ESSAI DE PUISSANCE D'ACETATE DE GLATIRAMERE PAR BIOMARQUEURS DE REPONSE ARNM

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专利权人:

MYLAN INC.

发明人:

SMITH, JEFFREY P.,LIPSKY, PETER E.

申请号：

CA2903805

公开号：

CA2903805A1

申请日:

2014.03.12

申请国别(地区):

CA

年份:

2014

代理人:

摘要：

The invention describes assays for determining the potency of a test lot of glatiramer acetate (GA) by quantitating and comparing the levels of mRNA response biomarkers produced in mouse T-cells in response to stimulation with the test lot or a reference standard lot of GA, wherein the T-cells are obtained from mice immunized with the test lot or the reference standard lot of GA. Methods for identifying mRNA response biomarkers useful in the assays of the invention also are described.

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