Invention Grant
- Patent Title: Euglobulin-based method for determining the biological activity of defibrotide
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Application No.: US17396028Application Date: 2021-08-06
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Publication No.: US11746348B2Publication Date: 2023-09-05
- Inventor: Terenzio Ignoni , Vijay Kumar , Khalid Islam
- Applicant: GENTIUM S.R.L.
- Applicant Address: IT Villa Guardia
- Assignee: GENTIUM S.R.L.
- Current Assignee: GENTIUM S.R.L.
- Current Assignee Address: IT Villa Guardia
- Agency: COOLEY LLP
- Main IPC: C12N15/11
- IPC: C12N15/11 ; C12N9/68 ; A61K31/711 ; A61K38/36 ; C12Q1/37 ; C12Q1/56 ; G01N33/86

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.
Public/Granted literature
- US20210363519A1 EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE Public/Granted day:2021-11-25
Information query
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