Anion exchange chromatography (AEX) operated in flowthrough mode is often used as a polishing step during the purification of monoclonal antibodies (MAbs). It helps remove residual impurities (host cell protein (HCP), DNA, protein A ligand) and provides a contribution to viral clearance, which has important ramifications for regulatory agencies[1]. Traditional AEX column chromatography utilizes a positive charged ligand under which the negatively charged impurities and viruses are bound to the resin while the positively charged MAb is not retained and is recovered in the flowthrough. AEX column chromatography can often achieve effective (&gt;4 log10 reduction of virus or LRV) virus reduction across the step[2]. AEX membrane adsorbers have convective flow properties that allow for higher operating flow rates and effective MAb loading, however a more limited data set exists on viral clearance for this technology. This paper summarizes a case study evaluating the partitioning of a four virus panel (MVM, XMuLV, Reo3, PrV) for a MAb using several marketed AEX membrane adsorbers across a range of operating conditions (impurity load, flow rate, feed pH and conductivity) to show process robustness in comparison with traditional AEX column chromatography. [1] ICH. 1998. Guidance of Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, Q5A. Geneva, Switzerland: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Fed Regist. 1998; 63:51074-51084. [2] Miesegaes G, Lute S, Reed E, Brorson K. Viral Clearance by Flow-Through Mode Ion Exchange Columns and Membrane Adsorbers. Biotech Progress. 2014;14:1,124-131.

Maximizing productivity with AEX membrane adsorbers: Impact on robustness and edge of failure

251st National Meeting (2016)

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