Protein A chromatography is widely used as capture step in monoclonal antibody purification processes. Many types of chromatographic media are commercially available for this application however mainly Agarose and Porous glass based products are considered as standard mAb purification platforms due to high dBC and high operational flow rates. In fact process optimization of Protein A step is mainly aimed to have higher capacity and lower elution volumes in shorter process time.
In this context Kaneka has been investigating highly cross-linked Cellulose as possible alternative to such commercial products. Using both Native & Alkaline Stable Genetically engineered Protein A ligands Kaneka is developing new mAb capture media, having similar properties with highly cross-linked Agarose as soft gel resin type. Alkaline stable Protein A is designed to have no Fab binding, which leads to improved elution profile.
Some case studies will be presented comparing performance characteristics of Kaneka Protein A Cellulose with Agarose derived products showing the extremely high potential of this new mAb purification platform.