Unlike mammalian drug substance manufacturing which requires prolonged periods of cell culturing, mRNA drug substance production is a cell-free process that involves linearization of plasmid DNA(pDNA), mixing it with enzymes and nucleotides to allow for its transcription into mRNA, and mRNA capping, etc.
※ Samsung Biologics will add mRNA vaccine DS production capability to its existing facility by the first half of 2022.
mRNA vaccine production begins with in-vitro transcription, where the linearized pDNA is synthesized to form mRNA in a reactor. Then, the mRNA is purified in steps involving chromatography and ultrafiltration(UF)/diafiltration(DF) to prepare for the formulation stage. Finally, the purified mRNA is encapsulated into Lipid Nanoparticles (LNP) through precise pump mixing technology to prevent degradation and to allow for in vivo delivery.
Because a mRNA vaccine is susceptible to degradation upon changing temperatures, it is subject to strict storage conditions. Samsung Biologics is able to meet such challenges though its upright and walk-in storage systems with temperature as low as -70°C as needed
How a mRNA vaccine is made
Enzymes + Buffers + Nucleotides = mRNA
Why Samsung Biologics?
As the global biologics market gets more competitive, clients' needs and market uncertainty is growing more than ever before. Samsung Biologics promises that your invaluable molecule will be delivered to the market safely and quickly. Whether you are looking for standalone services or a seamless, integrated manufacturing service from clinical to commercial, we are focused on providing an unsurpassed level of customer service dedicated to the needs of our individual customers. We believe and are committed to an on-time, in-full delivery of the products we manufacture with our flexible manufacturing solutions and proven expertise.
- Fully Integrated
One Stop Service
- Offering services from clinical to commercial manufacturing with dedicated QC lab and RA support
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of the Art Facility
- Newly built facilities fully compliant with cGMP that guarantee you the best environment for your product
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1K to 15K
- With various different scales, we have a solution for you