The agreement will help Moderna scale up manufacturing capacity in the US as it seeks to reach its target of 1 billion doses globally in 2021.
Manufacture will take place at BioPharma Solutions’ fill/finish sterile manufacturing facilities located in Bloomington, Indiana. The site has capabilities and expertise in parenteral delivery systems and clinical and commercial vaccine manufacturing, including preventive and seasonal vaccines for global markets.
In addition, Bloomington offers a range of production and commercialization services, including clinical development, formulation, packaging and commercial launch capabilities.
Baxter’s BioPharma Solutions business is a contract manufacturing organization that specializes in parenteral (injectable) pharmaceuticals, including vaccines. It has operated in Bloomington for approximately 20 years and employs more than 700 individuals on its 600,000 square foot campus.
“We have seen a remarkable demonstration of scientific and health care expertise in the effort to develop vaccines for COVID-19,” said Marie Keeley, vice president, Baxter BioPharma Solutions. “Baxter is honored to provide our deep expertise in vaccine manufacturing to help partners like Moderna bolster the supply of their vaccine.”
Moderna had shipped around 55 million doses to the US Government as of February 24; and plans to ramp up deliveries to around 40 million doses a month as of April.
The US government has ordered a total of 300 million doses from Moderna: with Moderna planning to complete delivery of the first 100 million doses by the end of the first quarter 2021, the second 100 million doses by the end of May 2021 and the third 100 million doses by the end of July 2021.
Moderna recently highlighted the capacity of the fill-and-finish process as one of the constrains on the current production process, and is also working on allowing 15 doses to be drawn from each vial to increase capacity.
“We welcome the opportunity to work with Baxter BioPharma Solutions on fill/finish manufacturing for the Moderna COVID-19 Vaccine in the US,” said Juan Andres, Moderna’s Chief Technical Operations and Quality Officer. “This additional production will help us continue to scale up our manufacturing capacity in the country.”
On the other side of the Atlantic, Baxter BioPharma Solutions will provide manufacturing services for Novavax’s vaccine candidate from its facility in Halle/Westfalen in Germany. The site has broad sterile manufacturing capabilities, offers current good manufacturing practices (cGMP) manufacturing and is designed to deliver products with optimum efficiency and speed to market.
Novavax’s vaccine is currently under a rolling review with the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).