Many protein and peptide purification challenges encountered in the biopharmaceutical industry consist of the purification of the product from a mixture of impurities with similar adsorptive properties. The MCSGP process, which represents a highly efficient continuous countercurrent chromatographic purification technology platform, is particularly suited for these �difficult� separations as it is capable of performing linear gradients and three-fraction separations and achieving high yield and purity simultaneously.In certain purification challenges a three-fraction separation is not sufficient e.g. for the purification of charged monoclonal antibody (mAb) variants for pre-clinical studies. However, by extending the MCSGP process with further sections, additional fractions may be separated. In this presentation, the general approach for the extension of the MCSGP process for multi-fraction separations is outlined. Experimental data for a four-fraction separation of charged mAb variants of Erbitux� is presented and the performance of the extended process and batch chromatography is compared.

Extended MCSGP process for continuous four-fraction separation: Case study of monoclonal antibody variants

241st National Meeting (2011)

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