Ultrafiltration for Bioprocessing
- 1st Edition - February 23, 2015
- Latest edition
- Author: Herbert Lutz
- Language: English
Ultrafiltration for Bioprocessing is key reading for all those involved in the biotechnology and biopharmaceutical areas. Written by a leading worker in the area, it includ… Read more
- Focuses on ultrafiltration for biopharmaceuticals—other books look at general ultrafiltration or general biopharmaceuticals
- A mix of theory and practical applications—other books tend to be more theory-oriented
- Addresses the main issues encountered in development and scale-up through recommendations and case studies
All those involved in Biotechnology and Biopharmaceuticals
- About the contributors
- About the editor
- Preface
- Acknowledgments
- 1: Fundamentals
- Abstract
- 1.1. Membrane pore sizes
- 1.2. Applications
- 1.3. Modes of operation
- 1.4. Module hydraulics
- 1.5. Basic system and operation
- 1.6. Process development and validation
- 1.7. Systems and troubleshooting
- 2: Membranes
- Abstract
- 2.1. General properties
- 2.2. Materials and formation
- 2.3. Membrane structures
- 2.4. Solvent transport
- 2.5. Solute sieving
- 2.6. Retention ratings
- 2.7. Solute passage modelling
- 2.8. Solvent transport with electrical charges
- 2.9. Solute transport with electrical charges
- 2.10. Osmotic pressure
- 2.11. Process permeability
- 2.12. Polarization
- 3: Modules
- Abstract
- 3.1. Stirred cell
- 3.2. Hollow fibres and tubes
- 3.3. Spirals
- 3.4. Cassettes
- 3.5. Module characteristics
- 3.6. Module shear
- 3.7. Comparison of flat sheet and tube modules
- 3.8. Other modules
- 4: Module performance
- Abstract
- 4.1. Solute transport mechanisms
- 4.2. Velocities and friction factors
- 4.3. Concentrations and mass transfer coefficients
- 4.4. Stirred cell velocities and torque
- 4.5. Stirred cell concentrations and mass transfer coefficient
- 4.6. Slit channel velocities and friction factor
- 4.7. Slit channel concentrations and mass transfer coefficient
- 4.8. Tube velocities and friction factor
- 4.9. Tube concentrations and mass transfer coefficient
- 4.10. Cassette velocities and friction factor
- 4.11. Cassette concentrations and mass transfer coefficient
- 5: Configurations
- Abstract
- 5.1. Batch concentration
- 5.2. Fed-batch concentration
- 5.3. Batch diafiltration
- 5.4. Constant volume diafiltration
- 5.5. Batch process sizing and optimum diafiltration concentration
- 5.6. Constant mass batch diafiltration
- 5.7. Single-pass or continuous concentration
- 5.8. Single-pass or continuous diafiltration
- 5.9. Selection of system configuration and operating methods
- 6: Pre-processing operations
- Abstract
- 6.1. Module installation
- 6.2. Flushing
- 6.3. Integrity testing
- 6.4. Module equilibration in buffer
- 7: Processing
- Abstract
- 7.1. Membrane and module selection
- 7.2. Process operating conditions selection
- 7.3. Standard batch protein processing
- 7.4. High concentration operation
- 7.5. Protein aggregation and precipitation
- 7.6. Adsorbed solutes
- 7.7. Cwall operation
- 7.8. Variable volume diafiltration operation
- 7.9. Mass flux operation (Bala Raghunath and Herb Lutz)
- 7.10. Fractionation operation
- 8: Post-processing
- Abstract
- 8.1. Product recovery
- 8.2. Cleaning
- 8.3. Sanitization
- 8.4. Post CIP measurements
- 8.5. Storage
- 9: Systems
- Abstract
- 9.1. Basic system components and layout
- 9.2. System design targets
- 9.3. Hardware components
- 9.4. Membrane holder
- 9.5. Process monitoring and control
- 9.6. Sampling
- 9.7. Pressure sensors
- 9.8. Temperature sensors
- 9.9. Flow meters and compressed gas supply
- 9.10. Buffer and protein concentrations
- 9.11. Level measurement
- 9.12. Other sensors
- 9.13. Layout
- 9.14. Cost considerations
- 10: Validation
- Abstract
- 10.1. Scaling
- 10.2. Quality and process attributes
- 10.3. Process parameters
- 10.4. Design space (operating set-points and windows)
- 10.5. Characterization studies
- 10.6. Cleaning/reuse studies
- 10.7. Extractables
- 10.8. Equipment and facilities
- 10.9. Monitoring and re-validation
- 11: Troubleshooting
- Abstract
- 11.1. Troubleshooting methodology
- 11.2. Ultrafiltration troubleshooting
- 11.3. Failure mode: low yield or yield loss
- 11.4. Failure mode: changes in water permeability
- 11.5. Failure mode: changes in process permeability
- 11.6. Failure mode: high feed channel resistances
- 11.7. Failure mode: post-use integrity test failures
- 11.8. Failure mode: excipient clearance
- 11.9. Failure mode: poor product quality (aggregation/activity)
- 11.10. Troubleshooting case study
- 12: Conclusion
- Abstract
- 12.1. Historical overview
- 12.2. Recent developments and current research
- 12.3. Trends and likely future developments
- 12.4. Summary
- Appendix A
- Index
- Edition: 1
- Latest edition
- Published: February 23, 2015
- Language: English
HL
Herbert Lutz
Herbert Lutz is a leading international authority with multiple patents, publications, presentations, and courses in the field. He has degrees in chemistry and chemical engineering from the University of California, Santa Barbara and attended graduate school in Business and Chemical Engineering at MIT. He has worked in the field of separations and purification for 30 years. Herb is a principal consulting engineer with Millipore Corporation and currently focuses on the development, validation, scale-up and troubleshooting of new downstream purification applications such as virus clearance, sterile filtration, clarification, tangential flow filtration, chromatographic purification, and membrane adsorbers. He has also worked in product management, and strategic marketing. As a thought leader in the field, Herb is a frequent conference presenter, chair, and has assisted in organizing several conferences. He has published several book chapters including the Membrane Separation Section of Perry’s Chemical Engineer’s Handbook, holds a filtration patent, is on the scientific advisory board for Biopharm International, and has published in the areas of scaling, ultrafiltration, membrane adsorption, integrity testing and virus clearance. Mr. Lutz has taught membrane applications for Millipore, for the ASME Bioprocess course, and for the Society for Bioprocessing Professionals.