Last month, the University of Oxford announced that the first member of the public had been enrolled into a clinical trial and there were plans to have 500 volunteers vaccinated by mid-May, Sarah Gilbert, lead researcher, told The Lancet.
In order to support the manufacturing process for the vaccine, an alliance of partners has been set up to support the scaling of production for the vaccine candidate, known as ChAdOx1 nCoV-19 and developed by the Jenner Institute.
Halix, a Dutch contract development and manufacturing organization (CDMO) specialized in biologics, stated that it had become part of the initiative and had made its new facility in Leiden Bioscience Park available to produce the vaccine.
The first step for the CDMO will be the tech transfer, which will be shared by Pall Biotech in the UK, before beginning the industrial scale production of drug substance for clinical trials.
In doing so, Halix will use its 1,000L single-use bioreactor capacity, which the company had previously applied to producing vaccines for the Chikungunya and Zika viruses.
The partnership’s other contributors include the University of Oxford’s Jenner Institute, the Vaccine Manufacturing and Innovation Centre, Pall Biotech and Cobra Biologics.
According to the partners, the vaccine that is being worked on is based on the Jenner Institute’s adenovirus vaccine vector technology.
The chosen candidate was selected as a result of its ‘strong single-dose immune response’, as well as the fact it is not a replicating virus and therefore cannot cause infection in the vaccinated individual.
Gilbert’s team was awarded a £2.2m ($2.5m) by the UK’s National Institute for Health and Research to scale up their efforts in moving the vaccine through pre-clinical and clinical trials.
According to Gilbert, the best-case scenario could see a readout from Phase III trials by fall of this year and the ability to manufacture the vaccine at a large scale.