COVID-19 vaccine manufacturing centre gains MHRA approval; ready to produce tens of millions of doses in the UK
The two suites, operated by Oxford Biomedica and located in Oxford, will become operational this month and will act as a rapid deployment centre ahead of the opening of a permanent VMIC facility next year.
The first COVID-19 vaccine lined up for production at the centre will be AstraZeneca’s COVID-19 vaccine candidate: which is currently in a Phase 3 trial in the UK.
Four months from start to approval
The two 1000L scale manufacturing suites aim to rapidly build capability in the UK to manufacture a COVID-19 vaccine in the UK. With the first suite having been approved by the MHRA last month and the second this week, the facility now has the ability to make tens of millions of doses.
Development of the suites started after an agreement made in June between VMIC - a not-for-profit organisation established to provide the UK’s first strategic vaccine development and advanced manufacturing capability – and gene and cell therapy group Oxford Biomedica. Four months later the suites have been approved by the UK’s MHRA - a testament to hard work and collaboration, according to the partners.
Dr Matthew Duchars, Chief Executive, VMIC, 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.”
The two GMP suites are housed within Oxford Biomedica’s new 7,800m2 commercial manufacturing centre, Oxbow. The facility – which contains a total of six manufacturing suites of which two are allocated to the VMIC – is a new construction: giving VMIC a ready-made blank canvas and thus helping speed up the creation of the facility. The VMIC has been responsible for procuring specialist manufacturing equipment for the suites.
Oxbox is Oxford Biomedica’s new 7,800 m2 commercial manufacturing centre, located in Oxford, UK.
Phase I of Oxbox is 4,200 m2 of developed area consisting of six GMP 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. The first two suites were approved by the MHRA in May, with the two VMIC suites following in September and this week.
The Oxbox 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.
The instalment of the equipment for the first fill-finish suite is expected to be completed by the end of the year. Phase II will provide for the flexible expansion of up to a further six GMP clean room suites.
Oxford Biomedica is also providing training and technical assistance to VMIC staff to accelerate operational readiness.
Providing scaled-up manufacture of viral vector based vaccines, the immediate focus of the VMIC is a COVID-19 vaccine with the University of Oxford / AstraZeneca adenovirus vector vaccine candidate AZD1222 being first in line.
Permanent facility for 2021
The UK’s VMIC was founded in 2018 by the University of Oxford, Imperial College and London School of Hygiene and Tropical Medicine with support from industrial partners, MSD, Johnson and Johnson, and Cytiva (formerly GE Life Sciences). The Centre’s main funding comes from a £158m ($204m) grant from UK Research and Innovation, as part of the UK Government’s Industrial Strategy Challenge Fund, with £10m ($13) coming from industry partners and other businesses.
The initiative – which was established pre-coronavirus pandemic – was created to fast track the development and manufacture of early stage vaccines for known diseases and serve the UK’s response to emerging infectious diseases.
VMIC is creating a 7,000 m2 vaccines manufacturing facility at the Harwell Science and Innovation Campus in Oxfordshire, which is due to open in 2021. This facility will be able to produce 70 million doses over its first six month period.
VMIC envisions 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.