Samsung Biologics, a leading contract development and manufacturing organization (CDMO), has made mRNA vaccine production a key component of its expansion plans. After providing fill/finish services for Moderna’s COVID-19 mRNA vaccine, Samsung Biologics focused on developing end-to-end mRNA vaccine production capabilities, constructing a new mRNA drug substance suite at its headquarters in Songdo, South Korea.
The new mRNA vaccine production suite, which was completed in May 2022, is further evidence of the CDMO’s reputation for efficiency in constructing new facilities. Since its establishment in 2011, Samsung Biologics has grown at a rapid pace, with three plants in operation and a fourth currently under construction and planned to be fully operational ahead of schedule in 2023.
In a recent interview, Samsung Biologics CEO John Rim explained that the company’s ability to construct facilities on accelerated time lines has been crucial in establishing itself as an industry leader.
“Operational excellence has been crucial to our strong performance; we do an outstanding job for our customers and, for example, are able to build facilities faster than any other player in the industry,” said Rim. “We now have three plants of roughly 30,000, 150,000, and 180,000 liters respectively, all of which are running at almost full capacity, and phase one of a fourth 240,000-plus liter plant will come online in October 2022.”
End-to-End mRNA Vaccine Production
Samsung Biologics’ initial involvement in mRNA vaccine production was on the drug product end of the process. In providing aseptic fill/finish services for Moderna, Samsung Biologics utilized its filling, dispensing, and sealing systems — as well its cold-chain storage capabilities — to transfer an mRNA drug substance into vials. It was also responsible for labeling and packaging the vaccines.
In its partnership with Moderna, Samsung Biologics did not manufacture the mRNA drug substance for the vaccines at its facilities. But with the construction of its new facilities, the CDMO is now able to provide drug substance services, making it a true end-to-end mRNA vaccine production provider.
The new facility enables Samsung Biologics to synthesize mRNA using a pDNA linearization process, which involves treating DNA molecules with enzymes and nucleotides so they can be transcribed into mRNA molecules. The transcription process is in vitro, meaning the drug substance is produced without involving living cells. The mRNA is then stabilized using a protective layer of liquid nanoparticles and stored in refrigerated units with temperatures as low as minus 70 degrees Celsius.
This in vitro technique avoids the time-consuming process of growing a virus in mammalian cells or chicken eggs, as traditional vaccines are produced. Because the mRNA drug substance can be easily edited and synthesized quickly, mRNA vaccine production provides unique advantages for targeted therapeutics and treating fast-mutating diseases.
And because Samsung Biologics now provides a one-stop approach to mRNA vaccine production, synthesizing and stabilizing mRNA molecules at a single point, its process reduces the risk of contamination and degradation that can occur when mRNA is handled and transported across several locations.
“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 June 2021 statement announcing the CDMO’s initial plans to construct the new mRNA vaccine production facility.
Less than a year later, the facility is fully operational, and it has already been used to produce COVID-19 vaccines for GreenLight Biosciences.
“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 a press release announcing the completion of the project’s first commercial-scale engineering run.
Samsung Biologics’ Plans for Multidimensional Growth
Samsung Biologics’ expanded mRNA vaccine production capabilities are part of a larger growth strategy organized around three pillars: diversifying the company’s portfolio, expanding manufacturing capacity, and increasing its global reach.
The fast-paced approach to constructing new facilities is central to Samsung Biologics’ multidimensional growth strategy.
“Samsung Biologics finished the construction of three plants in only seven years. I’ve worked in a few global biopharmaceutical firms, but never saw any companies that could do what we can,” said Rim during a press conference at the 2022 Bio International Convention. “It normally takes four years to construct a facility, but we are nearly two times faster than our competitors. We have very many young talented employees and smart people contributing to the growth of Samsung Biologics.”
And in addition to constructing new facilities, Samsung Biologics is investing in building a more diverse portfolio. Its expanded mRNA vaccine production capabilities are a key part of this effort, as is its increased focus on biosimilars. Earlier this year, Samsung Biologics announced that it had acquired full ownership of Samsung Bioepis, a biosimilars company founded as a joint venture between Samsung Biologics and Biogen.
This growth comes as Samsung Group announced that it will invest 450 trillion KRW (about $350 billion) over the course of the next five years in developing its various businesses, with Samsung Biologics expected to be a central focus in the biopharmaceutical sector.
Rim is optimistic about the CDMO’s plans for growth and emphasized the importance of hiring more employees in addition to constructing new facilities.
“Of course, I am very proud of what we have been able to achieve at Samsung Biologics, but I would like to emphasize that all our successes are down to our employees,” he said. “Looking forward, we will continue to increase headcount, including at our U.S. R&D center, expand our footprint in the U.S. and Europe more generally, and develop our portfolio offerings across monoclonal antibodies, mRNA, and cell and gene therapies.”