FIELD: medicine.
SUBSTANCE: group of inventions relates to the determination of activity of a therapeutic cell composition. A method is disclosed for the determination of activity of a sample containing auxiliary cells (hereinafter – FC) and/or alpha-beta TCR+ T-cells, including bringing the sample containing FC and/or alpha-beta TCR+ T-cells into contact with mitogenic stimulus; and determination of a number of FC and/or alpha-beta TCR+ T-cells in the sample, in which ribosome protein S6 is phosphorylated (hereinafter – pS6). The number of FC and/or alpha-beta TCR+ T-cells in the sample, in which pS6 is phosphorylated, characterizes the activity of FC and/or alpha-beta TCR+ T-cells, respectively, in the sample. The method is carried out before freezing FC and/or alpha-beta TCR+ T-cells, or is carried out on FC and/or alpha-beta TCR+ T-cells, which were frozen. A method for the determination of a therapeutic dose of FC and/or alpha-beta TCR+ T-cells, using the specified method for the determination of activity, and a product for implementation of the specified method for the determination of activity are also disclosed.
EFFECT: group of inventions provides for a fast and quantitative method for the assessment of activity of a therapeutic cell composition.
15 cl, 5 dwg, 12 tbl, 12 ex
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