Publisher's Synopsis
Freeze-drying and formulation are the last steps involved in the manufacturing of biological products. As most biological products today are protein in nature, the process of freeze-drying and formulation must ensure preservation or restoration of the integrity of the protein structure. This volume brings together information on freeze-drying principles as well as present and future directions in freeze-drying. Basic and applied scientists share their ideas on the role of water in this field and describe the advances made in optimizing and monitoring freeze-drying equipment, processes and formulation with respect to both traditional freeze-dried vaccines and freeze-dried products derived from recombinant and hybridoma methodologies.;Focus is also placed on new regulatory concerns that have arisen since the Center for Biologics Evaluation and Research of the Food and Drug Administration and the International Association of Biological Standardization last addressed this topic in 1976.
