Guy’s & St Thomas’ GMP Facility
Biomedical Research Centre GMP Unit
Overview
The BRC GMP Unit is a flexible space to make Advanced Therapy Medicinal Products (ATMPs) such as cell and gene therapies for clinical trials. The unit is capable of operating as contract manufacture for ATMP Manufacture. The unit is operation 12 hours a day for 48 weeks per year.
Manufacturing Capability
3 independent Grade D suites with Grade A 4-glove isolators: room sizes 15m2, 15m2, 20m
- Fully equipped for closed processing
- Liquid Nitrogen Cell Storage
- Support rooms
- Category 2 biological containment
- Flow cytometry suite
- Genomics suit
Process Capability
- Adherent cells
- Suspension cells
- T cells
- Tissue processing
- Gene modified cells
- Patient specific processes
- Bulk allogeneic processes
- Vial Filling processes
Experience
Closed processing of cells in suspension including: TRegs and CAR modified T cells
Storage, reconstitution and trial-site supply of MSCs and oncolytic viral ATMPs
Sterilisation by filtration and aseptic filling of IMPs
Licenses Held
MHRA MIA IMP: 11387 (6280106)
MHRA Specials: 11387 (6280106)
HTA: 22643
Team
Production: Chris Fisher
Quality: Dr Drew Hope
QP: Gillian Lewis, Prof Farzin Farzaneh
Address
Clinical Research Facility,
15th Floor, Tower Wing,
Guy’s Hospital, Great Maze Pond,
London, SE1 9RT
Location & Website
The facilities on this site took part in a survey in 2011 and have subsequently confirmed their license status.
If you are the manager of a facility licensed for ATMP manufacture in the UK, not included on this site and would like it to be please email angela@atmpmanufacture.org
