Samsung Biologics, one of the world’s largest contract development and manufacturing organizations (CDMOs), is known for its expertise in partnering with pharmaceutical companies to produce monoclonal antibodies. But the company is pursuing a multidimensional growth plan, and a key pillar of this strategy, according to CEO John Rim, is portfolio diversification. During the pandemic, Samsung Biologics partnered with Moderna to provide fill/finish services for a COVID-19 mRNA vaccine. Since then, the CDMO has invested further in its mRNA vaccine production capabilities, which it expects to be an important growth driver in the coming years.
The 2021 COVID-19 vaccines were the first mRNA vaccines approved for human use, but several other applications of mRNA therapeutics and vaccines are currently in development, including treatments for cancer, autoimmune diseases, and respiratory conditions. With these innovations in mind, Samsung Biologics is continuing to invest in mRNA vaccine production.
“The mRNA story has just begun. To cope with the rising demand for vaccines worldwide, the company proactively ventured to invest in expanding its mRNA vaccine production facility,” said Samsung Biologics’ Esther Yoo in a recent white paper. “Samsung Biologics has built a cross-functional team dedicated to support mRNA services, including project management, manufacturing, quality, manufacturing science and technology (MSAT), and other activities, comprising experts from leading global companies in the mRNA field.”
The mRNA Story
For decades, scientists have understood the unique benefits of mRNA vaccines and therapeutics. Because mRNA vaccine production is an in vitro process that involves sequencing DNA rather than growing a virus in cells, the process is easily scalable on efficient time lines. It’s also agile, as mRNA sequences can be edited and tested digitally, then quickly implemented to adjust to fast-changing viruses such as COVID-19. This editability can also be harnessed to produce personalized cancer vaccines.
However, it wasn’t until recently that researchers realized the benefits of mRNA vaccine production. The breakthrough was in large part due to the discovery that coating mRNA in lipid nanoparticles could prevent the degradation of fragile mRNA molecules.
Once the pandemic hit, the research community and regulators came together to push mRNA vaccine technology forward at an unprecedented rate, and mRNA vaccine production has now become a reality. The benefits continue to motivate research into novel applications, and the development and manufacturing technology continues to improve.
Yet, as Yoo notes, the technology is still in its early stages, and there are few companies with the experience to handle end-to-end mRNA vaccine production needs.
“With newer technologies like mRNA, there is no standardization across different CDMOs at this time, with each developing their own solutions, and nothing has yet been truly optimized,” she said. “Developers of mRNA products, therefore, want to work with CDMOs that are true partners who are willing to take the time to understand each project and work together collaboratively to optimize and refine the development and manufacturing process.”
End-to-End mRNA Vaccine Production Solutions
Samsung Biologics built its mRNA vaccine production capabilities on a foundation of experience in end-to-end development and manufacturing. The CDMO emphasizes the value of a one-stop-shop approach, both because of its faster time frames and because of the flexibility to handle the unique needs of each project.
“For COVID-19 mRNA vaccines in the market, production of mRNA drug substance, encapsulated (LNP) final product, and fill/finish activities have often been conducted at different sites, increasing the risk of contamination, time, and cost,” explained Yoo. “Samsung Biologics’ mRNA facility provides end-to-end solutions from pDNA linearization to fill/finish, all under one roof. The facility allows production from lab to commercial scale; from 5 to 200 liters.”
Samsung Biologics demonstrated these capabilities in July 2022 when it completed a commercial-scale run of mRNA vaccine production for GreenLight Biosciences’ COVID-19 vaccine candidate. The run produced 650 grams of mRNA at a titer of 12 grams per liter and was completed only seven months after the initial technology transfer.
“This demonstrates a major achievement in our continuing goal to offer one-stop, end-to-end mRNA production from drug substance to aseptic fill/finish to commercial release, all from a single site, as we strive across our biomanufacturing network to fight the pandemic,” said Rim in an announcement of the production run’s completion.
While Samsung Biologics and the broader biopharmaceutical industry continue to focus on combating the ongoing COVID-19 pandemic, the pandemic response has opened the door to new applications for mRNA.
As stated in Yoo’s white paper, according to the U.S. National Library of Medicine database, there are over 1,800 ongoing clinical studies involving mRNA. A majority of these studies involve utilizing mRNA to target tumors, while other candidates offer treatments for diseases such as Lyme disease, colorectal cancer, HIV, influenza, and Zika virus. Other studies are looking into mRNA as a potential delivery system for gene therapies.
With its continued investment in end-to-end mRNA vaccine production, Samsung Biologics will look to partner with cutting-edge developers in this fast-evolving space.