Particles: Complimentary Technologies for Particle Characterization & Identification

Presented by Amber Fradkin,
Associate Director, Particle Characterization Core Facility at KBI Biopharma, October 12th 2016

Key Learning Objectives

-Importance of using orthogonal methods for particle identification

-What tools are available for the types of particles being analyzed

Significant advances have been made in analytical technology for the characterization and identification of particles present in pharmaceutical products. With these advances comes a tremendous amount of new data with which to characterize biologics, devices, and small molecules.

In parallel with these technological advances, the regulatory agencies have shown increased interest in more in-depth characterization of therapeutic products.

Careful interpretation of data and in-depth understanding of the method limitations is of utmost importance for using complementary methods to characterize particle profiles of therapeutic products for regulatory submissions.

This presentation demonstrates how multiple particle techniques can be used to adequately characterize therapeutic products and their particle populations. We provide case studies to highlight the advantages of particle methods for characterizing:

  • A commercially available brand of filgrastim and its biosimilar
  • A commercially available Recombinate and its infusion system
  • A commercially available topical ointment consisting of two API’s of distinct PSDs