Contracts with CDMOs Catalent, Emergent Biosolutions, Cobra, and Novasep and the retrofitting of a facility in Ohio will support AstraZeneca and the Oxford University’s COVID-19 vaccine candidate.
AstraZeneca was among the second wave of Big Pharma firms to enter the rush to develop a vaccine against the coronavirus SARS-CoV-2 that causes COVID-19 in April when it teamed with the Jenner Institute and the Oxford Vaccine Group at the University of Oxford on its ChAdOx1 nCoV-19 program.
Production of the vaccine – now known as AZD1222 – has been supported by the Clinical BioManufacturing Facility (CBF) for the Nuffield Department of Medicine, Pall Biotech, Cobra Biologics and Halix. But as it progresses into Phase II/III trials and AstraZeneca has broadened out its manufacturing network in preparation for further scale-up.
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Last month, Oxford Biomedica was added to the growing list of manufacturers, and now AstraZeneca has inked contracts with several more contract development and manufacturing organizations (CDMOs).
Catalent in Italy
Catalent announced this week it will provide vial filling and packaging to AstraZeneca from its facility in Anagni, Italy, acquired from Bristol-Myers Squibb last year.
“Anagni was a fit for AstraZeneca’s COVID-19 program because it is a state-of-the-art facility with proven commercial launch expertise,” a spokesperson from the CDMO told this publication.
“The facility had the necessary equipment already in place and was ready to quickly begin work with minimal investment. The facility has the capacity to produce hundreds of millions of doses. Catalent is working on several leading candidates and cumulatively, could eventually support over a billion vaccine doses across its network.”
Financial details have not been disclosed, but we were told Catalent is working closely with AstraZeneca “for the tech transfer and large-scale production of AZD1222 in the coming months.”
Emergent, Novasep, and Cobra
Meanwhile, Emergent Biosolutions – which has also been contracted to support both J&J and Novavax’ COVID-19 vaccine candidates – has inked a deal worth $87 million to reserve large-scale manufacturing capacity through 2020 for the vaccine candidate, as well as provide development services, technology transfer, analytical testing, and drug substance process and performance qualification.
Novasep has also been contracted to produce the vaccine’s active substance in Europe from its site in Seneffe, Belgium.
And Cobra Biologics has upped its collaboration on the vaccine, supplying large-scale capacity to the project. “The agreement with AstraZeneca comes at an opportune time for us as we bring three additional viral vector suites online as part of our ongoing advanced therapies expansion program,” Cobra’s CEO Peter Coleman said in a statement.
Inhouse manufacturing
As well as third-parties, AstraZeneca is turning to its own production network to support the COVID-19 vaccine.
The firm’s West Chester, Ohio is being retrofitted by engineering firm Jacobs to upgrade an existing idle filling line to support formulation, vial filling, visual inspection and packaging of the COVID-19 vaccine at the earliest date possible in the fall of 2020.
All the expanded capacity will help prepare for clinical and commercial success of the vaccine and comes as AstraZeneca commits to supply Europe’s Inclusive Vaccines Alliance (IVA) with 400 million doses, with deliveries starting by the end of the year.
In a press release this week, the firm said total manufacturing capacity for AZD1222 now stands at two billion doses, though it is unclear how this is split between itself and its growing list of partners.