Immunoaffinity adsorption: process-scale isolation of therapeutic-grade biochemicals.

This review describes immunoaffinity purification as a tool for the process-scale isolation of high-value, therapeutic-grade biochemicals from complex media. To this end, practicalities of activation, antigen coupling and operation in anti-human IgG monoclonal antibody recovery have been studied using cyanogen-bromide activated Sepharose CL-4B and composite Macrosorb K4AX immobilised with polyclonal human IgG as a model for general immunoaffinity systems. The characteristics required of solid phases are discussed in the context of the efficient application of bioselective processes early in the purification sequences. The importance of the technique for isolating biologically active biomolecules for in-vivo administration has been discussed in the light of current, stringent regulatory requirements. Finally, the prospect of scale-up and automation of the technique has been evaluated.