mRNA vaccine production played a key role in the success of Samsung Biologics in 2021. The company, a leading contract development and manufacturing organization (CDMO), held its 11th Annual General Shareholders Meeting on March 28, 2022, and CEO John Rim discussed Samsung Biologics’ involvement with mRNA technology in his letter to shareholders. In the letter, Rim noted Samsung Biologics’ role as a manufacturer of COVID-19 mRNA vaccines in 2021 and outlined the company’s plans to expand its mRNA capabilities in 2022.  

A Successful Manufacturing Partnership

Samsung Biologics’ involvement in mRNA vaccine production in 2021 centered on its successful partnership with Moderna to manufacture Moderna’s COVID-19 vaccine. Samsung Biologics provided fill/finish services for the vaccines at its facilities in Songdo, South Korea.

Rim noted that the CDMO was the first in Korea to perform fill/finish manufacturing of Moderna’s COVID-19 mRNA vaccine and the first to receive approval from the Korean Ministry of Food and Drug Safety for mRNA vaccine production.

“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.

While the COVID-19 pandemic caused many industries to lose business and revenue, Samsung Biologics recorded a 35% increase in revenue in 2021. Its involvement in mRNA vaccine production was a key to this success, as the company utilized its substantial manufacturing capacity to help meet the unprecedented demand created by a worldwide pandemic.

“As soon as the COVID-19 pandemic occurred, we really focused around making sure that our supply chain and raw materials were robust,” said Samsung Biologics CEO John Rim in a recent interview. “We’ve also operated our plants 365 days, 24/7, because we have strict protocols and business continuity management systems that enable us to manage through the COVID pandemic without a hitch.”

Expanding mRNA Vaccine Production

While Samsung Biologics’ role in mRNA vaccine production remained on the manufacturing side in 2021, the CDMO plans to offer an extended, end-to-end manufacturing services for mRNA vaccines in 2022, providing drug substance services in addition to its drug product services. Drug substance services involve the production of the mRNA needed for a vaccine, whereas drug product services involve preparing the mRNA for delivery in the form of a vaccine.

Unlike Samsung Biologics’ mammalian drug substance manufacturing services, which uses cultured mammalian cells, mRNA drug substance manufacturing is a cell-free process. It involves the linearization of plasmid DNA (pDNA), combining the DNA with enzymes and nucleotides to allow for transcription into mRNA. The mRNA is then capped with liquid nanoparticles (LNPs) to enable delivery in a vaccine form. In addition, because mRNA is a fragile molecule and requires cold storage, Samsung Biologics stores mRNA in upright and walk-in storage systems with temperatures as low as minus 70 C.

The expansion in capabilities means that Samsung Biologics can provide all aspects of mRNA vaccine production, including drug substance production, fill/finishing, labeling and packaging, and cold storage, at its Songdo facilities. The company’s new mRNA drug substance manufacturing facility is expected to be ready for full operation in the first half of 2022.

In November 2021, Samsung Biologics announced a partnership with GreenLight Biosciences, a Medford, Massachusetts-based mRNA biotechnology company, to produce GreenLight’s mRNA vaccine candidate at commercial scale. In the letter to shareholders, Rim noted that the GreenLight vaccine candidate will be manufactured at Samsung Biologics’ new mRNA facility in 2022.

“We are delighted to partner with GreenLight to leverage our expertise in manufacturing a messenger RNA COVID-19 vaccine candidate to better serve patients in lower-income countries,” said Rim in the press release announcing the partnership. “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 messenger RNA 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 partnership with GreenLight signals that Samsung Biologics will continue to focus on mRNA vaccine production for COVID-19 applications, but its expanded capabilities mean that it’s well positioned in the mRNA space as the technology continues to develop in other promising areas.

A recent report in Nature on the industry outlook for mRNA vaccine production concluded that “With significant advances in mRNA biology, delivery, and manufacturing, the biotechnology and vaccine industries are poised for further investment in the development of novel products.”

Potential novel applications for mRNA vaccines include cancer treatments and the prevention of infectious diseases such as influenza, rabies, and Zika virus. As research and development continues in these areas, Samsung Biologics’ expanded mRNA capabilities and manufacturing capacity situate it as a potential leader in developing and manufacturing mRNA technology.

mRNA and Samsung Biologics’ Three Core Pillars

In his letter to shareholders, Rim noted that “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, enhancing portfolio diversification, and expanding its global footprint.”

mRNA vaccine production has played, and will continue to play, an important role in achieving these goals, as Samsung Biologics continues to offer industry-leading manufacturing capacity for vaccines and has now enhanced its portfolio with the ability to produce mRNA vaccine drug substances.

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