Biophysics for Therapeutic Protein Development

Introduction.- High Throughput Biophysical Approaches to Therapeutic Protein Development.- Techniques for Higher Order Structure Determination.- Biophysical Techniques for Protein Size Distribution Analysis.- Qualification of biophysical methods for the analysis of protein therapeutics.- Application of Biophysics to the Early Developability Assessment of Therapeutic Candidates and its Application to Enhance Developability Properties.- Application of Biophysics in Formulation, Process and Product Characterization: Selected Case Studies.- Biophysical Analysis in Support of Development of Protein Pharmaceuticals.- Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size.- Investigation of Non Conformance During Protein Therapeutic Manufacturing.- Higher order structure and protein aggregate characterization of protein therapeutics: perspectives from good manufacturing practices and regulatory guidance.- Index.... Mehr