Since 2005 the CBF has specialised in the development and manufacture of viral vector vaccines and gene therapy products. We work closely with the principal investigators from the Jenner Institute to progress novel vaccines for malaria, flu, HIV, and tuberculosis into Phase I/II clinical trials. We also have other collaborations with academic and clinical institutes, charitable bodies and commercial institutions worldwide.
The first batch of adenoviral vector vaccine was manufactured and released in 2007, and the first volunteer immunised in the same year. Since then, over 15 viral vector vaccines and gene therapy products have been manufactured for clinical trials directly or for further processing by third parties. As well as manufacturing vaccines, the CBF also imports, labels and certifies vaccines and advanced therapy products (ATMPs) for clinical trials.Since 2012, process development at the CBF has expanded to include virus-like particles, insect-line derived proteins and other ATMPs and vaccine types.
The Clinical BioManufacturing Facility (CBF) was formerly known as the Therapeutic Antibody Centre (TAC).
The TAC was established in Cambridge in 1990 by Professor Geoff Hale with Prof Herman Waldmann as the Clinical Director and moved to the current facility in Oxford in 1995. The TAC was the leading academic GMP facility for monoclonal antibody production. Over its 10 year history the TAC produced monoclonal antibodies and a number of related biologics that have been used by clinicians worldwide. The products have supported more than 5,000 patients in clinical trials; the results from these trials have led to the licensing of seven monoclonal antibodies to the pharmaceutical industry. In 2001 CAMPATH, an anti-CD52 monoclonal antibody, was licensed by the FDA (US Food and Drug Administration) for use in treating patients with chronic lymphocytic leukaemia and in 2003 had gross sales of 78.8 million US dollars. CAMPATH is also known as Alemtuzumab/Lemtrada, and was recently re-launched as a treatment for Multiple Sclerosis by Genzyme (Sanofi), with annual sales being forecast to reach 650 million US dollars by 2017. Recently, CAMPATH/Alemtuzumab was also used successfully as an anti-rejection drug in patients who had received kidney transplants (News - University of Oxford). For a brief overview of the CAMPATH development see also the University of Oxford Science Blog.
Until November 2005 the TAC was part of the Sir William Dunn School of Pathology but when Prof Geoff Hale resigned as Research Director to become CEO of BioAnaLab Ltd., the TAC became the Clinical BioManufacturing Facility and is now part of the Jenner Institute (Nuffield Department of Clinical Medicine).