The Good Manufacturing Practice (GMP) Unit is a flexible space to make cell and gene therapies for clinical trials.
The growing field of medicine, termed Advanced Therapy Medicinal Products (ATMPs), heralds a new era in patient care and treatment. These ATMPs are used to treat major indications that are currently unmet. However, as with all medicines, their safety and efficacy must be determined through clinical trials.
Our work
The Unit is currently manufacturing patient-specific ATMPs for clinical trials in head and neck cancer and recipients of liver or kidney transplants.
The GMP Unit is strategically placed within Guy’s Hospital to undertake the manufacturing requirements of ATMP clinical trials in collaboration with King’s College London and Commercial Companies. Our expertise is in closed-system cell cultures and purification.
Unit design
The GMP unit consists of three equipped clean-rooms flexibly designed to accommodate multiple production processes. The scale is small, perfect for early-phase trials.
Operational Hours
The GMP Core is operational for 48 weeks per year, between 08:00 and 20:00 hours each day. We run a hotel-style booking system, with three four-hour sessions daily per room.
Contact
Chris Fisher, Head of Advanced Therapy Production
Tel: +44 (0)207 188 7188 ext. 52362
Email: christopher.fisher@gstt.nhs.uk
Dr Drew Hope, Head of Advanced Therapy Quality
Tel: +44 (0)207 188 7188 ext. 52703
Email: andrew.hope@gstt.nhs.uk
NIHR Guy's and St Thomas' Biomedical Research Centre GMP Unit
Clinical Research Facility
15th Floor, Tower Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
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