ABSTRACT
This chapter reviews process development, process design, and design and operation concepts of large-scale chromatography systems used in biopharmaceutical manufacturing. The most common types of pumps used in modern, large-scale chromatography systems are the diaphragm pump and the lobe pump. A much simpler design of the large-scale chromatography system is required if only stepwise/isocratic elution is used in the process. The handling of chromatographic packings should be performed in accordance with the manufacturer's recommendations. The validation of media separation efficiency in preparative and large-scale chromatography is simply checked by determining the number of theoretical plates of a given column. The most widely used large-scale chromatography techniques are ion exchange, hydrophobic interaction, gel filtration and affinity.
