Samsung Biologics said on Tuesday it completed the first engineering run of its one-stop production system for large-scale commercial production of mRNA Covid-19 vaccine raw materials, following the contract manufacturing organization (CMO) for Moderna's mRNA vaccine.
Greenlight Bioscience and Samsung Biologics signed a partnership last year to produce mRNA vaccine candidates and announced that they will contribute to expanding the supply of vaccines in underdeveloped countries such as Africa.
After about seven months of technology transfer and scale-up, the construction of mRNA raw material drug production facilities was completed at the end of May.
The recently completed test production is a process verification stage conducted just before full-scale commercial production, and Samsung Biologics proved it has excellent production capacity at the level of Current Good Manufacturing Practices (cGMP).
In this test production, in vitro transcription (IVT) recorded results of more than 12-gram titer per standard liter, the maximum of the categories presented by its customers. The higher the titer, the higher the number of antibodies that can be harvested in a culture solution.
The second test production is scheduled to take place this month, and will optimize the production process based on the results of the first test production, said the company.
Accordingly, Samsung Biologics is actively seeking additional CMOs for mRNA vaccines with their recent participation in the mRNA-Based Therapeutics Summit held in Boston last month.
"One of the most difficult things in producing high-quality medicines is to develop from a small-scale to a large-scale commercial production," said Greenlight CEO Andrey Zarur. "We thank Samsung for its help and support in enabling large-scale production of mRNA vaccine candidates to meet the demand for Covid-19 vaccines."
Samsung Biologics CEO John Lim said that the company would be able to provide one-stop, end-to-end services, from raw materials to finished drug production in the mRNA field as well as antibody drugs.
Lim added, "We will strive to supply mRNA vaccines and therapeutics to be developed in the future more quickly through expanded services and production capacity."