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US 8,592,142 B2Granted
Analysis of amino acid copolymer compositions
AssigneeMomenta Pharmaceuticals, Inc.
InventorsXiangping Zhu, Zachary Shriver, Yanjie Jiang, Corinne Bauer, James Eric Anderson, Peter James Ahern
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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.
Claims19
A method of preparing a pharmaceutical composition comprising glatiramer acetate, the method comprising:
- providing a batch of glatiramer acetate;
- measuring the pyro-glutamate (pyro-Glu) content of the glatiramer acetate in a sample of the batch;
- and
- processing at least a portion of the batch of glatiramer acetate to produce a pharmaceutical composition comprising glatiramer acetate when the pyro-Glu content of the glatiramer acetate is within a range of 2000-7000 ppm relative to glatiramer acetate on a dry weight basis.
1 more element
Dependencies are inferred from the claim text.