| Listed site | cdmo | cdmo |
|---|
| Summary | Global CDMO offering cell line development, process and analytical development, formulation development, and clinical and commercial manufacturing for mammalian and microbial biologics. | Germany-based CDMO specializing in GMP-compliant microbial production of recombinant proteins, peptides, plasmid DNA, and bacterial vaccines with bioreactor capacity up to 1,500 litres and regulatory clearance from FDA, EMA, ANVISA, PMDA, and MFDS. |
|---|
| Services | - Cell-Line Development
- Process Development
- CMC Analytical Development
- Formulation Development
- Recombinant Protein Manufacturing
- Microbial Fermentation
- Upstream Processing
- Downstream Processing
- Quality Control Testing
- Stability Testing & Storage
- Monoclonal Antibody (mAb) Manufacturing
- Biologics Development & Manufacturing
- CMC Regulatory Submission Support
| - Process Development
- Upstream Processing
- Downstream Processing
- CMC Analytical Development
- Quality Control Testing
- Recombinant Protein Manufacturing
- Peptide Manufacturing
- Vaccine Manufacturing
- Microbial Fermentation
|
|---|
| Modalities | - Biologics (Monoclonal Antibodies)
- Biologics (Other)
| - Biologics (Other)
- Vaccine
- Peptide
|
|---|
| Indications | | Data not yet provided. |
|---|
| Locations | - Durham, Durham, North Carolina, United States
- Research Triangle Park, Research Triangle Park, North Carolina, United States
- Boulder, Boulder, Colorado, United States
- Louisville, Louisville, Colorado, United States
- The Woodlands, The Woodlands, Texas, United States
- Geneva, Geneva, Geneva, Switzerland
- Leuven, Leuven, Flemish Brabant, Belgium
- Patriot Park, Patriot Park, NC, United States
- Hamlin Road, Hamlin Road, NC, United States
- Hamlin Road, Durham, North Carolina, United States
- Cell Line Development Center of Excellence, Geneva, Switzerland
| - Headquarters / Development & Manufacturing, Germany, Germany
|
|---|
| Certifications | | - FDA · Identifier: FDA inspection - zero findings
- EMA · Identifier: EMA verified
- ANVISA · Identifier: ANVISA verified
- PMDA · Identifier: PMDA verified
|
|---|
| Reviews | Review summary appears after site-level review signal gate opens. | Review summary appears after site-level review signal gate opens. |
|---|