TY  - BOOK
AU  - Rey,Louis
AU  - May,Joan C.
TI  - Freeze-drying/lyophilization of pharmaceutical and biological products
T2  - Drugs and the pharmaceutical sciences
SN  - 0824719832 (acidfree paper)
AV  - RS199.F74 F74 1999
U1  - 615.19 21
PY  - 1999///]
CY  - New York
PB  - Marcel Dekker
KW  - Freeze-drying
KW  - Drugs
KW  - Drying
KW  - Biological products
KW  - Freeze Drying
KW  - methods
KW  - Biological Products
KW  - Pharmaceutical Preparations
N1  - 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

N2  - 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
ER  -