Samsung Bio plans to manufacture mRNA drug substance from 2022

Samsung Biologics will be entering the drug substance segment of the COVID-19 vaccine contract manufacturing business.

According to industry sources on May 31, Samsung Biologics is preparing to extend its facilities to produce the drug substance (DS) in mRNA COVID-19 vaccines. The addition will be made to the company’s plants 1, 2 and 3 in Incheon, and is expected to be completed by the first half of 2022.

In case of a successful contract deal and related technology transfer from the pharma companies with mRNA vaccines, such as Pfizer Inc. and Moderna Inc., Samsung will be able to produce the DS from the second half of 2022.

Germany’s CureVac AG is another company that is developing an mRNA vaccine candidate, scheduled to announce phase III trial results by the end of June.

A BIG STEP FORWARD FOR THE KOREAN BIO INDUSTRY

Samsung marked a big achievement earlier in May by signing a drug product (DP) manufacturing agreement with Moderna. But some experts noted that Moderna’s DS production, a more profitable part of the mass-scale vaccine production process, is done by its Swiss rival Lonza.  

Essentially, the DS producer makes the vaccine’s raw substance, whereas DP production consists of aseptic filling, finishing, labeling and packaging the product.

DS production generates two to three times more operating profit per dose than DP production, known to make a per-dose profit of one dollar to three dollars.

Industry insiders say that only a couple of global companies have the ability to manufacture the DS of mRNA vaccines, namely Pfizer and Lonza. They note that none of the Korean companies possess expertise in lipid nanoparticle (LNP) technology, essential in producing the raw substance of the mRNA vaccines.

In developing their vaccines, both Pfizer and Moderna used LNP technology.

While South Korea’s pharmaceutical company ST Pharm Co. does have a patent on LNP technology, the company lacks a track record for its mass production.

Samsung Biologics will receive an LNP technology transfer when it signs a DS contract manufacturing deal for mRNA vaccines.

Samsung Biologics is thus poised to be South Korea’s only maker of mRNA drug substances. SK Bioscience makes the drug substance for Novavax’s COVID-19 vaccines, which use recombinant proteins instead of mRNA molecules.

SK Bioscience is reported to be earning more than two to three dollars per dose for making the Novavax vaccine’s drug substance.

Novavax’s recombinant vaccines are supplied at around $16-22 per dose to the South Korean government with an operating margin above 40%. The mRNA vaccines are known to have a higher per-dose price than the recombinant vaccines.  

Write to Woo-sub Kim at duter@hankyung.com
Daniel Cho edited this article.