Characterization of glatiramer acetate C-terminal heterogeneity

4^th International Conference and Exhibition on Biologics & Biosimilars

October 26-28, 2015 Baltimore, USA

Mario DiPaola

Blue Stream Laboratories Inc., USA

Scientific Tracks Abstracts: J Bioanal Biomed

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.

Biography :

Mario DiPaola is CSO and Co-Founder of Blue Stream Laboratories, Inc. He holds a PhD in chemistry and also an MBA and has been in the biopharmaceutical industry for 20+ years in various roles from Scientist to Company Executive.

Email: mdipaola@bluestreamlabs.com