The two companies announced a strategic partnership in late 2021, with South Korean CDMO Samsung Biologics taking on manufacturing duties for Boston-based GreenLight Bioscience’s mRNA COVID-19 vaccine. Since then, tech transfer and scale-up from the lab bench to Samsung’s commercial facility has been completed in seven months, ‘demonstrating platform adaptability and scalability’.
GreenLight’s process—from drug substance and lipid nanoparticle formulation to bulk drug product—can be completed in the same facility, an important capability. GreenLight’s mRNA synthesis reaction had a titer of 12g/L at commercial scale and produced 650g of mRNA.
A clinical trial for the mRNA COVID-19 vaccine as a booster is expected to start this year, and the trial has shown the companies can supply the vaccine at commercial scale. A second engineering run will start in August, to implement improvements indicated by the first run and to demonstrate repeatability at scale.
The platform means GreenLight has been able to move from conceptualizing an mRNA vaccine to delivering released clinical trial material in less than two years, say the companies.
“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 John Rim, CEO and President at Samsung Biologics.
Earlier this year, Samsung Biologics completed the expansion of its mRNA drug substance manufacturing suite at its Songdo headquarters, where the company is now fully equipped to provide end-to-end mRNA production for clients.
Founded in 2008, GreenLight aims to ‘solve some of the world’s biggest problems by delivering on the full potential of RNA for human health and agriculture’, with the mRNA vaccine just one of the projects in its pipeline.
“One of the greatest challenges when producing quality pharmaceuticals is advancing from a small lab to large-scale commercial production,” said GreenLight CEO Andrey 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.”