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.