title: Improving impurities clearance by amino acids addition to buffer solutions for chromatographic purifications of monoclonal antibodies.
abstract: The performance of amino acids in Protein A affinity chromatography, anion exchange chromatography and cation exchange chromatography for monoclonal antibody purification was investigated. Glycine, threonine, arginine, glutamate, and histidine were used as buffer components in the equilibration, washing, and elution steps of these chromatographies. Improved clearance of impurity, high molecular weight species (HMW) and host cell proteins (HCP) was observed in the purification processes when using the amino acids as base-buffer constituents, additives or eluents compared with that of buffers without these amino acids. In addition, we designed a buffer system in which the mobile phases were composed of only a single amino acid, histidine, and applied it to the above three chromatographies. Effective HMW and HCP clearance was also obtained in this manner. These results suggest that amino acids may enhance impurity clearance during the purification of monoclonal antibodies.
authors.affiliation: Bioprocess Research and Development Laboratories, Production Division, Kyowa Hakko Kirin Co., Ltd., Takasaki, Gunma 370-0013, Japan. Electronic address: takashi.ishihara@kyowa-kirin.co.jp.
authors.forename: Takashi
authors.initials: T
authors.lastname: Ishihara
authors.affiliation: Bioprocess Research and Development Laboratories, Production Division, Kyowa Hakko Kirin Co., Ltd., Takasaki, Gunma 370-0013, Japan.
authors.forename: Mareto
authors.initials: M
authors.lastname: Hosono
mesh_terms: D000596:Amino Acids / Q000737:chemistry*; D000818:Animals; D000911:Antibodies, Monoclonal / Q000737:chemistry / Q000302:isolation & purification*; D016466:CHO Cells; D002852:Chromatography, Ion Exchange / Q000379:methods*; D006224:Cricetinae; D003412:Cricetulus
chemical_list: D000596:Amino Acids; D000911:Antibodies, Monoclonal
keywords: Biopharmaceutical; Cell cultures; Chromatography resins; Protein separation