Handbook of Process Chromatography

2nd Edition

Development, Manufacturing, Validation and Economics

Authors: Gunter Jagschies Gail Sofer Lars Hagel
Hardcover ISBN: 9780123740236
eBook ISBN: 9780080554518
Imprint: Academic Press
Published Date: 25th October 2007
Page Count: 382
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Description

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

Readership

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

Details

No. of pages:
382
Language:
English
Copyright:
© Academic Press 2008
Published:
Imprint:
Academic Press
eBook ISBN:
9780080554518
Hardcover ISBN:
9780123740236

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

Gail Sofer

Gail Sofer has been consulting with biotechnology and pharmaceutical companies for the past five years through the Fast Trak Validation(r) group of PharmaciaBiotech as the Director of International Validation Development. A series of publications on validation have provided guidance to many in this arena. She is active in organizations such as PDA and ASTM.

Affiliations and Expertise

GE Healthcare

Lars Hagel

Lars Hagel is a Ph.D. in analytical chemistry and also Associate Professor at the University of Uppsala. Dr. Hagel has held different management positions within the R&D department and is now a senior scientific consultant of Pharmacia Biotech. He is a member of the board for The Swedish Centre for Bioseparations, and he chairs the Centre for Bioprocess Technology. Dr. Hagel's research has focused upon practical implications of chromatography theory and he has published a vast number of papers and chapters, with special reference to gel filtration.

Affiliations and Expertise

Pharmacia Biotech AB