Automated mAb Workflows: Combining Multidimensional (Multi-D) Purifications With Product Analysis

By Phillip Elms, Gunjan Choudhary, and Jeff Habel

The purification of biologics, specifically monoclonal antibodies (mAbs), 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 amenable to completely automated purification. A single Multi-D method combining both purification and analysis on the NGC™ Chromatography System allows for hands-free, reproducible, and high-fidelity purifications with minimal user intervention.

Here, a typical mAb protein purification workflow was fully automated using the NGC System, and host cell protein (HCP) contamination was monitored by ELISA. This automated purification strategy utilizes a Protein A affinity capture and a buffer exchange column run in tandem followed by a pair of ion exchange (IEX) columns run in tandem before aggregation analysis using size exclusion chromatography (SEC). Final HCP-ELISA analysis demonstrated the ability to generate an automated single-purification method on the NGC System that is as effective as a more traditional sequential approach but with a much shortened time to completion.