Patent ID: 7429374
Filing Date: 2008-09-30
Classification: A61K,A61P,G01N

Abstract:
1. In a process for preparing a pharmaceutical composition containing glatiramer acetate, wherein during the process a batch of glatiramer acetate is tested to determine whether the batch of glatiramer acetate has a predetermined potency, the improvement comprising: immunizing female (SJLXBALB/C)F1 mice with a defined amount of a reference standard batch of glatiramer acetate, measuring separately the amount of interleukin-2 secreted by a primary culture of lymph node cells from the mice 9-11 days after immunization, comparing the amounts of interleukin-2 secreted which are so measured to determine the potency of the batch of glatiramer acetate being tested; and including in the pharmaceutical composition a batch so tested only if the potency is between 80% and 125% of the reference standard batch.