Under the terms, Catalent will provide vial filling and packaging capacity as well as additional staffing required for 24/7 manufacturing operations at the site to support Moderna’s production of a vaccine candidate intended to supply the US market starting in the third quarter of 2020.

Moderna has pledged to provide 100 million doses initially, and the companies are in discussions to secure fill-finish capacity for continued production of hundreds of millions more doses.

The agreement also calls for Catalent to provide clinical supply services from its facilities in Philadelphia, Pennsylvania, USA, including packaging and labeling, as well as storage and distribution to support Moderna’s Phase 3 clinical study for the Covid candidate.

Catalent’s chair and CEO, John Chiminski, said the company’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.

The CDMO’s state-of-the-art biologics facility in Bloomington will undertake the vial filling work under barrier isolator technology. Moderna will also be able to leverage the site’s recent packaging expansion, which provides fully automated and high-speed packaging capabilities to accelerate manufacturing timelines.

The Indiana 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.

In addition to Bloomington, the Catalent Biologics network has facilities in Brussels, Belgium, and Anagni, Italy, with capacity to perform sterile drug product manufacturing and packaging. In the US and Europe, the company can manufacture proteins, viral vectors for gene therapies and cell therapies, as well as providing pre-filled syringe manufacture and biologics analytical services.

Pacts with AstraZeneca and J&J

The pact with Moderna is not Catalent’s first exposure to work on a Covid-19 vaccine. The CDMO is also preparing to support the large-scale commercial supply of the University of Oxford’s vaccine candidate AZD1222 – being commercialized by AstraZeneca – starting in August this year.

Catalent Biologics will provide vial filling and packaging capacity to AstraZeneca from its facility in Anagni, readying the plant to enable round-the-clock manufacturing schedules. The aim is to supply hundreds of millions of doses of the vaccine candidate from August 2020 and potentially through to March 2022, pending approval by regulatory agencies.

Oxford’s recombinant adenovirus vaccine technology is currently in Phase II/III clinical trials.

Anagni is capable of providing aseptic liquid filling for biologics and sterile products across multiple vial sizes. The Italian site also provides primary and secondary packaging, including serialization, to support product launches for oral solids, sterile and biologics.

In the US, Catalent has a collaboration with Johnson & Johnson to ramp up capacity at its Bloomington, Indiana plant, leveraging its deep expertise in sterile formulation.. The joint goal is to reach 24/7 manufacturing schedules by January 2021.