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A series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.
In this article, the authors have detailed the best practices when optimizing and sizing anion exchange (AEX) membrane adsorbers for virus clearance. AEX chromatography is a powerful method to clear all types of virus by separating viruses from the product of interest based on ionic charge. Membrane adsorbers (macroporous membranes with chromatographic ligands attached that function similarly to resins containing identical ligands) offer several advantages over conventional resin chromatography, such as higher binding capacity for large molecules (i.e., viruses), >10-fold faster flow rates, use of up to 75% less buffer, and present a flexible single-use solution that does not require cleaning validation. These qualities make membrane adsorbers a perfect fit for flow through chromatography operations where virus clearance is expected. The authors therefore performed minute virus of mice (MVM) spiking studies with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions, such as conductivity, process pause, product loading, and virus spike purity. The results provide an understanding of the impact of the evaluated process parameters on the clearance of parvovirus.
for a PDF of the article.
Submitted: Nov. 5, 2020.
Accepted: Jan. 20, 2021.
Sherri Dolan is a global technology consultant for Virus Clearance at Sartorius North America; Paul Nolan and Craig Quinney are process scientists; Stephen Carey is an analyst; and Lorna Littlejohn*, email@example.com, is the manager of Confidence Virus Clearance Services; all are at Sartorius in Glasgow, Scotland.
*To whom all correspondence should be addressed.
Vol. 34, No. 4
When referring to this article, please cite it as S. Dolan, et al., “Using Anion Exchange Membrane Adsorbers to Ensure Effective Virus Clearance of Challenging Parvoviruses,” BioPharm International 34 (4) 2021.