Malvern Panalytical has announced its latest webinar, ‘Analytical Approaches and Regulatory Expectations for Characterisation and Control Strategies for Subvisible Particles in Biopharmaceutical Products’.
Significant advances have been made in analytical technology for the characterisation and identification of particles present in pharmaceutical products. With these advances comes a tremendous amount of new data to characterise biologics, devices and small molecules.
In parallel with these technological advances, the regulatory agencies have shown increased interest in more in-depth characterisation of therapeutic products. Careful interpretation of data and a deeper understanding of the method limitations is of utmost importance when using complementary methods to characterise particle profiles of therapeutic products for regulatory submissions.
This presentation demonstrates how multiple particle techniques can be used to adequately characterise therapeutic products and their particle populations.
This webinar will take place on 18 October from 10:30 (GMT-5:00) to 11:30.
Speaker Dr Amber Fradkin is director of particle characterisation core facility at KBI Biopharma. She received her PhD in Chemical Engineering within the pharmaceutical biotechnology programme with a specialisation 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. She currently holds the position of director at KBI Biopharma where she manages the particle characterisation Core that specialises in analytical methods for quantifying, characterising and identifying submicron, subvisible and visible particulates.
At Amgen, Amber was previously a scientist within the biomolecular structures and interactions group where she supported the biophysical characterisation of protein products with a speciality in subvisible particle characterisation and identification. She also managed subvisible particle characterisation for all commercial and late-stage clinical products and authored particle characterisation sections of numerous regulatory filings.
She has more than 12 years’ experience with analytical method development and validation, as well as formulation and stability strategy and protein biophysical characterisation. Prior to Amgen, Amber’s experiences include analytical and formulation development for Merck and Co and collaborations with BaroFold to employ high hydrostatic pressure to refold proteins and control subvisible particles.
Who should attend?
Those working in research and development (R&D), formulation and stability, analytical development, quality control and regulatory sectors should attend the webinar to gain an understanding of the technologies available for particle characterisation in pharmaceutical products, and how to choose the right combination of technologies to characterise a product’s particle profile.