Anion exchange based methods have become, due to their well documented ability to clear virus, DNA, endotoxins, and many protein impurities, an industry standard for large scale polishing of monoclonal antibodies. The most common formats used for polishing of antibodies are beaded particles or membranes derivatized with quaternary amines. In this paper we have studied the capacity to remove host cell proteins (HCP) and DNA at relatively short residence times of 1 minute or lower on quaternary amine based plain agarose resins and dextran grafted agarose resins. The dextran grafted resin showed a more than 10 fold increase in HCP removal capacity compared to the plain agarose resins. This paper will present results of HCP and DNA removal capacity under different process conditions as well as models looking at the impact of capacity on process economy and productivity of the three different formats.

Polishing of monoclonal antibodies post Protein A affinity chromatography: A technology study

239th National Meeting (2010)

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