| Listed site | cdmo | cdmo |
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| Summary | North American CDMO specializing in clinical-to-commercial biologics, small molecules, HPAPIs, and bioreagents with 50+ years of microbial fermentation and complex chemistry expertise across cGMP facilities in Canada. | Charles River provides discovery, development, and manufacturing services across the drug development continuum, including cell and gene therapy capabilities. |
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| Services | - Process Development
- CMC Analytical Development
- Technology Transfer
- Formulation Development
- Quality Control Testing
- CMC Regulatory Submission Support
- Microbial Fermentation
- Downstream Processing
- Upstream Processing
- Recombinant Protein Manufacturing
- HPAPI Manufacturing (High-Potency)
- API Synthesis & Manufacturing
- Small Molecule Development & Manufacturing
- Biologics Development & Manufacturing
- mRNA Manufacturing
- Cell-Line Development
| - 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 | - Small Molecule
- Biologics (Other)
- Oligonucleotide
- mRNA
- Gene Therapy
| - 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 | - Headquarters, Charlottetown, Prince Edward Island, Canada
- Research & Development, Charlottetown, Prince Edward Island, Canada
- New API Facility, Charlottetown, Prince Edward Island, Canada
- Dedicated Facility, Charlottetown, Prince Edward Island, Canada
- Large Scale Biomanufacturing Facility, Windsor, Nova Scotia, Canada
- Research & Development, Prince Edward Island, PE, Canada
- Headquarters, Prince Edward Island, PE, Canada
- New API Facility, Prince Edward Island, PE, Canada
- Dedicated Natural Extraction Facility, Prince Edward Island, PE, Canada
| - Headquarters, United States
- 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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