Exciting Expansion at Guy’s and St Thomas’ Advanced Therapy Manufacturing Facility for Cell and Gene Therapies
Scitech is proud to be supporting the expansion of the Advanced Therapy Manufacturing Platform at Guy’s and St Thomas’ NHS Foundation Trust (GSTT) – a critical development to meet the growing demand for clinical trial manufacturing of cell and gene therapies, in collaboration with the NIHR Maudsley Biomedical Research Centre at Kings College, London.
The facility, also known as the CRF GMP Unit, is a purpose-built environment for the manufacture of Investigational Medicinal Products (IMPs) and Specials for patients on clinical trials. Already a leader in regulatory T-cell immunotherapy manufacturing, the unit is now scaling up to support a broader range of advanced therapies, including stem cell-derived photoreceptors and adherent cell products.
Expansion Highlights:
- Two new ISO Class 7 cleanrooms
- Grade A processing areas with Class II Biosafety Cabinets or Isolators
- Improved material flow, controlled storage, and waste handling
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Up to 60% increase in production capacity
- Designing cleanrooms to enable full-room bio-decontamination (e.g. fumigation)
- Integrating CO₂ and compressed air lines
- Implementing controlled access and electronic pressure monitoring
- Designing segregated personnel and material flows
- Ensuring efficient use of GMP space for cost-effective ATMP delivery
- Achieving compliance with UK and EU regulatory frameworks for clinical trial manufacturing
Delivering in a Live Hospital Environment
One of the project’s key challenges was delivering construction within a live hospital setting. Scitech worked closely with GSTT to ensure minimal disruption to surrounding departments, maintaining full operational capacity and patient care throughout the programme.
This expansion reinforces GSTT’s position at the forefront of advanced therapy manufacturing and strengthens the UK’s capabilities in delivering innovative, GMP-compliant therapies for clinical trials.
