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US 7,884,187 B2Granted
Analysis of amino acid copolymer compositions
AssigneeMomenta Pharmaceuticals, Inc.
InventorsXiangping Zhu, Zachary Shriver, Yanjie Jiang, Corinne Bauer, James Eric Anderson, Peter James Ahern
Life of this patent
Estimating the term…
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.
Claims14
A method of preparing a drug product, the method comprising:
- providing a batch of glatiramer acetate;
- measuring the pyro-glutamate (gyro-Glu) content of the glatiramer acetate in a sample of the batch;
- processing at least a portion of the batch of glatiramer acetate as a drug product if 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, thereby preparing a drug product.
Dependencies are inferred from the claim text.