The biopharmaceutical industry is undergoing an mRNA revolution. Following the success of mRNA COVID-19 vaccines — the first mRNA vaccines approved for human use — biopharmaceutical companies are pushing to develop mRNA vaccines for other applications.
Samsung Biologics, a leading contract development and manufacturing organization (CDMO), has been part of this revolution as a fill-finish manufacturing service provider for Moderna’s COVID-19 mRNA vaccines. The CDMO has also expanded its mRNA vaccine production capabilities, adding mRNA vaccine drug substance manufacturing to its facilities in Songdo, South Korea.
The decision to expand its mRNA capabilities comes as Samsung Biologics is experiencing significant growth, supported in part by record revenues in 2021, when the CDMO recorded a 35% increase in revenue compared to 2020. And in its first-quarter 2022 earnings report, Samsung Biologics announced that it continues to grow at a record pace, with a 96% year-over-year revenue increase.
“Samsung Biologics’ strong start to the 2022 fiscal year was driven by building momentum around our long-term growth strategy and expanding capacity,” said Samsung Biologics CEO John Rim in a statement on the earnings report. “Our first-quarter financial performance demonstrates a significant and sustained level of customer demand in our services and capabilities.”
The addition of expanded mRNA vaccine production capabilities is a key part of the long-term growth strategy outlined by Rim. As the mRNA revolution in biopharma continues, Samsung Biologics is focused on meeting increasing demand for mRNA-based therapeutics.
Samsung Biologics’ mRNA Vaccine Production Capabilities
In 2021, Samsung Biologics provided CMO services for Moderna’s COVID-19 mRNA vaccine.
“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),” explained Rim in a March 2022 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.”
As a provider of aseptic fill/finish services, Samsung Biologics performed the crucial final step in mRNA vaccine production, transferring the sterile mRNA drug substance to a sterile vial to ensure there is no contamination across batches of vaccines.
This process involves utilizing precise filling, dispensing, and sealing systems, as well as maintaining meticulous clean room environments, temperature monitoring, and storage conditions.
In addition to fill/finish services, Samsung Biologics provided labeling and packaging for Moderna’s vaccines at its Songdo facilities.
While maintaining these drug product capabilities, Samsung Biologics recently has added drug substance manufacturing. This means that Samsung Biologics can now produce the drug substance itself, rather than have that substance shipped to its facilities.
The result is a fully integrated, end-to-end mRNA vaccine production process, offering clients a one-stop shop solution for mRNA needs that can reduce the amount of time required to produce a vaccine.
Why Expand mRNA Vaccine Production Capabilities?
Samsung Biologics’ decision to expand its mRNA vaccine production capabilities comes as the technology is in a crucial stage of development. After decades of research, the COVID-19 vaccines produced by Moderna and other biopharma companies were a breakthrough in mRNA research. As the first mRNA vaccines approved for human use, these vaccines represented the potential of the technology.
This potential stems from the ability to edit and test mRNA vaccine candidates using computer models, allowing researchers to quickly test several potential solutions and determine the effective arrangement of the needed mRNA molecule. This fast-moving approach stands in contrast to the traditional approach to producing vaccines, which involves growing candidate forms of a virus in mammalian cells or chicken eggs, a process that can take months as the virus is collected, adapted to a lab, and shipped to different locations.
“The capability for mRNA to be easily edited not only makes it the ideal tool to combat viruses that can quickly mutate, but also gives it the potential to be used in the treatment of countless other diseases,” explained James Choi, executive vice president and chief information and marketing officer at Samsung Biologics, in a recent interview with the European Pharmaceutical Review.
There has been, and will continue to be, an urgent need to quickly develop vaccines for a disease as deadly and capable of mutating as COVID-19. The mRNA vaccine production process was ideally suited to meeting this challenge. However, researchers are investigating the potential of this process beyond COVID-19 applications.
For example, researchers are working on mRNA vaccines for infectious diseases such as influenza, Zika virus, and rabies. And mRNA’s easy editability could make it an effective means of targeting specific cells in the treatment of cancer.
Samsung Biologics and the Future of mRNA Vaccines
The demand for mRNA vaccine production brought on by the COVID-19 pandemic has been unprecedented. With increasing innovation in the mRNA space, the number of effective applications for mRNA vaccines is likely to increase in future years, benefiting patients with a variety of conditions.
Samsung Biologics’ expansion of its mRNA vaccine production capabilities signals that it will continue to be involved in the future of mRNA as this technology develops.