Date: 2016-01-13
Type of information: Validation of a production plant
Compound: biomanufacturing facility for cell and gene therapy products
Company: Oxford Biomedica (UK)
Therapeutic area: Cancer - Oncology - Regenerative Medicine - Genetic diseases
Type agreement: validation of a production plant
Action mechanism:
Disease:
Details: * On January 13, 2016, Oxford BioMedica, a gene and cell therapy group, announced 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. The 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 Oxford Biomedica 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. Purposely designed around the Group’s current and future state LentiVector® based platform processes, the 560m2 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. Further capacity expansion at the Group’s existing Harrow House facility (also based in Oxford) is scheduled for completion in the first half of 2016 and will provide a third independent suite designed to house Oxford BioMedica’s next generation of serum free, suspension cell line based processes. The continued investment in the Group’s specialist biomanufacturing facilities and capabilities will help Oxford BioMedica address the industry’s challenges of bridging clinical and commercial supply, one of the main hurdles associated with the rapid progression of gene and cell therapies through Phase II and Phase III clinical trials, and then ultimately to market. Importantly, it also provides the opportunity for Oxford BioMedica to maintain its world-leading position as the LentiVector® platform supplier of choice for its current and future partners.
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