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COVID-19 vaccine

Samsung Biologics gears up to produce mRNA drug substance

To use mRNA technology not only for COVID-19 vaccines but also for other drugs including cancer vaccines

By Sep 01, 2021 (Gmt+09:00)

A Samsung Biologics’ official is checking a device at its plant
A Samsung Biologics’ official is checking a device at its plant

South Korea’s Samsung Biologics Co. is gearing up for the drug substance (DS) sector of the messenger ribonucleic acid (mRNA)-based COVID-19 vaccine contract manufacturing business.

The move is expected to allow the biotech arm of Samsung Group to obtain the full production capability since it is already able to put the DS of COVID-19 vaccines in vials, seal and package them for shipment.

Samsung Biologics is slated to buy a land of 10,279 square meters in Songdo, Incheon, where the world’s largest contract manufacturing organization (CMO) operates plants, according to sources on Aug. 31.

The contract drug maker is known to set up facilities at the site for plasmid deoxyribonucleic acid (DNA), a raw material of the DS of mRNA vaccines, and plan to produce the vaccines and other undiluted medicines with the plasmid DNA at its nearby three factories. The company is expected to complete the construction of the facilities by the first half of 2022, industry sources have said earlier.
Samsung Biologics’ headquarters and factories in Songdo, Incheon
Samsung Biologics’ headquarters and factories in Songdo, Incheon


BETTER PROFITABILITY

Samsung Biologics in May signed a drug product (DP) manufacturing deal with Moderna, a contract that involves putting vaccines into vials or syringes, sealing them and packaging them up for shipping, but not making the vaccine’s DS itself. There are only a few drug makers including Swiss Lonza with capability of the DS of mRNA vaccines in the globe.

Profitability from producing DS as a CMO is double or triple of one from DP business. The sector is less difficult than DS business, although it needs high technologies and processing know-how such as aseptic filling.

Samsung Biologics’ move on the DS business is a start of the group’s ambition to grow the biotech unit to the world’s top contract development and manufacturing organization (CDMO) as a part of a 240 trillion won ($207.5 billion) investment plan.

Samsung Biologics aims to start production of the DS of mRNA vaccines from next year with plasmid DNA manufactured from the new facilities. The company is understood to revamp its three existing plants to produce the DS in the first half of 2022.

NOT ONLY TO MAKE COVID-19 VACCINES BUT ALSO TO DEVELOP OTHER DRUGS

The move is not only to make COVID-19 vaccines but also to develop other medicines such as anticancer drugs and cancer vaccines using mRNA technology, which are expected to quickly grow in the future.

“If they apply mRNA vaccines to cancers, they can develop patient-specific vaccines using information on DNA of individual patients,” said a Samsung Securities analyst Seo Keung-hee.

Germany’s BioNTech already started phase 2 clinical trials in June for melanoma cancer patients of a combined treatment using an mRNA cancer vaccine candidate and Sanofi's immuno-oncology drug Libtayo. Moderna is working on clinical trials for patients with solid cancer of a combined treatment. It is also developing vaccines against various viruses such as human immunodeficiency virus (HIV).

The global mRNA vaccine and medicine market is expected to grow $15.4 billion by 2026 from $9.4 billion this year, according to the bio industry.

“We will see various vaccines and medicines since the COVID-19 proved safety of mRNA’s technology and effect,” said an industry source. “Samsung Biologics will be able to secure the enormous future market once it sets up a system for total production of DS and finished vaccines.”

Write to Jae-young Han at jyhan@hankyung.com

Jongwoo Cheon edited this article.

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