US2016312264A1PendingUtilityA1

Analysis of amino acid copolymer compositions

Assignee: MOMENTA PHARMACEUTICALS INCPriority: Apr 16, 2008Filed: Jul 5, 2016Published: Oct 27, 2016

Est. expiryApr 16, 2028(~1.7 yrs left)· nominal 20-yr term from priority

Inventors:Xiangping Zhu Zachary Shriver Yanjie Jiang Corinne Bauer James E. Anderson Peter James Ahern

C08G 69/10C07K 14/001C12Y 304/19003A61P 37/00A61P 43/00A61K 31/785G01N 33/6812A61K 38/02C12Q 1/37

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Claims

Abstract

Methods for analyzing, selecting, characterizing or classifying compositions of a co-polymer, e.g., glatiramer acetate are described. The methods entail analysis of pyro-glutamate in the composition, and, in some methods, comparing the amount of pyro-glutamate present in a composition to a reference standard.

Claims

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What is claimed is: 
     
         1 . A method of selecting a batch of a composition comprising an amino acid copolymer, the method comprising:
 providing a batch of a composition comprising an amino acid copolymer;   measuring the amount of pyro-glutamate (pyro-Glu) in the batch; and   selecting the batch if the amount of pyro-Glu in the batch is within a predetermined range,   thereby selecting a batch of a composition comprising an amino acid copolymer.

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