HAYDEN, MICHAEL,TOWFIC, FADI GEORGE,KOLITZ, SARAH ELISABETH,ZESKIND, BENJAMIN JAMES,LADKANI, DAVID,HASSON, TAL,HAYARDENY, LIAT,GROSSMAN, IRIS
申请号:
CA2952849
公开号:
CA2952849A1
申请日:
2015.07.01
申请国别(地区):
CA
年份:
2016
代理人:
摘要:
The present invention provides a process for characterizing a glatiramer acetate related drug substance or drug product comprising the steps of: a) obtaining a batch of the glatiramer acetate related drug substance or drug product; b) contacting mammalian cells with an amount of the glatiramer acetate related drug substance or drug product of step a); and c) determining the level of expression of at least one gene; thereby characterizing the glatiramer acetate related drug substance or drug product of step a).