3rd Edition
Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products
Glimpses into the Realm of Freeze-Drying: Classical Issues and New Ventures; Louis Rey
Structural and Dynamic Properties of Bulk and Confined Water; Marie-Claire Bellissent-Funel and Jose Teixeira
Freezing and Annealing Phenomena in Lyophilization; Jim A. Searles
Phase Separation of Freeze-Dried Amorphous Solids: The Occurrence and Detection of Multiple Amorphous Phases in Pharmaceutical Systems; Adora M. Padilla and Michael J. Pikal
The Use of Microscopy, Thermal Analysis, and Impedance Measurements to Establish Critical Formulation Parameters for Freeze-Drying Cycle Development; Kevin R. Ward and Paul Matejtschuk
The Relevance of Thermal Properties for Improving Formulation and Cycle Development: Application to Freeze-Drying of Proteins; Stéphanie Passot, Ioan Cristian Tréleéa, Michèle Marin, and Fernanda Fonseca
Freezing- and Drying-Induced Perturbations of Protein Structure and Mechanisms of Protein Protection by Stabilizing Additives; John F. Carpenter, Ken-ichi Izutsu, and Theodore W. Randolph
Mechanisms of Protein Stabilization During Freeze-Drying Storage: The Relative Importance of Thermodynamic Stabilization and Glassy State Relaxation Dynamics; Michael J. Pikal
Formulation Characterization; D. Q. Wang
Practical Aspects of Freeze-Drying of Pharmaceutical and Biological Products Using Nonaqueous Cosolvent Systems;
Dirk L. Teagarden, Wei Wang, and David S. Baker
Regulatory Control of Freeze-Dried Products: Importance and Evaluation of Residual Moisture;
Joan C. May
Freeze-Drying of Biological Standards; Paul Matejtschuk, Michelle Stanley, and Paul Jefferson
Molecular Mobility of Freeze-Dried Formulations as Determined by NMR Relaxation Times, and Its Effect on Storage Stability; Sumie Yoshioka and Yukio Aso
Scanning Electron Microscopy: A Powerful Tool for Imaging Freeze-Dried Material; Tauno Jalanti
Pharmaceutical Packaging for Lyophilization Applications; Claudia Dietrich, Florian Maurer, Holger Roehl, and Wolfgang Frieß
Closure and Container Considerations in Lyophilization; Fran L. DeGrazio
Extractables and Leachables as Container Closure Considerations in Lyophilization; Diane Paskiet and Fran L. DeGrazio
Optimizing the Throughput of Freeze-Dryers Within a Constrained Design Space; Jim A. Searles
Monitoring and Control of Industrial Freeze-Drying Operations: The Challenge of Implementing Quality-by-Design (QbD); Miquel Galan
Process Analytical Technology in Industrial Freeze-Drying; Antonello A. Barresi, Davide Fissore, and Daniele L. Marchisio
Practical Considerations for Freeze-Drying in Dual Chamber Package Systems; Dirk L. Teagarden, Stanley M. Speaker, Susan W. H. Martin, and Thomas Österberg
Lyophilization and Irradiation as an Integrated Process; Dalal Aoude-Werner and Florent Kuntz
Appendix: Table, Saturation Vapor Pressure of Ice
Index
Biography
Rey, Louis
