Temperature Based Process Characterization of Pharmaceutical Freeze-Thaw Operations.

ABSTRACT: In biopharmaceutical production processes, freeze-thaw operations are used to ensure product integrity during long hold times, but they also introduce additional stresses such as freeze concentration gradients that might lead to a loss of protein activity. Process characterization of freeze-thaw operations at different scales should be conducted with attention to freezing time and boundary effects to ensure the product stability throughout the process and process development. Currently, process characterization often relies on one or very few temperature probes that detect freezing times based on raw temperature, which is largely influenced by freezing-point depression in case of concentrated solutions. A method to detect freezing based on the second derivative of temperature measurements

SUBMITTER: Weber D 

PROVIDER: S-EPMC8062970 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature