Samsung Biologics-Moderna Cooperation on COVID-19 Vaccines
Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Samsung Biologics, a leading global CDMO providing a fully integrated end-to-end contract development and manufacturing service, announced on May 23 a manufacturing services and supply agreement in which Samsung Biologics will provide large scale, commercial fill-finish manufacturing for mRNA-1273, Moderna’s COVID-19 vaccine.
Upon execution of the deal, technology transfer will commence immediately at Samsung Biologics’ facilities in Incheon, South Korea, utilizing a state-of-the-art production line equipped for aseptic fill-finish, labeling, and packaging services to support the production of hundreds of millions of doses of Moderna’s COVID-19 vaccine intended for the supply of markets outside the U.S. starting in the third quarter of 2021.
“This vaccine is paramount to people around the world in the fight against the COVID-19 pandemic, and we truly appreciate our client Moderna for entrusting and choosing to partner with Samsung Biologics for the fill and finish of this important vaccine,” said John Rim, CEO of Samsung Biologics. “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.”
“We are pleased to partner with Samsung Biologics for this fill and finish manufacturing, which will help us continue to scale up our manufacturing capacity outside the U.S.,” said Juan Andres, Moderna’s chief technical operations and quality officer. “We and our manufacturing partners remain committed to defeating the COVID-19 pandemic.”
Under the contract, Samsung BioLogics will handle the process of putting original vaccine sent from Moderna into glass bottles. It does not produce raw materials for the vaccine, which is done by Swiss pharmaceutical company Lonza.
Samsung Biologics’ deal with Moderna is different from SK Bioscience's contracts with AstraZeneca and Novavax, under which SK Bioscience takes charge of the entire manufacturing process from undiluted vaccine solution production to finishing production.
The fill and finish manufacturing process also requires substantial technical skills because it involves quality maintenance and aseptic treatment of the vaccine. Since its launch of the fill and finish manufacturing business in 2012, Samsung BioLogics has received approval from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA) for a total of 16 cases.