2015 Fiscal Year Final Research Report
Bioanalytical methods for therapeutic monoclonal antibodies using selective separation technique
| Project/Area Number |
25460040
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Physical pharmacy
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| Research Institution | University of Shizuoka |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
Hayashi Hideki 岐阜薬科大学, 薬学部, 准教授 (00419665)
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| Project Period (FY) |
2013-04-01 – 2016-03-31
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| Keywords | 抗体医薬 / HPLC分析 |
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| Outline of Final Research Achievements |
In this study, we developed a simple, sensitive, accurate, and rapid analytical method for detecting therapeutic monoclonal antibodies in plasma samples using immunoaffinity purification e HT-RPLC with fluorescence detection. We successfully applied both methods to the bioanalyses of plasma samples obtained from cancer and RA patients who were administered each drug. The methods described here are applicable for planning
optimal therapeutic programs, and also for the evaluation of biological equivalencies in the development of biosimilars.
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| Free Research Field |
物理系薬学
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