How Blast Freezing Affects The Quality Of Bottled Drug Substance: Test Results And Insights

When freezing drug substances in bottles, the risk of cryoconcentration—where solutes concentrate unevenly as ice forms—poses a serious threat to product quality. To better understand this phenomenon, a study investigated the bulk-scale freezing of a surrogate solution in a conventional blast freezer, focusing on dye distribution, pH, and conductivity changes.

Test results confirmed that freezing in bottles leads to a more pronounced concentration gradient than other container types. They also visually documented the "Volcano Effect," where the formation of an ice front pushes the remaining liquid core and its concentrated solutes toward the center and top of the bottle, creating areas of extremely high concentration. This non-uniform distribution can severely impact the integrity and stability of biopharmaceutical products.

Learn how the Volcano Effect happens and discover the controlled freezing solution that was developed to address these risks, demonstrating a significantly more uniform distribution of solutes. Download the full article for a deep dive into the test methods and results.