Over 40% of FDA-approved protein drugs are sold as solid powders, mainly produced by lyophilization. This process is effective but slow. Stability studies, which ensure product quality, take months or years due to slow degradation, delaying new drug availability and manufacturing improvements.
This project will evaluate a novel analytical
method, called solid-state hydrogen deuterium exchange with mass spectrometric analysis
(ssHDX-MS), as an alternative to stability studies for proteins in solid powders. ssHDX-MS takes
just days to complete and the results are highly correlated with formulation-induced stability
changes.
For the two studied lyophilized proteins, ssHDX-MS predicted stability in ~400 hrs, vs. 12 months for a standard stability study.
ssHDX-MS was demonstrated on a protein that underwent a novel Microglassification(TM) technique as well as a spray dried formulation.
Decrease the risk of post-approval CMC changes and enable high-resolution evaluation of novel drying technologies for recombinant proteins.
Evaluation of ssHDX-MS as a potential tool to rapidly determine the stability of lyophilized drug products during process development and formulation.
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Purdue University
Genentech, Inc.
Lindy Biosciences, Inc.
