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

Contributor(s):

Material type: Text

TextSeries: Drugs and the pharmaceutical sciences ; v. 137.Publisher: New York : Marcel Dekker, [2004]Copyright date: ©2004Edition: Second edition. revised and expandedDescription: vxvi, 613 pages : illustrations ; 24 cmContent type:

text

Media type:

unmediated

Carrier type:

volume

ISBN:

0824748689

Subject(s):

DDC classification:

615.19 22 F

Online resources:

Abstract

Contents:

Foreword -- Preface -- Contents -- Chapter 1: Glimpses into the Realm of Freeze-Drying: Fundamental Issues -- Chapter 2: Structural and Dynamic Properties of Bulk and Confined Water -- Chapter 3: Mechanisms of Protein Stabalization During Freeze-Drying and Storage: The Relative Importance of Thermodynamic Stabalization and Glassy State Relaxation Dynamics -- Chapter 4: Freezing and Annealing Phenomena in Lyophilization -- Chapter 5: Freezing- and Drying-Induced Pertubations of Protien Structure and Mechanisms of Protein Protection by Stabilizing Additives -- Chapter 6: Molecular Mobility of Freeze-Dried Formulations as Determined by NMR Relaxation, and it's Effect on Storage Stability -- Chapter 7: Formulation Characterization -- Chapter 8: Practical Aspects of Freeze-Drying of Pharmaceutical and Biological Products Using Non-Aqueous Co-Solvent Systems -- Chapter 9: Cosure and Container Considerations in Lyophilization -- Chapter 10: Advanced Glassware for Freeze-Drying -- Chapter 11: Critical Steps in the Preperation of Elastomeric Closures for Biopharmaceutical Freeze-Dried Products -- Chapter 12: Development of a New Concept for Bulk Freeze-Drying: LYOGUARD Freeze-Dry Packaging -- Chapter 13: Regulatory Control of Freeze-Dried Products: Importance and Evaluation of Residual Moisture -- Chapter 14: Freeze-Drying of Biological Standards -- Chapter 15: Industrial Freeze-Drying for Pharmaceutical Applications -- Chapter 16: Development of Process Data in a Pilot Plant Transferable to Production -- Chapter 17: Technical Procedures for Operation of Cleaning-in-Place/Sterilization-in-place Process for Production Freeze-Drying Equipment -- Chapter 18: Global Validation of Freeze-Drying Cycle Parameters by Using Integral HFT Systems -- Chapter 19: Lyophilizer Qualification: Some Practical Advice. Chapter 20: Lyophilization Process Validation -- Chapter 21: A New Development: Irradiation of Freeze-Dried Vaccine and Other Select Biological Products -- Chapter 22: Some Leading Edge Prospects in Lyophilization -- Index.

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Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Books	Main library A10	Pharmacy ( Pharmaceutical Technology )	615.19 F (Browse shelf(Opens below))	Available		00000700

Foreword --
Preface --
Contents --
Chapter 1: Glimpses into the Realm of Freeze-Drying: Fundamental Issues --
Chapter 2: Structural and Dynamic Properties of Bulk and Confined Water --
Chapter 3: Mechanisms of Protein Stabalization During Freeze-Drying and Storage: The Relative Importance of Thermodynamic Stabalization and Glassy State Relaxation Dynamics --
Chapter 4: Freezing and Annealing Phenomena in Lyophilization --
Chapter 5: Freezing- and Drying-Induced Pertubations of Protien Structure and Mechanisms of Protein Protection by Stabilizing Additives --
Chapter 6: Molecular Mobility of Freeze-Dried Formulations as Determined by NMR Relaxation, and it's Effect on Storage Stability --
Chapter 7: Formulation Characterization --
Chapter 8: Practical Aspects of Freeze-Drying of Pharmaceutical and Biological Products Using Non-Aqueous Co-Solvent Systems --
Chapter 9: Cosure and Container Considerations in Lyophilization --
Chapter 10: Advanced Glassware for Freeze-Drying --
Chapter 11: Critical Steps in the Preperation of Elastomeric Closures for Biopharmaceutical Freeze-Dried Products --
Chapter 12: Development of a New Concept for Bulk Freeze-Drying: LYOGUARD Freeze-Dry Packaging --
Chapter 13: Regulatory Control of Freeze-Dried Products: Importance and Evaluation of Residual Moisture --
Chapter 14: Freeze-Drying of Biological Standards --
Chapter 15: Industrial Freeze-Drying for Pharmaceutical Applications --
Chapter 16: Development of Process Data in a Pilot Plant Transferable to Production --
Chapter 17: Technical Procedures for Operation of Cleaning-in-Place/Sterilization-in-place Process for Production Freeze-Drying Equipment --
Chapter 18: Global Validation of Freeze-Drying Cycle Parameters by Using Integral HFT Systems --
Chapter 19: Lyophilizer Qualification: Some Practical Advice. Chapter 20: Lyophilization Process Validation --
Chapter 21: A New Development: Irradiation of Freeze-Dried Vaccine and Other Select Biological Products --
Chapter 22: Some Leading Edge Prospects in Lyophilization --
Index.

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