|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, including 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 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.
We offer stand-alone packages for process development that includes preliminary POC packages to evaluate developability of new candidates, along with stand-alone analytical development, formulation development, stability and release testing.
KBI Biopharma's state-of-the-art facilities are located in the North Carolina Center for Biomanufacturing in Durham, North Carolina near the Research Triangle Park.