Biophysical Characterization of Proteins in Developing Biopharmaceuticals
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Biophysical Characterization of Proteins in Developing Biopharmaceuticals
Houde, Damian J.; Berkowitz, Steven A.
Elsevier Science & Technology
11/2019
586
Mole
Inglês
9780444641731
15 a 20 dias
940
Descrição não disponível.
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
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
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3-Dimensional structure; Advance biophysical tools; Aggregation; Analytical target profile (ATP)Target measurement uncertainty (TMU)FUV-CD spectroscopy; Band sedimentation; Bench-top instrument; Biologics candidate selection; Biopharmaceutical; Biopharmaceuticals; Biophysical characterization; Biophysical fingerprint; Biophysical properties; Biophysical solution properties; Biophysical toolbox; Biosimilar; Biosimilarity; Biosimilars; Calibration methods; Calibration standards; Candidate selection; Chromatography; Circular dichroism (CD)Data collection protocols; Colloidal stability; Common practices; Comparability; Conformation; Conformational changes; Conformational stability; Coulter counter; Covalent labeling; Data analysis; Data processing; Data validation; Density gradient sedimentation equilibrium; Developability; Differential scanning calorimetry (DSC)Protein formulation; Diffusion; Drug variant analysis; Drug variant forms; Drug; Dynamic light scattering (DLS)Light scattering (LS)Molecular weight; Dynamic light scattering; Electric sensing zone method; Electrophoresis; Field flow fractionation; Flow microscopy; Fluorescence; Formulation development; Glyosylation; High throughput; Higher order structure (HOS)Conformation; Higher-order structure; Hydrodynamic volume; Hydrodynamics; Infrared; Instrument settings; Instrumentation; Ion-mobility mass spectrometry; Lifecyle approach; Light obscuration; Log keeping; Molecular weight; Monoclonal antibody; Nanoparticle tracking analysis; Native mass spectrometry; Non-covalent interactions; Optical activity; Optical cell calibrations; Optical cells; Physical properties; Post-translation modifications (PTMs)Dynamics; Procedure performance qualification (PPQ)Procedure performance criterion or criteria (PPC)Protein circular dichroism data bank; Protein dynamics; Protein folding; Protein-protein interaction; Record keeping; Reportable value; Reproducibility; Resonant mass measurements; Risk assessment; Secondary bonds; Secondary structure analyses; Sedimentation coefficient; Sedimentation equilibrium; Sedimentation velocity; Self-association; Silent HOS changes; Size-exclusion chromatography; Small angle x-ray scattering (SAXS)Static light scattering (SLS)Software; Spatial structure; Spectroscopy; Standard biophysical tools; Statistical test of variance; Subvisible particles; SV-AUC; Synchrotron radiation circular dichroism (SRCD)Troubleshooting; System suitability; Temporal structure; Therapeutic protein stability; Therapeutic proteins; Thermodynamics; Totality of the evidence; UV-Absorbance; Visible particles; Visual inspection; Websites; You-tube informational videos
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
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
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
3-Dimensional structure; Advance biophysical tools; Aggregation; Analytical target profile (ATP)Target measurement uncertainty (TMU)FUV-CD spectroscopy; Band sedimentation; Bench-top instrument; Biologics candidate selection; Biopharmaceutical; Biopharmaceuticals; Biophysical characterization; Biophysical fingerprint; Biophysical properties; Biophysical solution properties; Biophysical toolbox; Biosimilar; Biosimilarity; Biosimilars; Calibration methods; Calibration standards; Candidate selection; Chromatography; Circular dichroism (CD)Data collection protocols; Colloidal stability; Common practices; Comparability; Conformation; Conformational changes; Conformational stability; Coulter counter; Covalent labeling; Data analysis; Data processing; Data validation; Density gradient sedimentation equilibrium; Developability; Differential scanning calorimetry (DSC)Protein formulation; Diffusion; Drug variant analysis; Drug variant forms; Drug; Dynamic light scattering (DLS)Light scattering (LS)Molecular weight; Dynamic light scattering; Electric sensing zone method; Electrophoresis; Field flow fractionation; Flow microscopy; Fluorescence; Formulation development; Glyosylation; High throughput; Higher order structure (HOS)Conformation; Higher-order structure; Hydrodynamic volume; Hydrodynamics; Infrared; Instrument settings; Instrumentation; Ion-mobility mass spectrometry; Lifecyle approach; Light obscuration; Log keeping; Molecular weight; Monoclonal antibody; Nanoparticle tracking analysis; Native mass spectrometry; Non-covalent interactions; Optical activity; Optical cell calibrations; Optical cells; Physical properties; Post-translation modifications (PTMs)Dynamics; Procedure performance qualification (PPQ)Procedure performance criterion or criteria (PPC)Protein circular dichroism data bank; Protein dynamics; Protein folding; Protein-protein interaction; Record keeping; Reportable value; Reproducibility; Resonant mass measurements; Risk assessment; Secondary bonds; Secondary structure analyses; Sedimentation coefficient; Sedimentation equilibrium; Sedimentation velocity; Self-association; Silent HOS changes; Size-exclusion chromatography; Small angle x-ray scattering (SAXS)Static light scattering (SLS)Software; Spatial structure; Spectroscopy; Standard biophysical tools; Statistical test of variance; Subvisible particles; SV-AUC; Synchrotron radiation circular dichroism (SRCD)Troubleshooting; System suitability; Temporal structure; Therapeutic protein stability; Therapeutic proteins; Thermodynamics; Totality of the evidence; UV-Absorbance; Visible particles; Visual inspection; Websites; You-tube informational videos
