Ireland, 12th Feb 2024: Hitech Health, a Contract Development and Manufacturing Organisation (CDMO) for advanced therapies, has opened an additional facility in County Galway, Ireland. The new high-specification manufacturing centre is equipped with state-of-the-art technologies to help develop, manufacture and test sterile formulations including cell and gene therapies. Cell and gene therapies offer revolutionary treatments which repair, replace, regenerate and re-engineer genes, cells and tissues to restore normal function or enhance their ability to fight diseases, like cancer.
The new manufacturing centre operates to Good Manufacturing Practice (GMP) standards and is certified to European Medicine Agency (EMA) standards by the Health Products Regulatory Authority (HPRA). It will provide the global Advanced Therapies industry with GMP manufacturing services for their clinical studies, helping to accelerate these novel therapies through commercialisation. The multi-disciplinary team at Hitech Health have extensive experience helping Advanced Therapy developers progress their therapies to help treat unmet medical needs.
The new manufacturing centre adds to Hitech Health’s capabilities for our clients that have been supported since the company was founded in 2013. Hitech Health’s expert team are working with clients including in the US, Europe and the United Kingdom. We are responsible for the certification, release and supply of multiple different cell and gene therapies that are currently in clinical trials.
Brian Harrison, Managing Director of Hitech Health, commented:
“I am delighted to announce the opening of this manufacturing centre that offers our clients capacity for GMP manufacture of these life changing medicines for treating patients. Partnerships and collaboration are at the core of successful research and innovation and this is a major focus for Hitech Health. Advanced Medicines including cell and Gene Therapy products is the fastest growing sector of new product development. There were 7 new advanced medicines approved by the FDA in 2023. This number is expected to increase to between 10-20 per year by 2025. Hitech Health is a company with the capability to support the development of these new therapies in this fast growing area of medicines which is pivotal for treating patients with rare disease.
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