Higher Order Structure Analysis for Biopharmaceutical Quality and Comparability

Event Overview

Analysis of the higher order structure (HOS) of a protein is crucial to understand its function, how potential changes can affect critical quality attributes (CQAs) throughout the product life cycle, and for comparability studies during biosimilar development.

In this webcast, experts will review the role biophysical techniques play in understanding the HOS of protein-based therapeutics. The discussion will include an overview of the challenges associated with identifying, assessing, and testing CQAs during development and manufacturing of protein-based drugs; a review of advancements in biophysical methods for characterization and comparability studies; an explanation of regulatory expectations; and an examination of the role that hydrogen/deuterium exchange–mass spectrometry (HDX–MS) can play in higher order structure analysis and epitope mapping.

Key Learning Objectives

• Understand the role biophysical characterization plays in various stages on biopharmaceutical development and manufacturing
• Review limitations of existing biophysical methods for the elucidation of HOS of biopharmaceuticals and advances that have led more widespread adoption
• Understand the general principles of HDX–MS and how the higher resolution provided by this method complements and interprets conventional lower resolution analytical methods

For more information, please contact:

McKenzie Landgraf
Life Sciences Marketing Manager
t: +1 877 677 2667