Drug Substances
Drug Substances are ingredients used in the production of Drug Products. Drug Substances can be generated via synthesis, fermentation, CGMP cell culture, extraction, or a combination of methods. For example, antibodies extracted from cell culture are considered Drug Substances.
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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 at Any Size
- Large Scale
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As the world's leading CDMO by production capacity, we can offer large-scale commercial mammalian cell culture. Our 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 and new manufacturing technology, we offer multiple CGMP cell culture facilities to deliver the production volumes our clients require 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.
CGMP Cell Culture at Multiple Scales and Capacities
Our mammalian manufacturing capabilities can fit various processes and production volumes for maximum flexibility.
- Plant 130,000 L
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- Plant 2154,000 L
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- Plant 3180,000 L
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- Plant 4 240,000 L
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- Plant 5 **180,000 L
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* Plant 3 has Fed-batch with N-1 Perfusion Capability
** To be operational in April 2025
- Learn more about Plant 5
Connect with our manufacturing experts