title: Membrane ion-exchange chromatography for process-scale antibody purification.
abstract: 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.
authors.affiliation: Department of Recovery Sciences, Genentech, Inc., South San Francisco, CA 94080, USA. hknudsen@gene.com
authors.forename: H L
authors.initials: HL
authors.lastname: Knudsen
authors.forename: R L
authors.initials: RL
authors.lastname: Fahrner
authors.forename: Y
authors.initials: Y
authors.lastname: Xu
authors.forename: L A
authors.initials: LA
authors.lastname: Norling
authors.forename: G S
authors.initials: GS
authors.lastname: Blank
mesh_terms: D000906:Antibodies / Q000302:isolation & purification*; D002852:Chromatography, Ion Exchange / Q000379:methods*; D008567:Membranes, Artificial
chemical_list: D000906:Antibodies; D008567:Membranes, Artificial