| Listed site | cdmo | cdmo |
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| Summary | Charles River provides discovery, development, and manufacturing services across the drug development continuum, including cell and gene therapy capabilities. | CDMO partner offering end-to-end biologics development and manufacturing from pre-clinical through commercialization, with expertise in cell culture, microbial fermentation, cell and gene therapy, and cGMP manufacturing across US and European facilities. |
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| Services | - 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
| - Cell-Line Development
- Process Development
- CMC Analytical Development
- Quality Control Testing
- Formulation Development
- Stability Testing & Storage
- CMC Regulatory Submission Support
- Upstream Processing
- Downstream Processing
- Microbial Fermentation
- Recombinant Protein Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- Biologics Development & Manufacturing
- Vaccine Manufacturing
- Viral Vector Manufacturing
- Cell Therapy Manufacturing
- Technology Transfer
- Sterile Fill-Finish & Aseptic Manufacturing
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| Modalities | - Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Cell Therapy
- Gene Therapy
- AAV / Viral Vector Platform
| - Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Cell Therapy
- Gene Therapy
- Vaccine
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| Indications | - Oncology
- Immunology
- Neurology
| Data not yet provided. |
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| Locations | - Headquarters, United States
- North America, North America
- Europe, Europe
- Asia, Asia
| - Headquarters, Cambridge, MA, USA
- College Station, College Station, TX, USA
- Holly Springs, Holly Springs, NC, USA
- Research Triangle Park, Research Triangle Park, NC, USA
- Thousand Oaks, Thousand Oaks, CA, USA
- Billingham, Billingham, UK
- Wilton, Wilton, UK
- Hillerød, Hillerød, Denmark
- Japan, Japan
- US Facility, United States
- United States, United States
- Headquarters
- Commercial-scale manufacturing, Hillerød, Denmark
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| Certifications | - 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
| 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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