ABSTRACT

Chromatography is unique in achieving the high standards of product purity dictated by the regulatory authorities for the commercial bioproducts. Apart from that, and in contrast to other separation techniques, there is no heat generation and the shear stresses are much less significant, therefore preserving the integrity of sensitive biomolecules. It is now well established either as an analytical tool or as a production scale unit operation in industrial processes of enzymes and drugs production. However, the design of a large scale chromatographic process is very complex and involves many factors which are not primarily “chromatographic” (e.g. economic considerations, process hygiene, fouling of the stationary phase, purity of the final product, integration with other up-and downstream operations, productivity, etc.). Reviews of the existing knowledge have been published (Ruckenstein and Lesins (1988), Yang and Tsao (1982), Janson and Hedman (1982), Freitag and Horváth (1996)).