Biophysical Methods for Biotherapeutics Discovery and Development Applications

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.

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.

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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