Drug Substance Manufacturing
Samsung Biologics ensures exceptional product quality and safety with a proven track record of high batch success rates, enabling a seamless scale-up from clinical to commercial manufacturing. Our DS suites feature bioreactors ranging from 1,000 L to 15,000 L, offering both single-use and stainless-steel production options to meet diverse manufacturing needs.
Modalities
Building on our extensive experience manufacturing next-generation biologics, we continue to invest in new modalities and technologies. By aligning closely with your evolving needs, we are committed to delivering the highest-quality products while maximizing client satisfaction.
CGMP Cell Culture Capabilities
Our manufacturing capabilities can fit various processes and production volumes for maximum flexibility. We ensure operational excellence by integrating innovative technologies across flexible production scales. With services such as N-1 perfusion for high concentration and single-use ATF for reduced contamination risk, Samsung Biologics optimizes operations to drive seamless biopharmaceutical production.
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- Commercial
- As the world’s leading CDMO by production capacity, we specialize in large-scale commercial mammalian cell culture. Our state-of-the-art production suites are equipped with a wide range of chromatography columns, UF/DF skids, virus filtration skids, product pool vessels, and Grade A bulk filling capacity, enabling us to meet any complex needs. With diverse bioreactor sizes, Samsung Biologics is well positioned to collaborate with you throughout the product lifecycle, ensuring seamless management of drug supply.
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- Mid to Late-stage Clinical
- With a range of bioreactor sizes, cutting-edge manufacturing technologies, and extensive technical expertise, Samsung Biologics is the ideal partner for your clinical manufacturing needs. We support all pre-BLA activities including process characterization, and our seamless go-to-market and post-launch product lifecycle management services can meet commercial and CMC needs.
Facility
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Plant 130 kL -
Plant 2154 kL*N-1 Perfusion
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Plant 3180 kL*N-1 Perfusion
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Plant 4240 kL*N-1 Perfusion
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Operational in April 2025Plant 5180 kL*N-1 Perfusion
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- kL
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Capacity to be
available with Plant 5
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- %
- Batch success rate
