KBI Biopharma, Inc.
Contract development and manufacturing for complex biologics with 30+ years of expertise.
Global CDMO offering cell line development, process and analytical development, formulation development, and clinical and commercial manufacturing for mammalian and microbial biologics. 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 is a contract development and manufacturing organization (CDMO/CMO) specializing in comprehensive development and manufacturing services for biologics. The company offers vertically-integrated solutions spanning cell line development, process development, analytical development, formulation development, characterization, and both clinical and commercial manufacturing.
Service Capabilities
Mammalian & Microbial Platforms:
- Cell line development for both mammalian and microbial expression systems
- Process development including cell culture and fermentation
- Analytical development and characterization services
- Formulation development
- Clinical and commercial manufacturing at scale
Specialized Expertise:
- Bispecific antibody development and manufacturing with proprietary platforms
- Particle characterization and biophysical characterization
- Mass spectrometry core facility services
- Comprehensive analytical science for complex biologics
Proprietary Technologies
KBI operates several proprietary technology platforms:
- SUREtechnology Platform™ featuring SURE CHO-M Cell Line™ and SUREmAb™
- PUREplatform™ with PUREcoli™ for microbial expression
- PROGRAMview™ digital solutions for program management
The company emphasizes quality, efficiency, and accelerated timelines for complex biologics development and manufacturing, with over 30 years of industry experience.
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
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
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