Patent ID: 9714898
Date: 2017-07-25
CPC Classifications: A61K,C07K,C08G,G01N,Y10S

Claim:
1. A method of manufacturing a glatiramer acetate drug product, the method comprising: (a) providing a batch of a composition comprising glatiramer acetate; (b) measuring one or both of alpha helical content of the glatiramer acetate and random coil content of the glatiramer acetate in the batch; and (c) manufacturing a glatiramer acetate drug product using at least a portion of the batch only if: i) the measured alpha helical content of glatiramer acetate in the batch is 53.8% to 65.0% under reference conditions, ii) the measured random coil content of glatiramer acetate in the batch is 46.2% to 35.0% under reference conditions, or iii) the measured alpha helical content of glatiramer acetate in the batch is 53.8% to 65.0% under reference conditions and the measured random coil content of glatiramer acetate in the batch is 46.2% to 35.0% under reference conditions, wherein the reference conditions are 5° C. in 10 mM sodium phosphate at pH 7.0, wherein the step of manufacturing a glatiramer acetate drug product comprises adding mannitol to at least a portion of the batch.