BookLinda O. Narhi, editor.
Summary: This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.
Contents:
Introduction / Linda O. Narhi
High-Throughput Biophysical Approaches to Therapeutic Protein Development / Feng He, Vladimir I. Razinkov
Techniques for Higher-Order Structure Determination / James Kranz, Fatma AlAzzam, Atul Saluja
Biophysical Techniques for Protein Size Distribution Analysis / Ziping Wei, Alla Polozova
Qualification of Biophysical Methods for the Analysis of Protein Therapeutics / Yijia Jiang, Cynthia Li, John Gabrielson
Application of Biophysics to the Early Developability Assessment of Therapeutic Candidates and Its Application to Enhance Developability Properties / Hasige Sathish, Nicolas Angell, David Lowe
Application of Biophysics in Formulation, Process, and Product Characterization: Selected Case Studies / Satish K. Singh, Qin Zou, Min Huang
Biophysical Analysis in Support of Development of Protein Pharmaceuticals / Sreedhara Alavattam, Barthelemy Demeule
Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size / Tingting Wang, Sangeeta B. Joshi
Investigation of Nonconformance During Protein Therapeutic Manufacturing / Zai-Qing Wen, Gianni Torraca, Guiyang Li
Higher-Order Structure and Protein Aggregate Characterization of Protein Therapeutics: Perspectives from Good Manufacturing Practices and Regulatory Guidance / Evi B. Struble, John F. Cipollo.