Biophysics for Therapeutic Protein Development

1. Introduction
Linda O. Narhi

2. High-Throughput Biophysical Approaches to Therapeutic Protein Development
Feng He, Vladimir I. Razinkov, C. Russell Middaugh, Gerald W. Becker

3. Techniques for Higher-Order Structure Determination
James Kranz, Fatma AlAzzam, Atul Saluja, Juraj Svitel, Wasfi Al-Azzam

4. Biophysical Techniques for Protein Size Distribution Analysis
Ziping Wei, Alla Polozova

5. Qualification of Biophysical Methods for the Analysis of Protein Therapeutics
Yijia Jiang, Cynthia Li, John Gabrielson

6. Application of Biophysics to the Early Developability Assessment of Therapeutic Candidates and Its Application to Enhance Developability Properties
Hasige Sathish, Nicolas Angell, David Lowe, Ambarish Shah, Steven Bishop

7. Application of Biophysics in Formulation, Process, and Product Characterization: Selected Case Studies
Satish K. Singh, Qin Zou, Min Huang, Muralidhara Bilikallahalli

8. Biophysical Analysis in Support of Development of Protein Pharmaceuticals
Sreedhara Alavattam, Barthelemy Demeule, Jun Liu, Sandeep Yadav, Mary Cromwell, Steven J. Shire

9. Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size
Tingting Wang, Sangeeta B. Joshi, Ozan S. Kumru, Srivalli Telikepalli, C. Russell Middaugh, David B. Volkin

10. Investigation of Nonconformance During Protein Therapeutic Manufacturing
Zai-Qing Wen, Gianni Torraca, Guiyang Li, Xiaolin Cao, Chanel K. Yee

11. Higher-Order Structure and Protein Aggregate Characterization of Protein Therapeutics: Perspectives from Good Manufacturing Practices and Regulatory Guidance
Evi B. Struble, John F. Cipollo, Chava Kimchi-Sarfaty, Zuben E. Sauna, Jack A. Ragheb, Ewa Marszal

Avainsanat: Biomedicine, Pharmacology/Toxicology, Medical Biochemistry, Protein Science, Protein-Ligand Interactions, Pharmacology/Toxicology, Biophysics and Biological Physics