Virus Reduction And Impurity Removal Potential Of Nuvia aPrime 4A Resin

By William H. Rushton, Xuemei He, Irene Chen, Sharon Bola, Akunna Iheanacho, Coral Fulton, Jenifer Dean, William Kerns, Kaye Peden, Katelyn Pritchard, Erin Reynolds, and Sreyry Schaerdel

We utilized a design of experiments (DOE) approach to investigate the effect of buffer pH and conductivity on the clearance of the minute virus of mice (MVM) as well as the removal of other productor process-related impurities by the mixed-mode chromatography Nuvia aPrime 4A Resin. Results from this study have offered insights on the interactions between the resin and MVM particles, as well as the design space for the removal of this virus. Although there is no single solution for every product or purification process, practical considerations for developing a mixed-mode chromatography process with effective impurity clearance will be discussed in this application note.

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