A guide to link and apply biophysics for developing biopharmaceuticals
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. This allows for a comprehensive view of:
* Which biophysical studies are needed for which stage and for what purpose,
* How and when to apply the techniques,
* What types of characterization regulatory agencies expect, and
* The limitations of each technique and type of application.
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.
Über den Autor und weitere Mitwirkende
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.