| 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. | 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 | - 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
| - 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)
- Antibody-Drug Conjugate (ADC)
- mRNA
- Cell Therapy
- Gene Therapy
- 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 | - Headquarters, Seattle, Washington, USA
- Copenhagen, Copenhagen, Denmark
- Heidelberg, Heidelberg, Germany
- Milan, Milan, Italy
- Chiba, Chiba, Japan
- Yokohama, Yokohama, Japan
| - 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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