The Clinical BioManufacturing Facility (CBF) holds a manufacturing authorisation (MA) from the MHRA, permitting it to manufacture biologics for early phase clinical trials.
The Clinical BioManufacturing Facility (CBF) is the University of Oxford’s GMP (Good Manufacturing Practice) manufacturing facility. It has over 18 years experience producing biological investigational medicinal products (IMPs) according to GMP for early phase clinical trials.
The CBF hold a manufacturer’s authorisation for investigational medicinal products – ie MIA (IMP) – from the Medicines and Healthcare Products Regulatory Agency (MHRA). This allows them 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.
The CBF aims to provide the link between academic research and clinical drug development, to allow all their collaborators to make rapid progress into clinical trials.
The CBF’s GMP manufacturing facility enables them to:
meet the special demands for phase I/II clinical trials of novel biotech products within the academic and commercial sectors
deliver effective short term treatments to the clinic providing long term benefits to the patient