Moderna and Catalent have entered into a collaboration for large-scale, commercial fill-finish manufacturing of the former’s mRNA-based COVID-19 vaccine candidate (mRNA-1273) at the latter’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 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.
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.
John Chiminski, Chair and Chief Executive Officer of Catalent. “Catalent’s proven expertise in manufacturing scale-up and commercial production are well suited to support Moderna’s efforts to prepare for wide-scale supply of this vaccine candidate so that it is available if appropriate to address the pandemic.”
Catalent’s state-of-the-art 875,000 square-foot biologics facility in Bloomington will undertake this vial filling work under barrier isolator technology.
Moderna will leverage the site’s recent packaging expansion, which provides fully automated and high-speed packaging capabilities to accelerate manufacturing timelines.