Includes bibliographical references and index at the end of each chapters.

Online resource; title from PDF title page (ebrary, viewed September 17, 2014).

Front Cover; Biophysical Characterization of Proteins in Developing Biopharmaceuticals; Copyright; Contents; List of Contributors; About the Editors; Preface; List of Abbreviations and Symbols; Chapter 1 -- The Complexity of Protein Structure and the Challenges it Poses in Developing Biopharmaceuticals; 1.1 THE BASICS OF PROTEIN HIGHER-ORDER STRUCTURE (HOS); 1.2 THE SEARCH FOR HOW PROTEINS ATTAIN THEIR CORRECT HOS: THE PROTEIN FOLDING PROBLEM; 1.3 SURPRISES IN THE WORLD OF PROTEIN FOLDING: INTRINSICALLY DISORDERED OR UNSTRUCTURED PROTEINS (AN APPARENT CHALLENGE TO THE ...

1.4 PROTEINS AND THE BIOPHARMACEUTICAL INDUSTRY: PROBLEMS AND CHALLENGES1.5 CONCLUSION; References; Further Reading; Chapter 2 -- Biophysical Characterization and Its Role in the Biopharmaceutical Industry; 2.1 DRUG DEVELOPMENT PROCESS; 2.2 PROTEIN DRUGS (BIOPHARMACEUTICALS); 2.3 THE ROLE OF BIOPHYSICAL CHARACTERIZATION IN BIOPHARMACEUTICAL DRUG DEVELOPMENT; 2.4 THE CHALLENGES IN CONDUCTING BIOPHYSICAL MEASUREMENTS TO DETECT CHANGES IN A PROTEIN DRUG''S HOS; 2.5 REGULATORY NEEDS AND CONSIDERATIONS; References; Further Reading; Chapter 3 -- Biopharmaceutical Industry''s Biophysical Toolbox.

3.1 ATTRIBUTES OF A SINGLE BIOPHYSICAL TOOL TO CHARACTERIZE AND DETECT CHANGES IN THE HIGHER ORDER STRUCTURE OF A BIOPHARMACEUTICAL3.2 STUDYING THE BIOPHYSICAL PROPERTIES OF A BIOPHARMACEUTICAL AS AN INDIRECT APPROACH FOR CHARACTERIZING CHANGES IN ITS HOS; 3.3 GENERAL CONSIDERATIONS IN ANALYZING THE BIOPHYSICAL PROPERTIES OF BIOPHARMACEUTICALS; 3.4 THE UTILITY OF USING STRESS TO MONITOR CHANGES IN THE HOS PROFILE OF A PROTEIN DRUG; 3.5 PRESENT BIOPHYSICAL TOOLBOX; 3.6 CONCLUSION; References; Further Reading.

Chapter 4 -- An Introduction and Hierarchical Organization of the Biophysical Tool in Section II4.1 INTRODUCTION; 4.2 THE STANDARD CLASS OF BIOPHYSICAL TOOLS USED IN THE BIOPHARMACEUTICAL INDUSTRY; 4.3 THE ADVANCED CLASS OF BIOPHYSICAL TOOLS USED IN THE BIOPHARMACEUTICAL INDUSTRY; 4.4 AN OVERVIEW OF SECTION II; References; Further Reading; Chapter 5 -- The Value of UV, Fluorescence, and FTIR Spectroscopy in Biopharmaceutical Development; 5.1 INTRODUCTION; 5.2 THE ORIGINS OF ELECTRONIC ABSORPTION, FLUORESCENCE, AND FT-IR SPECTROSCOPY; 5.3 CONFORMATIONAL ANALYSIS OF PROTEINS IN SOLUTION.

5.4 OPTICAL SPECTROSCOPY AND PRODUCT COMPARABILITY5.5 OPTICAL SPECTROSCOPY AND HIGH-THROUGHPUT METHODS; 5.6 SOLID-STATE MEASUREMENTS; 5.7 CONCLUSIONS; References; Chapter 6 -- Circular Dichroism Spectroscopy for Protein Characterization: Biopharmaceutical Applications; 6.1 INTRODUCTION; 6.2 INSTRUMENTATION; 6.3 DATA GENERATED; 6.4 GUIDE TO COLLECTING GOOD DATA; 6.5 DATA PROCESSING AND ANALYSES; 6.6 ROLE IN THE RESEARCH INDUSTRY; 6.7 TECHNOLOGY AVAILABILITY; 6.8 FUTURE DEVELOPMENTS; Acknowledgments; References; Further Reading.

Chapter 7 -- Size-Exclusion Chromatograph (SEC) in Biopharmaceutical Process Development.

Biophysical Characterization of Proteins in Developing Biopharmaceuticals is concerned with the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure this book takes the reader on a journey on how to best achieve this goal using the key relevant and practical methods commonly employed in the biopharmaceutical industry today as well as up and coming promising methods that are now gaining increasing attention. As a general resource guide this book has been written with the intent to help tod.