End-to-End Drug Substance Manufacturing
Samsung Biologics delivers advanced drug substance manufacturing services with a proven track record and high batch success rates. Our scalable biologics CDMO operations ensure seamless clinical-to-commercial manufacturing while adhering to strict CGMP manufacturing standards. Our bioreactor capacity ranges from 1,000 L to 15,000 L, including both single-use bioreactor manufacturing and stainless steel options, enabling flexible large-scale biologics manufacturing tailored to diverse process requirements. Learn more about our expertise in Biopharma Manufacturing.
Modalities
With extensive experience in next-generation biologics, Samsung Biologics continuously invests in novel modalities and cutting-edge technologies. Our services encompass monoclonal antibody manufacturing, recombinant protein manufacturing, mRNA manufacturing, and ADC manufacturing, ensuring alignment with evolving client needs and regulatory compliance. Our commitment to Quality Assurance and Quality Control maximizes product integrity and client satisfaction.
CGMP Cell Culture Capabilities
Our CGMP manufacturing environment supports diverse cell culture processes and volumes for maximum flexibility. We implement innovative bioprocess technologies such as N-1 perfusion for high cell density and single-use ATF to reduce contamination risk. As a leading mammalian cell culture CDMO, Samsung Biologics optimizes operations for seamless biopharmaceutical production. Our commercial manufacturing suites feature advanced equipment for virus filtration, chromatography, and Grade A bulk filling capacity to meet complex production needs. Partner with us for full lifecycle support including Drug Substance Manufacturing and Process Development.
-
Commercial
- As one of the top biologics CDMO by production capacity, Samsung Biologics specializes in large-scale biologics manufacturing with a focus on commercial mammalian cell culture services. Our advanced production suites are equipped with chrmoatography columns, UF/DF skids, virus filtration skids, product pool vessels, and Grade A bulk filling capability to address complex process demands. With flexible bioreactor sizes, Samsung Biologics collaborates with clients throughout the entire product lifecycle, ensuring efficient and reliable drug substance manufacturing and drug product manufacturing for seamless drug supply management. Discover our Biopharma Manufacturing capabilities.
-
Mid to Late-stage Clinical
- Samsung Biologics offers comprehensive CGMP manufacturing services tailored to mid- to late-stage clinical development. Our versatile bioreactor capacities, state-of-the-art technologies, and deep technical expertise make us a reliable partner for clinical manufacturing and process characterization. We support all pre-BLA activities and provide integrated post-launch lifecycle management, efficiently addressing commercial and CMC requirements. Learn about our Process Development and Analytical Development services designed to accelerate your biologics development timeline.
Facility
Samsung Biologics operates multiple state-of-the-art plants equipped with scalable bioreactors from 1,000 L to 15,000 L, both single-use and stainless steel, to support mid- to late-stage clinical and commercial biologics manufacturing. Our production capacity and technical expertise make us a trusted biologics CDMO partner for clients worldwide.
-
Plant 130 kL -
Plant 2154 kL*N-1 Perfusion
-
Plant 3180 kL*N-1 Perfusion
-
Plant 4240 kL*N-1 Perfusion
-
Plant 5180 kL*N-1 Perfusion
-
- kL
- Total Capacity
-
- %
- Batch success rate
Related Content