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Uniquely placed world class expertise and services for first in human studies
Advanced Therapy Medicinal Products (ATMPs) herald a new era in patient care and treatment.
Our Good Manufacturing Practice (GMP) Unit offers a flexible and secure environment for the production of ATMPs including cell and gene therapies and tissue engineered products for first in human clinical studies, and early phase clinical trials.
The GMP Unit helps trials advance as smoothly and efficiently as possible. Its co-location with the MHRA Phase I Clinical Research Facility and the BRC’s Flow Cytometry and Immune Monitoring Platforms at Guy’s Hospital provides a unique environment for ATMP studies. This co-location enables us to manufacture and administer ATMPs to patients within one site, and deliver trial endpoints safely and efficiently.
The GMP Unit is strategically placed within Guy’s Hospital to undertake the manufacturing requirements of ATMP clinical trials in collaboration with our academic partner King’s College London, as well as industry partners and commercial customers. 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.
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. Get in touch with us at firstname.lastname@example.org to find out more about our work, to discuss your project or to work with us.