Patent ID: 7923215

Claim:
A process for measuring the potency of a test batch of glatiramer acetate relative to the known potency of a reference standard batch which comprises a) immunizing female (SJLXBALB/C)F1 mice between 8 and 12 weeks of age with a predetermined amount of glatiramer acetate from the reference standard batch; b) preparing a primary culture of T-cells from the mice of step (a) 9-11 days after immunization; c) separately incubating at least five reference samples, each of which contains a predetermined number of cells from the primary culture of step (b) and a predetermined amount of glatiramer acetate between 1 μg/ml and 25 μg/ml from a reference standard batch; d) incubating at least two samples, each of which contains a predetermined number of cells from the primary culture of step (b) and a predetermined amount of glatiramer acetate from the test batch; e) determining for each sample in steps (c) and (d), the amount of interleukin-2 secreted by the cells in each sample after 18-21 hours of incubation of such sample; f) correlating the amounts of interleukin-2 secreted by the samples incubated with the test batch of glatiramer acetate with the amounts of interleukin-2 secreted by the samples incubated with the reference standard batch of glatiramer acetate so as to determine the potency of the test batch of glatiramer acetate relative to the reference standard batch of glatiramer acetate, wherein in each sample in steps (c) and (d), the predetermined number of cells is substantially identical, and wherein for each sample containing a predetermined amount of glatiramer acetate from the test batch there is a corresponding reference sample containing a substantially identical predetermined amount of glatiramer acetate from the reference standard batch.