Invention Grant
- Patent Title: Glatiramer acetate response biomarker mRNA potency assay
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Application No.: US14206681Application Date: 2014-03-12
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Publication No.: US10344330B2Publication Date: 2019-07-09
- Inventor: Jeffrey P. Smith , Peter E. Lipsky
- Applicant: Mylan Inc.
- Applicant Address: US PA Canonsburg
- Assignee: MYLAN INC.
- Current Assignee: MYLAN INC.
- Current Assignee Address: US PA Canonsburg
- Agency: Wilson Sonsini Goodrich & Rosati
- Main IPC: C12Q1/6883
- IPC: C12Q1/6883 ; C07H21/04

Abstract:
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.
Public/Granted literature
- US20140272987A1 GLATIRAMER ACETATE RESPONSE BIOMARKER mRNA POTENCY ASSAY Public/Granted day:2014-09-18
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