The deal allows Catalent to provide vial filling and packaging capacity for Moderna’s mRNA-based Covid-19 candidate
Clinical-stage biotechnology company Moderna has selected Catalent for fill-finish manufacturing of its Covid-19 vaccine candidate.
Catalent will be responsible for the commercial fill-finish manufacturing of Moderna’s mRNA-based Covid-19 candidate (mRNA-1273) at its biologics facility in Bloomington, Indiana.
Under the deal, Catalent will offer vial filling and packaging capacity, as well as additional staffing needed for round the clock manufacturing operations at the site to support the production of an initial 100 million doses of the vaccine candidate.
Moderna intends to supply the initial doses of the vaccine candidate to the US market in the third quarter of this year.
Moderna chief technical operations and quality officer Juan Andres said: “We appreciate this collaboration with Catalent and the flexibility of their team to deliver critical fill-finish capacity for mRNA-1273 at unprecedented speed.”
Both firms are also involved in negotiations to secure fill-finish capacity for the continued production of hundreds of millions of additional doses.
Catalent will also offer clinical supply services, including packaging and labeling
Catalent will also deliver clinical supply services from its facilities in Philadelphia of Pennsylvania. The services comprise of packaging and labeling, in addition to storage and distribution to support Moderna’s Phase 3 clinical study for the Covid-19 candidate.
Catalent’s advanced 875,000ft² Bloomington biologics facility will conduct vial filling using barrier isolator technology.
Moderna is said to leverage the site’s recent packaging expansion, which offers fully automated and high-speed packaging capabilities to advance manufacturing timelines.
Bloomington facility has the proficiency 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.
Catalent chair and CEO John Chiminski said: “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.”
Recently, Catalent has agreed to supply vial filling and packaging capacity to British pharmaceutical company AstraZeneca.
Catalent Biologics network includes facilities in Brussels of Belgium and Anagni of Italy, which carry out sterile drug product manufacturing and packaging services.
The network’s facilities in the US and Europe are used for the manufacturing of manufacturing proteins, viral vectors for gene therapies and cell therapies, as well as to offer pre-filled syringe manufacture and biologics analytical services.