A typical monoclonal antibody (MAb) purification process begins with capture on a protein A chromatography medium (resin), followed by polishing steps by for example ion exchange chromatography. The polishing steps need to overcome several challenges. Removal of aggregates, one of the major goals of the purification process, is such an obstacle.
Today, higher titers (>3 g/L) in upstream production are common. This might lead to higher aggregate levels and consequently increase the demands on downstream processing. A newly developed grafting technology, resulting in a high-capacity and high-resolution cation exchange (CIEX) medium designed for polishing of monoclonal antibodies, can help solve this problem.
This study shows that this medium can handle variations in upstream production, with maintained yield and aggregate removal levels.