Membrane ion-exchange chromatography for process-scale antibody purification.
The large-scale production of recombinant monoclonal antibodies demands economical purification processes with high throughputs. The potential for ion-exchange membrane adsorbers to replace traditional ion-exchange columns was evaluated. Breakthrough capacities of commercially available cation-exchange membranes were determined as a function of flow-rate and layer number. Due to economic and process restrictions, cation-exchange membranes may not currently be advantageous for process-scale antibody purification in a bind and elute mode. However, anion-exchange membranes in a flow-through mode may provide a reasonable alternative to columns for the removal of low levels of impurities such as DNA, host cell protein, and virus.
Knudsen
H L
HL
Department of Recovery Sciences, Genentech, Inc., South San Francisco, CA 94080, USA. hknudsen@gene.com
Fahrner
R L
RL
Xu
Y
Y
Norling
L A
LA
Blank
G S
GS
D000906:Antibodies / Q000302:isolation & purification*; D002852:Chromatography, Ion Exchange / Q000379:methods*; D008567:Membranes, Artificial
D000906:Antibodies; D008567:Membranes, Artificial