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US 9,395,374 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
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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.
Claims14
A method for manufacturing a pharmaceutical composition comprising glatiramer acetate, the method comprising:
- preparing an amino acid copolymer of L-glutamic acid, L-alanine, L-lysine, and L-tyrosine, wherein the preparing step comprises co-polymerizing N-carboxy anhydrides of L-alanine, benzyl-protected L-glutamic acid, trifluoroacetic acid (TFA)-protected L-lysine, and L-tyrosine to generate a first material;
- treating the first material to deprotect the benzyl-protected L-glutamic acid therein and to partially depolymerize the first material, thereby generating a second material;
- treating the second material to deprotect the TFA-protected L-lysine to produce a third material;
- and purifying the third material, to thereby produce the copolymer of L-glutamic acid, L-alanine, L-lysine, and L-tyrosine;
- measuring pyro-glutamate content of the copolymer in a sample of the copolymer;
- measuring the peak average molecular weight (Mp) of the copolymer;
- processing the copolymer to produce a pharmaceutical composition comprising glatiramer acetate only if the measured pyro-glutamate content of the copolymer in the sample is within 2000-7000 parts per million (ppm) on a dry weight/dry weight basis,
- thereby producing a pharmaceutical composition comprising glatiramer acetate.
5 more elements
Dependencies are inferred from the claim text.