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Reliable and
Flexible Partner -
Samsung Biologics offers advanced CGMP facilities providing safe and reliable clinical and commercial biologics. All processes are CGMP-compliant and meet the standards defined by regulatory authorities. Our dedication to quality and optimized services are visible in everything we do from clinical to commercial production.
Mammalian Cell Culture
- Large Scale
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As the world’s largest CDMO by production capacity, we can offer the large-scale commercial manufacturing of drug substance in multiple scales and capacity. The downstream suites are equipped with chromatography skids, columns, UF/DF skids, virus filtration skids, and Grade A bulk filling capacity, as well as product pool vessel capacities from 200 liters to 15,000 liters to handle a wide range of pool volumes.
- Small Scale
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Equipped with a wide range of bioreactor sizes as well as new manufacturing technology, we offer multiple CGMP manufacturing facilities to deliver the production volumes required by our clients at any given time. Our small-scale manufacturing facility has the same best-in-class characteristics and equipment as our large-scale plants, featuring stainless steel and single-use bioreactors at 1,000 liter scale, and one purification suite with pre- and post-viral segregation.
Multiples Scales, Multiple Capacities,
to fit various processes for any production volume
- sCMO4,000L
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- Plant 130,000L
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- Plant 2150,000L
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- Plant 3180,000L
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- 1 * Plant 3 has Fed-batch with N-1 Perfusion Capability
mRNA Vaccines
- 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 will add mRNA vaccine DS production capability to its existing facility by the first half of 2022.
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Manufacturing
Process -
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.
- Storage
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Because mRNA vaccines are 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 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.