systems: T: (021) 242-8330 E: infoire@paciv.com

Irish PharmaChem – Summer 2022

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Irish PharmaChem – Summer 2022 19/11/2021 13:07

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Irish Pharmachem Summer 2022 Edition

Articles inside

SECTOR OVERVIEW