CELLULAR METHOD OF DETERMINING DEFIBROTIDE EFFECTIVENESS Russian patent published in 2020 - IPC G01N33/50 G01N33/15 

FIELD: biotechnology.

SUBSTANCE: group of inventions relates to cellular methods of determining biological activity of defibrotide. Disclosed is a method of determining activity of lot of defibrotide, including stages of growing a cell culture of mammals; cell incubation with solution, containing at least one cytotoxic agent, and at least one concentration of defibrotide from said batch; determining cell viability after the incubation step; assessing the effectiveness of the lot of defibrotide based on measurement of cell viability by comparing cell viability of a defibrotide batch with cell viability for a reference lot of defibrotide; and calculation of defibrotide-based batch activity, wherein said cytotoxic agent is fludarabine, 9-beta-D-arabinofuranose-2-fluoroadenine (F-Ara-A) or doxorubicin. Also disclosed is a method for controlling stability of batches of defibrotide or pharmaceutical formulations, including defibrotide, and use of said method for controlling the amount of defibrotide in the formulations and ensuring content in the formulations of accurate and stable dosages in the manufacturing process, as well as for measuring biological activity of various batches of defibrotide.

EFFECT: group of inventions provides a reliable method of determining biological activity of defibrotide, enables to titrate the activity of defibrotide obtained by different methods or from different initial substances, and also enables to establish units of measurement for effective and safe introduction of defibrotide.

17 cl, 10 dwg, 3 tbl, 10 ex