Biophysical Characterization of Proteins in Developing Biopharmaceuticals 2nd Edition by Damian Houde, Steven Berkowitz 0444641734 9780444641731

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ISBN 10: 0444641734

ISBN 13: 9780444641731

Author: Damian J. Houde, Steven A. Berkowitz

Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on 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 explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today’s industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals.

In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical’s developability and the technical decision-making process needed when dealing with biophysical characterization data.

• Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development
• Highlights the capabilities and limitations of each technique
• Discusses the underlining science of each tool
• Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools
• Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry

Biophysical Characterization of Proteins in Developing Biopharmaceuticals 2nd Table of contents:

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

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. UV-absorbance, fluorescence and FT-IR 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 and vibrational spectroscopy and product comparability

5.5. Optical and vibrational spectroscopy and high throughput methods

5.6. Solid-state measurements

5.7. Conclusions

Chapter 6. Biopharmaceutical applications of protein characterisation by circular dichroism spectroscopy

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 chromatography (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. Expanding the dynamic size range that can be characterized in a single SV-AUC run

9.7. Band SV-AUC

9.8. Sedimentation equilibrium, SE-AUC

9.9. Density-gradient SE-AUC

9.10. AUC detectors

9.11. Miscellaneous helpful information about conducting AUC experiments

9.12. The introduction of the next (third) generation analytical ultracentrifuge (Optima) by Beckman Coulter

9.13. Conclusions

Chapter 10. Submicrometer, micrometer 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

13.1. Introduction

13.2. Physical basis of the technique

13.3. The appropriate technique for a particular problem

13.4. Method requirements and performance

13.5. Data processing (procedures)

13.6. Role in research versus process development

13.7. Technology update: recent and future advances and unique applications

Chapter 14. Chromatography (other than size-exclusion chromatography) and electrophoresis

14.1. Introduction

14.2. Common features of concern when using chromatography and electrophoresis as biophysical characterization tools

14.3. Chromatography

14.4. Electrophoresis

14.5. Some novel methods where chromatography or electrophoresis was used to help biophysical characterize protein biopharmaceuticals

14.6. Characterizing the chromatographic and electrophoretic separations

14.7. The challenge that come with the ever-increasing higher resolution chromatography and electrophoresis when characterizing protein biopharmaceuticals

14.8. Summary

III. Concluding remarks on the biophysical characterization of biopharmaceuticals

Chapter 15. Challenges with the biophysical characterization of complex (multi-chain assembly, chemically modified, big and high concentration) biopharmaceuticals

15.1. Introduction

15.2. Complex biopharmaceuticals I: multi-polypeptide chain protein in vivo assembly

15.3. Complex biopharmaceuticals III: novel multi-polypeptide chain protein assembly in vivo to form bispecific antibodies

15.4. Complex biopharmaceuticals IV: via in vitro chemical modifications or in vivo recombinant coupling

15.5. Complex biopharmaceuticals V: assembly of large multi-protein biopharmaceutical structures – viral vectors (in gene therapy)

15.6. Complex biopharmaceuticals VI: high concentration biopharmaceuticals (mAbs)

15.7. Summary

Chapter 16. The rigor of statistical analysis in assessing biophysical data: A lifecycle approach

16.1. Introduction

16.2. Description of the lifecycle approach

16.3. Characteristics of biophysical procedures

16.4. Statistical approaches in stage 1 of the lifecycle approach

16.5. Statistical approaches in stage 2 of the lifecycle approach

16.6. Statistical assessment in stage 3 of the lifecycle approach

16.7. Considerations for successful implementation of a lifecycle approach: management of biophysical procedures

16.8. Summary

Chapter 17. Developability in biophysical characterization

17.1. Introduction

17.2. Computational structural methods and their use in lead candidate selection and in engineering

17.3. Formulation considerations for developability screening

17.4. Critical quality attribute based testing in developability

17.5. Colloidal stability: predicting protein solution behavior

17.6. Viscosity and various mature and emerging viscosity technologies

17.7. Conformational stability

17.8. Conclusion and future of aspects of developability

Chapter 18. Technical decision making using biophysical data

18.1. Introduction

18.2. Current perspectives and recent trends

18.3. Future direction

18.4. Conclusion

Chapter 19. Biophysical characterization: an integral part of the “totality of the evidence” concept

19.1. Biopharmaceutical development

19.2. An introduction to the “totality of the evidence” and its more global meaning in developing biopharmaceuticals

19.3. Biophysical characterization in developing protein biopharmaceuticals

19.4. Building a Biopharmaceutical’s biophysical fingerprint

19.5. Detecting small differences in biopharmaceuticals via biophysical characterization measurements

19.6. Conclusion

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Damian Houde,Steven Berkowitz,Biophysical,Characterization