Freeze-drying/lyophilization of pharmaceutical and biological products /
Freeze-drying/lyophilization of pharmaceutical and biological products /
edited by Louis Rey, Joan C. May.
- ix, 477 pages : illustrations ; 24 cm.
- Drugs and the pharmaceutical sciences ; 96 .
- Drugs and the pharmaceutical sciences ; v. 96. .
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.
0824719832 (acidfree paper)
99026168
Freeze-drying.
Drugs--Drying.
Biological products--Drying.
Freeze Drying--methods.
Biological Products.
Pharmaceutical Preparations.
RS199.F74 / F74 1999
615.19 / F
W1 / DR893B v.96 1999 QH 324.9 / F857 1999
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.
0824719832 (acidfree paper)
99026168
Freeze-drying.
Drugs--Drying.
Biological products--Drying.
Freeze Drying--methods.
Biological Products.
Pharmaceutical Preparations.
RS199.F74 / F74 1999
615.19 / F
W1 / DR893B v.96 1999 QH 324.9 / F857 1999