公开(公告)号：US20250075206A1

公开(公告)日：2025-03-06

申请号：US18953184

申请日：2024-11-20

Applicant: GENTIUM S.R.L.

Inventor： Terenzio IGNONI ,  Vijay KUMAR ,  Khalid ISLAM

IPC: C12N15/11 ,  A61K31/711 ,  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.

公开(公告)号：US20180334672A1

公开(公告)日：2018-11-22

申请号：US15844801

申请日：2017-12-18

Applicant: GENTIUM S.R.L.

Inventor： Terenzio IGNONI ,  Vijay KUMAR ,  Khalid ISLAM

IPC: C12N15/11 ,  G01N33/86 ,  C12Q1/37 ,  A61K31/711 ,  C12Q1/56

CPC classification number: C12N15/11 ,  A61K31/711 ,  C12N2310/127 ,  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 27.5 to 32.5 IU/mg and, more preferably, from 28 to 32 IU/mg.

公开(公告)号：US20210363519A1

公开(公告)日：2021-11-25

申请号：US17396028

申请日：2021-08-06

Applicant: GENTIUM S.R.L.

Inventor： Terenzio IGNONI ,  Vijay KUMAR ,  Khalid ISLAM

IPC: C12N15/11 ,  A61K31/711 ,  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.

公开(公告)号：US20200208148A1

公开(公告)日：2020-07-02

申请号：US16816741

申请日：2020-03-12

Applicant: GENTIUM S.R.L.

Inventor： Terenzio IGNONI ,  Vijay KUMAR ,  Khalid ISLAM

IPC: C12N15/11 ,  G01N33/86 ,  C12Q1/56 ,  C12Q1/37 ,  A61K31/711

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.

公开(公告)号：US20230357762A1

公开(公告)日：2023-11-09

申请号：US18351241

申请日：2023-07-12

Applicant: GENTIUM S.R.L.

Inventor： Terenzio IGNONI ,  Vijay KUMAR ,  Khalid ISLAM

IPC: C12N15/11 ,  A61K31/711 ,  C12Q1/37 ,  C12Q1/56 ,  G01N33/86

CPC classification number: C12N15/11 ,  A61K31/711 ,  C12Q1/37 ,  C12Q1/56 ,  G01N33/86 ,  C12N2310/127

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.

公开(公告)号：US20210388350A1

公开(公告)日：2021-12-16

申请号：US17459169

申请日：2021-08-27

Applicant: GENTIUM S.R.L.

Inventor： Terenzio IGNONI ,  Vijay KUMAR ,  Khalid ISLAM

IPC: C12N15/11 ,  A61K31/711 ,  C12Q1/56 ,  G01N33/86 ,  C12Q1/37

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.