KBI Biopharma, Inc.
Global CDMO for mammalian cell line development and biologics manufacturing
Listed on cdmo.directory
Global CDMO offering cell line development, process development, analytical services, and cGMP clinical and commercial manufacturing for biologics including monoclonal antibodies and recombinant proteins. Headquartered in Durham, United States.
Modalities
Development & manufacturing
Structured CDMO capabilities from verified public sources.
Development (D)
Manufacturing (M)
Biologics / bioreactor infrastructure
- Bioreactor type
- Single-Use / Disposable
Regulatory clearances
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
Indications
About this organization
KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated drug development and biologics manufacturing services. The organization specializes in mammalian cell line development, process analytical and formulation development, and clinical and commercial cGMP manufacturing.
Key Capabilities:
- Cell line development with advanced modular technology
- Process development and analytical services
- Clinical and commercial cGMP manufacturing for mammalian and microbial programs
- Monoclonal antibody development and manufacturing (SUREmAb™ platform powered by Selexis)
- Support for preclinical and clinical drug candidates
Scale & Reach: KBI serves 500+ customer partners globally, with six locations across Europe and the USA. The organization supports advancement of 170+ drug candidates in preclinical and clinical development and manufactures ten commercial products.
Certifications
| Authority | Identifier | Source |
|---|---|---|
| FDA | cGMP | View |
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
Hamlin Road
Durham · North Carolina · United States
Cell Line Development Center of Excellence
Geneva · Switzerland
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