title: A novel primary amine-based anion exchange membrane adsorber.
abstract: A novel anion exchange membrane adsorber is presented which shows excellent impurity removal under different buffer conductivities ranging from 2 to 2 7mS/cm. The membrane utilizes a primary amine ligand (polyallylamine) and was designed specifically to bind impurities at high salt concentrations. Studies with DNA, endotoxin, and virus spiked into buffer at varying salt conditions were done, resulting in clearance of >3, 4, and 4 LRV, respectively, with negligible change on increasing salt up to 27 mS/cm conductivities. Verification of virus removal in mAb feedstocks is also shown. The data are compared with other membrane adsorbers and a conventional resin which utilize traditional chemistries to demonstrate improved purification performance with the primary amine ligand. Additional data on scale-up of the membrane adsorber device is discussed. A stacked flat-sheet design was implemented to ensure linear scale-up of performance using bovine serum albumin (BSA) as a model. The linearly scalable device, coupled with the highly effective membrane for virus, DNA, and endotoxin removal, represents a step forward in polishing technology for the purification of monoclonal antibodies and recombinant proteins.
authors.affiliation: Millipore Corp., 80 Ashby Road, Bedford, MA 01730, USA. maybelle.woo@merckgroup.com
authors.forename: Maybelle
authors.initials: M
authors.lastname: Woo
authors.forename: Navid Z
authors.initials: NZ
authors.lastname: Khan
authors.forename: Jonathan
authors.initials: J
authors.lastname: Royce
authors.forename: Ushma
authors.initials: U
authors.lastname: Mehta
authors.forename: Brian
authors.initials: B
authors.lastname: Gagnon
authors.forename: Senthil
authors.initials: S
authors.lastname: Ramaswamy
authors.forename: Neil
authors.initials: N
authors.lastname: Soice
authors.forename: Michele
authors.initials: M
authors.lastname: Morelli
authors.forename: Kwok-Shun
authors.initials: KS
authors.lastname: Cheng
mesh_terms: D000327:Adsorption; D000588:Amines / Q000737:chemistry*; D000818:Animals; D002417:Cattle; D002852:Chromatography, Ion Exchange / Q000295:instrumentation / Q000379:methods*; D004247:DNA / Q000737:chemistry / Q000302:isolation & purification; D004731:Endotoxins / Q000737:chemistry / Q000302:isolation & purification; D006801:Humans; D008567:Membranes, Artificial; D011506:Proteins / Q000737:chemistry / Q000302:isolation & purification; D011994:Recombinant Proteins / Q000737:chemistry / Q000302:isolation & purification; D012710:Serum Albumin, Bovine / Q000737:chemistry / Q000302:isolation & purification; D014780:Viruses / Q000737:chemistry / Q000302:isolation & purification
chemical_list: D000588:Amines; D004731:Endotoxins; D008567:Membranes, Artificial; D011506:Proteins; D011994:Recombinant Proteins; D012710:Serum Albumin, Bovine; D004247:DNA