Ultrafiltration (UF) is a key process in the bioprocessing area and is used in almost every bioprocess. The book is written by a leading worker in the area and includes many practical applications and case studies. It is key reading for all those involved in the biotechnology and biopharmaceutical areas.
• Focuses on ultrafiltration for biopharmaceuticals. Other books look
at general ultrafiltration or general biopharmaceuticals
• Is 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/or case studies
• Uses extensive case study material
• Application of mass flux approach for selected applications such as vaccine manufacturing
- Fundamentals - membrane pore sizes, applications, modes of operation, module hydraulics, basic system and operation, references
- Membranes - materials and formation, structures, permeability, solute separation, specifications, process flux, references
- Modules - general, stirred cell, hollow fiber and tubes, plate and frame open and screen channels, spirals, others, modeling, manufacturing, performance, advantage and disadvantages, uses, hydraulic control, specs, shear, polarization holdup, materials, references
- Process configurations - single pass with and without pumps, batch, fed-batch, advantages and disadvantages, concentration, batch and continuous constant volume diafiltration, constant mass diafiltration, optimum diafiltration Preprocessing - installation, flushing, integrity testing, equilibration
- Processing - objectives, scaling, dynamics, TMP and xflow excursions, concentration and diafiltration, sizing, safety factor, mass flux, case studies (MAb, insulin, high conc, vaccine, fractionation)
- Recovery - yield, methods, advantages and disadvantages, recovery curve
- Cleanup - objectives, cleaners, conditions, NWP
- Manufacturing systems - measurement and control, PandID, SOP, component selection, pump, tank, retentate valve, pressure drops, layout, specs., start-up, minimum working volume, heat exchanger, holder configuration Validation - design qualification, installation and operation qualification, process qualification, ongoing monitoring and control, process changes
- Trouble shooting - purity, yield, flux, pressure drop, IT, NWP, case studies: temp, NaOH, start-up, cleaning, DP Appendices - temperature correction factor, chemical compatibility chart
Bioprocessing firms worldwide; departments of process development, operations, validation, quality control, regulatory, training. Also regulators and consultants. University faculties with general bioengineering programs in chemical engineering departments.
The author 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 area of separations and purification for 30 years. Herb is a principal consulting engineer with Millipore Corporation and currently focuses on the development, validatation, scale-up and trouble-shooting 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.