2010 Fiscal Year Final Research Report
Study on Quality Management of Processing and System Management of Cell Therapy in Translational Research.
| Project/Area Number |
20590535
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Applied pharmacology
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| Research Institution | The University of Tokyo |
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Principal Investigator |
NAGAMURA Fumitaka The University of Tokyo, 医科学研究所, 准教授 (90282491)
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| Co-Investigator(Kenkyū-buntansha) |
NAGAMURA Tokiko 東京大学, 医科学研究所, 講師 (90332585)
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| Co-Investigator(Renkei-kenkyūsha) |
TOJO Arinobu 東京大学, 医科学研究所, 教授 (00211681)
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| Project Period (FY) |
2008 – 2010
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| Keywords | 細胞調製 / トランスレーショナルリサーチ / 品質管理 / 無菌保証 |
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| Research Abstract |
We studies on the effective quality assurance methods and manufacturing system for products utilized in Translational Research of academia. PCR analysis for the detection of bacterial contamination in cell products was shown to be useless due to the impaired sensitivity. Existence of cells was considered to affect the sensitivity. On the other hand, Gram stein was proved to be useful in terms of sensitivity, convenience, and instantaneousness. Floating bacteria detected by continuous environmental measurement were shown to be human resident ones, and this result indicated that we should focus on human resident bacteria, when we operate cell processing facility.
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