Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this process has met with many changes, as have the regula
Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this process has met with many changes, as have the regula
Foreword Preface Contributors 1. Glimpses into the Realm of Freeze-Drying: Classical Issues and New Ventures 2. Structural and Dynamic Properties of Bulk and Confined Water 3. Freezing and Annealing Phenomena in Lyophilization 4. Phase Separation of Freeze-Dried Amorphous Solids: The Occurrence and Detection of Multiple Amorphous Phases in Pharmaceutical Systems 5. The Use of Microscopy Thermal Analysis and Impedance Measurements to Establish Critical Formulation Parameters for Freeze-Drying Cycle Development 6. The Relevance of Thermal Properties for Improving Formulation and Cycle Development: Application to Freeze-Drying of Proteins 7. Freezing- and Drying-Induced Perturbations of Protein Structure and Mechanisms of Protein Protection by Stabilizing Additives 8. Mechanisms of Protein Stabilization During Freeze-Drying Storage: The Relative Importance of Thermodynamic Stabilization and Glassy State Relaxation Dynamics 9. Formulation Characterization 10. Practical Aspects of Freeze-Drying of Pharmaceutical and Biological Products Using Nonaqueous Cosolvent Systems 11. Regulatory Control of Freeze-Dried Products: Importance and Evaluation of Residual Moisture 12. Freeze-Drying of Biological Standards 13. Molecular Mobility of Freeze-Dried Formulations as Determined by NMR Relaxation Times and Its Effect on Storage Stability 14. Scanning Electron Microscopy: A Powerful Tool for Imaging Freeze-Dried Material 15. Pharmaceutical Packaging for Lyophilization Applications 16. Closure and Container Considerations in Lyophilization 17. Extractables and Leachables as Container Closure Considerations in Lyophilization 18. Optimizing the Throughput of Freeze-Dryers Within a Constrained Design Space 19. Monitoring and Control of Industrial Freeze-Drying Operations: The Challenge of Implementing Quality-by-Design (QbD) 20. Process Analytical Technology in Industrial Freeze-Drying 21. Practical Considerations for Freeze-Drying in Dual Chamber Package Systems 22. Lyophilization and Irradiation as an Integrated Process Appendix: Table Saturation Vapor Pressure Of Ice Index
Foreword Preface Contributors 1. Glimpses into the Realm of Freeze-Drying: Classical Issues and New Ventures 2. Structural and Dynamic Properties of Bulk and Confined Water 3. Freezing and Annealing Phenomena in Lyophilization 4. Phase Separation of Freeze-Dried Amorphous Solids: The Occurrence and Detection of Multiple Amorphous Phases in Pharmaceutical Systems 5. The Use of Microscopy Thermal Analysis and Impedance Measurements to Establish Critical Formulation Parameters for Freeze-Drying Cycle Development 6. The Relevance of Thermal Properties for Improving Formulation and Cycle Development: Application to Freeze-Drying of Proteins 7. Freezing- and Drying-Induced Perturbations of Protein Structure and Mechanisms of Protein Protection by Stabilizing Additives 8. Mechanisms of Protein Stabilization During Freeze-Drying Storage: The Relative Importance of Thermodynamic Stabilization and Glassy State Relaxation Dynamics 9. Formulation Characterization 10. Practical Aspects of Freeze-Drying of Pharmaceutical and Biological Products Using Nonaqueous Cosolvent Systems 11. Regulatory Control of Freeze-Dried Products: Importance and Evaluation of Residual Moisture 12. Freeze-Drying of Biological Standards 13. Molecular Mobility of Freeze-Dried Formulations as Determined by NMR Relaxation Times and Its Effect on Storage Stability 14. Scanning Electron Microscopy: A Powerful Tool for Imaging Freeze-Dried Material 15. Pharmaceutical Packaging for Lyophilization Applications 16. Closure and Container Considerations in Lyophilization 17. Extractables and Leachables as Container Closure Considerations in Lyophilization 18. Optimizing the Throughput of Freeze-Dryers Within a Constrained Design Space 19. Monitoring and Control of Industrial Freeze-Drying Operations: The Challenge of Implementing Quality-by-Design (QbD) 20. Process Analytical Technology in Industrial Freeze-Drying 21. Practical Considerations for Freeze-Drying in Dual Chamber Package Systems 22. Lyophilization and Irradiation as an Integrated Process Appendix: Table Saturation Vapor Pressure Of Ice Index
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