Samsung Biologics, a leading contract development and manufacturing organization (CDMO), announced it’s completed the construction of an mRNA drug substance production suite at its plant in Songdo, South Korea. The CDMO had already established drug product capabilities for mRNA vaccine production, providing fill/finish manufacturing, labeling, and packaging for Moderna’s COVID-19 mRNA vaccines. The addition of drug substance capabilities means that Samsung Biologics can now produce the active ingredient for mRNA vaccines at its facilities, making it a one-stop shop for mRNA vaccine production.
Samsung Biologics’ announcement comes as the biopharmaceutical industry is actively exploring the potential of mRNA. Moderna and Pfizer’s COVID-19 vaccines were the first mRNA vaccines approved for human use, and they were a significant breakthrough for the technology, which has been in development for decades. The success of these vaccines has exhibited the potential of mRNA technology and newly developed mass production methods for lipid nanoparticle (LNP) encapsulation technologies, which can effectively stabilize mRNA.
Samsung Biologics’ end-to-end capabilities position the CDMO to continue to play a role in mRNA vaccine production as these technologies evolve.
Samsung Biologics’ Partnership With GreenLight Biosciences
The first mRNA vaccine produced at Samsung Biologics’ new facility is Massachusetts-based GreenLight Biosciences’ COVID-19 vaccine candidate. Samsung Biologics is manufacturing the vaccines at commercial scale.
When the partnership was initially announced in late 2021, both companies emphasized their hopes that the vaccines would contribute to vaccine equity as the world continues to battle COVID-19.
“We are delighted to partner with Samsung to manufacture mRNA for our COVID vaccine trial. There is an urgent need to develop vaccines for the whole world,” GreenLight CEO Andrey Zarur said in a statement announcing the partnership. “Our vaccine trial will open the way to make vaccines that are available to everybody, not just citizens of developed countries.”
“We are delighted to partner with GreenLight to leverage our expertise in manufacturing an mRNA COVID-19 vaccine candidate to better serve patients in lower income countries,” added Samsung Biologics CEO John Rim. “This collaboration demonstrates a major milestone for Samsung Biologics as we will commence our expanded capabilities and operations to provide one-stop end-to-end mRNA production from drug substance to aseptic fill/finish to commercial release, all from a single site. At this time of urgent global demand, we will strive for seamless service across our biomanufacturing network to fight the COVID pandemic and in turn, help make progress toward Korea’s vaccine hub goal.”
The Future of mRNA Vaccine Production
While Samsung Biologics and other biopharma companies remain committed to manufacturing mRNA vaccines for COVID-19, researchers are investigating other innovative applications for mRNA, with possible mRNA treatments for diseases ranging from influenza to cancer.
For example, researchers are investigating different structures of mRNA. One potential avenue is therapeutics that utilize circular RNAs (circRNAs), which play a role in diseases such as cancer, cardiovascular disease, and neurological disease.
A recent Nature report examined the evolution of mRNA vaccine production for non-COVID applications and noted a wide variety of potential applications, including preventive, or prophylactic, vaccines and therapeutic vaccines used to treat existing conditions. According to the report, the total risk-adjusted market size for non-COVID prophylactic mRNA vaccines is expected to reach $7 billion to $10 billion by 2035. The report also found that the market for personalized cancer vaccines (PCVs) could reach $7 billion to $10 billion by 2035.
Much of the industry excitement around the potential for mRNA vaccine production comes from mRNA’s capacity to be quickly and easily edited and synthesized, making it an efficient alternative to traditional vaccine production, which requires a time-consuming process of growing a virus in mammalian cells or chicken eggs.
“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.
Advancements in technology that enable easy editing of mRNA have coincided with advancements in the development of LNPs used to coat mRNA molecules and ensure stability. COVID-19 mRNA vaccines marked the first mass production of these LNPs, which could potentially be used for mRNA vaccines developed for non-COVID applications.
Samsung Biologics’ Growth Strategy
Samsung Biologics’ expansion of its mRNA vaccine production capabilities is a key component of its broader growth strategy, which encompasses three pillars.
“Samsung Biologics aims to maximize its financial performance and lay a strong foundation to deliver sustainable future growth based on three core pillars: increasing manufacturing capacity (capacity), enhancing portfolio diversification (portfolio), and expanding its global footprint (geography),” said Rim in a March 2022 letter to shareholders.
With its expanded mRNA vaccine production facilities, Samsung Biologics is diversifying its portfolio. While the CDMO has established industry-leading capacity for the production of monoclonal antibodies (mAbs), its investment in mRNA is a step toward its goal of building a wide-ranging biopharmaceuticals company with an impact in a number of areas.
Samsung Biologics’ growth has been fueled by increasing revenues in recent years amid rising demand for CDMO services. The company reported a 35% revenue increase in 2021 and 96% year-over-year growth in the first quarter of 2022.
As Samsung Biologics continues to grow, its expanded mRNA vaccine production capabilities signal that it’s prepared to continue to play a role in the production of innovative mRNA technologies.