Moderna partners with Catalent for fill-finish manufacturing of COVID-19 Vaccine Candidate
- by Team ABLE - 26 Jun, 2020
Clinical stage biotechnology company Moderna Inc and NYSE-listed Catalent Inc. have collaborated for a 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.
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).
As part of the agreement, Catalent will provide vial filling and packaging capacity, as well as additional staffing required for 24x7 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 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.”
On June 11, 2020, Moderna announced that enrolment 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 provide vial filling and packaging capacity, as well as additional staffing required for 24x7 manufacturing operations.