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：US11236328B2

公开(公告)日：2022-02-01

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 ,  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.

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.

公开(公告)号：US10393731B2

公开(公告)日：2019-08-27

申请号：US15529814

申请日：2015-11-23

Applicant: GENTIUM S.R.L.

Inventor： Terenzio Ignoni ,  Vijay Kumar ,  Claudio Verga

IPC: G01N33/50

Abstract: The present invention relates to cell-based methods for determining the biological activity of defibrotide. In particular, the invention provides a method for assessing the potency of defibrotide by assessing the viability of mammalian cells in the presence of at least one cytotoxic agent and one or more concentrations of defibrotide. Such methods are particularly useful for standardizing pharmaceutical compositions comprising defibrotide.

公开(公告)号：US11746348B2

公开(公告)日：2023-09-05

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 ,  C12N9/68 ,  A61K31/711 ,  A61K38/36 ,  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：US20230194502A1

公开(公告)日：2023-06-22

申请号：US18170644

申请日：2023-02-17

Applicant: GENTIUM S.R.L.

Inventor： Terenzio IGNONI ,  Vijay KUMAR ,  Claudio VERGA

IPC: G01N33/50

CPC classification number: G01N33/5014 ,  G01N33/5064

Abstract: The present invention relates to cell-based methods for determining the biological activity of defibrotide. In particular, the invention provides a method for assessing the potency of defibrotide by assessing the viability of mammalian cells in the presence of at least one cytotoxic agent and one or more concentrations of defibrotide. Such methods are particularly useful for standardizing pharmaceutical compositions comprising defibrotide.

公开(公告)号：US20200057051A1

公开(公告)日：2020-02-20

申请号：US16551505

申请日：2019-08-26

Applicant: GENTIUM S.R.L.

Inventor： Terenzio IGNONI ,  Vijay KUMAR ,  Claudio VERGA

IPC: G01N33/50

Abstract: The present invention relates to cell-based methods for determining the biological activity of defibrotide. In particular, the invention provides a method for assessing the potency of defibrotide by assessing the viability of mammalian cells in the presence of at least one cytotoxic agent and one or more concentrations of defibrotide. Such methods are particularly useful for standardizing pharmaceutical compositions comprising defibrotide.

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.