Handbook of Process Chromatography: Development, Manufacturing, Validation and Economics

Hardcover | December 8, 2007

byGünter Jagschies, Gail K. Sofer, Lars Hagel

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

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From the Publisher

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 wil...

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...

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Format:HardcoverDimensions:382 pagesPublished:December 8, 2007Publisher:Academic PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0123740231

ISBN - 13:9780123740236

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Extra Content

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