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COVID-19 vaccine partnership

Samsung Biologics to make Moderna’s mRNA vaccine from Q3

By May 23, 2021 (Gmt+09:00)

4 Min read

South Korea-US vaccine partnership event held in Washington D.C. May 22 (From left: Samsung Biologics CEO John Rim, South Korean President Moon Jae-in, Moderna CEO Stéphane Bancel)
South Korea-US vaccine partnership event held in Washington D.C. May 22 (From left: Samsung Biologics CEO John Rim, South Korean President Moon Jae-in, Moderna CEO Stéphane Bancel)

Samsung Biologics Co. will be manufacturing the US company Moderna’s COVID-19 vaccine (mRNA-1273) from the second half of this year in Korea.

According to Samsung Biologics on May 23, the two companies will immediately begin technology transfer processes at its facilities in Incheon, South Korea, to produce hundreds of millions of doses of the coronavirus vaccine from the third quarter of 2021 for distribution outside the US.

Samsung Biologics said that the large-scale, commercial fill-finish manufacturing deal for Moderna’s mRNA-1273 will include aseptic fill-finish, labeling as well as packaging services.

“Due to the high level of urgency in supplying the vaccine to the global population, we have set an immediate action plan and schedule to make mRNA-1273 available for commercial distribution in the early second half of 2021,” said Samsung Biologics CEO John Rim.

“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 of the US,” said Moderna’s Chief Technical Operations and Quality Officer Juan Andres.

PARTIAL VICTORY ONLY FOR SAMSUNG?

While some industry experts say that Samsung Biologics’ partnership with Moderna marks a big achievement for the Korean biopharmaceutical industry, others note that the agreement is limited solely to the drug product (DP) stage of the manufacturing process.  
They highlight that the DP stage is essentially a packaging process, as Moderna mRNA vaccine’s raw substance, commonly known as the drug substance (DS), that Samsung Biologics will fill, finish, label and package will actually be made by its Swiss rival, Lonza.

The DS production is considered to be the most important and profitable part of the mass-scale vaccine production process. The DP stage, on the other hand, has a lower profit margin and does not require an advanced level of technology.

Moderna’s drug substance is solely manufactured by Lonza, whereas it has many other DP suppliers across the world, including Catalent of the US, ROVI of Spain and Recipharm of Sweden.

Lonza's facility in Portsmouth, New Hampshire, makes Moderna's mRNA vaccine.
Lonza's facility in Portsmouth, New Hampshire, makes Moderna's mRNA vaccine.

It is also unlikely that Samsung Biologics partnership with Moderna will expand further to include DS production, for a few key reasons. 

First, Lonza has the second-largest drug production capacity in the world after Samsung Biologics, meaning that the Swiss company is large enough to manufacture the DS volume in demand.

Second, Lonza and Moderna have already completed the technology transfer for the DS production, which normally takes around a year. Industry analysts say that Moderna and Lonza over the past year have almost co-developed the mRNA vaccine from the very early stages, and that Moderna would have contacted other parties such as Samsung earlier if it needed another DS partner.

Third, Lonza and Moderna are in a 10-year DS production agreement. The analysts thus note it would be unlikely for Moderna to sign another DS production agreement with another company due to possible complications around infringement of patent rights and technology leaks.

“Having independently developed a large-scale manufacturing process for Moderna’s COVID-19 vaccine, Lonza already has an upper hand in the production of mRNA vaccines,” said an official in the biopharmaceutical industry.  

SK, NOVAVAX AGREE TO DEVELOP & MAKE NEXT-GENERATION VACCINES

Samsung Biologics’ announcement to make the vaccine by the third quarter of this year comes right after its signing of a related agreement with Moderna on May 22 at the South Korea-US vaccine partnership event, held in Washington D.C. as a part of South Korean President Moon Jae-in’s state visit to the US.

Present at the partnership event from the South Korean side were the country’s president, health minister, trade and industry minister, SK Group Chairman, SK Bioscience CEO and Samsung Biologics CEO, while from the US side the country’s health secretary, the Novavax CEO and the Moderna CEO were present.

“South Korea, with its advanced vaccine manufacturing capabilities and skilled talent, is supplying multiple COVID-19 vaccines to the world including those of AstraZeneca and Novavax. The government will provide all possible measures of support to make the country a true global vaccine hub,” said the South Korean President Moon Jae-in at the event.

Another key partnership formed at the event was the trilateral MOU between South Korea’s health ministry, SK Bioscience Co. and Novavax on the development and production of an array of vaccines.

Under the deal, SK Bioscience and Novavax will jointly develop next-generation vaccines including a COVID-19 variant vaccine and other conjugate vaccines.

In addition, South Korea’s Ministry of Trade, Industry and Energy (MOTIE), Ministry of Health and Welfare (MOHW) and Moderna also signed a trilateral agreement on the US company’s potential investment in Korea.

Moderna has agreed to make efforts to increase investment in vaccine manufacturing facilities in Korea and employ talent in the country, while the two ministries will provide relevant assistance regarding Moderna’s business and investment activities in Korea.

Write to Do-won Lim and Ye-jin Jun at van7691@hankyung.com
Daniel Cho edited this article.
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