Mario DiPaola
Blue Stream Laboratories, Inc., USA
Title: Characterization of glatirameracetate C-terminal heterogeneity
Biography
Biography: Mario DiPaola
Abstract
Glatiramer acetate, the active ingredient in the multiple sclerosis drug, CopaxoneTM, developed by Teva is a complex mixture of synthetically produced polypeptides composed of four amino acids, which include glutamic acid, alanine, tyrosine and lysine at a molar ratio of 0.141, 0.427, 0.095, 0.338. Initiation of the synthesis of the polypeptides requires the addition of diethylamine which results in the partial capping of the carboxy-termini. Blue Stream Laboratories has developed a series of analytical and mass spectrometric approaches to analyze the heterogeneity of the carboxy-termini of glatiramer acetate. Such methods and the analysis of several lots of glatiramer acetate to assess comparability between originator and biosimilar lots by these methods will be discussed.
