Testing the Limits of Ion Mobility Mass Spectrometry to Compare a Nonbiological Complex Drug Product and Purported Generics-- A Case Study with Copaxone.

Ion mobility mass spectrometry (IMMS) is a two-dimensional technique that allows separation of ionized molecules based on molecular size, shape, and mass-to-charge ratio (m/z). It has rapidly become a valuable application for analyzing isomeric compounds in a complex matrix (for example, proteomic and llipidomic samples) or complex mixtures of structurally related and isobaric analytes (such as oil samples or polymer blends). IMMS was investigated as a possible technique to compare purported generic products with Copaxone (glatiramer acetate), a drug for treating relapsing-remitting multiple sclerosis that contains a very complex mixture of synthetic peptides. The analysis was performed on 15 randomly chosen batches of Copaxone and five batches of purported generics that are marketed drugs in their country of origin. [ABSTRACT FROM AUTHOR]