Protein Chromatography - Process Development and Scale-Up

An all-in-one practical guide on how to efficiently use chromatographic separation methodsBased on a training course that teaches the theoretical as well as practical aspects of protein bioseparation to bioprocess professionals, this fully updated and revised new edition offers comprehensive coverage of continuous chromatography and provides readers with many relevant examples from the biopharmaceutical industry. Divided into two large parts, Protein Chromatography: Process Development and Scale-Up, Second Edition presents all the necessary knowledge for effective process development in chromatographic bioseparation, both on small and large scale. The first part introduces chromatographic theory, including process design principles, to enable the reader to rationalize the set-up of a bioseparation process. The second part illustrates by way of case studies and sample protocols how the theory learned in the first part may be applied to real-life problems. Chapters look at: Downstre am Processing of Biotechnology Products; Chromatography Media; Laboratory and Process Columns and Equipment; Adsorption Equilibrium; Rate Processes; and Dynamics of Chromatography Columns. The book closes with chapters on: Effects of Dispersion and Rate Processes on Column Performance; Gradient Elution Chromatography; and Chromatographic Column Design and Optimization.-Presents the most pertinent examples from the biopharmaceutical industry, including monoclonal antibodies-Provides an overview of the field along with design tools and examples illustrating the advantages of continuous processing in biopharmaceutical productions-Focuses on process development and large-scale bioseparation tasks, making it an ideal guide for the professional bioengineer in the biotech and pharma industries-Offers field-tested information based on decades of training courses for biotech and chemical engineers in Europe and the U.S.Protein Chromatography: Process Development and Scale-Up, Second Editio n will appeal to biotechnologists, analytical chemists, chromatographers, chemical engineers, pharmaceutical industry, biotechnological industry, and biochemists.

Inhaltsverzeichnis:

PrefaceDOWNSTREAM PROCESSING OF BIOTECHNOLOGY PRODUCTSIntroduction Bioproducts and their ContaminantsBioprocessesBiosimilarsRole of Chromatography in Downstream ProcessingEnvironmental Impact of Biopharmaceutical ProcessingReferencesINTRODUCTION TO PROTEIN CHROMATOGRAPHYIntroductionBasic Principles and DefinitionsModes of OperationPerformance FactorsSeparation Performance MetricsCHROMATOGRAPHY MEDIAIntroductionInteraction Types and ChemistryBuffers and Mobile PhasesPhysical Structure and PropertiesLABORATORY AND PROCESS COLUMNS AND EQUIPMENTIntroductionLaboratory-scale SystemsProcess Columns and EquipmentADSORPTION EQUILIBRIUMIntroductionSingle Component SystemsMulti-component SystemsEmpirical Correlation of Equilibrium DataReferencesRATE PROCESSESIntroductionRate MechanismsBatch Adsorption KineticsDYNAMICS OF CHROMATOGRAPHY COLUMNSIntroductionMaterial Balance EquationsLocal Equilibrium DynamicsMulti-component SystemsDisplacement ChromatographyEFFECTS OF DISPERSION AND RATE PROC ESSES ON COLUMN PERFORMANCEIntroductionEmpirical Characterization of Column EfficiencyModeling and Prediction of Column EfficiencyGRADIENT ELUTION CHROMATOGRAPHYIntroductionGeneral Theory for Gradient Elution with Linear IsothermsLGE Relationships and the Iso-Resolution for Ion Exchange Chromatography LGE Relationships for RPC and HICGradient Elution at High Protein LoadsSeparations with pH GradientsReferencesCHROMATOGRAPHIC COLUMN DESIGN ADN OPTIMIZATIONIntroductionChromatographic Process Steps and ConstraintsDesign for CaptureDesign for Chromatographic ResolutionSMB DesignReferencesINDEX