Already contracted for fill/finish of the so-called Oxford Vaccine, CDMO Catalent will now make the drug substance for the potential COVID-19 prophylactic from its site in Maryland.

AZD1222 – previously known as ChAdOx1 nCoV-19 – is one of the leading vaccines against the coronavirus SARS-CoV-2 that causes COVID-19. Developed by the Jenner Institute and the Oxford Vaccine Group at the University of Oxford, Anglo-Swedish Big Pharma firm AstraZeneca partnered on the project in April and the candidate is currently in large-scale Phase II/III trials.

Aiming for an unprecedented approval speed, AstraZeneca has focused heavily on ensuring there will be enough doses available globally, and in its latest announcement has teamed with contract development and manufacturing organization (CDMO) Catalent for commercial drug substance manufacturing.

Image: iStock/kiattisakch

Catalent will carry out the work from its viral vector production facility in Harmans, Maryland – added to its network last year through the $1.2 billion acquisition of Paragon Bioservices – running multiple production trains in parallel beginning later in this quarter.

A Catalent spokesperson would not divulge how much capacity would be taken up by the project but told us new suite capacity will be completed specifically for this project at the site.

The demand for viral vectors is high driven by increased gene therapy pipelines and now solutions to the coronavirus pandemic. As such, demand outstrips available capacity and according to some estimates developers have to wait 10-12 months for a manufacturing slot at an outsourcing partner. Other estimates are less conservative.

Catalent did not explain how AstraZeneca was able to secure a slot so quickly but did tell us: “This project will not affect any of our other gene therapy or viral vector projects. All customer projects and Catalent’s overall phased future expansion plans will proceed as planned.”

COVID-19 projects

Catalent is already working on AZD1222 after AstraZeneca contracted the firm in June for vial filling and packaging from its facility in Anagni, Italy.

But beyond Catalent, AstraZeneca has struck deals with other CDMOs including Oxford Biomedica, Cobra Biologics, Halix, Emergent Biosolutions and Novasep. On top of this, AstraZeneca is utilizing its own manufacturing network to support the vaccine.

Catalent, meanwhile, is involved in numerous other COVID-19 projects across its global network. In June, the CDMO said it is working with over 40 customers on therapies, vaccines, and diagnostics, including Operation Warp Speed (OWS) projects such as Johnson & Johnson’s recombinant effort and Moderna’s mRNA vaccine candidate.