Objective

The purification of biologics, and specifically monoclonal antibodies (mAb), frequently involves multiple chromatography columns and buffer systems. The prevalence of small-batch biologic production allows the use of smaller chromatographic columns, which can be more amenable to completely automated purification. A single Multi-D method combining both purification and analysis on the NGC^TM Chromatography System allows for completely hands-free, reproducible, and high-fidelity purifications without scientist intervention. By automating purification, in-line analysis can be added at any point in the workflow to investigate a small portion of the sample before saving the rest or continuing the purification. 

Here, a typical mAb protein purification and analysis workflow is fully automated followed by host cell protein (HCP) quantitation with ELISA. A single method combines a Protein A and desalting column (for neutralisation) in tandem with and ion exchange pair in tandem before aggregation analysis using size exclusion chromatography (SEC). Final HCP-ELISA quantitation demonstrates the ability to generate a single purification method on the NGC^TM  Chromatography System that is as effective as doing each purification step individually.