| 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. | ProBioGen AG is a CDMO offering cell line development, process development, GMP manufacturing and analytical services for proteins, antibodies, viral vectors and vaccines. It also provides technology platforms for biopharmaceutical manufacturing. |
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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
| - Analytical Method Development & Validation
- ICH Stability Studies
- EU EMA Regulatory Strategy
- US FDA Regulatory Strategy
- Cell-Line Development
- Process Development
- Biologics Development & Manufacturing
- Recombinant Protein Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- Viral Vector Manufacturing
- AAV Manufacturing
- Lentiviral Vector Manufacturing
- Vaccine Manufacturing
- Technology Transfer
- CMC Analytical Development
- Quality Control Testing
- Stability Testing & Storage
- Formulation Development
- CMC Regulatory Submission Support
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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)
- Gene Therapy
- Vaccine
- AAV / Viral Vector Platform
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| Indications | 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
| - Berlin, Berlin, Berlin, Germany
- Cairo, Cairo, Cairo Governorate, Egypt
- Headquarters, Berlin, Berlin, Germany
- Office, Berlin, Berlin, Germany
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| Certifications | Data not yet provided. | - EMA · Identifier: GMP compliant
- FDA · Identifier: GMP compliant
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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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