Date: 2016-07-28
Type of information: Validation of a production plant
Compound: biomanufacturing facility for cell and gene therapy products
Company: Oxford Biomedica (UK)
Therapeutic area: Regenerative Medicine
Type agreement: validation of a production plant
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Details: * On July 28, 2016, Oxford BioMedica announced that it 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 clean room suite in Harrow House and at its new laboratories at Windrush Court for 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 three-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. Oxford BioMedica now has three flexible clean room 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.
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