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AssigneeGentium S.R.L.
InventorsTerenzio Ignoni, Vijay Kumar, Khalid Islam
Estimating the term…
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 27.5 to 32.5 IU/mg and, more preferably, from 28 to 32 IU/mg.
A method for determining the biological activity of defibrotide, which comprises the steps of:
A liquid defibrotide formulation, having a biological activity of 25 to 35 IU/mg of defibrotide, preferably from 27.5 to 32.5 IU/mg, more preferably, from 28 to 32 IU/mg.
A container which contains a liquid defibrotide formulation and which has a biological activity of 5000 to 7000 IU, preferably 5500 to 6500 IU, more preferably 5600 to 6400.
Dependencies are inferred from the claim text.