OXFORD: Oxford Biomedica plc has announced 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.”