Purification of monoclonal antibodies entirely in flow-through mode

• Published in: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Vol. 1061-1062; pp. 110 - 116
• Main Authors: Yamada, Tsuyoshi, Yamamoto, Koichi, Ishihara, Takashi, Ohta, Shigeru
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.09.2017
• Subjects: Animals; Antibodies, Monoclonal - analysis; Antibodies, Monoclonal - chemistry; Antibodies, Monoclonal - isolation & purification; Biopharmaceutical process; CHO Cells; Chromatography, Affinity - methods; Chromatography, Gel - methods; Cricetinae; Cricetulus; Depth filtration; Flow-through purification; Monoclonal antibody; Flow-through purification; Biopharmaceutical process; Monoclonal antibody; Depth filtration
• ISSN: 1570-0232; 1873-376X
• DOI: 10.1016/j.jchromb.2017.07.002

•An antibody purification process entirely in flow-through mode was achieved.•Buffer exchange improved the impurity clearance by depth filtration.•A combination of depth filters improved impurity clearance. A depth filter is widely used in biopharmaceutical manufacturing process. In this study, we found that buffer exchange to reduce conductivity dramatically improved the removal of impurities in depth filtration. The host cell protein clearance was comparable to that of protein A affinity chromatography, which is generally used as a first capture step in monoclonal antibody purification. In addition, a combination of different depth filters showed enhanced purification. Additional flow-through purification is possible without any sample preparation, and a biopharmaceutical-quality purity level (<100ppm for host cell protein and <5% for high molecular weight species) can be attained. These results represent the possibility of an antibody manufacturing process using an entirely flow-through mode.