- Overview
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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 mRNA Service
A Trusted Navigator in Your Novel Path to Success
We offer one-stop mRNA Manufacturing
mRNA and saRNA / DS & DP Manufacturing / Aseptic Fill/Finish / Process Development / Process Characterization
Our experts serving you through a fully-equipped MSAT laboratory, dedicated to mRNA
Our customized quality control of mRNA are conducted in-house, enabling faster release without undue delays
With Samsung Biologics’ mRNA service, let’s forge ahead towards the next breakthrough
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Manufacturing
Process -
mRNA 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.
- Storage
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Because mRNA is susceptible to degradation upon changing temperatures, it is subject to strict storage conditions. Samsung Biologics is able to meet such challenges through its upright and walk-in storage systems with temperatures as low as -70°C as needed.
How mRNA vaccines are made
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DNA
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Enzymes + Buffers + Nucleotides = mRNA
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mRNA+LNP
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Drug product
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.