| Listed site | cdmo | cdmo |
|---|
| 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. | Advanced therapies CDMO providing discovery, process development, manufacturing, and regulatory support for cell therapies, viral vectors, mRNA, and gene editing programs from preclinical through commercial scale. |
|---|
| 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
| - Cell-Line Development
- Cell Therapy Manufacturing
- Viral Vector Manufacturing
- mRNA Manufacturing
- Process Development
- CMC Analytical Development
- Technology Transfer
- Quality Control Testing
- CMC Regulatory Submission Support
- Vaccine Manufacturing
|
|---|
| Modalities | - mRNA
- Cell Therapy
- Gene Therapy
- Vaccine
- AAV / Viral Vector Platform
| - mRNA
- Cell Therapy
- Gene Therapy
- Vaccine
- AAV / Viral Vector Platform
|
|---|
| Indications | - Oncology
- Metabolic
- Infectious Disease
- Rare Disease
| |
|---|
| 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
| - Corporate Headquarters and BaseCamp Waltham, Waltham, MA, USA
- BaseCamp Pittsburgh, Pittsburgh, PA, USA
- Gene Editing and Research & Development Site, Durham, NC, USA
- Process Development Labs and Corporate Offices, Waltham, MA, USA
|
|---|
| 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
| - ICMC · Identifier: ICMC™ Certified for Clinical and Commercial Cell and Gene Therapy Manufacturing Capabilities
|
|---|
| Reviews | Review summary appears after site-level review signal gate opens. | Review summary appears after site-level review signal gate opens. |
|---|