Biophysical Characterization of Proteins in Developing Biopharmaceuticals

ISBN-13: 9780444641731 / Angielski / Miękka / 2019 / 586 str.

Damian J. Houde; Steven A. Berkowitz

Spis treści

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