| Listed site | both | cdmo |
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| Summary | 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. | Dedicated AAV gene therapy CDMO with a 200,000+ sq. ft. cGMP facility featuring 20 suites and bioreactors up to 5,000L, supporting 60+ clients across 35+ indications with high-yield manufacturing and seamless regulatory compliance. |
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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
| - AAV Manufacturing
- Viral Vector Manufacturing
- Upstream Processing
- Downstream Processing
- CMC Analytical Development
- Process Development
- Sterile Fill-Finish & Aseptic Manufacturing
- Vial Filling
- Stability Testing & Storage
- Quality Control Testing
- CMC Regulatory Submission Support
- Technology Transfer
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| Modalities | - Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Cell Therapy
- Gene Therapy
- AAV / Viral Vector Platform
| - Gene Therapy
- AAV / Viral Vector Platform
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| Indications | - Oncology
- Immunology
- Neurology
| - Rare Disease
- Neurology
- Ophthalmology
- Immunology
- Infectious Disease
- Cardiovascular
- Metabolic
- Respiratory
- Dermatology
- Gastroenterology
- Nephrology
- Women's Health
- Psychiatry
- Oncology
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| Locations | - Headquarters, United States
- North America, North America, USA/Canada
- Europe, Europe, Multiple
- Asia, Asia, Multiple
- North America, North America
- Europe, Europe
- Asia, Asia
| - Headquarters & Manufacturing (The Hearth), Grove City, Ohio, United States
- Headquarters & Manufacturing, Grove City, Ohio, United States
- The Hearth (Manufacturing Facility)
- The Hearth (Manufacturing Facility), United States
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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
| - EU GMP · Identifier: EU GMP Compliant
- FDA · Identifier: cGMP Compliant
- EMA · Identifier: EU GMP
- FDA · Identifier: cGMP
- EMA · Identifier: cGMP
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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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