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 developmentHighlights the capabilities and limitations of each techniqueDiscusses the underlining science of each toolEmpowers industrial biophysical chemists by providing a roadmap for applying biophysical toolsOutlines the needs for new characterization and analytical tools in the biopharmaceutical industry

I: Proteins and Biophysical Characterization in the Biopharmaceutical Industry 1. The Complexity of Protein Structure and the Challenges it Poses in Developing Biopharmaceuticals 2. Biophysical Characterization and Its Role in the Biopharmaceutical Industry 3. Biopharmaceutical Industry's Biophysical Toolbox

II: The Selected Biophysical Tools in the Biopharmaceutical Industry 4. An Introduction and Hierarchical Organization of the Biophysical Tool 5. The Value of UV, Fluorescence, and FTIR Spectroscopy in Biopharmaceutical Development 6. Circular Dichroism Spectroscopy for Protein Characterization: Biopharmaceutical Applications 7. Size-Exclusion Chromatograph (SEC) in Biopharmaceutical Process Development 8. Scattering Techniques for the Characterization of Biopharmaceuticals 9. Characterizing Biopharmaceuticals using Analytical Ultracentrifugation 10. Sub-visible and Visible Particle Analysis in Biopharmaceutical Research and Development 11. Differential Scanning Calorimetry in the Biopharmaceutical Sciences 12. Biophysical Mass Spectrometry for Biopharmaceutical Process Development: Focus on Hydrogen/Deuterium Exchange 13. One- and Two-Dimensional NMR Techniques for Biopharmaceuticals 14. Use of Chromatography and Electrophoresis for indirectly assessing Biophysical Characterization

III: Concluding Remarks on the Biophysical Characterization of Biopharmaceuticals 15. Biophysically Characterization of very large Biopharmaceuticals 16. Statistical Analysis of Biophysical Characterization Data 17. Biopharmaceutical Developability 18. Technical Decision-making dealing with Biophysical Characterization Data 19. Biophysical Characterization: An Integral Part of the "Totality of the Evidence" Concept