Astellas Ireland recently announced an expansion of its biopharmaceutical manufacturing facility at the Kerry Technology Park in Tralee. The investment will support the installation of a second aseptic filling line and associated manufacturing infrastructure, representing the next phase of development at the site, building upon the successful foundation established with the site’s groundbreaking in March 2024.
According to the company, the project will double the drug product manufacturing capacity at the Tralee facility, creating additional roles across engineering, production, quality, logistics, and support functions by 2029.
This follows the company’s €330 million investment in a new state-of-the-art biopharmaceutical facility and second Kerry facility in 2023. The new Kerry facility is scheduled to officially open its doors in early 2027.
This project is supported by the Irish Government through IDA Ireland. Minister for Children, Disability, and Equality Norma Foley said: “Astellas has been an extraordinary success story for county Kerry. Building on the strong track record and excellence of the Killorglin facility, this new development in Tralee is a game-changer for our capital town and the entire south-west region. The doubling of drug product manufacturing capacity in the Tralee facility and the additional employment it brings is a very significant uplift to the local economy and community. We are incredibly proud in Kerry to be home to two state-of-the-art Astellas facilities. I’d like to thank Astellas Ireland for their longstanding and valued commitment to county Kerry and also acknowledge the work of IDA Ireland, Kerry County Council, and all State agencies involved.”
Minister for Enterprise, Tourism, and Employment Peter Burke said: “Astellas’ decision to further expand its Tralee facility is a strong endorsement of Kerry’s growing role in Ireland’s life sciences ecosystem. This investment demonstrates how regional locations can successfully attract and support complex, high-value manufacturing operations. As Astellas continues to scale its presence in Tralee, this expansion will create additional highly skilled career opportunities and further strengthen the south-west’s reputation as a location of choice for international investment and advanced manufacturing. I wish Astellas success in this next growth phase.”
The Tralee facility will manufacture medicines for global markets and is designed to support additional products from Astellas’ development pipeline as they progress towards commercialisation.
Mr Tetsuya Kawasako, Global Head of Pharma Manufacturing, and President of Astellas Ireland, said: “Astellas has a proud and long-established presence in Ireland, with our operations supporting the reliable supply of medicines to patients around the world. The continued development of our Tralee facility reflects our confidence in Ireland, in the region, and in the talented people who will bring this state-of-the-art facility to life. This expansion is a planned continuation of our original investment in Tralee. It enables us to build additional capability into the facility in a phased and disciplined way, responding to an evolving portfolio and patient needs while making the best use of the infrastructure already being developed. We greatly value the continued support of IDA Ireland and our local partners and we look forward to building on that partnership as Tralee becomes an important part of Astellas’ global manufacturing network.”
Ms Mary Buckley, Executive Director, IDA Ireland, said: “Astellas’ decision to expand its new biopharmaceutical manufacturing facility in Tralee is a strong endorsement of Ireland’s position as a leading location for advanced life sciences and of the talent and partnership available in the south-west region. Building on the company’s €330 million commitment to the site, this additional investment will create further highly skilled roles in Kerry and strengthen Astellas’ capacity to supply medicines for global markets. IDA Ireland is proud to support Astellas as it continues to grow its significant presence here and contribute to the development of Ireland’s world-class biopharmaceutical ecosystem.”
HPRA Publishes 2025 Annual Report
The Health Products Regulatory Authority (HPRA) has published its 2025 annual report. The report highlights the HPRA’s continued contribution to protecting public and animal health through the regulation of medicines, medical devices, and other health products, while responding to a complex and evolving national and European regulatory environment.
During 2025, the HPRA’s key activities included:
► Authorisation of 473 new human medicines following assessment of their safety, quality, and effectiveness.
► Issuing 95 authorisations for clinical trials of human medicines under the EU Clinical Trials Regulation.
► Continuing the assessment of veterinary medicines, with 1,966 authorised medicines for animal use on the Irish market at year-end.
► Receipt of 8,565 suspected adverse reaction reports for human medicines.
► Receipt and assessment of 4,638 medical device vigilance reports, in addition to undertaking 564 market surveillance cases.
► Completion of 108 good manufacturing practice (GMP) inspections at sites producing human medicines or active substances and 11 GMP inspections of veterinary medicines manufacturers.
► Undertaking 191 market surveillance cases relating to cosmetic products.
► Coordinating 54 recalls of medicines, comprising 41 human medicines, and 13 veterinary medicines.
► Detention of 763,027 dosage units of falsified and other illegal medicines, while securing the amendment or shutdown of 4,762 websites, e-commerce listings, and social media pages associated with the sale of illicit medicinal products.
The HPRA also continued its active contribution at European and international level throughout 2025. This included acting as rapporteur or co-rapporteur for 13 centrally authorised human medicines and being assigned a further seven centralised assessment roles during the year. The HPRA was also the co-ordinator of 54 scientific advice requests via the European Medicines Agency across a broad range of conditions.
Ms Grainne Power, HPRA Chief Executive, commented: “The availability of medicines remained a priority during 2025, with ongoing global supply pressures highlighting the importance of robust regulatory systems, strong partnerships, and coordinated action. Through our contribution to medicines availability initiatives, crisis preparedness activities, and regulatory policy development, we continued to strengthen our ability to anticipate, prevent, and mitigate potential disruptions for patients and healthcare professionals.
“We completed a highly successful ‘Benchmarking of European Medicines Agencies’ assessment, continued our participation and influence across the European regulatory network and broader international regulatory initiatives, and launched the new HPRA website as part of our ongoing digital transformation programme. Internally, we introduced a career and capabilities framework for staff and launched a new learning and development platform, further strengthening our capacity to meet future challenges and opportunities.”
Ms Power also acknowledged the significant contribution of Dr Lorraine Nolan, whose decade as Chief Executive helped strengthen the HPRA’s regulatory impact, organisational capability, and standing both nationally and internationally.
IPU Calls for National Shingles Vaccination Programme for Over-65s and Immunocompromised Patients
The Irish Pharmacy Union (IPU) has called for the introduction of a national shingles vaccination programme for adults aged 65 years and older and immunocompromised individuals.
The IPU said the introduction of a national programme for these groups would be consistent with recommendations from the national immunisation advisory committee and international best practice. It would also help ensure that those most at risk of serious illness and long-lasting complications from shingles can access vaccination regardless of their ability to pay.
Shingles (herpes zoster) can have a significant impact on patients, particularly older and more vulnerable people. Complications can include post-herpetic neuralgia, neurological complications, and prolonged pain, which can significantly affect quality-of-life and, in some cases, result in a loss of independence.
Ms Rebecca Barry, Chair of the IPU’s community pharmacy committee, said: “Community pharmacists regularly see the impact shingles can have on patients. For some people, it is not simply a short-term illness. The pain and other complications can continue for prolonged periods and have a very significant impact on their quality-of-life and independence.
“Older people and those who are immunocompromised can be particularly vulnerable to shingles and its complications. Vaccination is a safe and effective way of reducing the risk and protecting those who are most vulnerable.”
Shingles vaccination is currently available privately, including through community pharmacies, but patients must meet the cost themselves. The IPU said this can create an unnecessary barrier to vaccination and result in unequal access for those who may be most at risk.
This places Ireland “out of line” with many other countries, including the UK, which commenced a vaccine programme over a decade ago, and many EU neighbours such as Germany, Spain, Greece, and France.
Ms Barry added: “A national programme would help ensure that access is based on clinical need rather than ability to pay. It would protect those most vulnerable to shingles, help people remain healthy and independent and potentially reduce demands on other parts of the health service.”
According to the IPU, community pharmacists have extensive experience in delivering vaccination services and are “ideally placed to support the delivery of a national shingles vaccination programme safely and effectively”.
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