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
Amber Fradkin,
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.
Amber also holds a Masters in Science from the University of Colorado at Boulder plus a Bachelors of Science from the Colorado School of Mines. Amber currently holds the position of Associate Director at KBI Biopharma where she manages the Particle Characterization Core that specializes in analytical methods for quantifying, characterizing and identifying submicron, subvisible and visible particulates.
Previously, at Amgen Inc., Amber was a Scientist within the biomolecular structures and interactions group where she supported biophysical characterization of protein products with a specialty in subvisible particle characterization and identification. She managed a team of 5 to support all subvisible particle characterization for commercial and late stage clinical products and authored particle characterization sections of numerous regulatory filings.
She has over 9 years of experience (5 years industry) with analytical method development and validation, protein refolding and purification, formulation and stability strategy, and protein biophysical characterization.
Prior to Amgen, Amber's experiences include analytical and formulation development for Merck & Co. and collaborations with BaroFold, Inc. to employ high hydrostatic pressure to refold proteins and control and characterize subvisible particles.
- mportance of using orthogonal methods for particle identification
- What tools are available for the types of particles being analyzed
- CMC Consultant
- QC Managers
- Heads of Quality and Analytics
- Analytic Scientists
