Methods for assessing and/or selecting as suitable for commercial release glatiramer acetate, including assessing the consumption, and/or relative reaction kinetics of one or more the amino acid N-Carboxyanhydrides (NCAs) present during the first step of the polymerization reaction in the glatiramer acetate manufacturing process are provided.
提供了评估和/或选择适合商业发布的
醋酸格拉替麦(glatiramer acetate)的方法,包括评估在
醋酸格拉替麦制造过程的第一步中存在的一个或多个
氨基酸N-羧基酸酐(NCAs)的消耗和/或相对反应动力学。