WEBINAR: Tuesday, April 23 at 2:00pm ET!
Solid-State Hydrogen Deuterium Exchange with Mass Spectrometric Analysis (ssHDX-MS):
A new analytical method to accelerate the development
of lyophilized protein drug products and processes
When: Tuesday, April 23, at 2:00pm ET
Where: On your PC or mobile device
About Our Speaker:
Elizabeth (Liz) Topp is a professor at Purdue University in the Department of Industrial and Physical Pharmacy. She holds a bachelor’s degree in chemical engineering from the University of Delaware, a master’s degree in chemical and biochemical engineering from the University of Pennsylvania, and a Ph.D. in pharmaceutics from the University of Michigan. Her research is concerned with the stability and formulation of protein drugs, with particular emphasis on lyophilized solids.
WEBINAR DESCRIPTION: The development of lyophilized protein drug products, and of the lyophilization processes that produce them, depends on time-consuming shelf-stability studies to assure product quality. These studies can take months to years to complete. Our group has developed ssHDX-MS to measure protein structure and matrix interactions in lyophilized solids with high resolution. Recently, we have shown that ssHDX-MS results are highly correlated with shelf-stability for a monoclonal antibody. In addition, we have shown that ssHDX-MS is sensitive to both process and formulation differences that are not detected by other methods. Since ssHDX-MS studies can be completed in weeks rather than months or years, the method shows promise as a surrogate for stability studies in developing lyophilized protein drug products and processes. This webinar will describe the ssHDX-MS method and summarize our results.