Business
MHRA approval to manufacture in new facility
MHRA approval to manufacture in new facility.
About this update from Oxford Biomedica Plc
[{"type":"text","content":"\n \nRNS Number : 6564L Oxford Biomedica PLC 13 January 2016 \n\n \n \n \n \n \n \nOxford BioMedica Announces Successful MHRA Inspection and Approval to Manufacture at its new Facility in Yarnton, Oxford\n \n \n- New manufacturing facility fully operational \n- Creates extra capacity for wholly-owned pipeline, Novartis partnership and other new potential customers \n \nOxford, UK - 13 January 2016: Oxford BioMedica plc (\"Oxford BioMedica\" or \"the Group\") (LSE: OXB), a leading gene and cell therapy group, today announces that it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture bulk drug material for Investigational Medicinal Products (IMPs) at the Group's recently established and commissioned specialist biomanufacturing facility in Yarnton, Oxford, UK. \n \nThe MHRA conducted a site-specific inspection in November 2015 to evaluate whether the Group's existing manufacturing processes and quality management systems had been effectively extended and implemented at the new Yarnton facility and remained in accordance with EU Good Manufacturing Practice (GMP) standards. MHRA has now confirmed that Oxford BioMedica's operations at Yarnton are in compliance with the principles and guidelines of GMP. Consequently, the facility at Yarnton is now fully-operational and authorised to perform GMP manufacturing activities. The successful delivery and licensing of the Yarnton facility provides the Group with a second fully independent GMP manufacturing site, strengthening the robustness of the Group's biologics supply chain, adding dual sourcing capability and doubling capacity. This additional capacity will support Oxford BioMedica's own proprietary programmes in development as well as consolidating key current and potential new strategic relationships such as the well-established CAR-T focussed partnership with Novartis for CTL-019.\n \nPurposely designed around the Group's current and future state LentiVector® based platform processes, the 560m2/6,028ft2 of additional clean room space at Yarnton's state-of-the-art facility bolsters the Group's manufacturing capabilities, and increases total operational capacity across both sites to 950m2/10,226ft2. Further capacity expansion at the Group's existing Harro...