KBI Biopharma
The CDMO for Solving Complex Challenges
About KBI Biopharma
KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally.
KBI Biopharma is more than a CDMO, we are the resource for solutions that help our clients bring the most complex biotherapeutics to patients in need globally.
Whether you need a solution for early development challenges or commercial-scale manufacturing, we have the expertise, tools, and technologies to make it happen. Let’s solve the complexities of biologics together, because your breakthroughs deserve a partner invested in your innovation.
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Years of Experience
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Client Partners
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Drug Candidates
KBI Offerings
Multi-decade Expertise in Complex Molecules: Proven success across 200+ first-in-human programs, with extensive experience in developing and scaling complex recombinant therapeutics, including mAbs, Fc-fusion proteins, multispecific Abs, and conjugates.
End-to-End Biologics Support: Comprehensive solutions from cell line development to commercial manufacturing supported by advanced analytical science capabilities.
Advanced Cell Line Development: Industry-recognized mammalian SUREtechnology Platform™, powered by Selexis®, and microbial PUREplaform™ deliver high-titer accelerated timeline manufacturing solutions for complex and simple recombinant proteins.
State-of-the-Art Facilities: 10 x 2,000L single-use bioreactor capacity across clinical and commercial mammalian manufacturing, and a 2,000L fermenter for advanced microbial processes.
Analytical Excellence: Industry-leading capabilities for characterization and release testing with over 20 years of experience.
Digital Innovation: Advanced platforms like PROGRAMview™ and the Analytics Portal offer unmatched transparency, streamlined collaboration, and real-time access to program data.
Standardized, Yet Flexible Manufacturing Solutions: Agile, scalable approaches tailored to unique biologics development and manufacturing challenges.
Global Reach, Local Expertise: Strategically located facilities across the U.S. and Europe, providing reliable, high-quality solutions with a deep understanding of regional needs.
Confidence Through Transparency: Clear and open communication and data-driven insights at every stage of the partnership.
World Class Facilities
Venture Center
RTP, NC
Analytical & Process Development
Process & Analytical Development
Process Characterization
Cell Line Development
Hamlin Road
Durham, NC
Mammalian
Clinical & Commercial cGMP Manufacturing
Analytical, Formulation, Stability
QC Mass Spectrometry Core Facility
Dedicated Cell-Based Assay Labs
Patriot Park
Durham, NC
Mammalian
Commercial cGMP Manufacturing
6x2000L Flexible Process Trains for Campaign Production
Boulder Facility Boulder, CO
Microbial
Cell Line Development leveraging KBI PUREplatform™ and PUREcoli™
Process & Analytical Development
Particle Characterization Core
cGMP Manufacturing
Louisville Facility Louisville, CO
Analytical
Analytical Technologies
Leading Biophysical Characterization
Geneva Facility Geneva, Switzerland
Cell Line, Analytical, and Process Development
Best-in-class Cell Line Development using KBI SUREtechnology Platform™, powered by Selexis®, and SURE CHO-M Cell LineTM
Process & Analytical Development