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Towards A Unified Process Development Strategy For Batch And Continuous Chromatography

Source: GE Healthcare Life Sciences

Here we describe a process development methodology that enables design of either a batch or a continuous chromatography step based on the same set of experimental data. As a series of small columns can mimic one single large column with the same diameter and a bed height equal to the total bed height of the smaller columns, a multicolumn setup was used for characterization of a bind-and-elute (B/E) monoclonal antibody (MAb) capture step. A multicolumn setup was also used for investigating the effect of chromatography medium (resin) lifetime on dynamic binding capacity (DBC) at different breakthrough (BT) levels. The obtained results provide information to be used for designing the capture step, operated in either batch or continuous process mode.