Platform processes for mAb purification have been widely implemented in the biopharmaceutical industry. A typical platform process includes a Protein A capture step, followed by one or two chromatography based polishing steps to further remove impurities. Although packed bed columns are still the workhorse for mAb purification, single-use membrane adsorbers (MA), such as Q based MAs, are gaining more usage for flow-through polishing operations. This paper will present development data evaluating two membrane adsorbers, Sartobind STIC and a prototype salt-tolerant cation exchange MA, for polishing Bayer mAb products. Both MAs exhibited enhanced salt-tolerance compared to earlier generation anion and cation exchange MAs. Operational parameters were defined to maximize CHOP and aggregate removal without sacrificing product yield. A new purification process built on Protein A chromatography and two subsequent MA flow-through polishing steps was evaluated. Detailed experimental data will be presented to demonstrate that MA technology is a viable alternative to packed bed column chromatography for mAb purification.

Evaluation of membrane adsorbers as platform polishing technology for recombinant monoclonal antibody (mAb) purification

245th National Meeting (2013)

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