| Listed site | cdmo | cdmo |
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| Summary | Global CDMO offering development and manufacturing for protein expression biologics, pDNA, mRNA, viral vectors (AAV, LVV, RVV), and genetically engineered cells with scale-out manufacturing capabilities. | 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. |
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| Services | - Technology Transfer
- Process Development
- Cell-Line Development
- CMC Analytical Development
- Formulation Development
- Quality Control Testing
- Sterile Fill-Finish & Aseptic Manufacturing
- CMC Regulatory Submission Support
- Recombinant Protein Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- Upstream Processing
- Downstream Processing
- Cell Therapy Manufacturing
- Viral Vector Manufacturing
- AAV Manufacturing
- Lentiviral Vector Manufacturing
- ADC (Antibody-Drug Conjugate) Manufacturing
- mRNA Manufacturing
- Biologics Development & Manufacturing
- Vial Filling
- Prefilled Syringe (PFS) Filling
| - 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
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| Modalities | - Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Cell Therapy
- Gene Therapy
- AAV / Viral Vector Platform
- mRNA
- Antibody-Drug Conjugate (ADC)
| - mRNA
- Cell Therapy
- Gene Therapy
- Vaccine
- AAV / Viral Vector Platform
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| Indications | Data not yet provided. | - Oncology
- Metabolic
- Infectious Disease
- Rare Disease
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| Locations | - Headquarters, Seattle, Washington, USA
- Copenhagen, Copenhagen, Denmark
- Heidelberg, Heidelberg, Germany
- Milan, Milan, Italy
- Chiba, Chiba, Japan
- Yokohama, Yokohama, Japan
| - Breakthrough Campus (Headquarters), Fargo, North Dakota, USA
- Advance Campus, Fargo, North Dakota, USA
- Innovate Campus, Madison, Wisconsin, USA
- Discovery Center, Waltham, Massachusetts, USA
- Headquarters
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| Certifications | Data not yet provided. | - 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
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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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