Moderna & Catalent Collaboration For Developing COVID-19 Vaccine
An agreement for manufacturing Moderna’s mRNA-based COVID-19 vaccine candidate (mRNA-1273) in large-scale at Catalent’s biologics facility in Bloomington, Indiana was signed by Moderna and Catalent. 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 at the site, Catalent will provide additional staffing required for 24×7 manufacturing operations, along with vial filling and packaging capacity, as part of the deal.
For the continued production of hundreds of millions of additional doses, the companies are in discussions to secure fill-finish capacity.
To support Moderna’s Phase III clinical study for this candidate, clinical supply services from Catalent’s facilities in Philadelphia, along with storage and distribution, packaging and labeling will be provided by Catalent.
Moderna’s CTO and quality officer, Juan Andres said, “Seeing both teams work together for supporting the common good is wonderful. To deliver critical fill-finish capacity for mRNA-1273 at unprecedented speed, we appreciate this collaboration with Catalent and the flexibility of their team.”
The CEO and chair of Catalent, John Chiminski commented that for addressing this critical public health need, Catalent is proud to partner with Moderna in its work. To ensure that the vaccine is available if appropriate to address the pandemic, Moderna’s efforts to prepare for a wide-scale supply of this vaccine candidate is well suited to Catalent’s proven expertise in manufacturing scale-up and commercial production.”
This vial filling work under barrier isolator technology will be done at Catalent’s 875,000 square-foot biologics facility in Bloomington. In order to accelerate the manufacturing timelines, the site’s recent packaging expansion providing high-speed and fully automated packaging capabilities will be leveraged, said a Moderna official.
The facility has deep expertise in sterile formulation, with drug substance manufacturing and development and drug product fill-finish capacity across cartridges, prefilled syringes, and liquid and lyophilized vials, along with primary and secondary packaging.
Catalent Biologics network, in addition to its Bloomington location, has facilities that perform sterile drug product manufacturing and packaging in Italy, Brussels, Belgium and Anagni, and for providing pre-filled syringe manufacture and biologics analytical services, for manufacturing viral vectors for cell therapies and gene therapies, and proteins in the US and Europe.
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Moderna & Catalent Collaboration
