The purification of biologics and specifically monoclonal antibodies 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 method combining both tandem and multi-D methodologies on a chromatography system allows for completely hands-free, reproducible, and high fidelity purifications without scientist intervention. In addition to automating purification, in-line analysis can be added at any point of the purification workflow to investigate a small portion of the sample before saving the rest or continuing with the purification.<br/><br/>Here, a typical mAb protein purification workflow is fully automated and analyzed for HCPs with ELISA. A single method combines a protein A and neutralization tandem with an ion exchange pair in tandem before aggregation analysis using size exclusion chromatography. Final HCP-ELISA analysis demonstrates the ability to generate a single purification method on a chromatography system that is as effective as doing each purification step individually.

Automating mAb purification workflows: Combining tandem and multi-D purification methodology with sample analysis

251st National Meeting (2016)

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