As Moderna’s potential vaccine for the novel coronavirus moves into late-stage trials, the company is taking steps to ensure it has the manufacturing services required to deliver sufficient levels of any commercial product.
Previously, Moderna had secured the partnership of Lonza to boost its manufacturing capacity for a billion doses of its potential mRNA vaccine, mRNA-1273.
The company has also confirmed that it has reached an agreement with the contract development and manufacturing organization (CDMO) Catalent for the fill-finish of the vaccine.
The work will be carried out at Catalent’s Bloomington, US, facility, with the CDMO providing vial filling and packaging capacity, as well as bringing on additional staff members to support a production schedule that will be carried out continuously.
Catalent is preparing to provide 100 million doses of the finished product for the US market, beginning in the third quarter of 2020. According to the companies, there are ongoing discussions regarding additional supply beyond this initial amount.
The company’s 875,000-square-foot Bloomington site will be responsible for vial filling, using automated packaging capabilities and vial filling using barrier isolator technology.
In addition to this, the CDMO will provide clinical supply services from its Philadelphia facilities, which include packaging, labeling, storage, and distribution, related to the Phase III clinical study of the potential vaccine.
Outside of the US, Catalent’s biologics-focused network includes sites in Brussels, Belgium, and Anagni, Italy.
The CDMO has already agreed to provide fill-finish services from the latter site to AstraZeneca for the potential commercial supply of AZD1222.
In a similar arrangement, Catalent confirmed that manufacturing would be taking place round-the-clock to ensure the supply of hundreds of millions of doses from August 2020 for AZ.
