Non-GMP Manufacturing for Preclinical Success
Our Non-GMP manufacturing biologics services include generating toxicology study materials and evaluating processes for GMP scale-up manufacturing. To minimize risk and accelerate timelines, we also provide toxicology material generation through pool-based methods.
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Drug Substance Manufacturing
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- 50 L and 200 L single-use bioreactor manufacturing
- AKTA process and UF/DF equipment for confirming downstream robustness and scalability
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Drug Product Manufacturing
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- Aseptic vial filling services for preclinical studies (2R-50R)
- Flip-cap crimping for secure, reliable supply
These offerings integrate seamlessly with Analytical Development and Biopharma Quality services to ensure readiness for GMP manufacturing.
CGMP Clinical Manufacturing Services
Our CGMP clinical manufacturing facilities provide the same best-in-class equipment and processes as large-scale production, ensuring efficient GMP scale-up manufacturing as your therapeutic advances towards regulatory approval.
From seed bioreactor process development to clinical biologics manufacturing facility scale-up, our team delivers high-quality drug substance and drug product materials. These services complement our expertise in Biopharma Development, Cell Line Development, and ADC (Antibody-Drug Conjugates).
From seed bioreactor process development to clinical biologics manufacturing facility scale-up, our team delivers high-quality drug substance and drug product materials. These services complement our expertise in Biopharma Development, Cell Line Development, and ADC (Antibody-Drug Conjugates).
Drug Substance
- sP1
- FlaskCulture
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- 20 L (N-3) (nominal volume) Wave bioreactor
- 40 L (N-2) (w.v) Seed bioreactor
- 200 L (N-1) (w.v) Seed bioreactor
- 1000 L (N) (w.v) Production bioreactor
- sP2
- FlaskCulture
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- 20 L (N-3) (nominal volume) Wave bioreactor
- 50 L (N-2) (w.v) Seed bioreactor
- 200 L (N-1) (w.v) Seed bioreactor
- 1000 L (N) (w.v) Production bioreactor
- sP1
- FlaskCulture
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- 20 L (N-3) (nominal volume) Wave bioreactor
- 40 L (N-2) (w.v) Seed bioreactor
- 200 L (N-1) (w.v) Seed bioreactor
- 1000 L (N) (w.v) Production bioreactor
- sP2
- FlaskCulture
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- 20 L (N-3) (nominal volume) Wave bioreactor
- 40 L (N-2) (w.v) Seed bioreactor
- 200 L (N-1) (w.v) Seed bioreactor
- 1000 L (N) (w.v) Production bioreactor
Drug Product
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- • Filling rate: up to 600 vials/hr for DP#3 (up to 12,000 vials/hr for DP#1, up to 18,000 vials/hr for DP#2)
- • Filling range: 0.2 ml - 100 ml for DP#3 (0.1 ml - 100 ml for DP#1&2)
Related Content
Flexible Clinical Trial Manufacturing Services
Our Non-GMP and CGMP manufacturing services provide flexibility to support development strategies across a wide range of batch sizes. Leveraging operational excellence and integrated analytical testing, we ensure a seamless transition beyond your IND manufacturing support, enabling an efficient path through clinical trials. Whether producing small pilot batch biologics or preparing for large-scale biopharma manufacturing, Samsung Biologics’ expert team provides end-to-end support to help you navigate complex regulatory and clinical requirements. Learn more about our capabilities in Process Development, Drug Substance Manufacturing, and Drug Product Manufacturing.