The effect of loading process on product collapse during large-scale lyophilization.

Lyophilization is a process commonly used by the pharmaceutical industry in order to enhance product stability by removal of the solvent, typically water. Previous studies have investigated several causes of variability during the lyophilization process, including freezing, vial placement within the lyophilization chamber, primary drying, and secondary drying. These differences can contribute to variability in cake appearance, moisture results, and stability profiles.