Alliance for the scale-up of a GMP manufacturing process and production of a coronavirus (SARS-CoV-2) vaccine (ChAdOx1 nCoV-19) formed
Leiden, The Netherlands (April 15,2020) – HALIX B.V. 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 B.V. 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 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, 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.
Alex Huybens, Chief Operations Officer of HALIX, states: “We are committed to working as one team across the industry bringing our collective expertise, track record and manufacturing capabilities, to support the Jenner Institute’s rapid clinical development of this nCoV-19 vaccine candidate to combat this evolving crisis as quickly as possible.”
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. Our brand new 6,700 m2 BSL2 GMP facility, located in Leiden (the Netherlands), provides both clinical and commercial scale manufacturing capabilities in fully independent, self-contained Grade B and C cleanrooms for virus products.
The clinical trial 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. For further information on the vaccine, visit: https://covid19vaccinetrial.web.ox.ac.uk/.
Founded in 2012 and based in Leiden, the Netherlands, HALIX is a corporate venture and spin-off of HAL Allergy serving customers since then as a contract development and manufacturing organization (CDMO). The company is licensed for the GMP manufacturing of biopharmaceutical drug substance and drug products in accordance with the relevant authorities. HALIX leverages single use state-of-the-art biopharmaceutical technologies to supply clinical trial material. This is supported by the generation of all required CMC documentation for regulatory submissions in worldwide clinical trial applications. As an end-to-end service provider, HALIX can support its customers all the way from initial development through to commercial launch as result of a successful product registration application. HALIX and HAL Allergy Group belong to the family owned Droege Group AG.
More information is available on: www.halix.nl
About Droege Group
Droege Group (founded in 1988) is an independent advisory and investment company under full family ownership. The company acts as a specialist for tailor-made transformation programs aiming to enhance corporate value. Droege Group combines its corporate family-run structure and capital strength into a family-equity business model. The group carries out direct investments with its own equity in corporate spin-offs and medium-sized companies in “special situations”. With the guiding principle “execution – following the rules of art”, the group is a pioneer in execution-oriented corporate development. Droege Group follows a focused investment strategy based on current megatrends (knowledge, connectivity, prevention, demography, specialization, future work, shopping 4.0). Enthusiasm for quality, innovation and speed determines the company’s actions. In recent years, Droege Group has successfully positioned itself in domestic and international markets and operates in 30 countries.
More information is available on: www.droege-group.com
Monique Lutgens – Manager Corporate Communications
Tel. + 31 (0)88 1959010