Increasing Productivity Of pDNA DSP Using Sample Displacement Chromatography

Plasmid DNA (pDNA) as a pharmaceutical product has stringent purity and efficacy requirements, and often one or more chromatographic steps are used in the downstream process. A high ligand density butyl-modified chromatographic monolith (CIMmultus® C4 HLD, part of CIMmultus® HiP² Plasmid Process Pack™ ) is currently employed in the polishing step of a pDNA purification process. It is mainly used for the separation of supercoiled (SC) pDNA separation from open circular (OC) and linear pDNA isoforms and the removal of remaining gDNA and RNA.

This application note presents a comparison of two different polishing processes employing monoliths, namely bind-elute (BE) and the more recently described sample displacement purification (SDP).