This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers.
Updates include:
- sources and productivity - types of products made today - experiences in clinical and licensed products - economics - current status of validation - illustrations and tables - automated column packing - automated systems
New topics include:
- the use of disposables - multiproduct versus dedicated production - design principles for chromatography media and filters - ultrafiltration principles and optimization - risk assessments - characterization studies - design space - platform technologies - process analytical technologies (PATs) - biogenerics - comparability assessments

Key Features

Key Features:
- new approaches to process optimiaztion - use of patform technologies - applying risk assessment to process design


This book is suitable for practitioners, consultants and students in Biotechnology.

Table of Contents

Preface Acknowledgements 1. Biopharmaceuticals Today 2. Process Capability and Production Scenarios 3. Process Design Concepts 4. Separation Technologies 5. Analysis 6. Cleaning and Sanitization 7. Validation 8. Economics 9. Basic Properties of Peptides, Proteons, Nucleic Acids, and Virus Particles 10. Optimization of Chromatographic Separations 11. Equipment 12. Column Packing Appendix A. Symbols and Definitions in Liquid Chromatography Appendix B. Dimensionless Numbers Appendix C. Activities for Biopharmaceutical Production from Genetically Engineered Mammalian Cells Appendix D. Simulations Using the Supplied Software


No. of pages:
© 2008
Academic Press
eBook ISBN:
Print ISBN:

About the author

Gunter Jagschies

Dr. Jagschies is a 30-year employee of GE Healthcare and a widely recognized expert in the chemistry-manufacturing-control of pharmaceutical/biotherapeutic products. He has published numerous papers on the development, manufacturing and economics of biotherapeutics, and in 2012 he received the BioProcess International award, “Thought Leader of the Decade.”

Affiliations and Expertise

Senior Director, GE Healthcare, Uppsala, Sweden