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