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 deeper understanding of the method limitations is of utmost importance when 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.
Summary
- Date:
- October 18 2018 - October 18 2018
- Time:
-
10:30 - 11:30
(GMT-05:00) Eastern [US & Canada] - Event type:
- Webinar - Live
- Language:
- English
Speakers
Dr. Amber Fradkin - Director, Particle Characterization Core Facility, at KBI Biopharma Inc.
Amber 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 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, 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 subvisible particle characterization for all commercial and late stage clinical products and authored particle characterization sections of numerous regulatory filings. She has over 12 years of experience with analytical method development and validation, formulation and stability strategy, and protein biophysical characterization. Prior to Amgen, Amber’s experiences include analytical and formulation development for Merck and Co. and collaborations with BaroFold, Inc. to employ high hydrostatic pressure to refold proteins and control subvisible particles.
More information
Who should attend?
Those working in the following areas:
Research and Development
Formulation and Stability
Analytical Development
Quality Control
Regulatory
What will you learn?
Attendees willl gain an understanding of which technologies are available for particle characterization in pharmaceutical products, and how to choose the right combination of technologies to characterize a product's particle profile.