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.
1. Chapter 4. An introduction and hierarchical organization of the biophysical tool in section II - p. 89 2. Chapter 5. UV-absorbance, fluorescence and FT-IR spectroscopy in biopharmaceutical development - p. 97 3. Chapter 6. Biopharmaceutical applications of protein characterisation by circular dichroism spectroscopy - p. 123 4. Chapter 7. Size-exclusion chromatography (SEC) in biopharmaceutical process development - p. 153 5. Chapter 8. Scattering techniques for the characterization of biopharmaceuticals - p. 185 6. Chapter 9. Characterizing biopharmaceuticals using analytical ultracentrifugation - p. 225 7. Chapter 10. Submicrometer, micrometer and visible particle analysis in biopharmaceutical research and development - p. 285 8. Chapter 11. Differential scanning calorimetry in the biopharmaceutical sciences - p. 311 9. Chapter 12. Biophysical mass spectrometry for biopharmaceutical process development: focus on hydrogen/deuterium exchange - p. 333 10. Chapter 13. One- and two-dimensional NMR techniques - p. 375 11. Chapter 14. Chromatography (other than size-exclusion chromatography) and electrophoresis - p. 431 12. III. Concluding remarks on the biophysical characterization of biopharmaceuticals - p. 456 13. Chapter 15. Challenges with the biophysical characterization of complex (multi-chain assembly, chemically modified, big and high concentration) biopharmaceuticals - p. 459 14. Chapter 16. The rigor of statistical analysis in assessing biophysical data: A lifecycle approach - p. 481 15. Chapter 17. Developability in biophysical characterization - p. 505 16. Chapter 18. Technical decision making using biophysical data - p. 527 17. Chapter 19. Biophysical characterization: an integral part of the “totality of the evidence” concept - p. 539 18. Index - p. 553
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.
1. Chapter 4. An introduction and hierarchical organization of the biophysical tool in section II - p. 89 2. Chapter 5. UV-absorbance, fluorescence and FT-IR spectroscopy in biopharmaceutical development - p. 97 3. Chapter 6. Biopharmaceutical applications of protein characterisation by circular dichroism spectroscopy - p. 123 4. Chapter 7. Size-exclusion chromatography (SEC) in biopharmaceutical process development - p. 153 5. Chapter 8. Scattering techniques for the characterization of biopharmaceuticals - p. 185 6. Chapter 9. Characterizing biopharmaceuticals using analytical ultracentrifugation - p. 225 7. Chapter 10. Submicrometer, micrometer and visible particle analysis in biopharmaceutical research and development - p. 285 8. Chapter 11. Differential scanning calorimetry in the biopharmaceutical sciences - p. 311 9. Chapter 12. Biophysical mass spectrometry for biopharmaceutical process development: focus on hydrogen/deuterium exchange - p. 333 10. Chapter 13. One- and two-dimensional NMR techniques - p. 375 11. Chapter 14. Chromatography (other than size-exclusion chromatography) and electrophoresis - p. 431 12. III. Concluding remarks on the biophysical characterization of biopharmaceuticals - p. 456 13. Chapter 15. Challenges with the biophysical characterization of complex (multi-chain assembly, chemically modified, big and high concentration) biopharmaceuticals - p. 459 14. Chapter 16. The rigor of statistical analysis in assessing biophysical data: A lifecycle approach - p. 481 15. Chapter 17. Developability in biophysical characterization - p. 505 16. Chapter 18. Technical decision making using biophysical data - p. 527 17. Chapter 19. Biophysical characterization: an integral part of the “totality of the evidence” concept - p. 539 18. Index - p. 553
