Pharmaceutical Science Reference from C.H.I.P.S.

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.


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

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Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products
edited by Louis Rey and Joan C. May
476 pages • $228.95 + shipping

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