Validation of Controlled Freezing and Thawing: A 9-L Bottle Study

摘要

Freeze-thaw processes affect the quality of biopharmaceutical proteins (1-13) and human cells (14). It has been reported that no method consistently controls freezing and thawing rates for biological formulations (1). My recent study refutes that claim with validated rate-controlled freezing and thawing of such formulations in 16-L single-use bags (IS).