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
- Studies on the Development of Manufacturing Processes for Pharmaceutical
Freeze-Dried Products
- Potential Prospects in Freeze-Drying
Index
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