Samsung Biologics
End-to-end biologics development and manufacturing at scale
Listed on cdmo.directory
Leading CDMO offering end-to-end biologics development and manufacturing from cell line development through aseptic fill-finish, with capabilities in drug substance, drug product, ADC, and mRNA services.
Modalities
Development & manufacturing
Structured CDMO capabilities from verified public sources.
Development (D)
Manufacturing (M)
Biologics / bioreactor infrastructure
- Bioreactor type
- Single-Use / DisposableStainless Steel
- Max bioreactor scale
- Large commercial (≤10,000 L)
Fill-finish formats
Regulatory clearances
Services
- Cell-Line Development
- Process Development
- CMC Analytical Development
- Technology Transfer
- CMC Regulatory Submission Support
- Recombinant Protein Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- ADC (Antibody-Drug Conjugate) Manufacturing
- mRNA Manufacturing
- Sterile Fill-Finish & Aseptic Manufacturing
- Quality Control Testing
- Biologics Development & Manufacturing
- Upstream Processing
- Downstream Processing
- Vial Filling
- Stability Testing & Storage
- Formulation Development
- Vaccine Manufacturing
- ADC Payload & Linker Synthesis
- Lipid Nanoparticle (LNP) Formulation
- Prefilled Syringe (PFS) Filling
- Cartridge Filling
- Lyophilization (Freeze Drying)
Indications
About this organization
Overview
Samsung Biologics is a leading contract development and manufacturing organization (CDMO) delivering high-quality end-to-end biologics with precision and at scale. The company offers seamless development and manufacturing services driven by continuous innovation and operational excellence.
Service Offerings
Research & Development
- Cell line development
- Process development and analytical development
- Formulation development
- CMC services and phase-appropriate technology platforms
- Organoid services
Manufacturing
- Drug Substance: Large-scale (5–15 kL) and small-scale (≤2 kL) clinical and commercial manufacturing
- Drug Product: Aseptic filling in liquid and lyophilized formats for vials, syringes, and cartridges
- Advanced Modalities: ADC development and manufacturing (payload & mAb preparation, conjugation, formulated bulk); mRNA DS and DP manufacturing (pDNA, IVT, LNP process development and manufacturing)
Quality Services
- Mycoplasma testing
- In vitro virus testing
- MVM qPCR testing
- Microbiology testing (microbial challenge, antimicrobial effectiveness, endotoxin, sterility, bioburden)
- Contract QC testing for batch release
Capabilities
The organization provides fully integrated, world-class CGMP facilities with seamless scale-up and commercial success focus. Services span from early development de-risking through clinical and commercial manufacturing with reliable global supply chains.
Locations
Bio Campus I
South Korea
Bio Campus II
South Korea
Headquarters / Bio Campus I
Incheon · Yeonsu-gu · Republic of Korea
Bio Campus II
Incheon · Yeonsu-gu · Republic of Korea
ADC Plant
Incheon · Yeonsu-gu · Republic of Korea
Samsung Biologics America
United States
Samsung Biologics Japan Office
Japan
Headquarters
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