Development of high performance separation and purification technology for cell therapy and biopharmaceuticals

2018 Fiscal Year Final Research Report

• Project/Area Number: 16H05083
• Research Category: Grant-in-Aid for Scientific Research (B)
• Allocation Type: Single-year Grants
• Section: 一般
• Research Field: Physical pharmacy
• Research Institution: Keio University
• Principal Investigator: Kanazawa Hideko 慶應義塾大学, 薬学部(芝共立), 教授 (10240996)
• Co-Investigator(Kenkyū-buntansha): 綾野 絵理 慶應義塾大学, 薬学部(芝共立), 研究員 (10424102)
• Project Period (FY): 2016-04-01 – 2019-03-31
• Keywords: 機能性高分子 / HPLC / タンパク精製 / 抗体医薬品 / 細胞分離 / 温度応答性クロマトグラフィー

Outline of Final Research Achievements

In recent years, the trends of drug discovery and medical care have changed, from small molecule drugs to biopharmaceuticals, genes, cell therapy, and regenerative medicine. New approaches and technologies need to be developed to respond to these changes in medical care. The development of a novel purification method for proteins, such as antibodies, under mild conditions is strongly needed. Cell separation method without modification of cell surfaces is strongly demanded for cell transplantation.
In this study, we developed temperature-responsive separation system to purify a antibody drug and cells.The prepared column would be applicable to various types of protein and cell separation applications by optimizing the properties of modified polymers. Therefore, the developed temperature-responsive column has the potential to be an effective protein and cell separation tool for biomedical applications.

Free Research Field

分離分析

Academic Significance and Societal Importance of the Research Achievements

タンパクの分離精製については，本研究で新規に開発した温度応答性固相抽出カラムにより，抗体医薬品の生理活性を維持しながら精製できることが示された。また，可変部位の違いのみで抗体同士の分離が可能であることから，抗体のFc領域と結合するプロテインA担体とは異なる機構で選択的に分離できることが示された。本研究では安価なシリカビーズを用いており，ラボスケールの抗体精製用固相抽出カラムのみならず，スケールアップによってバイオプロセスにおける精製法として，さらには抗体医薬品のみならず様々なタンパク質製剤の精製への応用も期待できる。さらに細胞を温度制御のみで選択的に分離可能な細胞クロマトグラフィーに成功した。