Protein Chromatography – Process Development and Scale–Up 2e

Giorgio Carta, PhD, is a professor in the Department of Chemical Engineering at the University of Virginia, Charlottesville (USA), where his research focuses on transport phenomena and bioseparations. He regularly organizes professional courses on various aspects of bioseparations, including a course on protein chromatography development and scale-up together with Alois Jungbauer.

Alois Jungbauer, PhD, is the head of protein technology and downstream processing at the Department of Biotechnology of the University of Natural Resources and Applied Life Sciences in Vienna (Austria). For more than 30 years, Professor Jungbauer has worked in biochemical engineering, with a focus on bioseparation, where he has published widely and holds 15 patents. He has also organized a biannual professional course in protein chromatography focused on mass transfer, dispersion, and scale-up.

Preface DOWNSTREAM PROCESSING OF BIOTECHNOLOGY PRODUCTS Introduction Bioproducts and their Contaminants Bioprocesses Biosimilars Role of Chromatography in Downstream Processing Environmental Impact of Biopharmaceutical Processing References INTRODUCTION TO PROTEIN CHROMATOGRAPHY Introduction Basic Principles and Definitions Modes of Operation Performance Factors Separation Performance Metrics CHROMATOGRAPHY MEDIA Introduction Interaction Types and Chemistry Buffers and Mobile Phases Physical Structure and Properties LABORATORY AND PROCESS COLUMNS AND EQUIPMENT Introduction Laboratory-scale Systems Process Columns and Equipment ADSORPTION EQUILIBRIUM Introduction Single Component Systems Multi-component Systems Empirical Correlation of Equilibrium Data References RATE PROCESSES Introduction Rate Mechanisms Batch Adsorption Kinetics DYNAMICS OF CHROMATOGRAPHY COLUMNS Introduction Material Balance Equations Local Equilibrium Dynamics Multi-component Systems Displacement Chromatography EFFECTS OF DISPERSION AND RATE PROCESSES ON COLUMN PERFORMANCE Introduction Empirical Characterization of Column Efficiency Modeling and Prediction of Column Efficiency GRADIENT ELUTION CHROMATOGRAPHY Introduction General Theory for Gradient Elution with Linear Isotherms LGE Relationships and the Iso-Resolution for Ion Exchange Chromatography LGE Relationships for RPC and HIC Gradient Elution at High Protein Loads Separations with pH Gradients References CHROMATOGRAPHIC COLUMN DESIGN ADN OPTIMIZATION Introduction Chromatographic Process Steps and Constraints Design for Capture Design for Chromatographic Resolution SMB Design References INDEX