Biophysical Characterization of Proteins in Developing Biopharmaceuticals

List of Contributors About the Editors Preface List of Abbreviations and Symbols

I: Proteins and Biophysical Characterization in the Biopharmaceutical Industry Chapter 1 - The Complexity of Protein Structure and the Challenges it Poses in Developing Biopharmaceuticals (Steven A. Berkowitz, Damian J. Houde) Chapter 2 - Biophysical Characterization and Its Role in the Biopharmaceutical Industry (Damian J. Houde, Steven A. Berkowitz) Chapter 3 - Biopharmaceutical Industry's Biophysical Toolbox (Damian J. Houde, Steven A. Berkowitz)

II: The Selected Biophysical Tools in the Biopharmaceutical Industry Chapter 4 - An Introduction and Hierarchical Organization of the Biophysical Tool in Section II (Damian J. Houde, Steven A. Berkowitz) Chapter 5 - The Value of UV, Fluorescence, and FTIR Spectroscopy in Biopharmaceutical Development (Mark Brader) Chapter 6 - Circular Dichroism Spectroscopy for Protein Characterization: Biopharmaceutical Applications (A.J. Miles, B.A. Wallace) Chapter 7 - Size-Exclusion Chromatograph (SEC) in Biopharmaceutical Process Development (Steven A. Berkowitz, Damian J. Houde) Chapter 8 - Scattering Techniques for the Characterization of Biopharmaceuticals, Pages 171-209, Lee Makowski, Steven A. Berkowitz, Damian J. Houde Chapter 9 - Characterizing Biopharmaceuticals using Analytical Ultracentrifugation (Steven A. Berkowitz, John S. Philo) Chapter 10 - Subvisible and Visible Particle Analysis in Biopharmaceutical Research and Development, Pages 261-286, Andrea Hawe, Sarah Zoells, Angelika Freitag, John F. Carpenter Chapter 11 - Differential Scanning Calorimetry in the Biopharmaceutical Sciences (Stephen J. Demarest, Verna Frasca) Chapter 12 - Biophysical Mass Spectrometry for Biopharmaceutical Process Development: Focus on Hydrogen/Deuterium Exchange (George M. Bou-Assaf, Alan G. Marshall) Chapter 13 - One- and Two-Dimensional NMR Techniques for Biopharmaceuticals (Yves Aubin, Daron I. Freedberg, David A. Keire)

III: Concluding Remarks on the Biophysical Characterization of Biopharmaceuticals Chapter 14 - Biophysical Characterization: An Integral Part of the "Totality of the Evidence? Concept (Damian J. Houde, Steven A. Berkowitz)

Index

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• Tecnologia farmacêutica
• Proteinas

Advance biophysical tools; Aggregation; Amino acids; Band sedimentation; Bench-top instrument; Bicinchoninic acid assay (BCA); Biopharmaceutical; Biophysical characterization; Biophysical fingerprint; Biophysical properties; Biophysical solution properties; Biophysical toolbox; Biosimilar; Biosimilarity; Biosimilars; Calibration schedule; Calibration standards; Cells standards; Chaperones; Chromatogram; Chromatography; Circular dichroism (CD); Comparability; Complex folds; Conformational changes; Cotranslational protein folding; Coulter counter; Covalent labeling; Data collection protocols; Data generated; Data processing; Density gradient sedimentation equilibrium; Detectors; Differential scanning calorimetry (DSC); Diffusion; Direct mass measurement; Drug; Drug variant analysis; Drug variant forms; Dynamic light scattering; Dynamic light scattering (DLS); Electric sensing zone method; Electromagnetic radiation; Electrophoresis; Field flow fractionation; Finer structural alteration; Flow microscopy; Fluorescence; Formulation development; Glyosylation; High throughput; Higher-order structure; Higher-order structure (HOS); Hydrodynamics; Infrared; Instrument settings; Instrumentation; Interference; Light obscuration; Light scattering (LS); Log keeping; Micro-heterogeneity; Molecular weight; Molten globule state; Motifs; Nanoparticle tracking analysis; Nuclear magnetic resonance; Optical cells; Pathlength; Peptide bond; Physical properties; Polypeptide backbone; Pore size; Post-translation modifications (PTMs); Process development; Protein concentration; Protein dynamics; Protein formulation; Protein-protein interaction; Proteins; Record keeping; Resonant mass measurements; Sedimentation coefficient; Sedimentation equilibrium; Sedimentation velocity; Self-association; Signal-to-noise; Silent HOS changes; Size-exclusion chromatography; Small angle x-ray scattering (SAXS); Sodium dodecylsulfate (SDS); Software; Spatial structure; Spectroscopy; Standard biophysical tools; Static light scattering (SLS); Subvisible particles; Super-secondary structures; Synchrotron radiation circular dichroism (SRCD); Technique; Technology; Temporal structure; Therapeutic protein stability; Thermodynamics; Three-dimensional (3D) structure; Totality of the Evidence; Troubleshooting; UV-absorbance; Visible particles; Visual inspection