KBI Biopharma Inc.

When your program demands precise answers, our over two decades of experience tackling complex challenges deliver rapid, dependable results powered by profound scientific expertise. Your analytical challenges demand comprehensive lifecycle support with customized solutions. Whether addressing comple...

To date, KBI has conducted over 130 successful protein, peptide, and vaccine formulation development programs. KBI's approach to formulation development is based on the strategic pairing of two complementary scientific disciplines: Establishing a comprehensive understanding of the thermal, physical, chemic...

KBI Biopharma has extensive experience developing purification processes for a wide variety of biotherapeutics, including: -Monoclonal antibodies-Bispecific antibodies -Enzymes -Fc fusion proteins -PEGylated proteins -Complex glycoproteins KBI supports 40+ annual programs ranging from FIH (First-in-Human)...

From sequence to optimized formulation; mechanistic predictions, not a black box.

KBI Biopharma delivers end-to-end process development services for both mammalian and microbial-based biologics, enabling efficient scale-up and robust transfer to cGMP manufacturing. Our team supports the full development cycle, from early-stage feasibility and small-scale protein production through up...

Global CDMO providing innovative solutions for your business. A KBI digital book.

Argonaut

Cell Line Development

Cell Line Development Rebate

First in Human

Gannt chart

Manufacturing

Durham, North Carolina (April 2, 2026) – KBI Biopharma, a leading global contract development and manufacturing organization (CDMO), has been named Fill-Finish CDMO of the Year and Best in Class for Cultural Fit in the Small/Mid-Sized CDMO Biologic categories at the 2026 CDMO Leadership Awards.

Up to $500k toward your first GMP batch

This year at CPHI Barcelona (24–26 October, 2023) we sat down with C-suite executives and HR professionals to discuss the looming talent crisis in the pharmaceutical industry. With hybrid working persisting post-pandemic and a growing skills gap, how can the pharmaceutical supply chain adjust to a changing labour force? 

Global CDMO Providing Innovative Biologic Solutions: KBI Digital Resource Book

In this Connect to Frankfurt session, Séverine Fagète, VP, Cell Line Development Services at Selexis (Geneva, Switzerland), and Brandon Brino (Durham, USA), Process Development Scientist and Group Leader at KBI Biopharma, present an overview of a streamlined process for the production of bispecific molecules.  

A pure microbial strain for clean, efficient therapeutic protein production.

The fast track to best-in-class cell lines

Use of high resolution mass spectrometry for targets quantitation of protein impurities

Easy access portal for timely results, all in one standalone services portal.

KBI + MilliporeSigma advance cytotoxic ADC manufacturing.

Scale smarter.

Your program. Faster, simpler, smarter.

From sequence to optimized formulation: Mechanistic predictions, not a black box.

Slow, unpredictable cell line development can cost you precious time, especially in early development, when timelines are tight and the pressure to deliver is high. KBI's Cell Line Development is made to flex, built to scale and proven to deliver. 

KBI's partner, Argonaut, can help your team manufacture with momentum across clinical and commercial phases, protecting yield and maximizing the value of every run. 

Argonaut is the home for high-value drug products and complex formulations.

Effective control of host cell protein (HCP) is crucial in biopharmaceutical production to ensure safety and regulatory compliance. Read more about KBI's use of High Resolution Mass Spectrometry for targeted quantitation of protein impurities.

KBI's cell line development - powered by Selexis TranspoEase - delivers an elite, category-setting transposase-based technology that is built on the SUREtechnology platform.

SUREmAb preemptively navigates technical hurdles for exceptional performance, delivering high titers (up to 18 g/L) with a streamlined, lower-cost workflow. 

KBI Biopharma and MilliporeSigma  have partnered to provide integrated end-to-end solutions for ADCs, combining expertise in process development, mAb intermediate manufacturing, bioconjugation, and bulk drug substance production.

U.S. based data-driven centered on your molecule.  KBI is your trusted partner for commercial manufacturing.

KBI Gannt Chart - From transfection to IND ready.

For emerging biologics, Phase I is just the beginning. If your early data looks promising, you'll need a partner ho can handle the next steps, without forcing a complete manufacturing reset.

Up to $500,000 toward your first GMP batch. Discover how!