Evaluation of an anion-exchange hollow-fiber membrane adsorber containing γ-ray grafted glycidyl methacrylate chains.
It is widely recognized that membrane adsorbers are powerful tools for the purification of biopharmaceutical protein products and for this reason a novel hollow-fiber AEX type membrane adsorber has been developed. The membrane is characterized by grafted chains including DEA ligands affixed to the pore surfaces of the membrane. In order to estimate the membrane performance, (1) dynamic binding capacities for pure BSA and DNA over a range of solution conductivity and pH, (2) virus reduction by flow-through process, and (3) HCP and DNA removal from cell culture, are evaluated and compared with several other anion-exchange membranes. The novel hollow-fiber membrane is tolerant of high salt concentration when adsorbing BSA and DNA. When challenged with a solution containing IgG the membrane has high impurity removal further indicating this hollow-fiber based membrane adsorber is an effective tool for purification of biopharmaceutical protein products including IgG.
Asahi Kasei Medical Co., Ltd., Bioprocess Development Department, Planova Division, Samejima, Shizuoka, Japan. shirataki.hb@om.asahi-kasei.co.jp
Hironobu
H
Shirataki
Chie
C
Sudoh
Takamitsu
T
Eshima
Yoshiro
Y
Yokoyama
Kazuo
K
Okuyama
D000327:Adsorption; D000818:Animals; D000838:Anions / Q000737:chemistry / Q000378:metabolism; D016466:CHO Cells; D002417:Cattle; D002852:Chromatography, Ion Exchange / Q000295:instrumentation* / Q000379:methods*; D006224:Cricetinae; D003412:Cricetulus; D004247:DNA / Q000302:isolation & purification; D004340:Drug Contamination; D004591:Electrophoresis, Polyacrylamide Gel; D004852:Epoxy Compounds / Q000737:chemistry* / Q000378:metabolism; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007074:Immunoglobulin G / Q000302:isolation & purification; D008689:Methacrylates / Q000737:chemistry* / Q000378:metabolism; D008855:Microscopy, Electron, Scanning; D016062:Porosity; D011485:Protein Binding; D012710:Serum Albumin, Bovine / Q000302:isolation & purification; D012965:Sodium Chloride / Q000737:chemistry; D014780:Viruses / Q000302:isolation & purification
D000838:Anions; D004852:Epoxy Compounds; D007074:Immunoglobulin G; D008689:Methacrylates; D012710:Serum Albumin, Bovine; D012965:Sodium Chloride; D004247:DNA; C007870:glycidyl methacrylate