2017 Fiscal Year Final Research Report
Studies on characteristics of aggregates contained in therapeutic intravenous immunoglobulins
| Project/Area Number |
26460249
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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 |
Medical pharmacy
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| Research Institution | National Institute of Health Sciences |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
原園 景 国立医薬品食品衛生研究所, 生物薬品部, 主任研究官 (20280753)
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| Project Period (FY) |
2014-04-01 – 2018-03-31
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| Keywords | 免疫グロブリン製剤 / IVIG / 凝集体 / 糖鎖 |
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| Outline of Final Research Achievements |
In this study, we evaluated protein aggregate/multimer contents and propensity to form aggregate of each human intravenous immunoglobulin product (IVIG) induced by various stresses. Aggregates induced by stirring at neutral or acidic conditions were analyzed by LC/MS/MS in order to investigate their characteristics. Fc oligosaccharide profiles of IgG1, IgG2/3 and IgG4 were not different between soluble and aggregated antibodies, but intensity of IgG4 glycopeptide significantly increased in aggregates. These results suggest that IgG4 subclass in IVIG is labile to mechanical stress, and that structure/physicochemical properties other than Fc oligosaccharide make contribution on aggregate formation of IVIG.
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| Free Research Field |
生物薬品学
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