Catalent has announced it will support a third ‘Operation Warp Speed’ COVID-19 candidate by providing commercial fill/finish for Moderna Therapeutics’ mRNA vaccine.
The deal announced this week will see contract development and manufacturing organization (CDMO) Catalent provide vial filling and packaging capacity from its facility in Bloomington, Indiana for Moderna Therapeutics’ vaccine candidate mRNA-1273.
“Moderna will leverage the site’s existing filling lines and recent packaging expansion, which provides fully automated and high-speed packaging capabilities to accelerate manufacturing timelines,” a Catalent spokesperson told Bioprocess Insider.
“Catalent and Moderna have announced production of an initial 100 million doses of the vaccine candidate intended to supply the US market – starting in the third quarter of 2020 – and are in discussions to secure fill-finish capacity for continued production of hundreds of millions of additional doses.”
On the drug substance side, Moderna has its own mRNA production facility in Norwood, Massachusetts supporting the vaccine, but has also inked contracts with CDMOs including Lonza.
Extra staff and 24/7 operations
Catalent will add extra staff to help service the contract.
“The Bloomington site is continuing to hire and train hundreds of additional staff to support 24×7 manufacturing and packaging schedules for multiple customer programs,” we were told.
“The site is hiring for positions at all levels, from entry-level through management positions, and across various functions including quality, manufacturing/operations, engineering, supply chain, product and process development, project management and information technology.”
Operation Warp Speed
mRNA-1273 is one of the frontrunners in the race to develop a vaccine against the coronavirus (SARS-CoV-2) and is set to enter Phase III trials in July.
It is also one of a handful of COVID-19 vaccine projects being assessed by the US Government under the title Operation Warp Speed, which looks to fund and support three to five programs against the virus.
Johnson & Johnson’s recombinant candidate is another on the list, as is AstraZeneca’s effort. Both are also being supported by Catalent, with the CDMO providing fill/finish from Bloomington for the former and providing fill/finish services for the latter from its site in Anagni, Italy.
Though these are the big names publicly announced by Catalent, the CDMO says it is actually working with over 40 customers on multiple COVID-related antivirals, vaccines, diagnostics and treatments across its network.
“While these programs are critical to addressing the global pandemic, Catalent will continue to meet its commitments to manufacture many other important and life-sustaining non-COVID-19 programs. Likewise, recent investments and expansions across our biologics network provide additional capacity, capabilities, automation, and throughput to support increased demand.
“As we navigate the COVID-19 pandemic, we will continue to put the patient first and do everything possible to keep our people safe and healthy, while we continue to strive to meet the needs and expectations of our customers.”