Mechanisms of the immune responses related to adverse reactions of therapeutic mAbs

Research Project

Project/Area Number	15K18884
Research Category	Grant-in-Aid for Young Scientists (B)
Allocation Type	Multi-year Fund
Research Field	Pharmacology in pharmacy
Research Institution	National Institute of Health Sciences
Principal Investigator	TADA Minoru 国立医薬品食品衛生研究所, 生物薬品部, 室長 (50506954)
Research Collaborator	AOYAMA Michihiko 国立医薬品食品衛生研究所, 生物薬品部, 研究員
Project Period (FY)	2015-04-01 – 2018-03-31
Project Status	Completed (Fiscal Year 2017)
Budget Amount *help	¥4,030,000 (Direct Cost: ¥3,100,000、Indirect Cost: ¥930,000) Fiscal Year 2017: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000) Fiscal Year 2016: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000) Fiscal Year 2015: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Keywords	抗体医薬品 / Fcγ受容体 / 有害作用 / 免疫応答
Outline of Final Research Achievements	The purpose of this study is to analyze immune-related reactions against therapeutic monoclonal antibodies (mAbs) or their variants including impurities, which may induce adverse reactions. We revealed the cytokine- and chemokine-release profiles induced by Fc-engineered mAbs, the recognition of host-cell proteins by pre-existing antibodies in human serum, and the relationship between the characteristic of mAbs aggregates and the activation of Fc gamma receptors.