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About

The Clinical BioManufacturing Facility is the University of Oxford’s GMP (Good Manufacturing Practice) manufacturing facility.

The Clinical BioManufacturing Facility has over 20 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 a variety of products including viral vector and recombinant protein vaccines and advanced therapy medicinal products (ATMPs) such as cell and gene 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.

News

Pandemic computer simulations to guide future vaccine trials

PSI scientists are launching a new computer simulations project to model vaccine clinical trial designs and strengthen global response to pandemic threats.

Professor Teresa Lambe elected to Fellowship of Academy of Medical Sciences

Professor Teresa Lambe OBE, Calleva Head of Immunology at the Oxford Vaccine Group, and Principal Investigator at the Pandemic Sciences Institute, has been elected a Fellow of the Academy of Medical Sciences, one of the most prestigious awards in the field.

PSI Director Professor Sir Peter Horby elected Fellow of Royal Society

Professor Sir Peter Horby has been elected as a Fellow of the Royal Society, joining a cohort of the world’s most eminent scientists, engineers and technologists who have made substantial contributions to the advancement of science.

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