In October, contract development and manufacturing organization (CDMO) Samsung Biologics began partial operations at its fourth plant in Songdo, South Korea. The partial completion of the plant was achieved in just 23 months and was the cornerstone of a year full of expansion for the CDMO. In addition to constructing the new facility, Samsung Biologics expanded its mRNA vaccine production capabilities, adding an end-to-end suite capable of drug substance and drug product services.
For Samsung Biologics, mRNA vaccine production is a key component of one of the three pillars of its growth strategy: portfolio diversification. While constructing facilities like Plant 4 adds to the CDMO’s industry-leading biomanufacturing capacity and its expertise in large-scale monoclonal antibody production, the company is also taking steps to branch out into growing areas of innovation in the biopharmaceuticals space, including mRNA and biosimilars.
“Samsung Biologics will leap forward as a global biopharmaceutical company with three business areas: CDMO, biosimilars, and new drugs,” said Samsung Biologics president and CEO John Rim in his 2022 letter to shareholders.
Opportunities for mRNA Innovation
Researchers have been intrigued by the potential of mRNA vaccines for decades, but it took the onset of the global COVID-19 pandemic to accelerate mRNA research and produce the first vaccines approved for human use.
Unlike traditional vaccines, which require growing small amounts of a virus in live cells, mRNA vaccine production is an in vitro (cell-free) process in which mRNA is synthesized and edited to cause the body to create targeted disease-fighting proteins. The upside of this technology is that it avoids the time-consuming process of growing a virus, and mRNA can be easily edited, with the necessary information quickly shared electronically among researchers. This enables vaccine developers to test and adapt vaccines as needed without relying on the potentially costly and time-consuming process of growing new viruses. Once the proper formulation is discovered, production can be quickly scaled up.
It’s not hard to see why this approach was ideally suited to combat a fast-mutating worldwide virus like COVID-19.
For Samsung Biologics, the onset of mRNA vaccine production during the pandemic was an opportunity to utilize its expertise in large-scale manufacturing to help produce life-saving vaccines.
“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). 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,” said Rim in his 2022 letter to shareholders.
This continued effort involves Samsung Biologics’ partnership with GreenLight Biosciences. The CDMO has partnered with the Boston-based biopharmaceutical company to produce a commercial-scale run of GreenLight’s mRNA COVID-19 vaccine.
The project marks Samsung Biologics’ first use of its expanded mRNA vaccine production capabilities, and for Rim, the speed at which the project moved from lab bench to commercial scale manufacturing — just seven months — is indicative of the potential of this kind of end-to-end approach.
“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 statement on the completion of the project’s first production run.
For Andrey Zarur, CEO of GreenLight Biosciences, the project demonstrated the benefits of collaboration with a CDMO that can scale up the manufacture of biologics developed by smaller companies.
“One of the greatest challenges when producing quality pharmaceuticals is advancing from a small lab to large-scale commercial production,” said Zarur. “We are grateful for the help and support of Samsung in demonstrating that our small mRNA process can scale in a linear fashion to the industrial scale that will be needed to help satisfy the vaccine needs of humanity.”
While the Moderna and GreenLight partnerships have focused on COVID-19 applications of mRNA vaccine production, scientists at Samsung Biologics are optimistic about the future of mRNA research and development, noting that mRNA could be used in vaccines and therapeutics to treat conditions ranging from cancer to HIV.
“From what I have observed and what we can see in the market, the global mRNA vaccines and therapeutics market is forecasted to grow steadily in the next few years,” said Huisub Lim, lead scientist of mRNA manufacturing at Samsung Biologics, in a recent Q&A on mRNA market trends. “This is largely because mRNA can create therapeutics based on a novel mechanism of action for applications that cannot be targeted by existing antibody platforms (e.g., gene editing, targeting of intracellular protein or pathogens, etc.). MRNA technology also is conducive to highly specific molecular designs and functionalities, giving it the potential to achieve greater efficacy than traditional drugs by addressing the underlying causes of disease.”
New Facilities, New Capabilities
Samsung Biologics’ commencement of Plant 4 partial operation and its expanded mRNA vaccine production suite in 2022 is in line with the CDMO’s ambitious growth strategy, which Rim sees as a key to the company’s success and connected to its role as part of Samsung Group.
“There’s no company in the world that can build facilities faster than Samsung and that really comes down to the Samsung DNA,” said Rim in a recent interview. “Having that track record, having that experience, enables us to do simultaneous construction. In record time [we do] engineering, procurement, construction, validation … facility ramp-up to [good manufacturing practice], probably 40% faster than all our competition. So that’s been spectacular. We are now on Plant 4 within 10 years, and I would say there’s no one in the world who’s done that, and no one who has the biologic capability of building those facilities that quickly.”
While new plants at Bio Campus 2 have yet to begin construction, the CDMO is clearly continuing to target growth with its plans for its new campus. As mRNA technology gains traction in the biologics space, Samsung Biologics has positioned itself to pursue a leading role as a developer and manufacturer of this technology through its facilities and capabilities.
