Collaboration in GMP manufacturing of a COVID-19 vaccine
Halix has joined a consortium of partners, under the guidance of the University of Oxford, to provide GMP manufacturing services supporting the large-scale production of a COVID-19 vaccine (ChAdOx1 nCoV-19), being developed by the university’s Jenner Institute. This GMP manufacturing scale-up is taking place alongside early-phase clinical trials. The trials are crucial in testing whether or not the vaccine is proven to be effective.
The nCoV-19 vaccine is based on the Jenner Institute’s adenovirus vaccine vector (ChAdOx1) technology, which was chosen as the most suitable candidate for a SARS-CoV-2 coronavirus vaccine as it can generate a strong single-dose immune response, and is not a replicating virus, so it cannot cause infection in the vaccinated individual.
Under the collaboration, Halix will utilise its brand new state-of-the-art GMP facilities, with capacity up to 1000 L SUB scale, applying its viral vector bioprocessing expertise, to transfer an industrial scale drug substance process from Pall in the UK, supporting the manufacture of ChAdOx1 nCoV-19 clinical trial material. Based on this transfer, Halix and the consortium will be in a position to manufacture at a larger scale. This is a key step in decreasing the time it would normally take to make the vaccine available for deployment, and could help to halt the further spread of this pandemic.
The large-scale manufacturing project is a collaborative effort, led by Dr Sandy Douglas at the Jenner Institute. The ChAdOx1 coronavirus vaccine alliance encloses viral vector manufacturing and regulatory compliance experts from the University of Oxford’s Jenner Institute and Clinical Biomanufacturing Facility, the Vaccine Manufacturing and Innovation Centre (VMIC), Pall Biotech and Cobra Biologics.
The clinical trial programme will recruit up to 510 volunteers, who will receive either the ChAdOx1 nCoV-19 vaccine or a control injection for comparison. Since late March, the University of Oxford has been recruiting individuals in the UK to take part in the vaccine trial. For further information on the vaccine is available online.