Patent ID: 7429374

Claim:
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, i) where at least two samples containing a predetermined number of such cells are incubated separately in the presence of a predetermined amount of the reference standard batch, and ii) where at least two samples containing the substantially identical predetermined number of cells are incubated separately in the presence of the same predetermined amount of the batch of glatiramer acetate being tested; 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.