DK2360479T3 - Forbedret monocytaktiveringsprøve til påvisning af pyrogene ikke-endotoxin-forureninger i medicinske produkter - Google Patents

Forbedret monocytaktiveringsprøve til påvisning af pyrogene ikke-endotoxin-forureninger i medicinske produkter

Info

Publication number: DK2360479T3
Authority: DK; Denmark
Prior art keywords: detection; medical products; activation assay; monocyte activation; endotoxin contaminants
Prior art date: 2005-12-22

Application number

DK11003878.3T

Other languages

English (en)

Inventor

Stephen Poole

Mehul Patel

Original Assignee

Baxter Int

Baxter Healthcare Sa

Sec Dep For Health

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2005-12-22

Filing date

2006-12-20

Publication date

2014-04-07

2006-12-20 Application filed by Baxter Int, Baxter Healthcare Sa, Sec Dep For Health filed Critical Baxter Int

2014-04-07 Application granted granted Critical

2014-04-07 Publication of DK2360479T3 publication Critical patent/DK2360479T3/da

Classifications

- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
- G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
- G01N33/5044—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics involving specific cell types
- G01N33/5047—Cells of the immune system
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
- G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
- G01N33/5044—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics involving specific cell types
- G01N33/5047—Cells of the immune system
- G01N33/5055—Cells of the immune system involving macrophages
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
- G01N33/5091—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing the pathological state of an organism
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6863—Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6863—Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors
- G01N33/6869—Interleukin
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/52—Assays involving cytokines
- G01N2333/54—Interleukins [IL]
- G01N2333/5412—IL-6
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/70—Mechanisms involved in disease identification
- G01N2800/7095—Inflammation

Landscapes

Health & Medical Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Immunology (AREA)
Engineering & Computer Science (AREA)
Molecular Biology (AREA)
Biomedical Technology (AREA)
Chemical & Material Sciences (AREA)
Urology & Nephrology (AREA)
Hematology (AREA)
Cell Biology (AREA)
Food Science & Technology (AREA)
General Health & Medical Sciences (AREA)
Biotechnology (AREA)
Pathology (AREA)
General Physics & Mathematics (AREA)
Medicinal Chemistry (AREA)
Physics & Mathematics (AREA)
Analytical Chemistry (AREA)
Biochemistry (AREA)
Microbiology (AREA)
Tropical Medicine & Parasitology (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Bioinformatics & Cheminformatics (AREA)
Toxicology (AREA)
Physiology (AREA)
Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
Investigating Or Analysing Biological Materials (AREA)
Micro-Organisms Or Cultivation Processes Thereof (AREA)

DK11003878.3T 2005-12-22 2006-12-20 Forbedret monocytaktiveringsprøve til påvisning af pyrogene ikke-endotoxin-forureninger i medicinske produkter DK2360479T3 (da)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
US75297005P	2005-12-22	2005-12-22
EP06846727A EP1977252B1 (en)	2005-12-22	2006-12-20	Improved monocyte activation test better able to detect non-endotoxin pyrogenic contaminants in medical products

Publications (1)

Publication Number	Publication Date
DK2360479T3 true DK2360479T3 (da)	2014-04-07

Family

ID=37913652

Family Applications (2)

Application Number	Title	Priority Date	Filing Date
DK06846727.3T DK1977252T3 (da)	2005-12-22	2006-12-20	Forbedret monocytaktiveringsprøve med bedre evne til påvisning af pyrogene ikke-endotoxin-kontaminanter i medicinske produkter
DK11003878.3T DK2360479T3 (da)	2005-12-22	2006-12-20	Forbedret monocytaktiveringsprøve til påvisning af pyrogene ikke-endotoxin-forureninger i medicinske produkter

Family Applications Before (1)

Application Number	Title	Priority Date	Filing Date
DK06846727.3T DK1977252T3 (da)	2005-12-22	2006-12-20	Forbedret monocytaktiveringsprøve med bedre evne til påvisning af pyrogene ikke-endotoxin-kontaminanter i medicinske produkter

Country Status (16)

Country	Link
US (5)	US7736863B2 (da)
EP (2)	EP2360479B1 (da)
JP (1)	JP4686611B2 (da)
KR (1)	KR101352222B1 (da)
CN (2)	CN103901208B (da)
AU (1)	AU2006330562B2 (da)
BR (1)	BRPI0620434A2 (da)
CA (1)	CA2633523A1 (da)
DK (2)	DK1977252T3 (da)
ES (2)	ES2400965T3 (da)
HK (1)	HK1199753A1 (da)
MX (1)	MX2008008138A (da)
PL (2)	PL1977252T3 (da)
PT (2)	PT1977252E (da)
SG (1)	SG179468A1 (da)
WO (1)	WO2007076411A1 (da)

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DE102006031483B4 (de) *	2006-07-07	2009-12-24	Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V.	Zellulärer Pyrogentest
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ES2509616T3 (es) *	2009-06-25	2014-10-17	Nestec S.A.	Procedimientos de diagnóstico del síndrome del intestino irritable
AU2011280997A1 (en)	2010-07-23	2013-02-28	President And Fellows Of Harvard College	Methods of detecting autoimmune or immune-related diseases or conditions
CA2806304A1 (en)	2010-07-23	2012-01-26	President And Fellows Of Harvard College	Methods of detecting prenatal or pregnancy-related diseases or conditions
FR2978774B1 (fr) *	2011-08-02	2015-02-20	Roquette Freres	Methodes de detection des contaminants des circuits de production de polymeres de glucose
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US20140295477A1 (en) *	2011-09-01	2014-10-02	Fresenius Medical Care Holdings, Inc	Kit For Sampling And Detection Of Endotoxin In Aqueous Solution
US9523694B2 (en)	2011-12-21	2016-12-20	Grifols, S.A.	Identification of atypical antibodies in human blood and blood products
BR112014029808B1 (pt) *	2012-05-29	2021-12-07	Roquette Frères	Método para testar a eficácia de uma etapa de purificação ou etapas de purificação na presença ou na natureza de moléculas pró-inflamatórias em polímeros de glicose ou hidrolisados dos mesmos e método otimizado para purificar polímeros de glicose ou hidrolisados dos mesmos
EP2901156B1 (en) *	2012-09-26	2018-06-20	Cook Biotech Incorporated	Medical device design, manufacture and testing systems
MX387912B (es)	2014-03-21	2025-03-19	Roquette Freres	Método optimizado para descontaminar la produccion de polímeros de glucosa y los hidrolizados de polímero de glucosa.
CA2978340C (en)	2015-03-27	2024-05-28	Regeneron Pharmaceuticals, Inc.	Maytansinoid derivatives, conjugates thereof, and methods of use
FR3037063B1 (fr)	2015-06-04	2017-05-19	Roquette Freres	Procede optimise de decontamination de l'amidon utilise comme matiere premiere pour l'obtention de polymeres de glucose destines a la dialyse peritoneale
EP3171170A1 (en) *	2015-11-17	2017-05-24	Lionex GmbH	Device for use in elispot
CA3042428A1 (en)	2016-11-08	2018-05-17	Regeneron Pharmaceuticals, Inc.	Steroids and protein-conjugates thereof
EP4063493A4 (en) *	2019-11-19	2024-03-06	Mican Technologies Inc.	METHOD FOR ASSESSING THE SAFETY OF A SUBSTANCE IN VITRO USING IMMORTALIZED HUMAN MYELOID CELLS
EP4006546A1 (en) *	2020-11-30	2022-06-01	Medizinische Hochschule Hannover	Application of stem-cell derived monocytes in a monocyte activation test (mat) for the assessment of pyrogenicity and inflammatory potential
US20260079156A1 (en) *	2022-09-06	2026-03-19	Mat Research B.V.	Improved monocyte activation test
EP4692331A4 (en) *	2023-03-30	2026-07-22	Hoshi Univ	CELLS, METHOD FOR DETECTING A PYROGENIC SUBSTANCE IN A SAMPLE, AND KIT INTENDED FOR USE FOR DETECTING A PYROGENIC SUBSTANCE

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2006
- 2006-12-20 PT PT68467273T patent/PT1977252E/pt unknown
- 2006-12-20 AU AU2006330562A patent/AU2006330562B2/en not_active Ceased
- 2006-12-20 WO PCT/US2006/062424 patent/WO2007076411A1/en not_active Ceased
- 2006-12-20 SG SG2012017133A patent/SG179468A1/en unknown
- 2006-12-20 US US11/613,866 patent/US7736863B2/en active Active
- 2006-12-20 CA CA002633523A patent/CA2633523A1/en not_active Abandoned
- 2006-12-20 PL PL06846727T patent/PL1977252T3/pl unknown
- 2006-12-20 CN CN201310252724.0A patent/CN103901208B/zh not_active Expired - Fee Related
- 2006-12-20 CN CN2006800488729A patent/CN101346630B/zh not_active Expired - Fee Related
- 2006-12-20 PL PL11003878T patent/PL2360479T3/pl unknown
- 2006-12-20 EP EP11003878.3A patent/EP2360479B1/en active Active
- 2006-12-20 ES ES06846727T patent/ES2400965T3/es active Active
- 2006-12-20 BR BRPI0620434-1A patent/BRPI0620434A2/pt not_active IP Right Cessation
- 2006-12-20 DK DK06846727.3T patent/DK1977252T3/da active
- 2006-12-20 PT PT110038783T patent/PT2360479E/pt unknown
- 2006-12-20 EP EP06846727A patent/EP1977252B1/en active Active
- 2006-12-20 JP JP2008547757A patent/JP4686611B2/ja not_active Expired - Fee Related
- 2006-12-20 DK DK11003878.3T patent/DK2360479T3/da active
- 2006-12-20 MX MX2008008138A patent/MX2008008138A/es active IP Right Grant
- 2006-12-20 KR KR1020087017829A patent/KR101352222B1/ko active Active
- 2006-12-20 ES ES11003878.3T patent/ES2477588T3/es active Active
2010
- 2010-04-26 US US12/767,514 patent/US8058021B2/en active Active
- 2010-04-26 US US12/767,537 patent/US8053200B2/en active Active
2011
- 2011-11-10 US US13/293,868 patent/US9023647B2/en active Active
2015
- 2015-01-02 HK HK15100025.2A patent/HK1199753A1/xx unknown
- 2015-04-06 US US14/679,651 patent/US9671411B2/en active Active

Also Published As

Publication number	Publication date
US7736863B2 (en)	2010-06-15
HK1161638A1 (en)	2012-07-27
PT2360479E (pt)	2014-07-10
AU2006330562B2 (en)	2013-05-02
BRPI0620434A2 (pt)	2011-11-16
ES2400965T3 (es)	2013-04-15
CN103901208B (zh)	2016-08-24
CN101346630B (zh)	2013-07-17
CN103901208A (zh)	2014-07-02
US20120058559A1 (en)	2012-03-08
ES2477588T3 (es)	2014-07-17
KR20080080400A (ko)	2008-09-03
US8058021B2 (en)	2011-11-15
US9671411B2 (en)	2017-06-06
EP2360479A3 (en)	2011-08-31
PL1977252T3 (pl)	2013-07-31
DK1977252T3 (da)	2013-03-04
JP2009521690A (ja)	2009-06-04
ES2400965T8 (es)	2013-06-04
PL2360479T3 (pl)	2014-09-30
US20100203557A1 (en)	2010-08-12
HK1199753A1 (en)	2015-07-17
KR101352222B1 (ko)	2014-02-04
JP4686611B2 (ja)	2011-05-25
US8053200B2 (en)	2011-11-08
EP2360479B1 (en)	2014-04-02
EP1977252A1 (en)	2008-10-08
US20100203551A1 (en)	2010-08-12
PT1977252E (pt)	2013-01-28
AU2006330562A1 (en)	2007-07-05
US9023647B2 (en)	2015-05-05
EP1977252B1 (en)	2012-12-05
HK1119243A1 (en)	2009-02-27
CA2633523A1 (en)	2007-07-05
CN101346630A (zh)	2009-01-14
US20150285819A1 (en)	2015-10-08
US20070184496A1 (en)	2007-08-09
MX2008008138A (es)	2008-11-28
WO2007076411A1 (en)	2007-07-05
SG179468A1 (en)	2012-04-27
EP2360479A2 (en)	2011-08-24

Publication	Publication Date	Title
DK1977252T3 (da)	2013-03-04	Forbedret monocytaktiveringsprøve med bedre evne til påvisning af pyrogene ikke-endotoxin-kontaminanter i medicinske produkter
FI20050768L (fi)	2007-01-20	Terveydenseurantalaite ja laitemoduuli
DE602006009656D1 (de)	2009-11-19	1-ä(3-hydroxy-adamant-1-ylamino)-acetylü-pyrrolidin-2(s)-carbonitril-formulierung mit modifizierter freisetzung
BRPI0815380A2 (pt)	2015-02-10	Dispositivo de emissão de luz e dispositivo de iluminação compreendendo o mesmo
DE602007010995D1 (de)	2011-01-20	Trennmembran-Vorrichtung und dessen Waschverfahren
DE602006002286D1 (de)	2008-10-02	Optisches transparentes Element und optisches System damit
EP2079489A4 (en)	2013-01-02	ABSORBENT ARTICLE WITH ABSORPTION STRUCTURE
BRPI0817906A2 (pt)	2015-04-07	Elemento de filtro e sistema de filtro
IL223604B (en)	2018-07-31	System for detection of an analyte in a body fluid
EP1959903A4 (en)	2009-11-25	VOIDABLE ARTICLE
DE602006018919D1 (de)	2011-01-27	Fahrzeug und spurerkennungsvorrichtung
EP1954323A4 (en)	2009-09-02	REED STERILIZATION
EP2228657A4 (en)	2011-07-06	MICROCHIP AND BLOOD MONITORING DEVICE
BRPI0715346A2 (pt)	2013-11-26	Detecção de analitos e ácidos nucléicos
DOP2009000102A (es)	2010-10-31	Anticuerpos del agonista trkb y usos de los mismos
DE602006009463D1 (de)	2009-11-12	Blut via Nagel und Nagelverdampfungsvorrichtung
DE602006019198D1 (de)	2011-02-10	Probe- und haltevorrichtung
DK1510809T3 (da)	2013-04-22	Indretning til inspektion af produkter
BRPI0821244A2 (pt)	2014-12-23	Proteína de cereal hipoalergênica e seus usos
DE602006009996D1 (de)	2009-12-10	Optischer Kodierer und Gerät damit
EP1934551A4 (en)	2009-12-30	SYSTEM AND CLOTHING PIECE FOR DETECTING MOTION
EP2095767A4 (en)	2013-02-27	Blood sensor and blood inspection device using it
PL1899129T3 (pl)	2013-02-28	Sposób rozdzielania różnych dodatkowych składników polimerów oraz jego zastosowanie
EP1855124A4 (en)	2008-10-08	POSITION DETECTION SYSTEM AND RFID TERMINAL
EP2071328A4 (en)	2009-11-11	ELEMENT FOR OZONE DETECTION