The Clinical BioManufacturing Facility has over 18 years experience producing biological Investigational Medicinal Products (IMPs) according to the principles of GMP for early phase clinical trials. We hold a Manufacturer’s Authorisation for Investigational Medicinal Products (MIA (IMPs)) from the Medicines and Healthcare products Regulatory Agency (MHRA), which allows us to manufacture viral vector vaccines and advanced therapy medicinal products (ATMPs), including gene and cell therapy products. All IMPs are manufactured and released in accordance with the European Clinical Trials Directive (2004). The facility can also import IMPs from outside the EU for use in clinical trials within the European Union.
We aim to provide the link between academic research and clinical drug development, to allow all our collaborators to make rapid progress into clinical trials.
Our GMP manufacturing facility enables us to meet the special demands for phase I/II clinical trials of novel biotech products within the academic and commercial sectors and to deliver effective short term treatments to the clinic providing long term benefits to the patient.