Guy’s and St Thomas’ NHS Foundation Trust (GSTT) is expanding its Advanced Therapy Manufacturing Platform to meet rising demand for clinical trial production of cell and gene therapies.
The project is being delivered in collaboration with the NIHR Maudsley Biomedical Research Centre at King’s College London.
The facility – formally known as the Clinical Research Facility GMP Unit (CRF GMP Unit) – is a dedicated cleanroom environment designed for the manufacture of Investigational Medicinal Products (IMPs) and unlicensed Specials for use in clinical trials.
Already recognised for its work in regulatory T-cell immunotherapy, the unit is now being scaled up to accommodate a wider portfolio of advanced therapies, including stem cell-derived photoreceptors and adherent cell products.
The expansion will see the addition of two new ISO Class 7 cleanrooms
The expansion will see the addition of two new ISO Class 7 cleanrooms, Grade A processing areas equipped with Class II Biosafety Cabinets or isolators, and improved material flow systems.
Controlled storage, waste handling, and an overall increase of up to 60% in production capacity are also part of the upgrade.
Cleanroom design and engineering specialist Scitech has played a central role in the project, supporting it from concept through to full detailed design and now into the final stages of construction.
Headquartered in Woking, Surrey, Scitech specialises in the design, engineering, and construction of facilities for the life sciences, healthcare, and technology sectors.
Already recognised for its work in regulatory T-cell immunotherapy, the unit is now being scaled up to accommodate a wider portfolio of advanced therapies
Scitech’s scope of work included designing cleanrooms capable of full-room biodecontamination, integrating CO₂ and compressed air infrastructure, and implementing controlled access with electronic pressure monitoring.
The facility layout ensures segregated flows for personnel and materials, maximising GMP efficiency and regulatory compliance while enabling cost-effective delivery of Advanced Therapy Medicinal Products (ATMPs).
The project is being delivered within the operational 15th floor of a live hospital building, requiring close coordination with NHS staff and departments.
Controlled storage, waste handling, and an overall increase of up to 60% in production capacity are also part of the upgrade
Scitech worked in collaboration with GSTT to minimise disruption to patient care and ensure safety during construction.
“The onsite coordination has been to the millimetre, one of the most complex threading of utilities we have done, to fit into the space available,” said a Scitech spokesperson. “The work has been carried out safely on the 15th floor of an operational building with patients, families, doctors, and NHS staff working in rooms around, above, and below the site.”
The upgraded facility is expected to significantly enhance the Trust’s capacity to support clinical research and manufacture GMP-compliant therapies for a growing pipeline of advanced treatments, further reinforcing the UK’s capabilities in this rapidly evolving field.
Top image: Processing area in the CRF GMP Unit at Guy’s and St Thomas’ NHS Foundation Trust