| 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. | 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 | - 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
| - 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 | - Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Cell Therapy
- Gene Therapy
- Peptide
- Vaccine
- AAV / Viral Vector Platform
| - Gene Therapy
- AAV / Viral Vector Platform
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| Indications | Data not yet provided. | - Rare Disease
- Neurology
- Ophthalmology
- Immunology
- Infectious Disease
- Cardiovascular
- Metabolic
- Respiratory
- Dermatology
- Gastroenterology
- Nephrology
- Women's Health
- Psychiatry
- Oncology
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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 & 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 | Data not yet provided. | - 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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