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Biophysical Methods for Biotherapeutics
Discovery and Development Applications
Tapan K. Das (Edited by), TK Das (Author)
9780470938430, Wiley
Hardback, published 8 August 2014
376 pages
24.1 x 16 x 2.5 cm, 0.649 kg
With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods
• Chapters organized according to the sequential nature of the drug development process
• Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods
• Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity
• With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.
Preface vii About the Editor ix Contributors xi Section 1 Early Discovery Stages and Biotherapeutic Candidate Selection 1 Biophysical Methods Applied in Early Discovery of a Biotherapeutic: Case Study of an EGFR-IGF1R Bispecific Adnectin 3 2 X-Ray Crystallography for Biotherapeutics 25 3 Solubility and Early Assessment of Stability for Protein Therapeutics 65 Section 2 First-in-Human and up to Proof-of-Concept Clinical Trials 4 Biophysical and Structural Characterization Needed Prior to Proof of Concept 95 5 Nucleation, Aggregation, and Conformational Distortion 125 6 Utilization of Chemical Labeling and Mass Spectrometry for the Biophysical Characterization of Biopharmaceuticals 151 7 Application of Biophysical and High-Throughput Methods in the Preformulation of Therapeutic Proteins—Facts and Fictions 173 8 Bioanalytical Methods and Immunogenicity Assays 207 9 Structures and Dynamics of Proteins Probed by UV Resonance Raman Spectroscopy 243 10 Freezing- and Drying-Induced Micro- and Nano-Heterogeneity in Biological Solutions 269 Section 3 Phase III and Commercial Development 11 Late-Stage Product Characterization: Applications in Formulation, Process, and Manufacturing Development 287 12 Biophysical Analyses Suitable for Chemistry, Manufacturing, and Control Sections of the Biologic License Application (BLA) 317 Index 355
Michael L. Doyle, James W. Bryson, Virginie Lafont, Zheng Lin, Paul E. Morin, Lumelle A. Schneeweis, Aaron P. Yamniuk, and Joseph Yanchunas Jr.
Glen Spraggon
Sheng-Jiun Wu, Gary L. Gilliland, and Yiqing Feng
Angela W. Blake-Haskins, Yen-Huei Lin, Zhuchun Wu, Melissa D. Perkins, and Thomas M. Spitznagel
Christopher J. Roberts
Justin B. Sperry and Lisa M. Jones
Ahmad M. Abdul-Fattah and Hanns-Christian Mahler
Bonita Rup, Corinna Krinos-Fiorotti, Boris Gorovits, and Hendrik Neubert
Brian S. Leigh, Diana E. Schlamadinger, and Judy E. Kim
Alptekin Aksan, Vishard Ragoonanan, and Carol Hirschmugl
Christine P. Chan and Li Shi
Zahra Shahrokh, Nazila Salamat-Miller, and John J. Thomas
Subject Areas: Chemistry [PN]
