Moderna and Catalent to collaborate on COVID-19 vaccine manufacture
Catalent’s biologics facility will conduct large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate.
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 Indiana, US.
mRNA-1273 is an mRNA vaccine candidate against COVID-19 encoding for a prefusion stabilised form of the Spike (S) protein.
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 US 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’s biologics facility 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. The facility has expertise in sterile formulation, with drug substance development and manufacturing and drug product fill-finish capacity across liquid and lyophilised vials, pre-filled syringes and cartridges, as well as primary and secondary packaging.
Catalent will also provide clinical supply services from its facilities in Pennsylvania, including packaging and labelling, as well as storage and distribution to support Moderna’s Phase III 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.”