| Listed site | cdmo | cdmo |
|---|
| Summary | CDMO specializing in plasmid DNA and AAV viral vector manufacturing for cell and gene therapy, with digital-first platform emphasizing data integrity and collaboration. | Charles River provides discovery, development, and manufacturing services across the drug development continuum, including cell and gene therapy capabilities. |
|---|
| Services | - Viral Vector Manufacturing
- AAV Manufacturing
- Lentiviral Vector Manufacturing
- Process Development
- CMC Analytical Development
- Quality Control Testing
- Technology Transfer
- Cell-Line Development
- Upstream Processing
- Downstream Processing
- CMC Regulatory Submission Support
- Cell Therapy Manufacturing
| - 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
|
|---|
| Modalities | - Cell Therapy
- Gene Therapy
- AAV / Viral Vector Platform
| - Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Cell Therapy
- Gene Therapy
- AAV / Viral Vector Platform
|
|---|
| Indications | | - Oncology
- Immunology
- Neurology
|
|---|
| Locations | - Andelyn Corporate Center, Columbus, Ohio, United States
- Andelyn Development Center, Columbus, Ohio, United States
- Headquarters & Manufacturing, Columbus, Ohio, United States
- Facility 2, Columbus, Ohio, United States
- Headquarters & Manufacturing Facility 1, Columbus, Ohio, United States
- Manufacturing Facility 2, Columbus, Ohio, United States
- Headquarters & Facility 1, Columbus, Ohio, United States
| - Headquarters, United States
- North America, North America
- Europe, Europe
- Asia, Asia
|
|---|
| Certifications | - Dark Horse Consulting ICMC · Identifier: Initiative for Certification of Manufacturing Capabilities (ICMC™)
| - 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
|
|---|
| Reviews | Review summary appears after site-level review signal gate opens. | Review summary appears after site-level review signal gate opens. |
|---|