| Listed site | cdmo | cdmo |
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| Summary | Aldevron is a CDMO specializing in mRNA manufacturing with LNP encapsulation and fill/finish, viral vector production, plasmid DNA, and gene therapy solutions from discovery through commercialization. | Charles River provides discovery, development, and manufacturing services across the drug development continuum, including cell and gene therapy capabilities. |
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| Services | - mRNA Manufacturing
- Lipid Nanoparticle (LNP) Formulation
- Sterile Fill-Finish & Aseptic Manufacturing
- Process Development
- CMC Analytical Development
- Stability Testing & Storage
- Quality Control Testing
- Recombinant Protein Manufacturing
- Cell-Line Development
- Lentiviral Vector Manufacturing
- AAV Manufacturing
- Viral Vector Manufacturing
- Technology Transfer
- 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
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| Modalities | - mRNA
- Cell Therapy
- Gene Therapy
- 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 | - Oncology
- Metabolic
- Infectious Disease
- Rare Disease
| - Oncology
- Immunology
- Neurology
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| Locations | - Breakthrough Campus (Headquarters), Fargo, North Dakota, USA
- Advance Campus, Fargo, North Dakota, USA
- Innovate Campus, Madison, Wisconsin, USA
- Discovery Center, Waltham, Massachusetts, USA
- Headquarters
| - Headquarters, United States
- North America, North America
- Europe, Europe
- Asia, Asia
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| Certifications | - Germany (Competent Authority) · Identifier: Certificate of GMP Compliance of a Manufacturer
- FDA CBER · Identifier: Pre-License Inspection (PLI) and GMP audit - No Action Indicated (NAI)
- ISO · Identifier: ISO 13485:2016
| - 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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