Biopharmaceutical drugs or biologics are complex molecules, such as therapeutic proteins serving patients to treat a wide variety of clinical indications, including cancers, autoimmunity/inflammation, exposure to infectious agents, and genetic disorders. In manufacturing of such biologics drugs using cell culture, there are wide range engineering challenges across the industry independent of type of therapeutic protein made.

This book selectively talks about the most frequently encountered challenges and practical solutions backed up using scientific concepts, chemical engineering principles. Therefore, this book helps biopharmaceutical manufacturing engineers to investigate, and trouble shoot such complex manufacturing issues.

Furthermore, application of statistics in biopharmaceuticals has been accelerated for over a decade now. Though other books are available in the market, this book details the statistical methods with illustrative examples worked out using Microsoft Excel as tool.

Hence this book serves as an easy to adopt statistical handy tool for bioprocess engineers in biopharmaceutical industry. .