The volume explains how technologies developed in the last decade function similarly to unit operations for producing advanced biopharmaceuticals, such as hormones, cytokines, therapeutic enzymes, modified proteins, and transgenic products – to name a few. From large–scale animal cell bioreactors to patient–customized products, this volume describes the effects of new technologies on biopharmaceutical processes and guides users on how to apply new technologies in process development.
Chapter 1: Overview of the Biopharmaceutical Industry.
Chapter 2: Regulatory Requirements for Processing Biopharmaceuticals.
Chapter 3: Genomics, Proteomics, and Metabolomics Impact on Biopharmaceutical Processing.
Chapter 4: New Technologies in Biopharmaceutical Upstream Processing.
Chapter 5: New Technologies in Biopharmaceutical Downstream Processing.
Chapter 6: Biopharmaceutical Product Formulation, Preservation, and Presentation.
Chapter 7: Biopharmaceutical Product and Process Monitoring, Analysis and Control.
Chapter 8: Discrete Automation in BioProcessing Unit Operations.
Chapter 9: Emerging Biopharmaceutical Platforms.
Bibliography and Further Reading.
"This book provides an anthology of information in essentially all areas of bioprocessing...(and it) provides essential information on proven techniques that can make the evolutionary art form of biologic manufacturing more manageable...I know you will enjoy this book and find its information to be highly valuable for your work. Whether you are a beginner in this field or a seasoned veteran, this text will give you the reference material you need to successfully develop and produce biologics, while satisfying regulatory requirements."