London, UK – 07 August 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:Oxford Biomedica), a leading gene and cell therapy group, today announces that it has been granted a Manufacturer/Importer License (MIA), from the UK Medicines and Healthcare products Regulatory Agency (“MHRA”), to manufacture and distribute lentiviral vector material for commercial supply. This is in addition to the existing MIA (IMP) licence for Investigational Medicinal Products (IMPs) manufacture, which the Group has held for over 10 years.
Including significant know-how and proprietary analytical methods, Oxford BioMedica has established a world-leading platform for lentiviral vector bioprocessing at its state-of-the-art custom-built facilities in Oxford, UK, that allow full control over the entire lentiviral vector manufacturing process.
Oxford BioMedica recently signed an agreement with Novartis for the commercial and clinical supply of lentiviral vectors used to generate CTL019 and other undisclosed CAR-T products, for which Oxford BioMedica could potentially receive in excess of $100m from Novartis over the next three years.
In addition to the Novartis agreement, Oxford BioMedica has bioprocessing and process development partnerships with Immune Design and Orchard Therapeutics.
John Dawson, Chief Executive Officer of Oxford BioMedica, commented:
“Receiving regulatory approval for the manufacture of lentiviral vector material for commercial supply is another significant milestone for Oxford BioMedica. We look forward to working closely with our existing partners in lentiviral vector bioprocessing and process development, and believe that our expertise and technology will be of benefit to other companies working in gene and cell therapy.”
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