KBI Biopharma
Associated Experts
Job Title: Director, Particle Characterization Core Facility, KBI Biopharma
Associated Content
Subvisible Particle Characterization: Why Simply Counting Shadows Leaves You in the Dark
As the technology continues to improve so do the expectations of regulatory agencies for sponsors to characterize particles in these size ranges. However, multiple orthogonal methods are required to span the entire range and accurately characterize the particle profile. Each instrument has its own limitations based on detection method and properties of therapeutic protein products that must be well understood to generate high quality data....Continued