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 American Association of Pharmaceutical Scientists.