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Studies on characteristics of aggregates contained in therapeutic intravenous immunoglobulins

Research Project

Project/Area Number 26460249
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Medical pharmacy
Research InstitutionNational Institute of Health Sciences

Principal Investigator

Ishii-Watabe Akiko  国立医薬品食品衛生研究所, 生物薬品部, 部長 (50291117)

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)
Project Period (FY) 2014-04-01 – 2018-03-31
Project Status Completed (Fiscal Year 2017)
Budget Amount *help
¥5,070,000 (Direct Cost: ¥3,900,000、Indirect Cost: ¥1,170,000)
Fiscal Year 2016: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
Fiscal Year 2015: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2014: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Keywords免疫グロブリン製剤 / IVIG / 凝集体 / 糖鎖 / 免疫グロブリン
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.

Report

(5 results)
  • 2017 Annual Research Report   Final Research Report ( PDF )
  • 2016 Research-status Report
  • 2015 Research-status Report
  • 2014 Research-status Report
  • Research Products

    (10 results)

All 2017 2016 2015 2014

All Presentation (8 results) (of which Invited: 2 results) Book (2 results)

  • [Presentation] バイオ医薬品の品質管理戦略構築と分析法2017

    • Author(s)
      石井明子
    • Organizer
      JASIS 2017 特別セミナー 分析・科学機器と日本薬局方
    • Related Report
      2017 Annual Research Report
  • [Presentation] バイオ医薬品の安全性評価法の概要と留意点2017

    • Author(s)
      石井明子,斎藤嘉朗
    • Organizer
      日本免疫毒性学会
    • Related Report
      2017 Annual Research Report
  • [Presentation] バイオ医薬品の不純物評価・管理の概要2016

    • Author(s)
      石井明子
    • Organizer
      第43回日本毒性学会学術年会
    • Place of Presentation
      名古屋
    • Year and Date
      2016-06-30
    • Related Report
      2016 Research-status Report
  • [Presentation] バイオ医薬品(組換えタンパク質医薬品)の品質と免疫原性2016

    • Author(s)
      石井明子
    • Organizer
      第16回日本蛋白質科学会年会
    • Place of Presentation
      北九州
    • Year and Date
      2016-06-08
    • Related Report
      2016 Research-status Report
  • [Presentation] バイオ医薬品の免疫原性2016

    • Author(s)
      石井明子
    • Organizer
      第35回動物細胞工学会シンポジウム バイオ医薬品の物性と免疫原性
    • Place of Presentation
      東京
    • Year and Date
      2016-01-22
    • Related Report
      2015 Research-status Report
  • [Presentation] バイオ医薬品の品質に関する今後の展望2015

    • Author(s)
      石井明子
    • Organizer
      レギュラトリーサイエンス エキスパート研修会・専門コース
    • Place of Presentation
      東京
    • Year and Date
      2015-11-25
    • Related Report
      2015 Research-status Report
  • [Presentation] 抗体医薬品 さらなる発展への課題:規制の観点から2014

    • Author(s)
      石井明子
    • Organizer
      第39回日本薬学会関東支部学術講演会
    • Place of Presentation
      東京
    • Year and Date
      2014-12-13
    • Related Report
      2014 Research-status Report
    • Invited
  • [Presentation] バイオ医薬品の品質評価に関する最新動向2014

    • Author(s)
      石井明子
    • Organizer
      JASIS 2014日本薬局方セミナー
    • Place of Presentation
      東京
    • Year and Date
      2014-09-05
    • Related Report
      2014 Research-status Report
    • Invited
  • [Book] バイオ医薬品の品質管理戦略 第2章 品質特性解析 II不純物の評価2015

    • Author(s)
      新見伸吾,石井明子,原園景,川崎ナナ
    • Total Pages
      16
    • Publisher
      じほう
    • Related Report
      2015 Research-status Report
  • [Book] 動物細胞培養の手法と細胞死・増殖不良・細胞変異を防止する技術  第13章第2節 バイオ医薬品(組換えタンパク質医薬品)の品質関連規制と対応の留意点2014

    • Author(s)
      石井明子,川崎ナナ
    • Publisher
      技術情報協会
    • Related Report
      2014 Research-status Report

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Published: 2014-04-04   Modified: 2019-03-29  

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