Patent ID: 9410964
Filing Date: 2016-08-09
CPC Classification: A61K,A61P,C07K,C08G,C12Q,C12Y,G01N

Claim Text:
1. 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; 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.