Symposium

Symposium14「Recent Progress of the biologics analysis」

Sat. Nov 14, 2015 9:30 AM - 12:00 PM Room B (5ＦＳｍａｌｌＨａｌｌ)

Organizers:Masahiro Utoh (Pharmacokinetics and Bioanalysis Center, Shin Nippon Biomedical Laboratories, Ltd.), Takashi Kuwabara (Translational Research Unit, R&D Division, Kyowa Hakko Kirin Co., Ltd.), Chairs:Fujiko Takamura (Analysis & Pharmacokinetics Research Labs, Pharmacokinetics-Pharmacodynamics, Astellas Pharma Inc.), Jun Hosogi (Translational Research Unit, R&D Division, Kyowa Hakko Kirin Co.,Ltd)

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[SY-14-01] Government-private sector joint research project to establish and standardize immunogenicity assays in Japan

^○Shingo Niimi (Division of Medical Devices, National Institute of Health Sciences)

[SY-14-02] Immunogenicity testing strategy for Clinical Study Samples

^○Kazuhiro Nishimiya ¹, Kazuo Tokuda ¹, Takahide Uchimura ², Takehiko Kawanishi ¹ (1.Translational Clinical Reserch Science & Strategy Dept., Chugai Pharmaceutical Co., Ltd., 2.Chugai Reserch Institute for Medical Science, Inc.)

[SY-14-03] Development of novel TDM methods for therapeutic monoclonal antibodies

^○Kenichiro Todoroki , Toshimasa Toyoʼoka (School of Pharmaceutical Sciences, University of Shizuoka)

[SY-14-04] Development of the LCMS bioanalysis for antibody drug monitoring in plasma using Fab-selective limited proteolysis (nSMOL)

^○Takashi Shimada ¹, Noriko Iwamoto ¹, Naoe Yamane ³, Akinobu Hamada ² (1.Life Science Research Center, SHIMADZU Corporation, 2.Division of Clinical Pharmacology & Translational Research, Exploratory Oncology Research & Clinical Trial Center, National Cancer Center, 3.New technology development office, CMIC Pharma Science Co., Ltd.)