Freeze-drying of bioproducts: putting principles into practice.

The product and process parameters that determine successful freeze-drying are described and their interrelationships are explored. It is shown that the thermochemical and thermomechanical properties of water-soluble, amorphous materials form the basis of effective formulation design and that coordinated approaches to formulation and process development achieve optimum results with a minimum of trial-and-error experimentation.