GreenLight Biosciences and Samsung Biologics have signed a collaboration agreement for manufacturing messenger ribonucleic acid (mRNA) Covid-19 vaccines. Under the terms of the agreement, Samsung Biologics will be responsible for the production of GreenLight’s mRNA vaccine candidate at a commercial scale. Samsung will use GreenLight’s current production process, with GreenLight’s technology to be transferred to Samsung immediately.
The alliance intends to accelerate the manufacturing of the vaccine candidate required for Phase III clinical trials and commercial sales once regulatory approval is obtained.
The Samsung Group's drug-making unit announced the addition of new production facilities to its plant in Songdo, Incheon, with the goal of obtaining manufacturing approval from the US Food and Drug Administration by the first half of next year.
As part of the agreement, the two companies also agreed to increase their research and manufacturing efforts in order to distribute more COVID-19 vaccines to underdeveloped countries.
GreenLight Biosciences intends to finalize a separate partnership agreement with a local partner in Africa and begin phase 1 clinical trials as early as the first quarter of next year.
It is also in line with appeals made by the Coalition for Epidemic Preparedness Innovations (CEPI) and other organizations to increase vaccine production capacity worldwide for other infectious diseases.
Samsung Biologics CEO John Rim said: “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.
Last month, Samsung Biologics entered an agreement with Enzolytics to develop and produce monoclonal antibody therapies for human immunodeficiency virus (HIV) and SARS-CoV-2.
Source: 1.www.koreaherald.com, 2.www.pharmaceutical-technology.com