submicron particle analysis
subvisible particle analysis
for biologics, materials & small molecules
Significant improvements in analytical technology to quantify and characterize subvisible (1 – 100 µm) and submicron particles (≤1 µm) have prompted the regulatory agencies to require characterization of particles in these size ranges.
Multiple orthogonal methods are required to span the entire range and to accurately characterize the particle profile, as each instrument possesses limitations based on the detection strategy and sample solution properties. These limitations must be well understood to generate high-quality data.
KBI Biopharma has kept pace with technological advances, and over the years has developed extensive expertise in particle detection methodology, as well as in-depth particle data analysis.
Our Particle Characterization Core Facility provides specialized, state-of-the-art analysis for subvisible particles ranging in size from nanometer to micron.
Particle Profile Establishment
Dynamic Light Scattering (Zetasizer)
SEC with Multi-angle Light Scattering
Light Obscuration (HIAC)
Energy-Dispersive X-ray Spectroscopy (SEM-EDS)