cGMP Manufacturing
Our licensed cGMP facility supports cell banking/storage and the production of bulk drug substance for Watson and our partners. Three segregated clean room suites allow manufacture of biopharmaceutical products at a range of scales using mammalian and microbial production technologies (to Category level 2 containment).
Full flexibility of the suites is achieved through a combination of design features which include skid-mounted equipment, break out paneling, additional utility points and high use of disposable technologies. Validated equipment from highly reputable suppliers, robust utilities with pre-specified redundancy, together with a team of dedicated pharmaceutical engineers ensure that the facility operates consistently and remains within control.
Eden Biodesign’s facility has been regularly inspected by the UK’s MHRA (EMEA) and is approved for manufacture of Investigational Medicinal Products. The facility has, however, been designed to a standard sufficient to be compliant for future commercial production.
