Last checked at 13 May 2020 07:00
Oxford Biomedica receives MHRA approval for the first two manufacturing suites in Oxbox
Oxford, UK - 13 May, 2020: Oxford Biomedica plc (LSE:OXB) ("Oxford Biomedica" or "the Group"), a leading gene and cell therapy group, announced today the successful outcome of their recent UK Medicines & Healthcare products Regulatory Agency (MHRA) inspection, resulting in the issue of a Certificate of GMP compliance for the first two GMP manufacturing suites and supporting area such as warehouse, cold chain facilities and QC laboratories, in its new Oxbox manufacturing facility.
Oxbox is Oxford Biomedica's new 7,800 m2 commercial manufacturing centre, located in Oxford, UK. Phase I is 4,200 m2 of developed area consisting of six GMP manufacturing suites - four for viral vector production and two for fill-finish, warehousing and cold chain facilities and support laboratories. Construction was completed at the end of 2019. This approval by the MHRA of the first two suites enables commercial production of batches to commence for partner programmes within the coming weeks.
As previously announced the first fill / finish suite is expected to be operational by the end of the year with the other completed clean rooms in the first phase ready for equipment installation as demand increases. Phase II will provide for the flexible expansion of a further six GMP clean room suites.
This world class facility is suitable for the manufacture of a variety of viral vectors and will more than double Oxford Biomedica's manufacturing capacity, supporting further growth in revenues and partner programmes.
John Dawson, Chief Executive Officer of Oxford Biomedica, said: "We are delighted that despite COVID-19 the MHRA has been able to complete the inspection and sign off of the two suites and supporting areas within our world class Oxbox manufacturing facility. This not only secures facilities for our current and future cell and gene therapy partner programmes but also potentially provides access to the Oxford COVID-19 Vaccine Consortium for production of vaccine should the clinical trials prove to be successful."
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Oxford Biomedica plc
John Dawson, Chief Executive Officer Stuart Paynter, Chief Financial Officer Catherine Isted, Head of Corporate Development & IR
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T: +44 (0)1865 783 000 T: +44 (0)1865 783 000 T: +44 (0)1865 954 161 / E: ir@oxb.com
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Consilium Strategic Communications
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About Oxford Biomedica
Oxford Biomedica (LSE:OXB) is a leading, fully integrated, gene and cell therapy group focused on developing life changing treatments for serious diseases. Oxford Biomedica and its subsidiaries (the "Group") have built a sector leading lentiviral vector delivery platform (LentiVector®), which the Group leverages to develop in vivo and ex vivo products both in-house and with partners. The Group has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology, CNS disorders, liver diseases and respiratory disease. The Group has also entered into a number of partnerships, including with Novartis, Bristol Myers Squibb, Sanofi, Axovant Gene Therapies, Orchard Therapeutics, Santen, Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium and Imperial Innovations, through which it has long-term economic interests in other potential gene and cell therapy products. Oxford Biomedica is based across several locations in Oxfordshire, UK and employs more than 550 people. Further information is available at www.oxb.com