Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2484436 | Journal of Pharmaceutical Sciences | 2016 | 10 Pages |
Abstract
This study explored the ability to conduct primary drying during lyophilization at product temperatures above the glass transition temperature of the maximally freeze-concentrated solution (Tgâ²) in amorphous formulations for four proteins from three different classes. Drying above Tgâ² resulted in significant reductions in lyophilization cycle time. At higher protein concentrations, formulations freeze dried above Tgâ² but below the collapse temperature yielded pharmaceutically acceptable cakes. However, using an immunoglobulin G type 4 monoclonal antibody as an example, we found that as protein concentration decreased, minor extents of collapse were observed in formulations dried at higher temperatures. No other impacts to product quality, physical stability, or chemical stability were observed in this study among the different drying conditions for the different proteins. Drying amorphous formulations above Tgâ², particularly high protein concentration formulations, is a viable means to achieve significant time and cost savings in freeze-drying processes.
Keywords
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Authors
Roberto A. Depaz, Swapnil Pansare, Sajal Manubhai Patel,