Patent ID: 8324348

Claim:
A method of manufacturing a drug product comprising glatiramer acetate, the method comprising: obtaining a sample of a batch of glatiramer acetate; measuring, in the sample of the batch, the level of diethylamide-modified alanine fragments, diethylamide-modified lysine fragments, diethylamide-modified glutamic acid fragments, and diethylamide-modified tyrosine fragments; and processing at least a portion of the batch of glatiramer acetate to produce a drug product comprising glatiramer acetate if at least one of the following measured criteria are met: (i) the level of diethylamide-modified alanine fragments measured in the sample is 59.5-76.1% of the total diethylamide-modified fragments in the sample on a mol percent basis; (ii) the level of diethylamide-modified lysine fragments measured in the sample is 11.3-17.3% of the total diethylamide-modified fragments in the sample on a mol percent basis; (iii) the level of diethylamide-modified glutamic acid fragments measured in the sample is 9.9-15.0% of the total diethylamide-modified fragments in the sample on a mol percent basis; and (iv) the level of diethylamide-modified tyrosine fragments measured in the sample is 4.8-7.2% of the total diethylamide-modified fragments in the sample on a mol percent basis, thereby manufacturing a drug product comprising glatiramer acetate.