Biophysical characterization of proteins in developing biopharmaceuticals 1st Edition by Damian Houde, Steven Berkowitz 0444595732 9780444595737
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ISBN 10: 0444595732
ISBN 13: 9780444595737
Author: Damian J. Houde, Steven A. Berkowitz
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.
Table of contents:
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 Protein Structure–Function Paradigm)
1.4. Proteins and the Biopharmaceutical Industry: Problems and Challenges
1.5. Conclusion
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
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 Biopharmaceutical
3.2. 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
II. The Selected Biophysical Tools in the Biopharmaceutical Industry
Chapter 4. An Introduction and Hierarchical Organization of the Biophysical Tool in Section II
4.1. 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
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 Comparability
5.5. Optical Spectroscopy and High-throughput Methods
5.6. Solid-State Measurements
5.7. Conclusions
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
Chapter 7. Size-Exclusion Chromatograph (SEC) in Biopharmaceutical Process Development
7.1. Introduction
7.2. Basic Theory of Normal or Ideal SEC
7.3. Maximizing Sec Separation By Enhancing The Usage Of Pore Volume and Pore Structure
7.4. Characteristics of Pore Structure
7.5. Nonideal SEC Chromatography
7.6. Assessing and Maintaining an Optimum SEC Chromatography Method
7.7. Detectors
7.8. Multidetector SEC
7.9. Aggregation
7.10. Technology Advances
7.11. Conclusion
Chapter 8. Scattering Techniques for the Characterization of Biopharmaceuticals
8.1. Introduction
8.2. Intensity- and Time-Dependent Light Scattering
8.3. General Comment Concerning SLS and DLS
8.4. The “Dust Problem” in SLS and DLS
8.5. X-Ray Scattering: Characterization of Proteins in Solution Using Small-Angle X-Ray Scattering
Chapter 9. Characterizing Biopharmaceuticals using Analytical Ultracentrifugation
9.1. Introduction
9.2. Unique Features of the Analytical Ultracentrifuge That Make It Different from Other Centrifuges
9.3. Theory
9.4. Utility of AUC in the Biopharmaceutical Industry
9.5. Boundary SV-AUC
9.6. Band SV-AUC
9.7. Sedimentation Equilibrium, SE-AUC
9.8. Density-Gradient SE-AUC
9.9. AUC Detectors
9.10. Miscellaneous Helpful Information About Conducting AUC Experiments
9.11. Conclusion
Chapter 10. Subvisible and Visible Particle Analysis in Biopharmaceutical Research and Development
10.1. Introduction
10.2. Overview of Analytical Methods
10.3. General Recommendations and Pitfalls for Particle Analysis
10.4. Outlook and Conclusions
Chapter 11. Differential Scanning Calorimetry in the Biopharmaceutical Sciences
11.1. Background
11.2. DSC Instruments
11.3. Practical Considerations for DSC Use
11.4. Data Analysis
11.5. Applications of Solution DSC in Biopharmaceutical Discovery and Development
11.6. Applications of Solid-Sample DSC in Biopharmaceutical Discovery and Development
11.7. Conclusions
Chapter 12. Biophysical Mass Spectrometry for Biopharmaceutical Process Development: Focus on Hydrogen/Deuterium Exchange
12.1. Introduction
12.2. Synopsis of the Technique
12.3. Mechanism of Exchange
12.4. Advances in the Technique
12.5. Commercialization
12.6. Applications in the Biopharmaceutical Industry
12.7. Future Perspective
Chapter 13. One- and Two-Dimensional NMR Techniques for Biopharmaceuticals
13.1. Physical Basis of the Technique
13.2. The Appropriate Technique for a Particular Problem
13.3. Method Requirements and Performance
13.4. Data Processing (Procedures)
13.5. Role in Research vs Process Development
13.6. Technology Update: Recent and Future Advances and Unique Applications
III. Concluding Remarks on the Biophysical Characterization of Biopharmaceuticals
Chapter 14. Biophysical Characterization: An Integral Part of the “Totality of the Evidence” Concept
14.1. Biopharmaceutical Development
14.2. An Introduction to the “Totality of the Evidence” and Its More Global Meaning in Developing Biopharmaceuticals
14.3. Biophysical Characterization in Developing Protein Biopharmaceuticals
14.4. Building a Biopharmaceutical’s Biophysical Fingerprint
14.5. Detecting Small Differences in Biopharmaceuticals via Biophysical Characterization Measurements
14.6. Conclusion
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Tags: Damian Houde, Steven Berkowitz