Process-Scale Bioseparations For the Biopharmaceutical Industry
The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes. Bioseparations-also called downstream processing- can be a key source of competitive advantageto biopharmaceutical developers. Process Scale Bioseparations for the Biopharmaceutical Industry brings together scientific principles, empirical approaches, and...
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The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes. Bioseparations-also called downstream processing- can be a key source of competitive advantageto biopharmaceutical developers. Process Scale Bioseparations for the Biopharmaceutical Industry brings together scientific principles, empirical approaches, and practical considerations for designing industrial downstream bioprocesses for various classes of biomolecules.Using clear language along with numerous case studies, examples, tables, flow charts, and schematics, the book presents perspectives from experienced professionals involved in purification processes and industrial downstream unit operations. The authors provide useful experimental design strategies and guidelines for developing application-specific process scale bioseparations. Chapter topics include harvest by centrifugation and filtration, expanded bed chromatography, protein refolding, modes of preparative chromatography, methodologies for resin screening, membrane chromatography, protein crystallization, viral filtration, ultrafiltration/diafiltration, implementing post-approval downstream process changes for an antibody product, and future trends. Ideal for both new and experienced scientists in the biopharmaceutical industry and students, Process Scale Bioseparations for the Biopharmaceutical Industry is a comprehensive resource for all topics relevant to industrial process development.
Ch. 1Harvest of a therapeutic protein product from high cell density fermentation broths : principles and case study1Ch. 2Expanded bed adsorption for capture from crude solution59Ch. 3Product recovery by high-gradient magnetic fishing83Ch. 4Protein refolding and scale up123Ch. 5Bulk protein crystallization - principles and methods159Ch. 6Modes of preparative chromatography179Ch. 7Screening of chromatographic stationary phases227Ch. 8A priori prediction of chromatographic separations from protein structure data245Ch. 9Membrane chromatography : analysis of breakthrough curves and viral clearance277Ch. 10Ultrafiltration process design and implementation297Ch. 11Virus filtration process design and implementation333Ch. 12Product recovery from transgenic sources367Ch. 13Analytical strategy for biopharmaceutical development395Ch. 14Evaluation of viral clearance in purification processes419Ch. 15Advances in viral clearance449Ch. 16Protein A affinity chromatography for capture and purification of monoclonal antibodies and Fc-fusion proteins : practical considerations for process development463Ch. 17Polishing methods for monoclonal IgG purification491Ch. 18Making changes to a biopharmaceutical manufacturing process during development and commercial manufacturing : the REMICADE story507Ch. 19Linear scale-up of ultrafiltration of high viscosity process streamsCh. 20A membrane chromatography application : a rapid, high capacity gene therapy vector purification tool541
