Lyophilization

Removing water from a frozen product under vacuum, first by sublimation and then by desorption, to give a dry cake that is reconstituted before use. It improves the stability of proteins that degrade in solution, at the cost of long cycles, expensive equipment and more development work. Freeze-dryer capacity often limits how much a fill-finish site can produce. Japanese documents use the same term for the process and for the freeze-dried dosage form.