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US 2003/0170729 A1Published application
Process for the measurement of the potency of glatiramer acetate
AssigneeTeva Pharmaceutical Industries Ltd.
InventorEty Klinger
Life of this patent
Estimating the term…
Abstract
The subject invention provides a process for measuring the relative potency of a test batch of glatiramer acetate. In addition, the subject invention provides a process for preparing a batch of glatiramer acetate as acceptable for pharmaceutical use.
Claims17
A process for measuring the potency of a test batch of glatiramer acetate relative to the known potency of a reference 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 batch.
- b. preparing a primary culture of lymph node 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 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 batch of glatiramer acetate so as to determine the potency of the test 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 test batch there is a corresponding reference sample containing a substantially identical predetermined amount of glatiramer acetate from the reference batch.
4 more elements
A process for measuring the potency of a test batch of glatiramer acetate relative to the known potency of a reference batch which comprises
- a. immunizing a test mammal with a predetermined amount of glatiramer acetate from the reference batch;
- b. preparing a primary culture of cells from the test mammal 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 a 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 test batch;
- 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 test 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 test 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 immunization 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 batch.
4 more elements
Dependencies are inferred from the claim text.