Handbook of Process Chromatography
Development, Manufacturing, Validation and Economics
By- Lars Hagel, Pharmacia Biotech AB
- Günter Jagschies, GE Healthcare
- Gail Sofer, GE Healthcare
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
Audience
This book is suitable for practitioners, consultants and students in Biotechnology.
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Published: October 2007
Imprint: Academic Press
ISBN: 978-0-12-374023-6
Contents
- PrefaceAcknowledgements1. Biopharmaceuticals Today2. Process Capability and Production Scenarios3. Process Design Concepts4. Separation Technologies5. Analysis6. Cleaning and Sanitization7. Validation8. Economics9. Basic Properties of Peptides, Proteons, Nucleic Acids, and Virus Particles10. Optimization of Chromatographic Separations11. Equipment12. Column PackingAppendix A. Symbols and Definitions in Liquid ChromatographyAppendix B. Dimensionless NumbersAppendix C. Activities for Biopharmaceutical Production from Genetically Engineered Mammalian CellsAppendix D. Simulations Using the Supplied Software
