Abstract: The present invention provides methods of inducing anti-glatiramer acetate specific antibodies in a human subject afflicted with multiple sclerosis, comprising administration to the human subject of three subcutaneous injections of a 40 mg/ml dose of glatiramer acetate per week for at least 12 months, such that the level of anti-GA specific antibodies in the blood or serum of the human subject i) increases for up to about 6 months after an initial 40 mg/ml dose of glatiramer acetate of the administration is administered to the human subject; ii) increases at a greater rate during the first month after the initial 40 mg/ml dose of glatiramer acetate compared to the rate of increase after the first month to the third month after the initial 40 mg/ml dose of glatiramer acetate; iii) peaks at about 3 or about 6 months or between about 3 and about 6 months after the initial 40 mg/ml dose of glatiramer acetate; and iv) is higher than baseline at least about 12 months after the initial 40 mg/ml dose of glatiramer ac

Abstract: The present invention provides a process for characterizing a glatiramer acetate related drug substance or drug product comprising the steps of: a) obtaining a batch of the glatiramer acetate related drug substance or drug product; b) immunizing a mammal with a predetermined amount of a glatiramer acetate related drug substance or drug product; c) preparing a culture of cells from the mammal of step b) at a predetermined time after immunization; d) incubating cells from the culture of step c) with a predetermined amount of the glatiramer acetate drug related substance or drug product of step a); and e) determining the level of expression of at least one gene disclosed herein or determining the level of biological activity of the cells of step c) as disclosed herein, thereby characterizing the glatiramer acetate related drug substance or drug product of step a).