Water Activity as an Indicator for Antibody Storage Stability in Lyophilized Formulations.

ABSTRACT: Lyophilization remains a key method for preserving sensitive biopharmaceuticals such as monoclonal antibodies. Traditionally, stabilization mechanisms have been explained by vitrification, which minimizes molecular mobility in the lyophilized cake, and water replacement, which restores molecular interactions disrupted by water removal. This study proposes a novel design strategy that combines water activity and glass-transition temperature as the main indicators to predict long-term stability in lyophilized formulations. The water activity, calculated as the product of water activity coefficient and (residual) water content, serves as a mutual indicator of molecular interactions and influence of residual water content in the lyophilizate. By predicting beneficial excipient combinations thr

SUBMITTER: Zah M 

PROVIDER: S-EPMC11795528 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature