Clinical BioManufacturing Facility (CB)
University of Oxford
The Clinical BioManufacturing Facility is the University of Oxford’s GMP facility. We have over 20 years experience producing biological Investigational Medicinal Products (IMPs) 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.
- 5 grade C suites: one large 51 m2 are with two MBSCs, 2 smaller rooms (23 m2 and 11 m2) with one MBSC each and 2 rooms (17 m2 and 10 m2) with isolators operating to grade A for fill/finish.
- One grade D area 22.9m2 for preparation, staging and inspection and a through wall pharmaceutical autoclave.
Depends on product type – generally manufacture for Phase I/II trials
- Viral vector and vaccine manufacture
- Preparation of pre-GMP starting materials
- Master virus seed stock production
- Fill and finish
- Adherent/suspension mammalian cells
- Insect cells
- Virus like particles
- Recombinant proteins
- Master cell banks
- Process development
- QP importation of IMPs from outside the EU
- Labelling and QP certification to clincial trials
MHRA MIA IMP 21584
Production: Ms Emma Bolam
Quality: Dr Richard Tarrant
QP: Dr Eleanor Berrie
Clinical BioManufacturing Facility,
University of Oxford,
T: +44 (0)1865 744845
F: +44 (0)1865 741291
Location & Website
The facilities on this site took part in a survey in 2011 and have subsequently confirmed their license status.
If you are the manager of a facility licensed for ATMP manufacture in the UK, not included on this site and would like it to be please email email@example.com