Drying technologies for biotechnology and pharmaceutical applications [electronic resource] / edited by Satoshi Ohtake, Ken-ichi Izutsu, David Lechuga-Ballesteros.

Description based upon print version of record.

Cover -- Title Page -- Copyright -- Contents -- Chapter 1 Introduction -- Acknowledgement -- References -- Chapter 2 A Concise History of Drying -- 2.1 Introduction -- 2.2 History of Drying of Pharmaceutical Products -- 2.3 History of Selected Drying Technologies -- 2.3.1 Freeze Drying -- 2.3.2 Spray Drying -- 2.3.3 Fluidized-Bed Drying -- 2.3.4 Supercritical Drying -- 2.4 Concluding Remarks -- Acknowledgments -- References -- Part I Drug Product Development -- Chapter 3 Importance of Drying in Small Molecule Drug Product Development -- 3.1 Introduction -- 3.2 Drying Materials and Dryer Types

3.3 Directly Heated (Convective) Dryers -- 3.3.1 Tray Drying -- 3.3.1.1 Description -- 3.3.1.2 Utility -- 3.3.1.3 Drawbacks and Challenges -- 3.3.2 Fluidized-Bed Drying -- 3.3.2.1 Description -- 3.3.2.2 Determination of End Point of Drying -- 3.3.2.3 Advantages, Utility, and Drawbacks -- 3.3.3 Spray Drying -- 3.3.3.1 Description -- 3.3.3.2 Role in Formulation Development -- 3.4 Indirectly Heated (Conductive) Dryers -- 3.4.1 Rotary Drying -- 3.4.1.1 Description -- 3.4.1.2 Advantages and Drawbacks -- 3.4.2 Freeze Drying -- 3.4.2.1 Description -- 3.4.2.2 Advantages and Drawbacks

3.4.2.3 Role in Small Molecule Formulation Development -- 3.5 Emerging Drying Technologies -- 3.5.1 Supercritical Fluid (SCF) Drying -- 3.5.1.1 Description -- 3.5.1.2 Advantages and Drawbacks -- 3.5.1.3 Pharmaceutical Applications -- 3.5.2 Microwave Drying -- 3.5.2.1 Pharmaceutical Applications -- 3.6 Summary -- References -- Chapter 4 Drying for Stabilization of Protein Formulations -- 4.1 Protein Stability -- 4.1.1 Physical Instability of Proteins -- 4.1.2 Chemical Instability of Proteins -- 4.1.2.1 Disulfide Bond Formation -- 4.1.2.2 Deamidation -- 4.1.2.3 Oxidation -- 4.1.2.4 Glycation

4.1.3 Analysis of Protein Stability -- 4.1.3.1 Particle Analysis in Protein Formulations -- 4.1.3.2 Other Purity Tests for Proteins -- 4.1.3.3 Analysis of Higher-Order Structure -- 4.2 Protein Stability in the Dried State -- 4.2.1 Theoretical Considerations -- 4.2.1.1 Water Replacement Hypothesis -- 4.2.1.2 Glass Dynamics Hypothesis and Vitrification -- 4.2.2 Analysis of the Dried State -- 4.2.2.1 Investigation of Endo- and Exothermic Processes: Glass Transition and Crystallization -- 4.2.2.2 Sample Morphology: Crystalline or Amorphous Matrix? -- 4.2.2.3 Residual Moisture

Chapter 5 Vaccines and Microorganisms

Includes bibliographical references and index.