Samsung Biologics
(Photo : Samsung Biologics)

In March 2022, Samsung Biologics, a leading contract development and manufacturing organization (CDMO), held its 11th Annual General Shareholders Meeting (AGM). At the meeting, CEO John Rim outlined the company's plans to grow across three core pillars: increasing manufacturing capacity, enhancing portfolio diversification, and expanding its global footprint. According to Rim, Samsung Biologics, which played a key role in manufacturing mRNA vaccines to combat the COVID-19 pandemic, will continue to emphasize mRNA vaccine production to meet its portfolio diversification goals.

COVID-19 Catalyzes mRNA Vaccine Production

For decades, research in mRNA vaccines showed promise. These vaccines could potentially be produced quickly and easily edited, but the instability of mRNA molecules made finding an effective delivery system difficult. However, a breakthrough occurred with the discovery of a method of coating the mRNA in vaccines with lipid nanoparticles, and by the late 2010s, mRNA vaccine production seemed like a viable possibility.

But when the COVID-19 pandemic hit in early 2020, researchers working on these mRNA vaccines faced an unprecedented challenge: develop an effective prophylactic mRNA vaccine to boost immunity to COVID-19 that could be produced at a scale large enough to address a global pandemic and be approved for safe use on an accelerated time line.

Fortunately, the biopharma industry was able to meet this challenge, with companies such as Moderna and Pfizer developing mRNA vaccines used to vaccinate millions of people around the world against COVID-19. As a CDMO, Samsung Biologics played an essential role in this process, utilizing its substantial manufacturing capacity to speedily produce Moderna's COVID-19 vaccines at a large scale.

"Samsung Biologics was the first in Korea to perform fill/finish manufacturing of Moderna's COVID-19 mRNA vaccine and obtain approval from the Korean Ministry of Food and Drug Safety (MFDS)," said Rim in his letter to shareholders. "Samsung Biologics will continue to dedicate itself to providing a reliable supply of COVID-19 vaccines and treatments and contribute to the ending of the prolonged COVID-19 global pandemic."

Samsung Biologics' Extended mRNA Capabilities

For its partnership with Moderna, Samsung Biologics focused on the manufacturing side of production, providing fill/finish services at its facilities in Songdo, South Korea. However, as it continues to grow, the company has expanded its mRNA vaccine production services to provide end-to-end production, with drug substance capabilities in addition to its existing drug product capabilities.

This means Samsung Biologics can produce the mRNA needed for vaccines at its own facilities, rather than have the drug substance shipped to its facilities for drug product services such as fill/finishing, labeling, and packaging. Samsung Biologics is now able to handle all aspects of mRNA vaccine production and storage at its own facilities in Songdo.

This is in line with what Rim has said during the AGM, that "Samsung Biologics is adding an mRNA drug substance manufacturing facility, which is expected to be ready for CGMP [Current Good Manufacturing Practice] operations within the first half of this year, offering a true end-to-end manufacturing service for mRNA vaccines and therapeutics."

Applications Beyond COVID-19

The new facility and drug substance capabilities means Samsung Biologics is well positioned to keep pace with innovations in mRNA vaccine production for applications beyond COVID-19.

The pandemic has foregrounded COVID-19 mRNA vaccines, but promising research and development continues on other applications for mRNA technology, including oncology and the treatment of infectious diseases such as influenza, Zika virus, and rabies. A recent report in the journal Nature projected global sales of $800 million for prophylactic mRNA vaccines other than COVID-19 vaccines by 2035, with a total risk-adjusted market size of $7 billion to $10 billion. In addition, the report projected that the risk-adjusted market for mRNA personalized cancer vaccines (PCVs) would total $7 billion to $10 billion by 2035.

While Samsung Biologics has focused on COVID-19 mRNA vaccine production thus far, the extended capabilities will allow the CDMO to work with partners on other therapeutics as mRNA technology continues to advance.

"With this extended capability, we hope to support our partners in bringing novel mRNA vaccines and therapeutics to market at a faster pace," said Rim in a statement announcing Samsung Biologics' plans to expand its mRNA vaccine production capabilities in May 2021.

Building a Diverse Portfolio

mRNA vaccine production is one element in Samsung Biologics' broader portfolio expansion strategy. While mRNA drug substance capabilities will open the company to novel drug development in the mRNA space, it's taking a well-rounded approach to expanding its portfolio in other areas as well.

Samsung Biologics recently acquired full ownership of Samsung Bioepis, a joint venture it started with Biogen in 2012. Bioepis focuses on the development of biosimilars, which offer cost-effective alternatives to biologic reference medicines.

Rim addressed other areas of focus for Samsung Biologics in his letter to shareholders.

"As the demand for next-generation medicines such as cell and gene therapy is expected to increase steeply, Samsung Biologics is planning to expand its business portfolio to encompass viral vector and plasmid DNA, in addition to mRNA," said Rim.

While Samsung Biologics is building a diverse portfolio, its recent success in the mRNA space as a manufacturing partner, as well as its plans to offer end-to-end mRNA services at a newly constructed facility, are signs that mRNA vaccine production will remain a key area of focus for the company moving forward.