Impact of multiple re-use of anion-exchange chromatography media on virus removal.
We evaluated viral clearance in multiply-cycled anion-exchange media run in flow-through mode. We found that anion-exchange columns do not lose viral clearance capacity after extensive re-use, if they are cleaned with recommended buffers that do not chemically degrade the media. In contrast, anion-exchange (AEX) columns that are not cleaned or are cleaned with buffers that chemically degrade the media lost viral clearance capacity after extended use. In these cases, other performance attributes that changed at the same time were increased band spreading, decreased DNA clearance and accumulating backpressure that prevented re-use past 80-120 cycles. Thus, our data suggests that flow through mode anion-exchange columns that are cleaned with recommended cleaning buffers, and periodically monitored for band spreading, DNA clearance and/or backpressure need not be re-evaluated for viral clearance at the end of the validated media lifetime.
Norling
Lenore
L
Department of Recovery Sciences, Genentech Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
Lute
Scott
S
Emery
Rachel
R
Khuu
Wynn
W
Voisard
Mark
M
Xu
Yuan
Y
Chen
Qi
Q
Blank
Greg
G
Brorson
Kurt
K
D000837:Anion Exchange Resins; D002852:Chromatography, Ion Exchange / Q000379:methods*; D016133:Polymerase Chain Reaction; D014780:Viruses / Q000302:isolation & purification*
D000837:Anion Exchange Resins