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Particle Characterization

Particle Characterization Core Facility

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.

Publication | Subvisible Particle Characterization: Why Simply Counting Shadows Leaves You in the Dark

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.

Publication | Meeting Biopharmaceutical Analytical Requirements for Subvisible Particle Sizing and Counting

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.

≤1 μm

submicron particle analysis

1–100 μm

subvisible particle analysis

Method Development

for biologics, materials & small molecules

protein simple (1)

KBI’s Particle Characterization Core Facility Capabilities

Characterization & Identification

  • Particle Identification

  • Particle Profile Establishment

  • Biosimilarity/Comparability

  • Product Stability

  • Regulatory Support

Method Development

  • Biologics

  • Small Molecule

  • Materials

Routine Particle Testing