Moderna Collaborates with Catalent for Fill-Finish Manufacturing of mRNA-Based COVID-19 Vaccine Candidate

Moderna, Inc. (Cambridge, MA, USA) has entered into a collaboration with Catalent, Inc. (Somerset, N.J., USA) for large-scale, commercial fill-finish manufacturing of its mRNA-based COVID-19 vaccine candidate (mRNA-1273).

mRNA-1273 is an mRNA vaccine candidate against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein. Moderna has completed enrollment for its Phase 2 study of mRNA-1273 and is expected to begin Phase 3 study of approximately 30,000 participants in July 2020.

As part of the agreement with Moderna, Catalent will provide vial filling and packaging capacity, as well as additional staffing required for 24x7 manufacturing operations at its Indiana biologics facility in the US to support the production of an initial 100 million doses of the vaccine candidate intended to supply the US market starting in the third quarter of 2020. The facility will undertake 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. The facility has deep expertise in sterile formulation, with drug substance development and manufacturing and drug product fill-finish capacity across liquid and lyophilized vials, prefilled syringes, and cartridges, as well as primary and secondary packaging. 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 other facilities in the US, including packaging and labeling, 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, Moderna’s Chief Technical Operations and Quality Officer. “It has been wonderful to see both teams working together to support the common good.”

“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’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.”

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Moderna, Inc.
Catalent, Inc.