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.

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

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