Biophysics for Therapeutic Protein Development

Editors:

ISBN: 978-1-4614-4315-5 (Print) 978-1-4614-4316-2 (Online)

Table of contents (11 chapters)

  1. Front Matter

    Pages i-ix

  2. No Access

    Book Chapter

    Pages 1-5

    Introduction

  3. No Access

    Book Chapter

    Pages 7-31

    High-Throughput Biophysical Approaches to Therapeutic Protein Development

  4. No Access

    Book Chapter

    Pages 33-82

    Techniques for Higher-Order Structure Determination

  5. No Access

    Book Chapter

    Pages 83-97

    Biophysical Techniques for Protein Size Distribution Analysis

  6. No Access

    Book Chapter

    Pages 99-126

    Qualification of Biophysical Methods for the Analysis of Protein Therapeutics

  7. No Access

    Book Chapter

    Pages 127-146

    Application of Biophysics to the Early Developability Assessment of Therapeutic Candidates and Its Application to Enhance Developability Properties

  8. No Access

    Book Chapter

    Pages 147-172

    Application of Biophysics in Formulation, Process, and Product Characterization: Selected Case Studies

  9. No Access

    Book Chapter

    Pages 173-204

    Biophysical Analysis in Support of Development of Protein Pharmaceuticals

  10. No Access

    Book Chapter

    Pages 205-243

    Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size

  11. No Access

    Book Chapter

    Pages 245-260

    Investigation of Nonconformance During Protein Therapeutic Manufacturing

  12. No Access

    Book Chapter

    Pages 261-281

    Higher-Order Structure and Protein Aggregate Characterization of Protein Therapeutics: Perspectives from Good Manufacturing Practices and Regulatory Guidance

  13. Back Matter

    Pages 283-293