公开(公告)号：EP2975401A1

公开(公告)日：2016-01-20

申请号：EP14177705.2

申请日：2014-07-18

申请人： Hexal AG

发明人： Higel, Fabian ,  Seidl, Andreas ,  Demelbauer, Uwe

IPC分类号： G01N33/50

摘要： The present invention relates to a method for analyzing glycans of a recombinant glycoprotein in a liquid sample of a mammal. Specifically the method comprises a step of affinity purifying the recombinant glycoprotein from the sample, enzymatically releasing a glycan containing fragment from the immobilized glycoprotein, adding a reference standard containing isotopically labeled glycans, fluorescently label the glycans and analyzing the glycans using LC-MS. The present invention also relates to a method further comprising analyzing the glycans of the immobilized recombinant glycoprotein fragment, further comprising a pre-clearing step of the liquid sample, and releasing the glycans from the immobilized recombinant glycoprotein fragment. The methods allow for the use of a small sample volume and the possibility to operate with high throughput, such as in a 96-well plate sample preparation and are therefore suited to measure pharmacodynamics parameters of a recombinant glycoprotein in a mammal in clinical or pre-clinical studies.

摘要翻译： 本发明涉及一种分析哺乳动物液体样品中重组糖蛋白聚糖的方法。 具体地说，该方法包括从样品中亲和纯化重组糖蛋白的步骤，从固定的糖蛋白酶促释放含聚糖片段，加入含有同位素标记的聚糖的参考标准，荧光标记聚糖并使用LC-MS分析聚糖。 本发明还涉及一种进一步包括分析固定的重组糖蛋白片段的聚糖的方法，还包括液体样品的预清除步骤，以及从固定的重组糖蛋白片段释放聚糖。 这些方法允许使用小的样品体积和高通量操作的可能性，例如在96孔板样品制备中，因此适合于测量哺乳动物临床或预处理中重组糖蛋白的药效学参数， 临床研究。

公开(公告)号：EP2975401B1

公开(公告)日：2019-12-25

申请号：EP14177705.2

申请日：2014-07-18

申请人： Hexal AG

发明人： Higel, Fabian ,  Seidl, Andreas ,  Demelbauer, Uwe

IPC分类号： G01N33/50