Samsung Biologics
Samsung Biologics is a leading biopharmaceutical company committed to advancing biologics development and manufacturing. They focus on providing end-to-end development services, manufacturing advanced CGMP facilities, and ensuring high-quality processes. Their mission is to support clients with innovative solutions, scalable capacity, and operational excellence, emphasizing sustainability and continuous innovation in biomanufacturing.
Industries
Nr. of Employees
Very Large (1000+)
Samsung Biologics
Products
Manufacturing Services
Provides CGMP-compliant facilities for clinical and commercial biologics manufacturing, including drug substances and drug products.
Development Services
Offers end-to-end process management for biologics development, including discovery, cell line development, process development, and clinical manufacturing.
Quality
Ensures compliance with regulatory standards through quality assurance, quality control, biosafety testing, and analytical testing services.
Antibody-Drug Conjugates
Develops and manufactures antibody-drug conjugates, supported by GMP systems.
Manufacturing Services
Provides CGMP-compliant facilities for clinical and commercial biologics manufacturing, including drug substances and drug products.
Development Services
Offers end-to-end process management for biologics development, including discovery, cell line development, process development, and clinical manufacturing.
Quality
Ensures compliance with regulatory standards through quality assurance, quality control, biosafety testing, and analytical testing services.
Antibody-Drug Conjugates
Develops and manufactures antibody-drug conjugates, supported by GMP systems.
Services
Contract Development Services (CDO)
Integrated development services including cell line development, process and analytical development, formulation development, non‑GMP and cGMP small‑scale manufacturing (including 1 kL) and IND filing support.
Drug Substance manufacturing (small to large scale)
Clinical and commercial drug substance manufacturing services across multiple scales (small‑scale ≤2 kL; mid‑scale 5–15 kL; large‑scale facilities) with cGMP compliance.
Drug Product / Aseptic fill–finish
Clinical and commercial aseptic filling for liquid and lyophilized products across vials, syringes and cartridges; formulation handling and finished product supply.
ADC development and manufacturing services
Late‑discovery ADC development (conjugation, analysis, formulation) and manufacturing including payload and antibody preparation, conjugation and formulated bulk production.
mRNA drug substance and drug product process development and manufacturing
Process development and manufacturing services for mRNA drug substance and drug product, covering pDNA, in vitro transcription (IVT) and lipid nanoparticle (LNP) formulation.
Analytical testing and quality services
Contract analytical and QC testing including sterility, endotoxin, bioburden, microbial challenge, mycoplasma testing, in‑vitro virus testing and qPCR assays to support release and stability testing and regulatory submissions.
Contract Development Services (CDO)
Integrated development services including cell line development, process and analytical development, formulation development, non‑GMP and cGMP small‑scale manufacturing (including 1 kL) and IND filing support.
Drug Substance manufacturing (small to large scale)
Clinical and commercial drug substance manufacturing services across multiple scales (small‑scale ≤2 kL; mid‑scale 5–15 kL; large‑scale facilities) with cGMP compliance.
Drug Product / Aseptic fill–finish
Clinical and commercial aseptic filling for liquid and lyophilized products across vials, syringes and cartridges; formulation handling and finished product supply.
ADC development and manufacturing services
Late‑discovery ADC development (conjugation, analysis, formulation) and manufacturing including payload and antibody preparation, conjugation and formulated bulk production.
mRNA drug substance and drug product process development and manufacturing
Process development and manufacturing services for mRNA drug substance and drug product, covering pDNA, in vitro transcription (IVT) and lipid nanoparticle (LNP) formulation.
Analytical testing and quality services
Contract analytical and QC testing including sterility, endotoxin, bioburden, microbial challenge, mycoplasma testing, in‑vitro virus testing and qPCR assays to support release and stability testing and regulatory submissions.
Expertise Areas
- Biologics contract development and manufacturing (CDMO/CDO)
- Cell line development and cell banking
- Upstream and downstream process development and scale‑up
- Analytical method development and contract QC testing
Key Technologies
- Cell line development platforms
- Upstream bioprocessing (bioreactors, perfusion)
- Downstream purification and chromatography
- Aseptic fill‑finish and lyophilization systems