Development of a gigaporechromatographic resins that enables rapid and large-scale separation of biopharmaceuticals

2022 Fiscal Year Final Research Report

• Project/Area Number: 20K05228
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 27040:Biofunction and bioprocess engineering-related
• Research Institution: Kyoto Institute of Technology
• Principal Investigator: Kumada Yoichi 京都工芸繊維大学, 分子化学系, 准教授 (70452373)
• Project Period (FY): 2020-04-01 – 2023-03-31
• Keywords: chromatography / human antibodies / anion-exchange / giga pore

Outline of Final Research Achievements

In this study, we investigated the use of chromatographic carriers with gigapore structure in order to achieve high-efficiency and rapid chromatographic separation of biopharmaceuticals such as human antibodies. A chromatographic support with an epoxy-based monolithic structure was developed, and the performance of the resin in ion-exchange chromatography was investigated by static and dynamic methods. Consequently, compared with conventional agarose-based chromatography resins, high dynamic adsorption capacity and low HETP were obtained at high flow rates, and it was clarified that human antibodies could be separated with high resolution and high efficiency. The results obtained in this research was a superior and the resin can be applied to high-speed separation of various biopharmaceuticals including antibody drugs.

Free Research Field

生物化学工学

Academic Significance and Societal Importance of the Research Achievements

モノリス構造を有するエポキシ系クロマトグラフィビーズの開発によって従来では困難であった低圧力損失のカラムの大型化が可能となった。特に高速域における高い分解能を有するクロマトグラフィカラムの開発はこれまでになされておらず、優位性の高い成果である。また、既存のメタクリル系クロマトグラフィ担体のギガポア化についてもデキストラングラフティングの分子サイズをコントロールすることでポアボリュームと吸着容量を厳密に制御可能であることを明らかにした。これらの成果の学術的ならびに社会的意義は大きい。