| Listed site | cdmo | both |
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| Summary | Full-service CDMO offering cGMP and non-GMP mammalian, microbial, gene therapy, and cell therapy manufacturing from preclinical to commercial scale, with bioreactor capacity up to 50,000L. | Charles River Laboratories provides contract research, development, and manufacturing services across the full drug discovery and development continuum, supporting 80% of FDA-approved drugs over the past five years. |
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| Services | - Cell-Line Development
- Process Development
- CMC Analytical Development
- Formulation Development
- Stability Testing & Storage
- Quality Control Testing
- Upstream Processing
- Downstream Processing
- Recombinant Protein Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- Microbial Fermentation
- Vaccine Manufacturing
- AAV Manufacturing
- Viral Vector Manufacturing
- Vial Filling
- Lyophilization (Freeze Drying)
- Prefilled Syringe (PFS) Filling
- Sterile Fill-Finish & Aseptic Manufacturing
- Technology Transfer
- CMC Regulatory Submission Support
- Analytical Method Development & Validation
- ICH Stability Studies
| - CMC Regulatory Submission Support
- Quality Control Testing
- Technology Transfer
- Formulation Development
- Process Development
- Cell Therapy Manufacturing
- Viral Vector Manufacturing
- Recombinant Protein Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- Biologics Development & Manufacturing
- API Synthesis & Manufacturing
- Upstream Processing
- Downstream Processing
- CMC Analytical Development
- Stability Testing & Storage
- Cell-Line Development
- Microbial Fermentation
- Small Molecule Development & Manufacturing
- AAV Manufacturing
- Lentiviral Vector Manufacturing
- Sterile Fill-Finish & Aseptic Manufacturing
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| Modalities | - Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Cell Therapy
- Gene Therapy
- Peptide
- Vaccine
- AAV / Viral Vector Platform
| - Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Cell Therapy
- Gene Therapy
- AAV / Viral Vector Platform
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| Indications | Data not yet provided. | - Oncology
- Immunology
- Neurology
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| Locations | - Southborough, Southborough, Massachusetts, United States
- Zhangjiang (P01), Shanghai, Shanghai, China
- Lingang (IP02), Shanghai, Shanghai, China
- Lingang (IP03), Shanghai, Shanghai, China
- Headquarters, Southborough, Massachusetts, United States
| - Headquarters, United States
- North America, North America, USA/Canada
- Europe, Europe, Multiple
- Asia, Asia, Multiple
- North America, North America
- Europe, Europe
- Asia, Asia
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| Certifications | Data not yet provided. | - FDA · Identifier: 100 IND submissions containing Retrogenix® platform data
- EMA · Identifier: 100 IND submissions containing Retrogenix® platform data
- PMDA · Identifier: 100 IND submissions containing Retrogenix® platform data
- EMA · Identifier: Retrogenix® platform data support
- PMDA · Identifier: Retrogenix® platform data support
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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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