| Listed site | cdmo | cdmo |
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| Summary | End-to-end CDMO specializing in complex modalities including cell, gene, and RNA-based therapies with North American manufacturing facilities and development capabilities. | 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. |
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| Services | - Formulation Development
- CMC Analytical Development
- Technology Transfer
- Process Development
- Sterile Fill-Finish & Aseptic Manufacturing
- Vial Filling
- Prefilled Syringe (PFS) Filling
- Cartridge Filling
- Autologous Cell Therapy Manufacturing
- Allogeneic Cell Therapy Manufacturing
- Cell Therapy Manufacturing
- Recombinant Protein Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- Biologics Development & Manufacturing
- Bioconjugation Services
- Upstream Processing
- Downstream Processing
- Secondary Packaging & Labeling
- Quality Control Testing
- mRNA Manufacturing
- Vaccine Manufacturing
| - 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)
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| Modalities | - Biologics (Monoclonal Antibodies)
- Biologics (Other)
- mRNA
- Cell Therapy
- Gene Therapy
- Vaccine
| - Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Antibody-Drug Conjugate (ADC)
- mRNA
- Vaccine
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| Indications | Data not yet provided. | |
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| Locations | - Headquarters, Blue Ash, OH, USA
- Cincinnati, Cincinnati, OH, USA
- Philadelphia, Philadelphia, PA, USA
- Toronto, Toronto, ON, Canada
- Fremont, Fremont, California, United States
| - 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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| Certifications | - FDA · Identifier: cGMP
- FDA · Identifier: PAI
- FDA · Identifier: PFS & Vial Approval
- Health Canada · Identifier: Health Canada
- EMA · Identifier: Virtual Inspection
| Data not yet provided. |
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| Reviews | Review summary appears after site-level review signal gate opens. | Review summary appears after site-level review signal gate opens. |
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