Stability Testing for Lyophilized Biologics
Stability Testing for Lyophilized Biologics Comprehensive Guide to Stability Testing for Lyophilized Biologics Lyophilization, or freeze-drying, is a common strategy to improve the shelf life and stability of biopharmaceuticals—particularly those that are sensitive to heat, moisture, or chemical degradation in aqueous form. However, while lyophilized formats offer improved stability, they present unique challenges in stability…