Biophysical Characterization of Proteins in Developing Biopharmaceuticals

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 today’s industrial scientists working in the biopharmaceutical industry or the scientists of tomorrow who are planning a career in this industry on how to successfully implement these biophysical methodologies. In so doing a keen focus is placed on understanding the capability of these methodologies in terms of what information they can deliver. Aspects of how to best acquire this biophysical information on these very complex drug molecules, while avoiding potential pitfalls, in order to make concise, well informed productive decisions about their development are key points that are also covered.

Presents the reader with a clear understanding of the real world issues and challenges in using these methods.Highlights the capabilities and limitations of each method.Discusses how to best analyze the data generated from these methods.Points out what one needs to look for to avoid making faulty conclusions and mistakes.In total it provides a check list or road map that empowers the industrial scientists as to what they need to be concerned with in order to effectively do their part in successfully developing these new drugs in an efficient and cost effective manner.

List of Contributors About the Editors Preface List of Abbreviations and Symbols

I: Proteins and Biophysical Characterization in the Biopharmaceutical Industry Chapter 1 - The Complexity of Protein Structure and the Challenges it Poses in Developing Biopharmaceuticals (Steven A. Berkowitz, Damian J. Houde) Chapter 2 - Biophysical Characterization and Its Role in the Biopharmaceutical Industry (Damian J. Houde, Steven A. Berkowitz) Chapter 3 - Biopharmaceutical Industry's Biophysical Toolbox (Damian J. Houde, Steven A. Berkowitz)

II: The Selected Biophysical Tools in the Biopharmaceutical Industry Chapter 4 - An Introduction and Hierarchical Organization of the Biophysical Tool in Section II (Damian J. Houde, Steven A. Berkowitz) Chapter 5 - The Value of UV, Fluorescence, and FTIR Spectroscopy in Biopharmaceutical Development (Mark Brader) Chapter 6 - Circular Dichroism Spectroscopy for Protein Characterization: Biopharmaceutical Applications (A.J. Miles, B.A. Wallace) Chapter 7 - Size-Exclusion Chromatograph (SEC) in Biopharmaceutical Process Development (Steven A. Berkowitz, Damian J. Houde) Chapter 8 - Scattering Techniques for the Characterization of Biopharmaceuticals, Pages 171-209, Lee Makowski, Steven A. Berkowitz, Damian J. Houde Chapter 9 - Characterizing Biopharmaceuticals using Analytical Ultracentrifugation (Steven A. Berkowitz, John S. Philo) Chapter 10 - Subvisible and Visible Particle Analysis in Biopharmaceutical Research and Development, Pages 261-286, Andrea Hawe, Sarah Zölls, Angelika Freitag, John F. Carpenter Chapter 11 - Differential Scanning Calorimetry in the Biopharmaceutical Sciences (Stephen J. Demarest, Verna Frasca) Chapter 12 - Biophysical Mass Spectrometry for Biopharmaceutical Process Development: Focus on Hydrogen/Deuterium Exchange (George M. Bou-Assaf, Alan G. Marshall) Chapter 13 - One- and Two-Dimensional NMR Techniques for Biopharmaceuticals (Yves Aubin, Daron I. Freedberg, David A. Keire)

III: Concluding Remarks on the Biophysical Characterization of Biopharmaceuticals Chapter 14 - Biophysical Characterization: An Integral Part of the “Totality of the Evidence” Concept (Damian J. Houde, Steven A. Berkowitz)

Index