Boston-based RNA company Greenlight Biosciences is looking to take its COVID-19 vaccine candidate into Phase III trials, and the partnership will accelerate production for trials and – subject to regulatory approval – commercial scales.
The collaboration with Samsung will leverage GreenLight’s existing manufacturing process, with technology transfer from GreenLight to Samsung starting immediately.
Commercial production
Founded in 2008, GreenLight’s mission is to use RNA across human health and agriculture: including mRNA vaccines, therapeutics and a manufacturing platform.
Both companies highlight a commitment to vaccine equity and the need to produce enough mRNA vaccine doses for billions of people a year.
“We are delighted to partner with Samsung to manufacture messenger RNA for our Covid vaccine trial. There is an urgent need to develop vaccines for the whole world,” said GreenLight CEO Andrey Zarur. “Our vaccine trial will open the way to make vaccines that are available to everybody, not just citizens of developed countries.”
John Rim, CEO of Samsung Biologics, said: “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.
“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 (DS) to Aseptic Fill Finish (DP) 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 towards Korea's vaccine hub goal.”
Samsung Biologics plans to add messenger RNA vaccine drug substance (DS) manufacturing capability to the current facility in Songdo, ready for cGMP operations within the earlier part of the year in 2022.