Our Platform enables researchers to explore the growing field of Advanced Therapy Medicinal Products (ATMPs), which has heralded a new era in patient care and treatment.
The Good Manufacturing Practice (GMP) Unit is a flexible space to make cell and gene therapies for clinical trials.
ATMPs are increasingly being used to treat a range of conditions. As with all medicines, however, their safety and efficacy must be determined through clinical trials.
The GMP Unit helps trials advance as smoothly and efficiently as possible. It 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 GMP Unit consists of three equipped clean-rooms designed to accommodate multiple production processes. They are small-scale and therefore perfect for early-phase trials.
We manufacture cell and gene for a range of trials, with particular expertise in closed-system cell cultures and purification.
In addition to cell therapy and gene therapy production, the Unit can be used as a facility for manual aseptic filtration and fill projects for small scale Investigational Medicinal Product (IMP) batches or for the storage and reconstitution of IMPs.
The GMP Unit operates as either a Contract Manufacturing Organisation (CMO) in which all Production/QC staff are provided, or as a hotel facility in which external operators are trained to use the facility. The GMP Unit is open daily from 8am until 8pm for 48 weeks of the year. Each room has three four-hour sessions per day.
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