Ireland has a strong track record of attracting major investment from the largest pharma companies in the world. The foundation of Ireland’s life sciences industry has been the small-molecule sector and has since developed expertise in biologics manufacturing. Ireland is home to nine of the world’s top 10 pharmaceutical companies and is the world’s third-largest pharmaceuticals exporter. The country has proven to be a successful gateway to the EU, UK, US, and other RoW markets, with companies availing of the operational, financial, and geographic benefits of setting up here or partnering with Irish-based companies. World-class regulation is an important element of that. Ireland has an exemplary compliance record with agencies like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), both of which work closely with Ireland’s Health Products Regulatory Authority (HPRA).
The Growing Demand for Cell & Gene Therapies in Europe
There is rapidly growing diversity in therapeutic pipelines, including advancements in Cell & Gene Therapies Manufacturing. The global Advanced Therapeutic Medicinal Product (ATMP) market size was valued at USD 27.04 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 16.8% from 2023 to 2030. The emergence of cell and gene therapies has transformed the pharmaceutical industry and disease treatment landscape. It has opened new routes for the treatment of incurable diseases and several cancer types. The success of products such as Kymriah, Zolgensma, and others is the key factor driving the market.
Why Ireland for ATMP and Cell and Gene Therapy Manufacturing?
Ireland is actively supporting the growing field of cell and gene therapy, and companies are capitalising on the list of benefits that Ireland affords them. The Irish government is committed to making the country a global leader for the development, manufacture, supply, and adoption of advanced therapies, including cell and gene therapies and novel vaccines, through strong investment in world-class training and academic development, an innovative research base, and excellent clinical trials infrastructure. This synergy between industry and academia, bolstered by strong government support, has contributed to Ireland’s competitive edge in attracting and retaining talent in advanced therapies. For developers of cell and gene therapies, Ireland offers research and development incentives, access to an extensive network of clinical trial sites, and the availability of providers who have exemplary track records with regulatory authorities.
Key benefits of establishing ATMP manufacturing in Ireland include:
- World-class regulatory environment ensuring compliance with EMA, FDA, and HPRA standards.
- Strategic location offering seamless access to the EU, UK, and global markets.
- Tax incentives and R&D grants for biopharmaceutical companies.
- Highly skilled workforce with specialised expertise in advanced therapy manufacturing.
- Strong collaboration between industry and academia, fostering innovation in advanced therapies.
Comprehensive ATMP Manufacturer and Cell & Gene Therapies CDMO in Europe
HiTech Health is an ATMP Manufacturer in Europe, positioned at the forefront of Ireland’s Cell & Gene Therapies CDMO sector. Our EU GMP-certified manufacturing facility supports the development and manufacturing of advanced therapies from a strategic European base. HiTech Health was the first Irish company to secure a licence to contract manufacture cell and gene therapies on behalf of international clients. As a leading ATMP Manufacturer in Europe, our team of experts facilitates the transformation of a promising new therapy idea from initial development to the GMP manufacture of a drug to treat patients in a clinical environment, helping to accelerate the journey of advanced therapies towards commercialisation. Our GMP facility is equipped with cutting-edge technology designed to advance the development, production, and testing of sterile formulations.
HiTech Health also provides consulting services to biopharma companies to develop, launch, and support products. We hold Manufacturer’s / Importer’s Authorisations (MIAs) in both the EU and UK to seamlessly support companies with batch importation and release for clinical and commercial use. HiTech Health is working with early-stage developers to provide end-to-end cell & gene therapy CDMO services as well as batch approval and supply to clinical sites. For companies located outside Europe, we can support navigating the landscape for advanced medicines across all EU countries. Unlike the traditional pharmaceutical CDMO model, HiTech Health also has a logistics team to support the shipping and storage of time and temperature-sensitive therapies. Our expertise as a Cell & Gene Therapies CDMO allows us to provide comprehensive solutions tailored to the needs of biotech innovators and pharmaceutical companies.
Our full range of services to accelerate cell and gene therapy commercialisation, covering but not limited to:
- GMP manufacturing of ATMPs for clinical and commercial use.
- Regulatory consulting to support EMA, FDA, and HPRA approvals.
- Batch importation and release for the EU and UK markets under our Manufacturer’s / Importer’s Authorisations (MIAs).
- End-to-end CDMO services for early-stage developers.
- Logistics solutions for time and temperature-sensitive therapies.
- Clinical trial support, ensuring seamless supply chain management.
If you’d like to connect with a member of our team to learn more about our cell and gene therapy manufacturing services, please email info@hitech-health.com.
References
Enterprise Ireland – Pharma
IDA Ireland – Biopharma
Grand View Research – ATMP Market
HiTech Health – Cell and Gene Therapy Facility Launch
HiTech Health – Key Considerations for Selecting a Cell and Gene Therapy CDMO