发明名称 |
METHOD OF DETERMINING THE MOLECULAR WEIGHT DISTRIBUTION OF GLATIRAMER ACETATE USING MULTI-ANGLE LASER LIGHT SCATTERING (MALLS) |
摘要 |
The present, invention provides a process for characterizing a glatiramer acetate related drug substance (GARDS) or a glatiramer acetate related drug product (GARDP) comprising separating a batch of a GARDS or GARDP according to hydrophobicity and determining the molar mass of the separated material, thereby characterizing the GARDS or GARDP by molar mass as a function of hydrophobicity. |
申请公布号 |
WO2016176649(A1) |
申请公布日期 |
2016.11.03 |
申请号 |
WO2016US30277 |
申请日期 |
2016.04.29 |
申请人 |
TEVA PHARMACEUTICAL INDUSTRIES LTD.;TEVA PHARMACEUTICALS USA, INC.;KOMLOSH, Avraham, Arthur;PINKERT, Dalia |
发明人 |
KOMLOSH, Avraham, Arthur;PINKERT, Dalia |
分类号 |
G01N33/68;A61K38/00;C07K2/00 |
主分类号 |
G01N33/68 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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