
Biophysical Characterization of Proteins in Developing Biopharmaceuticals
- 1st Edition - September 5, 2014
- Imprint: Elsevier
- Editors: Damian J. Houde, Steven A. Berkowitz
- Language: English
- Hardback ISBN:9 7 8 - 0 - 4 4 4 - 5 9 5 7 3 - 7
- Paperback ISBN:9 7 8 - 0 - 4 4 4 - 6 3 8 1 0 - 6
- eBook ISBN:9 7 8 - 0 - 4 4 4 - 5 9 5 9 0 - 4
Biophysical Characterization of Proteins in Developing Biopharmaceuticals is concerned with the analysis and characterization of the higher-order structure (HOS) or conformat… Read more

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Request a sales quoteBiophysical 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.
Researchers in academia and corporate laboratories who develop new instrumental methods for characterisation of proteins in general and biopharmaceutical proteins specifically; researchers in industry who develop these proteins and need characterisation methods
- 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
- 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
- Chapter 1. The Complexity of Protein Structure and the Challenges it Poses in Developing Biopharmaceuticals
- 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
- Chapter 4. An Introduction and Hierarchical Organization of the Biophysical Tool in Section II
- 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
- Chapter 14. Biophysical Characterization: An Integral Part of the “Totality of the Evidence” Concept
- Index
- Edition: 1
- Published: September 5, 2014
- Imprint: Elsevier
- No. of pages: 426
- Language: English
- Hardback ISBN: 9780444595737
- Paperback ISBN: 9780444638106
- eBook ISBN: 9780444595904
DH
Damian J. Houde
SB
Steven A. Berkowitz
Dr. Berkowitz received a B.S. degree in Biology from Fairleigh Dickinson University and a Ph.D. degree in Biochemistry from New York University. He then spent several years as a post-doctoral fellow at Yale University and the NIH. After his post-doctoral work Dr. Berkowitz held various positions at Celanese Research Company, J.T. Baker, and Lederle Laboratories before taking his present position at Biogen Idec.