GENE EXPRESSION CHARACTERIZATION OF A GLATIRAMER ACETATE RELATED DRUG PRODUCT IN MAMMALIAN AND HUMAN CELLS

摘要

This invention provides a process tor characterizing a glatiramer acetate related drug substance - or drug product comprising the steps of: (a) obtaining a batch of the glatiramer acetate related drag substance or drug product; (b) contacting mammalian cells with an amount of the glatiramer acetate related drag substance or drug product of step (a); and (c) (i) determining the level of expression of at least one gene of Mmp12, Tgfbi Clec4n, Clec4a3, Fcer1g, Fcgr2b, Fcgr3, Csf3r, Il1r2 or Tbx21; (ii) determining the level of expression of at least one gene of Ahcyl2. Cln5, Cxcr6. Dhrs3, Egr2, Fabp5. Ptp4al, Gpr183, Lamp1, Ncoa4, Ptger4, Qk, Rragd, Sec24a, Seh1l, Sestd1, Slc30a4, Soat1 or Strip2; or (iii) determining the level of expression of at least one gene of Fam212a, Gzma, Itpr1 or Zbtb32, thereby characterizing the glatiramer acetate related drag substance or drag product of step (a).