Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products

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