Business
Manufacturing Approvals and Expansion Completed
Manufacturing Approvals and Expansion Completed.
About this update from Oxford Biomedica Plc
[{"type":"text","content":"\n \nRNS Number : 4524F Oxford Biomedica PLC 28 July 2016 \n\n \n \n \n \n \n \nOxford BioMedica Announces MHRA GMP Manufacturing Approvals and Completion of Expansion Phase\n \n- World-class centre for lentiviral gene therapy bioprocessing and process development approved and fully operational\n- Capital expenditure and expansion of Group's facilities now complete\n \nOxford, UK - 28 July 2016: Oxford BioMedica plc (\"Oxford BioMedica\" or the \"Group\") (LSE: OXB), a leading gene and cell therapy group, today announces 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 Good Manufacturing Practice (\"GMP\") analytical testing. Both state-of-the-art facilities in Oxford are now completely developed and fully operational.\n \nOxford 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.\n \nThe Group has now completed all necessary expansion and related capital expenditure requirements for its clean room 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. \n \nThe Group 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 p...