HALIX
BV 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 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 (COVID-19) 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 BV will utilise its brand new state-of-the-art GMP
facilities with capacity up to 1,000 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 BV 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.
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