KBI Biopharma, Inc
KBI Biopharma is a global Contract Development and Manufacturing Organization (CDMO) dedicated to driving breakthroughs in biopharmaceutical development and manufacturing. They focus on providing innovative biologic solutions, supporting the development and manufacturing of new biopharmaceuticals, and are committed to high standards, trust, learning, growth, and collaboration. With locations across the US and Europe, they offer a wide range of services including cell line development, process development, analytical development, formulation, characterization, clinical and commercial manufacturing, and advanced technologies like SUREtechnology Platform™ and PUREplatform™. Their mission is to positively impact patients worldwide through science-driven, customer-focused solutions.
Industries
Nr. of Employees
Very Large (1000+)
KBI Biopharma, Inc
Products
CHO-based cell line development platform
Integrated mammalian expression platform for generating stable, high-performing CHO cell lines to support biologics development and scale-up.
E. coli expression platform
Microbial expression platform engineered for efficient E. coli–based production of therapeutic proteins optimized for process efficiency and commercial use.
CHO-based cell line development platform
Integrated mammalian expression platform for generating stable, high-performing CHO cell lines to support biologics development and scale-up.
E. coli expression platform
Microbial expression platform engineered for efficient E. coli–based production of therapeutic proteins optimized for process efficiency and commercial use.
Services
Cell line development (mammalian and microbial)
Development of stable expression cell lines for mammalian (CHO) and microbial hosts to support discovery through clinical supply.
Process, analytical, and formulation development
End-to-end process development including cell culture, fermentation, purification, analytical development, and formulation optimization.
Characterization and analytical core services
Particle characterization, biophysical assays, and mass spectrometry services delivered via analytical core facilities and consulting.
Clinical manufacturing (mammalian and microbial)
Clinical-stage good manufacturing practice manufacturing and release/stability support for therapeutics and vaccines.
Commercial manufacturing and campaign production
Commercial-scale cGMP manufacturing including multi-train campaign production and commercial release/stability support.
Standalone analytical services portal
Web portal for quote requests, ordering, sample submission, and shipment tracking for analytical testing workflows.
Cell line development (mammalian and microbial)
Development of stable expression cell lines for mammalian (CHO) and microbial hosts to support discovery through clinical supply.
Process, analytical, and formulation development
End-to-end process development including cell culture, fermentation, purification, analytical development, and formulation optimization.
Characterization and analytical core services
Particle characterization, biophysical assays, and mass spectrometry services delivered via analytical core facilities and consulting.
Clinical manufacturing (mammalian and microbial)
Clinical-stage good manufacturing practice manufacturing and release/stability support for therapeutics and vaccines.
Commercial manufacturing and campaign production
Commercial-scale cGMP manufacturing including multi-train campaign production and commercial release/stability support.
Standalone analytical services portal
Web portal for quote requests, ordering, sample submission, and shipment tracking for analytical testing workflows.
Expertise Areas
- Cell line development (mammalian and microbial)
- Process development and scale-up (upstream and downstream)
- Analytical development and method lifecycle management
- Formulation development and stability
Key Technologies
- CHO-based mammalian expression platforms
- E. coli expression platforms
- Mass spectrometry
- Biophysical characterization methods