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    • 7. 发明申请
    • GLYCAN OXONIUM ION PROFILING OF GLYCOSYLATED PROTEINS
    • 糖基化蛋白质的甘氨酸氧离子特性
    • WO2018035350A1
    • 2018-02-22
    • PCT/US2017/047395
    • 2017-08-17
    • MOMENTA PHARMACEUTICALS, INC.
    • MADSEN, JamesFARUTIN, Victor
    • G01N30/72B01D59/44C12P21/00
    • C12P21/005G01N33/6848G01N33/6854
    • Methods disclosed herein include an improved technique for comparing a glycosylation profile of a first protein (e.g., an innovator protein drug) with a glycosylation profile of a second protein (e.g., a corresponding biogeneric/biosimilar). For example, a method of manufacture can include providing or obtaining a batch of a test glycoprotein drug substance, using mass spectrometry to acquire a test oxonium ion profile from a sample of the test glycoprotein drug substance batch, comparing the test oxonium ion profile to a corresponding target oxonium ion profile of a target glycoprotein drug product, and processing the batch of the test glycoprotein drug substance as a drug product if the difference between the test oxonium ion profile and the corresponding target oxonium ion profile is tolerable, or taking an alternative action if the difference between the test oxonium ion profile and the target oxonium ion profile is not tolerable.
    • 本文公开的方法包括用于比较第一蛋白(例如,创新蛋白药物)的糖基化分布与第二蛋白(例如,相应的生物基因/生物仿制药)的糖基化分布的改进技术。 例如,制造方法可包括提供或获得一批测试糖蛋白药物物质,使用质谱法从测试糖蛋白药物物质批次的样品获得测试氧鎓离子特征,将测试氧鎓离子特征与 如果测试氧鎓离子分布图和相应的目标氧鎓离子分布图之间的差异是可容忍的,或者采取替代动作,则将目标糖蛋白药物产品的相应目标氧鎓离子分布图,以及处理该批测试糖蛋白药物物质作为药品 如果测试的氧鎓离子分布和目标氧鎓离子分布之间的差异是不可容忍的。