| Listed site | cdmo | cdmo |
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| Summary | Full-service CDMO offering cGMP and non-GMP mammalian, microbial, gene therapy, and cell therapy manufacturing from preclinical to commercial scale, with bioreactor capacity up to 50,000L. | End-to-end CDMO specializing in complex modalities including cell, gene, and RNA-based therapies with North American manufacturing facilities and development capabilities. |
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| Services | - Cell-Line Development
- Process Development
- CMC Analytical Development
- Formulation Development
- Stability Testing & Storage
- Quality Control Testing
- Upstream Processing
- Downstream Processing
- Recombinant Protein Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- Microbial Fermentation
- Vaccine Manufacturing
- AAV Manufacturing
- Viral Vector Manufacturing
- Vial Filling
- Lyophilization (Freeze Drying)
- Prefilled Syringe (PFS) Filling
- Sterile Fill-Finish & Aseptic Manufacturing
- Technology Transfer
- CMC Regulatory Submission Support
- Analytical Method Development & Validation
- ICH Stability Studies
| - Formulation Development
- CMC Analytical Development
- Technology Transfer
- Process Development
- Sterile Fill-Finish & Aseptic Manufacturing
- Vial Filling
- Prefilled Syringe (PFS) Filling
- Cartridge Filling
- Autologous Cell Therapy Manufacturing
- Allogeneic Cell Therapy Manufacturing
- Cell Therapy Manufacturing
- Recombinant Protein Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- Biologics Development & Manufacturing
- Bioconjugation Services
- Upstream Processing
- Downstream Processing
- Secondary Packaging & Labeling
- Quality Control Testing
- mRNA Manufacturing
- Vaccine Manufacturing
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| Modalities | - Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Cell Therapy
- Gene Therapy
- Peptide
- Vaccine
- AAV / Viral Vector Platform
| - Biologics (Monoclonal Antibodies)
- Biologics (Other)
- mRNA
- Cell Therapy
- Gene Therapy
- Vaccine
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| Indications | Data not yet provided. | Data not yet provided. |
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| Locations | - Southborough, Southborough, Massachusetts, United States
- Zhangjiang (P01), Shanghai, Shanghai, China
- Lingang (IP02), Shanghai, Shanghai, China
- Lingang (IP03), Shanghai, Shanghai, China
- Headquarters, Southborough, Massachusetts, United States
| - Headquarters, Blue Ash, OH, USA
- Cincinnati, Cincinnati, OH, USA
- Philadelphia, Philadelphia, PA, USA
- Toronto, Toronto, ON, Canada
- Fremont, Fremont, California, United States
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| Certifications | Data not yet provided. | - FDA · Identifier: cGMP
- FDA · Identifier: PAI
- FDA · Identifier: PFS & Vial Approval
- Health Canada · Identifier: Health Canada
- EMA · Identifier: Virtual Inspection
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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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