Biophysical Methods for Biotherapeutics Discovery and Development Applications
by Das, Tapan K.Edition: 1st
Format: Hardcover
Pub. Date: 2014-04-28
Publisher(s): Wiley
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Summary
With a focus on practical applications of biophysical techniques, Biophysical Methods for Biotherapeutics helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods. Author Tapan K. Das links fundamental biophysics to the process of biopharmaceutical development using a chapter organization according to the steps of the drug development process. The text provides information to help organizations develop short- and long-term strategies for resource investment in biophysical research.
Author Biography
TAPAN K. DAS is the Director of the Mass Spectrometry and Biophysics Center of Excellence in the Analytical Development and Testing group at Bristol-Myers Squibb. He is responsible for biophysical and analytical development for biotherapeutics structure-function characterization, analytical comparability, protein particulate analysis, and support for commercial biotherapeutics products. Dr. Das is also the Chair of the Biotechnology Section of Ameri an Association of Pharmaceutical Scientists.
Table of Contents
Preface
About the Editor
Contributors
Section 1
Chapter 1 Biophysical Methods Applied in Early Discovery of a Biotherapeutic: Case Study of an EGFR-IGF1R Bispecific Adnectin
Michael L. Doyle, James W. Bryson, Virginie Lafont, Zheng Lin, Paul E. Morin, Lumelle A. Schneeweis, Aaron P. Yamniuk, and Joseph Yanchunas Jr.
Chapter 2 X-ray Crystallography for Biotherapeutics
Glen Spraggon
Chapter 3 Solubility and Early Assessment of Stability For Protein Therapeutics
Sheng-Jiun Wu, Gary L. Gilliland and Yiqing Feng
Section 2
Chapter 4 Biophysical and Structural Characterization Needed Prior to Proof of Concept
Angela W. Blake-Haskins, Yen-Huei Lin, Zhuchun Wu, Melissa D. Perkins, Thomas M. Spitznagel
Chapter 5 Nucleation, Aggregation, and Conformational Distortion
Christopher J. Roberts
Chapter 6 Utilization of Chemical Labeling and Mass Spectrometry for the Biophysical Characterization of Biopharmaceuticals
Justin B. Sperry and Lisa M. Jones
Chapter 7 Application of Biophysical and High Throughput Methods in the Preformulation of Therapeutic Proteins – Facts and Fictions
Ahmad M. Abdul-Fattah and Hanns-Christian Mahler
Chapter 8 Bioanalytical Methods and Immunogenicity Assays
Bonita Rup, Corinna Krinos-Fiorotti, Boris Gorovits, Hendrik Neubert
Chapter 9 Structures and Dynamics of Proteins Probed by UV Resonance Raman Spectroscopy
Brian S. Leigh, Diana E. Schlamadinger, and Judy E. Kim
Chapter 10 Freezing and drying-induced micro-/nanoheterogeneity in biological solutions
Alptekin Aksan, Vishard Ragoonanan, and Carol Hirschmugl
Section 3
Chapter 11 Late stage product characterization: applications in formulation, process and manufacturing development
Christine P. Chan and Li Shi
Chapter 12 Biophysical Analyses Suitable for Chemistry, Manufacturing and Control Sections of the Biological License Application (BLA)
Zahra Shahrokh, Nazila Salamat-Miller, John J. Thomas
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