Process‐Scale Chromatography

AbstractThe article contains sections titled:1.Introduction2.Chromatographic Techniques2.1.Adsorptive Methods2.1.1.Ion‐Exchange Chromatography2.1.2.Affinity Chromatography2.1.3.Hydrophobic Interaction Chromatography2.1.4.Reversed Phase Chromatography2.2.Gel Filtration3.Downstream Strategy3.1.Number of Preparative Steps3.2.Preparation of an Optimal Raw Material3.3.Development of a Chromatographic Purification System3.3.1.Screening of Chromatographic Methods (Method Scouting)3.3.1.1.The Gel Bank3.3.1.2.Experimental Data3.3.2.Logical Sequence of Chromatographic Steps3.3.2.1.Selection Criteria3.3.2.2.The Starting Step3.3.2.3.Subsequent Steps4.Optimization4.1.Purpose of Optimization4.2.Optimization Parameters4.2.1.Resolution4.2.2.Throughput4.3.Optimization of Ion‐Exchange Chromatography4.4.Optimization of Affinity Chromatography4.5.Optimization of Hydrophobic Interaction Chromatography4.6.Optimization of Gel Filtration5.Scaling Up5.1.Transfer Protocol5.2.Practical Examples and Case Studies5.3.Dimensioning of a Purification Cycle6.Process‐Scale Chromatography Plants6.1.Basic Design Requirements6.2.Plant Design6.2.1.The Chromatography Column6.2.2.Process Monitoring6.2.3.Pumps and Valves6.2.4.Automation and Safety Devices6.3.Effects of Apparatus on Separation7.Quality Assurance8.Developments