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Title Biophysics for therapeutic protein development / Linda O. Narhi, editor
Published New York : Springer, ©2013

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Description 1 online resource (297 pages)
Series Biophysics for the Life Sciences ; v. 4
Biophysics for the life sciences.
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
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
Bibliography Includes bibliographical references and index
Notes Print version record
Subject Proteins -- Biotechnology
Cell culture.
Proteins -- Synthesis.
Proteins -- Therapeutic use
Biophysics.
Protein drugs.
Proteins.
Protein engineering.
Drugs -- Design.
Proteins -- isolation & purification
Proteins
Biophysics
Proteins -- therapeutic use
Proteins -- chemical synthesis
Protein Engineering
Drug Design
Cells, Cultured
Protein Biosynthesis
protein.
MEDICAL -- Chemotherapy.
Proteins
Protein engineering
Drugs -- Design
Biophysics
Cell culture
Protein drugs
Proteins -- Biotechnology
Proteins -- Synthesis
Proteins -- Therapeutic use
Form Electronic book
Author Narhi, Linda O
ISBN 9781461443162
1461443164
1461443156
9781461443155