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www.fdanews.com/articles/203015-moderna-scales-up-vaccine-manufacturing-with-two-new-production-agreements

Moderna Scales Up Vaccine Manufacturing With Two New Production Agreements

June 3, 2021

Moderna has struck a fill-and-finish deal with Thermo Fisher Scientific to produce hundreds of millions of doses of Moderna’s messenger RNA-based COVID-19 vaccine at its Greenville, N.C., plant.

Moderna has also expanded an existing agreement with Lonza to manufacture drug substances for its booster vaccine candidate aimed at variant SARS-CoV-2 strains, as a 50-mcg dose if authorized.

Under the deal, Lonza will establish a new production facility in the Netherlands and help manufacture up to 300 million additional doses of the booster vaccine annually.

Through the new Lonza deal and a previously announced agreement with Rovi for drug substance manufacturing in Granada, Spain, Moderna now expects to supply 600 million booster variant vaccine doses to the EU per year.

The company recently announced a significant expansion of its facility in Norwood, Mass., and said this along with its other owned and partnered manufacturing facilities should increase global capacity in 2022 to 3 billion doses annually. The number will depend on the mix between the authorized vaccine at the 100 μg-dose level and potentially lower doses of variant booster vaccine candidates and pediatric vaccines, the company said.

In addition, Moderna recently enlisted Samsung Biologics for fill-and-finish work on its standard COVID-19 vaccine. Work will occur at Samsung’s plant in Incheon, South Korea, and support the manufacture of hundreds of millions of doses for nonU.S. distribution starting in the third quarter of the year.

Beyond those deals, Moderna has also tapped Catalent, Sanofi, Recipharm and Baxter BioPharma Solutions for vaccine manufacturing services over the past few months.

On Tuesday, Moderna filed a Biologics License Application with the FDA for the vaccine for inoculating individuals 18 years of age and older (DID, June 2). A full approval would allow the company to market it directly to consumers. — Jason Scott