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Open AccessArticle

Physicochemical and Biological Examination of Two Glatiramer Acetate Products

Specialty Research and Development, Teva Pharmaceutical Industries Ltd, Netanya 4250419, Israel
Author to whom correspondence should be addressed.
Biomedicines 2019, 7(3), 49;
Received: 5 June 2019 / Revised: 25 June 2019 / Accepted: 26 June 2019 / Published: 3 July 2019
PDF [1867 KB, uploaded 5 July 2019]


Herein we compared 40 mg/mL lots of the active ingredient, glatiramer acetate, manufactured by Mylan/Natco to the active ingredient, glatiramer acetate in Copaxone (Teva Pharmaceuticals, Ltd., Netanya Israel) using physicochemical (PCC) methods and biological assays. No differences were seen between the Mylan/Natco and Teva lots with some low resolution release PCC assays (amino acid analysis, molecular weight distribution, interaction with Coomassie Brilliant Blue G-250). Changes in polydispersity between Mylan/Natco and Copaxone lots were found using size exclusion chromatography and the high resolution PCC method, known as Viscotek, and suggestive of a disparity in the homogeneity of mixture, with a shift towards high molecular weight polypeptides. Using RPLC-2D MALLS, 5 out of 8 Mylan/Natco lots fell outside the Copaxone range, containing a high molecular weight and high hydrophobicity subpopulation of polypeptides not found in Copaxone lots. Cation exchange chromatography showed differences in the surface charge distribution between the Copaxone and Mylan/Natco lots. The Mylan/Natco lots were found to be within Copaxone specifications for the EAE model, monoclonal and polyclonal binding assays and the in vitro cytotoxicity assay, however higher IL-2 secretion was shown for three Mylan/Natco lots in a potency assay. These observations provide data to inform the ongoing scientific discussion about the comparability of glatiramer acetate in Copaxone and follow-on products. View Full-Text
Keywords: glatiramer acetate; multiple sclerosis; physicochemical assays; non-biological complex drugs; Copaxone glatiramer acetate; multiple sclerosis; physicochemical assays; non-biological complex drugs; Copaxone

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Komlosh, A.; Weinstein, V.; Loupe, P.; Hasson, T.; Timan, B.; Konya, A.; Alexander, J.; Melamed-Gal, S.; Nock, S. Physicochemical and Biological Examination of Two Glatiramer Acetate Products. Biomedicines 2019, 7, 49.

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