Freeze-Drying Lyophilization of Pharmaceutical and Biological Products edited by Louis Rey and Joan C. May

Freeze-Drying Lyophilization of Pharmaceutical and Biological Products
edited by Louis Rey and Joan C. May

This up-to-the-minute reference highlights the application of freeze-drying to pharmaceuticals—illustrating practical and industry-tested methods of preserving and reactivating delicate biologicals and biochemicals.

Written by over 20 international researchers, including both pure theoreticians and experienced technical experts, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products:

explains the lyophilization process step by step, from vacuum sublimation (primary drying) and desorption (secondary drying) to frozen storage and reconstitution
analyzes the behavior of complex molecules, such as proteins, in cryogenic processes
summarizes the extensive research on the key role of water in different phases and processes such as macromolecule—water and biopolymer—water interactions
describes technologies such as X-ray diffraction, nuclear paramagnetic resonance, electron scanning microscopy, differential scanning calorimetry, thermogravimetry, and thermoluminescence
explores effects of varying temperatures and rates of freezing on crystal structure
examines factors such as electric properties of frozen solutions
demonstrates computer and quantum simulations of molecular dynamics
evaluates new designs for semicontinuous and continuous freeze-drying that produces frozen, free-flowing, spherical granulates
and more!
Containing over 800 references, tables, diagrams, equations, drawings, and photographs, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products is indispensable for pharmacists; organic, medicinal, physical, and surface and colloid chemists; microbiologists and virologists; molecular and cell biologists; and graduate students in these disciplines.
Contents

Glimpses into the Realm of Freeze-Drying: Classical Issues and New Ventures
Potential Energy Surfaces, Computer Simulations, and the Structure of Water
Structural and Dynamic Properties of Bulk and Confined Water
Experimental Freeze-Drying: Procedures and Equipment
Freezing- and Drying-Induced Perturbations of Protein Structure and Mechanisms of Protein Protection by Stabilizing Additives
Mechanisms of Protein Stabilization During Freeze-Drying and Storage: The Relative Importance of Thermodynamic Stabilization and Glassy State Relaxation Dynamics
Regulatory Control of Freeze-Dried Products: Importance and Evaluation of Residual Moisture
Basic Aspects and Industrial Strategies for the Preservation of Microorganisms by Freezing and Drying
Industrial Freeze-Drying for Pharmaceutical Applications
Industrial Freeze-Drying of Vaccines Destined for Veterinary Purposes: An Overview
Manufacturing Principles of Freeze-Dried Collagen Sponges: Characteristics and Applications
Lyophilization Process Validation
Critical Steps in the Preparation of Elastomeric Closures for Biopharmaceutical Freeze-Dried Products
Technical Procedures for Operation of Cleaning-in-Place and Sterilization-in-Place Process for Production Freeze-Drying Equipment