ISOLATED SOLUBLE ALPHA-4 INTEGRIN, BETA-7 INTEGRIN AND ALPHA-4/BETA-7 HETERODIMER INTEGRIN
申请人:Société des Produits Nestlé S.A.
公开号:EP3536705A1
公开(公告)日:2019-09-11
The present invention provides a sensitive and specific indirect homogeneous mobility shift assay using size exclusion chromatography to measure biologics such as vedolizumab and ustekinumab in a patient sample. The assays of the present invention are particularly advantageous for detecting the presence or level of biologics that target complex or large antigens including cell surface proteins, transmembrane proteins, heavily glycosylated proteins, and multimeric proteins, as well as antigens that cannot be purified, impure antigens, and partially or substantially purified antigens. The present invention also provides isolated soluble α4β7 integrin heterodimers and isolated soluble IL-12p40 monomers that are suitable for use in the indirect assays described herein.
本发明提供了一种使用尺寸排除色谱法的灵敏而特异的间接均相迁移率测定法,用于测定患者样本中的生物制剂,如维多单抗和乌司替尼。本发明的检测方法特别适用于检测针对复杂或大型抗原(包括细胞表面蛋白、跨膜蛋白、重糖基化蛋白和多聚蛋白)的生物制剂的存在或水平,以及无法纯化的抗原、不纯抗原和部分或基本纯化的抗原。本发明还提供了分离的可溶性α4β7整合素异二聚体和分离的可溶性IL-12p40单体,它们适合用于本文所述的间接测定。