title: Viral clearance by flow-through mode ion exchange columns and membrane adsorbers.
abstract: Anion exchange (AEX) is a common downstream purification operation for biotechnology products manufactured in cell culture such as therapeutic monoclonal antibodies (mAbs) and Fc-fusion proteins. We present a head-to-head comparison of the viral clearance efficiency of AEX adsorbers and column chromatography using the same process fluids and comparable run conditions. We also present overall trends from the CDER viral clearance database. In our comparison of multiple brands of resins and adsorbers, clearance of three model viruses (PPV, X-MuLV, and PR772) was largely comparable, with some exceptions which may reflect run conditions that had not been optimized on a resin/membrane specific basis.
authors.affiliation: Office of Biotechnology Products,CDER/FDA, 10903 New Hampshire Ave., Silver Spring, MD, 20903.
authors.forename: G R
authors.initials: GR
authors.lastname: Miesegaes
authors.forename: S C
authors.initials: SC
authors.lastname: Lute
authors.forename: E K
authors.initials: EK
authors.lastname: Read
authors.forename: K A
authors.initials: KA
authors.lastname: Brorson
mesh_terms: D000911:Antibodies, Monoclonal / Q000302:isolation & purification; D001709:Biotechnology / Q000592:standards; D002852:Chromatography, Ion Exchange / Q000295:instrumentation / Q000379:methods; D016208:Databases, Factual; D008567:Membranes, Artificial; D011994:Recombinant Proteins / Q000302:isolation & purification / Q000592:standards; D014780:Viruses / Q000302:isolation & purification*
chemical_list: D000911:Antibodies, Monoclonal; D008567:Membranes, Artificial; D011994:Recombinant Proteins
keywords: DoE; anion exchange chromatography; design-of-experiments; downstream purification; membrane adsorbers; monoclonal antibodies; viral clearance