KBI Biopharma

The CDMO for Solving Complex Challenges 

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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

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Venture Center
RTP, NC

Analytical & Process Development

Process & Analytical Development

Process Characterization

Cell Line Development

hamlin rd

Hamlin Road
Durham, NC

Mammalian

Clinical & Commercial cGMP Manufacturing

Analytical, Formulation, Stability

QC Mass Spectrometry Core Facility

Dedicated Cell-Based Assay Labs

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Patriot Park
Durham, NC

Mammalian

Commercial cGMP Manufacturing

6x2000L Flexible Process Trains for Campaign Production

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Boulder Facility Boulder, CO

Microbial

Cell Line Development leveraging KBI PUREplatform™ and PUREcoli™

Process & Analytical Development

Particle Characterization Core

cGMP Manufacturing

Louisville

Louisville Facility Louisville, CO

Analytical

Analytical Technologies

Leading Biophysical Characterization

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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

As the icon of next-generation CDMOs, KBI Biopharma is driving breakthroughs in biopharmaceutical development and manufacturing that positively impact the lives of patients worldwide.

Latest KBI Biopharma News

KBI Biopharma Analytics Portal

Forget the back-and-forth emails for your critical data – have all your analytical testing needs met with a central hub for quote requests, ordering, sample submission and shipment tracking

Learn More