Weak partitioning chromatography for anion exchange purification of monoclonal antibodies

Biotechnology and Bioengineering
Brian D KelleySuresh Vunnum

Abstract

Weak partitioning chromatography (WPC) is an isocratic chromatographic protein separation method performed under mobile phase conditions where a significant amount of the product protein binds to the resin, well in excess of typical flowthrough operations. The more stringent load and wash conditions lead to improved removal of more tightly binding impurities, although at the cost of a reduction in step yield. The step yield can be restored by extending the column load and incorporating a short wash at the end of the load stage. The use of WPC with anion exchange resins enables a two-column cGMP purification platform to be used for many different mAbs. The operating window for WPC can be easily established using high throughput batch-binding screens. Under conditions that favor very strong product binding, competitive effects from product binding can give rise to a reduction in column loading capacity. Robust performance of WPC anion exchange chromatography has been demonstrated in multiple cGMP mAb purification processes. Excellent clearance of host cell proteins, leached Protein A, DNA, high molecular weight species, and model virus has been achieved.

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May 23, 2008·Biotechnology and Bioengineering·Jonathan L CoffmanBrian D Kelley
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Jun 14, 2008·Biotechnology and Bioengineering·David L WenselJon L Coffman
Jun 14, 2008·Biotechnology and Bioengineering·Brian D KelleyJon Coffman

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Citations

Jan 9, 2016·Protein Expression and Purification·Ewelina ŁojewskaTomasz Sakowicz
Mar 17, 2011·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Nicholas W Warne
Mar 23, 2010·Trends in Biotechnology·Abhinav A Shukla, Jörg Thömmes
Sep 21, 2010·Biotechnology Progress·Lisong Nathan MaoJohn Pieracci
Aug 13, 2011·Biotechnology and Bioengineering·Lisa Connell-CrowleyGanesh Vedantham
Nov 10, 2012·Biotechnology and Bioengineering·Timothy IskraRanga Godavarti
Apr 30, 2015·Biotechnology Advances·J F BuyelR Fischer
Nov 10, 2015·Biotechnology and Bioengineering·Thomas ElichChristopher J Morrison
Apr 9, 2017·Journal of Chromatography. a·Ellen O'ConnorWilliam Wang
Feb 26, 2013·Biotechnology and Bioengineering·Lisa Connell-CrowleyRon Gillespie
Apr 23, 2020·Nature Biotechnology·Brian Kelley
Jan 10, 2018·Bioengineering & Translational Medicine·Abhinav A ShuklaCarnley Norman
Mar 10, 2021·Biotechnology Progress·Brian KelleyMichael Kamarck
Nov 1, 2020·Journal of Chromatography. a·Jessica HungZheng Jian Li
Nov 11, 2011·Journal of Chromatography. a·Pete Gagnon

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