Freeze-drying/lyophilization of pharmaceutical and biological products / edited by Louis Rey, Joan C. May.

Includes bibliographical references and index.

Glimpses into the realm of freeze-drying - classical issues and new ventures; potential energy surfaces, computer simulations, and the structure of water; structural and dynamic properties of bulk and confined water; experimental freeze-drying procedures and equipment; freezing and drying-induced perturbations of protein structure and mechanisms of protein protection by stabilizing additives; mechanisms of protein stabilization during freeze-drying and storage - the relative importance of thermodynamic stabilization and glassy state relaxation dynamics; the regulatory control of freeze-dried products - importance and evaluation of residual moisture; basic aspects and industrial strategies for the preservation of microorganisms by freezing and drying; industrial freeze-drying for pharmaceutical applications; industrial freeze-drying of vaccines destined for veterinary purposes - an overview; manufacturing principles of freeze-dried collagen sponges - characteristics and applications; lyophilization process validation; critical steps in the preparation of elastomeric closures for biopharmaceutical freeze-dried products; technical procedures for operation of cleaning in place and sterilization in place process for production freeze-drying equipment; studies on the development of manufacturing processes for pharmaceutical freeze-dried products; potential prospects in freeze-drying.

Highlights the application of freeze-drying to pharmaceuticals, illustrating practical and industry-tested methods of preserving and reactivating delicate biologicals and biochemicals. The text discusses the basic principles and engineering aspects of lyophilization.