Complementary Techniques for Particle Characterization
Sponsored by: KBI Biopharma
- Subvisible Particles
- Visible Particles
Date: 12 October
Time: 3PM London/10AM New York
Ensuring Quality of Therapeutics with Orthogonal Analytical Methods for Particle Characterization
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
Associate Director, Particle Characterization Core Facility
Amber Fradkin received her Ph.D. in Chemical Engineering within the Pharmaceutical Biotechnology Program with a specialization in the field of immunogenicity of therapeutic protein aggregates at the University of Colorado at Boulder.