Dutch Halix BV will manufacture a ChAdOx1 nCoV-19 vaccine, developed at the University of Oxford .
Dutch CDMO HALIX B.V. has joined a research consortium coordinated by the University of Oxford, to provide GMP-compliant production of Vaccitech Ltd’s COVID-19 vaccine (ChAdOx1 nCoV-19) targeting the viral spike protein, which is clinically developed by the University’s Jenner Institute. The clinical program, led by Professor Sarah Gilbert at the Jenner Institute and Professor Andrew Pollard of the Oxford Vaccine Group, will recruit up to 510 volunteers, who will receive either the ChAdOx1 nCoV-19 vaccine or a control injection for comparison. Since March 23, 2020, The University of Oxford is recruiting individuals in the UK to take part in trialing the vaccine.
The nCoV-19 vaccine is based on the Jenner Institute’s licenced chimpanzee adenovirus vaccine vector (ChAdOx1) technology, which is expected to deliver a suitable candidate for a SARS-CoV-2 (COVID-19) vaccine as has been demonstrated to generate a strong single dose immune response, and is not a replicating virus, so it cannot cause infection in the vaccinated individual.Chimpanzee adenoviral vectors are a very well-studied vaccine type, having been used safely in thousands of subjects, from 1 week to 90 years of age, in vaccines targeting over 10 different diseases.
Coronaviruses have club-shaped spikes on their outer coats. Immune responses from other coronavirus studies suggest that these are a good target for a vaccine. The Oxford vaccine contains the genetic sequence of this surface spike protein inside the ChAdOx1 construct. After vaccination, the surface spike protein of the coronavirus is produced, which primes the immune system to attack the coronavirus if it later infects the body. Prof. Gilbert and team have previously developed a vaccine for another human coronavirus disease, which is Middle East Respiratory Syndrome (MERS), and this has shown promise in early clinical trials.
Under the agreement, HALIX B.V. will utilise its 1,000 L single use bioreactor suite within its 6,700 m2 BSL2 GMP facility, located in Leiden, 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 B.V. 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 with German Merck KGaA, 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.
HALIX has an established technical and quality track record for the development and GMP manufacture of viral vectors used against infectious diseases, such as HIV, ZIKA, chikungunya and the flu.