Quality by Design (QbD) in Freeze Drying

Freeze drying, or lyophilization, is a commonly used and well-established process in the pharmaceutical industry to preserve the original structure of a heat-sensitive product. The goal of this entry is to illustrate the difficulty in establishing a true ObD concept for pharmaceutical freeze drying, exemplifying the key interrelationship between physiochemical properties of a formulation, representativeness of procedures to measure such properties and possibilities to control them by PAT tools.