Oxford Biomedica plc, the leading gene and cell therapy group, has announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has issued a Certificate of GMP compliance for its fourth GMP manufacturing suite within the Group’s new Oxbox manufacturing facility.
Oxbox is Oxford Biomedica’s new 7,800 m2 commercial manufacturing centre. Phase I of Oxbox is 4,200 m2 of developed area consisting of six GMP (Good Manufacturing Practice) manufacturing suites – four for viral vector production and two for fill-finish, along with warehousing, cold chain facilities and support laboratories. Construction and commissioning of Phase I was completed at the end of 2019. This approval by the MHRA follows the initial approval of the first two Oxbox suites in May 2020, and the subsequent approval of the third suite in September.
John Dawson, Chief Executive Officer of Oxford Biomedica, said: “We are delighted that we now have all four GMP suites in Oxbox operational, more than doubling our manufacturing capacity from 2019. I want to personally thank all of those at Oxford Biomedica who have worked tirelessly to bring these suites on-line so quickly to enable the manufacturing at scale of the vaccine candidate. We also want to thank VMIC for their support with the rapid deployment of their equipment to our site, which has played a key part in achieving the operational readiness of these suites in this short timeframe.”
This world class facility is suitable for the manufacture of a variety of viral vectors and the approval of this fourth suite completes a phase of expansion that more than doubles Oxford Biomedica’s manufacturing capacity compared to 2019, supporting further growth in revenues and partner programmes.
Both this suite, and the suite approved in September, will be dedicated to the manufacture of a COVID-19 viral vector vaccine candidate. Equipment for these two suites has been provided by Harwell Campus -based VMIC (Vaccine Manufacturing and Innovation Centre) following the agreement signed with VMIC in June 2020.
Dr Matthew Duchars, Chief Executive, The Vaccines Manufacturing and Innovation Centre, said: “This is a milestone moment in the UK’s fight against COVID-19. These suites, which house VMIC equipment, will have the ability to make tens of millions of doses of the current leading vaccine candidate.
“The approval from the MHRA is testament to the hard work and dedication of teams across VMIC, Oxford Biomedica and all the partners working with us on this vital project.”
Andy Jones, Medicines Manufacturing Challenge Director at UK Research and Innovation (UKRI), said: “When we provided additional funding to both speed the building of VMIC and provide for a virtual manufacturing centre, we recognised that we needed both innovative approaches to vaccine development and the ability to deliver vaccines at speed and in volume. The approval, by the MHRA, of the manufacturing suites and VMIC equipment will ensure that a vaccine can rapidly be manufactured once an effective vaccine is approved.”
The permanent VMIC facility, due to open in 2021, will be located at the Harwell Science and Innovation Campus in Oxfordshire, UK. The state-of-the-art facility will house specialist equipment drawing on both innovative and traditional technologies. It is envisaged that much of the work at the new facility will be collaborative ventures with organisations ranging from small and medium sized businesses, through to large multinationals and NGOs such as Wellcome and CEPI, thereby underpinning the activity and strength of the UK in the vaccine area.
Last month Oxford Biomedica announced that it had signed an 18 month supply agreement with AstraZeneca UK Ltd for large-scale commercial manufacture of the adenovirus vector-based COVID-19 vaccine candidate, AZD1222.
AstraZeneca will pay Oxford Biomedica £15 million upfront as a capacity reservation fee. Subject to satisfactory scale up of manufacturing capacity and continuation of the vaccine programme, Oxford Biomedica expects to receive additional revenue in excess of £35 million plus certain materials costs for the manufacture of multiple large-scale batches of AZD1222 until the end of 2021.