Euglobulin-based method for determining the biological activity of defibrotide
AssigneeGentium S.R.L.
InventorsTerenzio Ignoni, Vijay Kumar, Khalid Islam
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Abstract
It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27 to 32 IU/mg and, more preferably, from 28 to 32 IU/mg.
Claims19
A method of treating Veno-Occlusive Disease (VOD) comprising administering to a patient in need thereof a defibrotide formulation consisting of defibrotide, sodium citrate, and water for injection, having a potency of 25 to 35 IU/mg, and a concentration of at least 80 mg/mL,
- wherein the defibrotide potency is determined by a method comprising the steps of:
- a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for plasmin which, by reaction with plasmin, provides a measurable product;
- and
- b) measuring the amount of product formed at successive times, to thereby determine the potency of the defibrotide.
Dependencies are inferred from the claim text.