Moderna (NSDQ:MRNA) and Catalent (NYSE:CTLT) today announced a collaboration for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate (mRNA-1273) at Catalent’s biologics facility in Bloomington, Ind.
Catalent will provide vial filling and packaging capacity, as well as additional staffing required for 24×7 manufacturing operations at the site to support production of an initial 100 million doses intended to supply the U.S. market starting in the third quarter of 2020. The companies said they are in discussions to secure fill-finish capacity for continued production of hundreds of millions of additional doses. Somerset, N.J.-based Catalent will also provide clinical supply services from its facilities in Philadelphia, including packaging and labeling, as well as storage and distribution to support Moderna’s Phase 3 clinical study for this candidate.
The randomized, 1:1 placebo-controlled trial is expected to begin in July and include approximately 30,000 enrolled U.S. participants in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Moderna’s trial will have a primary endpoint of the prevention of the symptomatic COVID-19 disease, with key secondary endpoints including prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2, the virus causing COVID-19. Primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic COVID-19, with 100 μg chosen as the optimal dose level, based on results from the Phase 1 study.
“We appreciate this collaboration with Catalent and the flexibility of their team to deliver critical fill-finish capacity for mRNA-1273 at unprecedented speed,” said Moderna CTO Juan Andres in a news release. “It has been wonderful to see both teams working together to support the common good.”
Catalent’s 875,000 ft2 facility in Bloomington will undertake this vial filling work under barrier isolator technology. Moderna (Cambridge, Mass.) will use the site’s recent packaging expansion, which provides fully automated and high-speed packaging to accelerate manufacturing timelines.