Biophysical Methods for Biotherapeutics: Discovery and Development Applications

This book focuses on the application of biophysical techniques and methods in the development of biotherapeutics. Four areas, all focusing on biotherapeutics development, are emphasized–– (1) novel applications and new methods of traditional biophysical techniques, (2) novel and emerging technologies and their applications, (3) biophysical applications relevant to stage-wise development of a clinical biotherapeutic candidate, and (4) thermodynamic, conformational and stabilization concepts aided by biophysical research.The chapters are laid out in a theme based on clinical phases of development, which gives a comprehensive view of what biophysical studies are needed for what phase and what purpose, how and when to apply the techniques, what type of characterization regulatory agencies expect, and the limitations of each technique and type of applications. Overall, this book helps formulation, analytical, and bioanalytical scientists in pharma and biotech industries better understand and use biophysical methods and assess impact on quality and immunogenicity. It also provides information to help organizations develop short- and long-term strategies for resource investment in biophysical research.

About the Author

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.