Upon execution of the deal, technology transfer will commence immediately. Samsung Biologics’ Incheon facilities will use a state-of-the-art production line equipped for aseptic fill-finish, labeling, and packaging services.
The agreement will support the production of hundreds of millions of doses of Moderna’s COVID-19 vaccine, destined to supply of markets outside of the US.
John Rim, CEO of Samsung Biologics, said: “Due to the high level of urgency in supplying the vaccine to the global population, we have set immediate action plans and schedule to make mRNA-1273 available for commercial distribution in the early second half of 2021.”
Moderna also signed a Memoranda of Understanding (MoU) with the government of South Korea last week. One MoU is with the Korea National Institute of Health (KNIH), an agency of the Korea Centers for Disease Control and Prevention Agency (KDCA) for a new collaboration on mRNA vaccine research in South Korea.
An additional MoU with the Ministry of Trade, Industry and Energy of the Republic of Korea (MOTIE), the Ministry of Health and Welfare of the Republic of Korea (MOHW) to explore local manufacturing opportunities for mRNA vaccines in South Korea.
The Ministry of Food and Drug Safety of South Korea last week authorized Moderna’s COVID-19 vaccine for adults aged 18+ under a Conditional Marketing Authorization, with GC Pharma as the marketing authorization holder and distributor. A supply agreement of 40 million doses for the country is in place.
As Moderna continues to scale its commercial network, it also plans to open a commercial subsidiary in South Korea in 2021.
Scaling up global capacity: Agreements with Aldevron, Catalent and Lonza among others
Moderna has been expanding its partnerships to help it ramp up production of its COVID-19 vaccine, mRNA-1273, up to 1 billion doses in 2021. This could rise to 3 billion doses in 2021, although this figure will depend on the dosage required for potential booster shots and the company’s next generation vaccine.
Its manufacturing footprint is divided between US and non-US market.
In the US, Moderna has announced an expanded partnership with Aldevron LLC this morning. Aldevron will supply plasmid DNA to serve as the genetic template for generating the COVID-19 mRNA vaccine and other investigational programs in Moderna’s pipeline.
Aldevron’s production of DNA continues to take place in its 70,000 sq ft GMP facility located in Fargo, North Dakota. Buildout and validation of an additional 189,000 sq ft expansion to the GMP facility on Aldevron’s 14-acre Breakthrough Campus has been completed, enabling additional manufacturing capacity.
Another recent agreement in the US will see the expansion of Moderna’s agreement with Catalent: with the latter dedicating a new high-speed vial filling line at its biologics facility in Bloomington, Indiana. Catalent will also provide inspection, labeling, cartoning, and final packaging.
Outside the US, Lonza announced earlier this month that it will add three more production lines for the vaccine at its site in Visp, Switzerland: with the lines to be operational by early 2022. It follows a 10-year strategic collaboration agreement for manufacturing the vaccine and additional products signed in May 2020, covering three production lines at Visp and another in Portsmouth in the US.
