KBI Biopharma is a leading contract development and manufacturing organization for the biopharmaceutical industry. We accelerate and optimize drug development and manufacturing programs for our client partners, which range from small start-up biotechs to global pharmaceutical and biotechnology companies and organizations in bio-defense. Our expertise in biophysical and biochemical protein characterization makes us highly successful in delivering optimal product stability and bioactivity for our clients.

Our Core Facilities include:
*Mass Spec Core Facility: KBI’s state-of-the-art mass spectrometry core facility delivers unparalleled structural characterization services to our clients.
*Particle Characterization Core Facility: KBI’s Particle Characterization Core Facility provides specialized, state-of-the-art analysis for subvisible particles ranging in size from nanometer to micron.

Our core capabilities include:
*Cell Line Development;
*Process Development;
*Analytical Development;
*Qualification, Validation;
*Biophysical Characterization;
*Formulation Development;
*Mammalian cGMP Manufacturing;
*Microbial cGMP Manufacturing;
*GMP Release and Stability.

Our scientific, quality and regulatory staff possesses the experience – proven through numerous IND and NDA submissions – to meet the challenges that arise at all stages of drug development. KBI Biopharma’s state-of-the-art facilities are located in North Carolina (at the North Carolina Center for Biomanufacturing in Durham and in the Research Triangle Park) and in Boulder, Colorado.