Patent ID: 8389228

Claim:
A process for measuring the potency of a batch of glatiramer acetate relative to the known potency of a reference batch which comprises a) immunizing a mouse with a predetermined amount of glatiramer acetate from the reference batch; b) preparing a primary culture of spleen T-cells from the mouse of step (a) at a predetermined time after immunization; c) separately incubating at least two 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 from the reference 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 batch of glatiramer acetate; e) determining for each sample in steps (c) and (d), the amount of a cytokine secreted by the cells in each sample after a predetermined time period of incubation of such sample; f) correlating the amounts of the cytokine secreted by the samples incubated with the batch of glatiramer acetate with the amounts of the cytokine secreted by the samples incubated with the reference batch of glatiramer acetate so as to determine the potency of the batch of glatiramer acetate relative to the reference 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 batch of glatiramer acetate there is a corresponding reference sample containing a substantially identical predetermined amount of glatiramer acetate from the reference batch.