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

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

By Jagschies, G√ľnter; Sofer, Gail K.; Hagel, Lars

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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

Subject: Allied Health & Medical -> Medical -> Pharmacology

Handbook of Process Chromatography: Development, Manufacturing, Validation and Economics
2nd edition
Publisher: Elsevier S & T 12/2007
Imprint: Academic Press
Language: English
Length: 382 pages

ISBN 10: 0123740231
ISBN 13: 9780123740236
Print ISBN: 9780123740236

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