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.
A new analytical method to accelerate the development of lyophilized protein drug products and processes.
Elizabeth (Liz) Topp is a professor 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.
LyoHUB, an industry consortium to advance lyophilization technology, will also be presented briefly.
LyoHUB, an industry consortium to advance lyophilization technology, will also be presented briefly.