Biophysical Methods for Biotherapeutics: Discovery and Development Applications - Hardcover

Hardcover

ISBN 10: 0470938439 ISBN 13: 9780470938430

Publisher: Wiley, 2014

Synopsis

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.

About this title

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.

From the Back Cover

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.

From the Inside Flap

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.

Edition details

• Publisher: Wiley
• Publication date: 2014
• Language: English
• ISBN 10: 0470938439
• ISBN 13: 9780470938430
• Binding: Hardcover
• Edition number: 1
• Number of pages: 384
• Editor: Das Tapan K.