Moderna and Catalent have 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, Indiana.
As part of the agreement, Catalent will provide vial filling and packaging capacity, as well as additional staffing required for 24×7 manufacturing operations at the site to support the production of an initial 100 million doses of the vaccine candidate intended to supply the U.S. market starting in the third quarter of 2020. The companies are in discussions to secure fill-finish capacity for continued production of hundreds of millions of additional doses.
mRNA-1273 is an mRNA vaccine candidate against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH). On June 11, 2020, Moderna announced that enrollment of younger adults (n=300) and the sentinel group of older adults (n=50) in its Phase 2 study of mRNA-1273 was complete and that its Phase 3 study of approximately 30,000 participants, is expected to begin in July 2020.
Catalent will also provide clinical supply services from its facilities in Philadelphia, Pennsylvania, including packaging and labelling, as well as storage and distribution to support Moderna’s Phase 3 clinical study for this candidate.
“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 Juan Andres, Chief Technical Operations and Quality Officer, Moderna
“Catalent is proud to partner with Moderna in its work to address this critical public health need,” commented John Chiminski, Chair and Chief Executive Officer of Catalent.
Catalent has also entered into partnerships with J&J and AstraZeneca recently for COVID-19 vaccines.