Physical Sciences Inc., in collaboration with the University of Connecticut, the University of Massachusetts Lowell, Purdue University, Genentech and Merck, has developed software modeling tools for lyophilization primary drying process development and scale-up. The user-friendly software incorporates a heat and mass transfer model of freeze-drying developed by Pikal et al. that includes the effects of statistical variation and heterogeneous drying, distinguishing sublimation from center, inner-edge and outer edge vials. Model validation experiments were performed on two industry-supplied drug formulations to test the ability of the new tool to develop primary drying cycles and correctly predict product temperatures and drying times. Results from these experiments demonstrated the predictive capability of the model, but highlighted the need to provide accurate model inputs for process parameters. The use of the process development and scale-up software model enables more rapid development of freeze-drying processes, and provides process knowledge and design spaces that support the development of optimized drying cycles. This work was performed under a Project Award Agreement from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and financial assistance award 70NANB17H002 from the U.S. Department of Commerce, National Institute of Standards and Technology. Presented by Emily Gong, Senior Research Scientist at PSI
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