approved stampOxford BioMedica, a leading gene and cell therapy group, has received approvals from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture bulk drug material for Investigational Medicinal Products at the group’s recently established and commissioned second specialist bioprocessing cleanroom suite in Harrow House and at its new laboratories at Windrush Court for Good Manufacturing Practice (GMP) analytical testing. Both state-of-the-art facilities in Oxford are now completely developed and fully operational.

Oxford BioMedica has established a leading platform for lentiviral vector bioprocessing with significant know-how as well as proprietary analytical methods based at its purpose-built facilities, which provides control over the entire lentiviral vector manufacturing process. The group’s capabilities have resulted in partnerships including an initial 3-year contract (with potential for extension) with Novartis under which the group is the sole source of lentiviral vector clinical supply for Novartis’ CTL-019 programmes and a second undisclosed CAR-T programme, as well as being a key partner for vector manufacture process development.

The group has now completed all necessary expansion and related capital expenditure requirements for its cleanroom and laboratory facilities for the manufacture, analysis and release of GMP-compliant lentiviral vector for use in clinical studies. Since October 2014, the Group has incurred approximately £26 million in expanding its bioprocessing and laboratory facilities.

The Group now has three flexible cleanroom suites in operation, including the Yarnton facility which has been producing lentiviral vector for Novartis’ CTL-019 programme steadily since the site was approved in January 2016, allowing the production of lentiviral vectors using both adherent cell factory and 200 litre large-scale, suspension bioreactor processes.

The new second suite at Harrow House is dedicated to serum-free, single use, bioreactor-based production of lentiviral vector to support next-generation vector manufacture, and will provide material to support Novartis, other current and future partners and the group’s in-house pipeline assets. The Windrush Court specialist laboratories include a dedicated polymerase chain reaction suite, a suite of three biosafety Category 3 laboratories – which are essential for the analysis and batch release of lentiviral vectors – and laboratories for process and product development.

Most of the Group’s employees are now based at Windrush Court, Harrow House and the Yarnton site and the Group will finally vacate its original Medawar Centre facility by the end of October 2016.

John Dawson, Chief Executive Officer of Oxford BioMedica, said: “The completion of the Group’s capacity expansion and these key regulatory approvals mark an important milestone for Oxford BioMedica.  The new world-class facilities have been designed to be highly flexible so as to serve the Group and its partners well for many years. We are now able to exploit our LentiVector platform to its full potential and we are excited by the progress we have made in developing a 200 L serum-free suspension production process that allows significantly larger volumes of vector to be produced at a significantly lower cost per patient dose. In summary, our world-class facilities, expertise and IP makes us an ideal partner for the bioprocessing and production of lentiviral vector for use in clinical studies and, in due course, commercial supply.”