Written by Dr. Amber Fradkin of KBI Biopharma, who manages the Particle Characterization Core Facility at KBI Biopharma in Boulder, Colorado.

KBI is a biopharmaceutical contract development and manufacturing organization (CDMO) headquartered in Durham, North Carolina, which specializes in accelerating the development of biological therapeutics. KBI’s Particle Core provides specialist particle characterizationwhich is tailored for the (bio)pharmaceutical industry, and includes profiling of particles post IV-infusion, investigation of the kinetics of particle formation, particle identification for forensics applications, API characterization, profiling of particles in drug products for biosimilarity and biocomparability, and assessment of formulation stability, amongst other services.