2021 Fiscal Year Final Research Report

Creation of antibody specific nucleic acid aptamers and their application to bio- process- and clinical analyses

Research Project

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Project/Area Number	19H03360
Research Category	Grant-in-Aid for Scientific Research (B)
Allocation Type	Single-year Grants
Section	一般
Review Section	Basic Section 47020:Pharmaceutical analytical chemistry and physicochemistry-related
Research Institution	University of Shizuoka
Principal Investigator	Todoroki Kenichiro 静岡県立大学, 薬学部, 教授 (70341451)
Co-Investigator(Kenkyū-buntansha)	林秀樹岐阜薬科大学, 薬学部, 教授 (00419665) 橋本博静岡県立大学, 薬学部, 教授 (40336590) 池袋一典東京農工大学, 工学(系)研究科(研究院), 卓越教授 (70251494) 鈴木昭夫岐阜大学, 医学部附属病院, 准教授 (80775148)
Project Period (FY)	2019-04-01 – 2022-03-31
Keywords	抗体医薬 / DNAアプタマー / バイオアナリシス / プロセスアナリシス
Outline of Final Research Achievements	In this research, we have developed seven types of high-affinity "anti-idiotypic DNA aptamers" that specifically recognize the complementarity-determining regions of therapeutic mAbs, and have successfully used them to realize (1) bioanalytical methods for drug monitoring in drug development and clinical settings, (2) process analysis technology (PAT) for use in the drug manufacturing process, and (3) simple diagnostic methods for point-of-care testing.This enables to overcome the problems of "lack of accuracy," "complicated operation," and "low robustness" of bioanalysis of therapeutic mAbs, and to provide new value to drug discovery, drug manufacturing, and clinical practice in Japan and overseas.
Free Research Field	分析化学
Academic Significance and Societal Importance of the Research Achievements	本課題の遂行により，従来の抗体医薬分析の課題であった精度管理，煩雑さ，頑健性課題を克服し，国内外の創薬，医薬品製造，臨床の現場に新たな価値を提供することができた。DNAアプタマーは，(1) 配列次第では抗体以上の親和性が期待できる，(2)自動合成機による化学合成が容易，(3) 高い化学安定性を有する，(4) 均質な状態で供給可能，などの利点がある。今回開発した抗体医薬やADCに対するアプタマーおよび種々の分析法は，新規性が高いだけでなく，新薬やバイオシミラー開発期間の効率化，効率的な抗体医薬生産，迅速な薬物治療効果判定や薬物投与計画策定への貢献が期待できる。