Biophysical Characterization of Proteins in Developing Biopharmaceuticals

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

I: Proteins and Biophysical Characterization in the Biopharmaceutical Industry1. The Complexity of Protein Structure and the Challenges it Poses in Developing Biopharmaceuticals2. Biophysical Characterization and Its Role in the Biopharmaceutical Industry3. Biopharmaceutical Industry's Biophysical ToolboxII: The Selected Biophysical Tools in the Biopharmaceutical Industry4. An Introduction and Hierarchical Organization of the Biophysical Tool5. The Value of UV, Fluorescence, and FTIR Spectroscopy in Biopharmaceutical Development6. Circular Dichroism Spectroscopy for Protein Characterization: Biopharmaceutical Applications7. Size-Exclusion Chromatograph (SEC) in Biopharmaceutical Process Development8. Scattering Techniques for the Characterization of Biopharmaceuticals9. Characterizing Biopharmaceuticals using Analytical Ultracentrifugation10. Sub-visible and Visible Particle Analysis in Biopharmaceutical Research and Development11. Differential Scanning Calorimetry in the Biopharmaceutical Sciences12. Biophysical Mass Spectrometry for Biopharmaceutical Process Development: Focus on Hydrogen/Deuterium Exchange13. One- and Two-Dimensional NMR Techniques for Biopharmaceuticals14. Use of Chromatography and Electrophoresis for indirectly assessing Biophysical CharacterizationIII: Concluding Remarks on the Biophysical Characterization of Biopharmaceuticals15. Biophysically Characterization of very large Biopharmaceuticals16. Statistical Analysis of Biophysical Characterization Data17. Biopharmaceutical Developability18. Technical Decision-making dealing with Biophysical Characterization Data19. Biophysical Characterization: An Integral Part of the "Totality of the Evidence" Concept