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
Durham, North Carolina, United States, North America
Patents
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
Development of stable expression cell lines for mammalian (CHO) and microbial hosts to support discovery through clinical supply.
End-to-end process development including cell culture, fermentation, purification, analytical development, and formulation optimization.
Particle characterization, biophysical assays, and mass spectrometry services delivered via analytical core facilities and consulting.
Clinical-stage good manufacturing practice manufacturing and release/stability support for therapeutics and vaccines.
Commercial-scale cGMP manufacturing including multi-train campaign production and commercial release/stability support.
Web portal for quote requests, ordering, sample submission, and shipment tracking for analytical testing workflows.
Development of stable expression cell lines for mammalian (CHO) and microbial hosts to support discovery through clinical supply.
End-to-end process development including cell culture, fermentation, purification, analytical development, and formulation optimization.
Particle characterization, biophysical assays, and mass spectrometry services delivered via analytical core facilities and consulting.
Clinical-stage good manufacturing practice manufacturing and release/stability support for therapeutics and vaccines.
Commercial-scale cGMP manufacturing including multi-train campaign production and commercial release/stability support.
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
News & Updates
Join KBI Biopharma at BIO International 2025 Booth # 2065 in Boston, Massachusetts from June 16-19, 2025.
Join KBI Biopharma at PEGS Boston from May 12-16, 2025 in Boston, Massachusetts.
Join KBI Biopharma at BIO KOREA Booth N28 from May 7-9, 2025 in Seoul, Korea.
An article about advanced mass spectrometry techniques for biotherapeutics.
A whitepaper on microbial protein expression standards.
Join KBI Biopharma at BIO International 2025 Booth # 2065 in Boston, Massachusetts from June 16-19, 2025.
Join KBI Biopharma at PEGS Boston from May 12-16, 2025 in Boston, Massachusetts.
Join KBI Biopharma at BIO KOREA Booth N28 from May 7-9, 2025 in Seoul, Korea.
An article about advanced mass spectrometry techniques for biotherapeutics.
A whitepaper on microbial protein expression standards.