Optimization of Methodologies to Study Freeze/Thaw Processes in Drug Substance Bottles.

ABSTRACT: Biological drug substance (DS) is often frozen to enhance storage stability, prolong shelf life, and increase flexibility during manufacturing. However, the freezing and thawing (F/T) of bulk DS at the manufacturing scale can impact product quality as a result of various critical conditions, including cryo-concentration during freezing, which are influenced, among other things, by product-independent process parameters (e.g., container type, fill level, F/T equipment, and protocols). In this article, we report the optimization of two major methodologies to study product-independent process parameters in DS bottles at the manufacturing scale, namely the recording of temperature profiles and liquid sampling after thawing to quantify the concentration gradients in the solution. We report expe

SUBMITTER: Pelaez SS 

PROVIDER: S-EPMC11417747 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature