High-Throughput Biophysical Approaches to Therapeutic Protein Development / Feng He ... [et al.] -- Techniques for Higher-Order Structure Determination / James Kranz ... [et al.] -- 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 early developability assessment of therapeutic candidates and its application to enhance developability properties / Hasige Sathish ... [et al.] -- Application of biophysics in formulation, process, and product characterization: selected case studies / Satish K. Singh ... [et al.] -- Biophysical analysis in support of development of protein pharmaceuticals / Sreedham Alayattam ... [et al.] -- Case studies applying biophysical techniques to better characterize protein aggregates and particulates of varying size / Tingting Wang ... [et al.] -- Investigation of noncomformance during protein therapeutic manufacturing / Zai-Qing Wen ... [et al.] -- Higher-order structure and protein aggregate characterization of protein therapeutics: perspectives from good manufacturing practices and regulatory guidances / Evi B. Struble ... [et al.]
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SUMMARY OR ABSTRACT
Text of Note
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