Euglobulin-based method for determining the biological activity of defibrotide
US11085043B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Mar 12, 2020 |
| Grant date | Aug 10, 2021 |
| Priority date | — |
| Expiry date | Mar 12, 2040 |
Classification
- Technology area (CPC C)Chemistry; Metallurgy
- CPC primaryC12N2310/127
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
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.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.