Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products

Summary

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 regulations that impact lyophilization practices. This volume addresses these changes with revised chapters on emerging developments in lyophilization technology, research, and industry procedures. Providing both a scientific and industrial perspective, this comprehensive text is a valuable resource for all those who use freeze-drying technology.

Table of Contents

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;

Regulatory Control of Freeze-Dried Products: Importance and Evaluation of Residual Moisture;

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

Index