Event Overview:
 
Protein characterization technologies have advanced in recent years, but implementing new methods requires an evaluation of their advantages and disadvantages, including speed, accuracy, cost, regulatory acceptance, and how they fit into the overall toolkit of orthogonal methods. This seminar will offer insights and experience from end users and regulators on advanced protein characterization technologies, including several that can be applied to multiple protein products to save time in method development.

High-Throughput Multi-Product Methods for Characterizing Monoclonal Antibodies
Dell Farnan, PhD, Senior Scientist and Group Leader, Protein Analytical Chemistry, Genentech, Inc.
 
This presentation will address advances in high-throughput liquid chromatography and electrophoretic methods for protein characterization, focusing on multi-product and high-throughput options such as CE-SDS, CIEF, pH-IEC, and UHPLC. In addition, we will discuss technological advances in sample preparation throughput and data handling automation.
 
Using NMR Spectroscopy to Determine the Higher Order Structure of Biopharmaceutical Products
Yves Aubin, PhD, NMR Laboratory, Protein Structure and Analysis Laboratories, BGTD, Centre for Biologics Research, Health Canada
 
Nuclear magnetic resonance (NMR) spectroscopy is a well-established technique for biomolecular structure determination, but underutilized in characterizing biotherapeutics because it is misperceived as too expensive or complicated. This presentation will demonstrate simple applications of NMR that easily provide detailed information on higher order structure. It also will address the complexity and cost of including NMR in the process and quality control environments.