Designing a MAb Purification Process:Based on Bio-Sequential Chromatography

摘要

In batch-mode chromatography, operating conditions do not allow full use of the total media capacity (1,2). Bio-Sequential Chromatography (BioSC~R) is an open-loop process for the separation of multicomponent solutions (3). The unique column of the batch mode is replaced by a series of smaller columns (from two to six). This design < maximizes the use of the media without product loss along the process sequences. The BioSC~R Lab automated system is based on the multicolumn chromatography process, designed and provided by Novasep. Studies have been performed to demonstrate the benefits on IgG purity of a downstream process (DSP) monoclonal antibody (MAb) platform with two continuous chromatography steps (4). This note features the outlines of the method used and the qualitative and quantitative results obtained for the product critical quality attributes (CQAs) (Table 2).