Start of Moderna Vaccine Technology Transfer... Fourth Domestic COVID-19 Vaccine Contract Manufacturing

[Image source=Yonhap News]

[Image source=Yonhap News]

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[Asia Economy Reporter Seo So-jung] Samsung Biologics and U.S. vaccine manufacturer Moderna have joined forces to globally supply messenger ribonucleic acid (mRNA) vaccines.


Samsung Biologics announced on the 23rd that it signed a contract with Moderna on the 22nd for the contract manufacturing of the COVID-19 messenger ribonucleic acid vaccine (mRNA-1273). With this, South Korea became the fourth country to manufacture COVID-19 vaccines under contract for foreign pharmaceutical companies, following AstraZeneca, Novavax, and Sputnik V.


The governments and companies of South Korea and the United States held a Korea-U.S. vaccine company cooperation event in Washington, D.C., where they signed four vaccine-related contracts and memorandums of understanding (MOUs), including the contract for Moderna vaccine contract manufacturing.


Under this contract, Samsung Biologics will immediately begin technology transfer for the Moderna vaccine and is scheduled to start full-scale aseptic filling, labeling, and packaging of hundreds of millions of doses for markets outside the U.S. starting in the third quarter.


John Rim, CEO of Samsung Biologics, said, "The Moderna vaccine is the most important vaccine for people worldwide fighting COVID-19," adding, "We have established a rapid production schedule to enable commercial supply by early the second half of this year in response to the urgent global vaccine demand."


Juan Andres, Moderna’s Chief Technology, Operations, and Quality Officer (CTO & QO), said, "We are very pleased to establish a finished product manufacturing partnership with Samsung Biologics," and added, "We expect this contract to help us continue expanding our production capacity outside the United States."


Moderna vaccine bulk produced overseas, finished product filling done domestically
Samsung Biologics holds largest production capacity... accounts for one-third of global contract manufacturing
Samsung Bio and Moderna Join Forces for Global Vaccine Supply... "Mass Production to Start from Q3" (Update) View original image


Under this contract, Samsung Biologics will produce the finished Moderna vaccine by filling bulk vaccine material produced overseas domestically.


The bio industry evaluated that Samsung Biologics’ strength in rapidly improving quality and competitiveness through the introduction of cutting-edge technology as a contract development and manufacturing organization (CDMO) was the driving force behind the contract signing.


Samsung Biologics operates contract manufacturing (CMO) services for biopharmaceuticals and contract development (CDO) services that provide cell line development, process development, and early clinical stage development from cell lines.


In particular, Samsung Biologics is a global CDMO company with an integrated biopharmaceutical production system at a single site and holds the world’s largest production capacity.


Currently, it has a total production capacity of 364,000 liters, including 30,000 liters at Plant 1, 154,000 liters at Plant 2, and 180,000 liters at Plant 3. The production capacity of Plant 4, which began construction in October last year with an investment of 1.7 trillion KRW, is 256,000 liters and is scheduled to partially operate from the end of next year.


With the addition of Plant 4, Samsung Biologics’ total production capacity will reach 620,000 liters, expected to account for about one-third of the global contract manufacturing market.


Recently, the number of orders has also been steadily increasing. As of the end of March this year, the cumulative number of CMO product orders is 57, and CDO orders are 68. The total number of manufacturing approvals obtained from global regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) is 85.


Samsung Biologics, which celebrated its 10th anniversary in April, announced its goal to become a global top-tier bio company by 2030 by establishing differentiated processes in quality, speed, price competitiveness, and efficiency through the introduction of cutting-edge technology.


The bio industry welcomed Samsung Biologics’ contract manufacturing agreement for the Moderna vaccine, saying it enables South Korea to emerge as a global hub for vaccine supply.



Lee Seung-gyu, Vice Chairman of the Korea Bio Association, said, "With the additional contract manufacturing of the Samsung Biologics vaccine, South Korea has become the fourth country to manufacture foreign pharmaceutical companies’ COVID-19 vaccines under contract," adding, "This is a result of recognition of the domestic bio industry’s production capacity, and we hope that advanced technology transfer will provide an opportunity for the domestic bio industry to take a step forward."


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