The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has approved Oxford Biomedica for two new manufacturing sites in Oxford.
Following an inspection, the MHRA has issued 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, at the firm’s new Oxbox manufacturing facility.
The facility is suitable for the manufacture of a variety of viral vectors and will more than double the firm’s manufacturing capacity, supporting further growth in revenues and partner programmes, it noted.
The MHRA’s approval enables commercial production of batches to commence for partner programmes within the coming weeks.
“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,” said John Dawson, chief executive of Oxford Biomedica.
“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.”