| 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. | 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 | - 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
| - 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 | - mRNA
- Cell Therapy
- Gene Therapy
- Vaccine
- AAV / Viral Vector Platform
| - Gene Therapy
- AAV / Viral Vector Platform
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| Indications | - Oncology
- Metabolic
- Infectious Disease
- Rare Disease
| - Rare Disease
- Neurology
- Ophthalmology
- Immunology
- Infectious Disease
- Cardiovascular
- Metabolic
- Respiratory
- Dermatology
- Gastroenterology
- Nephrology
- Women's Health
- Psychiatry
- Oncology
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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 & 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 | - 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
| - 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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