
Handbook of Process Chromatography
Development, Manufacturing, Validation and Economics
- 382 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
Handbook of Process Chromatography
Development, Manufacturing, Validation and Economics
About this book
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 systemsNew 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 assessmentsKey Features: - new approaches to process optimiaztion- use of patform technologies- applying risk assessment to process design
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Information
Table of contents
- Cover image
- Title page
- Table of Contents
- Preface
- Acknowledgements
- Chapter 1: Biopharmaceuticals Today
- Chapter 2: Process Capability and Production Scenarios
- Chapter 3: Process-Design Concepts
- Chapter 4: Separation Technologies
- Chapter 5: Analysis
- Chapter 6: Cleaning and Sanitization
- Chapter 7: Validation
- Chapter 8: Economics
- Chapter 9: Basic Properties of Peptides, Proteins, Nucleic Acids and Virus Particles
- Chapter 10: Optimization of Chromatographic Separations
- Chapter 11: Equipment
- Chapter 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
- Subject Index