DK1977252T3 - Forbedret monocytaktiveringsprøve med bedre evne til påvisning af pyrogene ikke-endotoxin-kontaminanter i medicinske produkter - Google Patents

Forbedret monocytaktiveringsprøve med bedre evne til påvisning af pyrogene ikke-endotoxin-kontaminanter i medicinske produkter

Info

Publication number
DK1977252T3
DK1977252T3 DK06846727.3T DK06846727T DK1977252T3 DK 1977252 T3 DK1977252 T3 DK 1977252T3 DK 06846727 T DK06846727 T DK 06846727T DK 1977252 T3 DK1977252 T3 DK 1977252T3
Authority
DK
Denmark
Prior art keywords
detect
medical products
better ability
monocyte activation
activation test
Prior art date
Application number
DK06846727.3T
Other languages
English (en)
Inventor
Mehul Patel
Stephen Poole
Original Assignee
Health Prot Agency
Baxter Int
Baxter Healthcare Sa
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.)
Filing date
Publication date
Application filed by Health Prot Agency, Baxter Int, Baxter Healthcare Sa filed Critical Health Prot Agency
Application granted granted Critical
Publication of DK1977252T3 publication Critical patent/DK1977252T3/da

Links

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6863Cytokines, 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
    • G01N33/6869Interleukin
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008Chemical 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
    • G01N33/5044Chemical 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
    • G01N33/5047Cells of the immune system
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008Chemical 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
    • G01N33/5044Chemical 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
    • G01N33/5047Cells of the immune system
    • G01N33/5055Cells of the immune system involving macrophages
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5091Chemical 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
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6863Cytokines, 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
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52Assays involving cytokines
    • G01N2333/54Interleukins [IL]
    • G01N2333/5412IL-6
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/70Mechanisms involved in disease identification
    • G01N2800/7095Inflammation

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Chemical & Material Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Cell Biology (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Pathology (AREA)
  • General Health & Medical Sciences (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Microbiology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Toxicology (AREA)
  • Bioinformatics & Cheminformatics (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)
DK06846727.3T 2005-12-22 2006-12-20 Forbedret monocytaktiveringsprøve med bedre evne til påvisning af pyrogene ikke-endotoxin-kontaminanter i medicinske produkter DK1977252T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US75297005P 2005-12-22 2005-12-22
PCT/US2006/062424 WO2007076411A1 (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
DK1977252T3 true DK1977252T3 (da) 2013-03-04

Family

ID=37913652

Family Applications (2)

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

Family Applications Before (1)

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

Country Status (16)

Country Link
US (5) US7736863B2 (da)
EP (2) EP1977252B1 (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) DK2360479T3 (da)
ES (2) ES2477588T3 (da)
HK (3) HK1119243A1 (da)
MX (1) MX2008008138A (da)
PL (2) PL1977252T3 (da)
PT (2) PT2360479E (da)
SG (1) SG179468A1 (da)
WO (1) WO2007076411A1 (da)

Families Citing this family (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1977252B1 (en) * 2005-12-22 2012-12-05 Baxter International Inc. Improved monocyte activation test better able to detect non-endotoxin pyrogenic contaminants in medical products
DE102006031483B4 (de) * 2006-07-07 2009-12-24 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Zellulärer Pyrogentest
JP4148367B1 (ja) * 2007-08-02 2008-09-10 富山県 細胞のスクリーニング方法
WO2009063307A2 (en) * 2007-11-14 2009-05-22 Bio-Technology General (Israel) Ltd. Inflammatory activity detection method using il-6
SG10201704689XA (en) 2008-01-18 2017-07-28 Harvard College Methods of detecting signatures of disease or conditions in bodily fluids
US20090239238A1 (en) * 2008-03-20 2009-09-24 Baxter International Inc. Methods for measuring pro-inflammatory substance levels in dialysis solutions and dialysis components
MX2010010271A (es) 2008-03-20 2010-12-02 Baxter Int Destruccion de productos microbianos a traves de digestion enzimatica.
US20090239819A1 (en) * 2008-03-20 2009-09-24 Run Wang Peritoneal dialysis solution test method
JP5736370B2 (ja) * 2009-06-25 2015-06-17 ネステク ソシエテ アノニム 過敏性腸症候群の診断方法
EP2596116A4 (en) 2010-07-23 2014-03-19 Harvard College METHODS FOR DETECTION OF AUTOIMMUNE OR IMMUNE-RELATED DISEASES / PATHOLOGIES
AU2011280936A1 (en) 2010-07-23 2013-02-28 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
EP3495816A1 (fr) * 2011-04-08 2019-06-12 Roquette Freres Methodes de detection de contaminants dans des solutions contenant des polymeres de glucose
MX356623B (es) * 2011-09-01 2018-06-06 Fresenius Medical Care Holdings Inc Equipo para muestreo y deteccion de endotoxina en solucion acuosa.
BR112014007802B1 (pt) 2011-12-21 2020-10-20 Grifols, S.A. método para identificar anticorpos reativos atípicos
EP2856154B1 (fr) * 2012-05-29 2018-03-14 Roquette Freres Méthodes de décontamination des circuits de production de polymères de glucose et d'hydrolysats de polymères de glucose
WO2014052593A1 (en) * 2012-09-26 2014-04-03 Cook Biotech Incorporated Medical device design, manufacture and testing systems
WO2015140477A1 (fr) 2014-03-21 2015-09-24 Roquette Freres Procede optimise de decontamination de production de polymeres de glucose et d'hydrolysats de polymeres de glucose
CN107995912A (zh) 2015-03-27 2018-05-04 里珍纳龙药品有限公司 美登素类衍生物、其偶联物和使用方法
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
WO2018089373A2 (en) 2016-11-08 2018-05-17 Regeneron Pharmaceuticals, Inc. Steroids and protein-conjugates thereof
JPWO2021100828A1 (da) * 2019-11-19 2021-05-27
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
WO2024052376A1 (en) * 2022-09-06 2024-03-14 Mat Research B.V. Improved monocyte activation test

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4434237A (en) * 1982-03-31 1984-02-28 Dinarello Charles A Human leukocytic pyrogen test for the detection of exogenous fever-producing substances
FR2615622B1 (fr) 1987-05-19 1994-05-06 Ire Medgenix Sa Dosage plasmatique de monokines
US5281540A (en) 1988-08-02 1994-01-25 Abbott Laboratories Test array for performing assays
FR2679659B1 (fr) 1991-07-23 1993-11-19 Medgenix Diagnostic Sa Procede de dosage in vitro de molecules au niveau de leur site de production par des cellules en culture et format technologique adapte.
WO1994010571A1 (en) 1992-10-30 1994-05-11 T Cell Sciences, Inc. Measurement of total molecule in a sample and methods based thereon
FR2699283B1 (fr) 1992-12-15 1995-03-03 Medgenix Diagnostic Test de pyrogénicite et kit de mise en Óoeuvre.
AU693437B2 (en) 1993-12-28 1998-07-02 Chiron Mimotopes Pty Ltd T-cell epitopes
DE19516247A1 (de) 1995-05-03 1996-11-07 Albrecht Prof Dr Wendel Pyrogen-Untersuchungsverfahren
US5910287A (en) * 1997-06-03 1999-06-08 Aurora Biosciences Corporation Low background multi-well plates with greater than 864 wells for fluorescence measurements of biological and biochemical samples
EP2295968B1 (en) 1999-12-03 2012-09-19 Baxter International Inc. Pyrogenicity test for use with automated immunoassay systems
AU2037402A (en) * 2000-12-12 2002-06-24 Australian Inst Marine Science Assay for paralytic shellfish toxin
DE60300580T2 (de) * 2002-02-12 2006-01-19 Biotage Ab Trennverfahren und vorrichtung zur durchführung eines solchen verfahrens
GB0207350D0 (en) * 2002-03-28 2002-05-08 Univ Sheffield Surface
EP1977252B1 (en) * 2005-12-22 2012-12-05 Baxter International Inc. Improved monocyte activation test better able to detect non-endotoxin pyrogenic contaminants in medical products

Also Published As

Publication number Publication date
CN103901208A (zh) 2014-07-02
PT2360479E (pt) 2014-07-10
US20100203557A1 (en) 2010-08-12
US20100203551A1 (en) 2010-08-12
EP2360479A2 (en) 2011-08-24
US20120058559A1 (en) 2012-03-08
EP2360479B1 (en) 2014-04-02
CN101346630A (zh) 2009-01-14
KR20080080400A (ko) 2008-09-03
US9023647B2 (en) 2015-05-05
PL1977252T3 (pl) 2013-07-31
CN103901208B (zh) 2016-08-24
EP1977252A1 (en) 2008-10-08
HK1119243A1 (en) 2009-02-27
AU2006330562B2 (en) 2013-05-02
SG179468A1 (en) 2012-04-27
US20070184496A1 (en) 2007-08-09
JP4686611B2 (ja) 2011-05-25
KR101352222B1 (ko) 2014-02-04
CA2633523A1 (en) 2007-07-05
HK1161638A1 (en) 2012-07-27
ES2400965T8 (es) 2013-06-04
BRPI0620434A2 (pt) 2011-11-16
ES2477588T3 (es) 2014-07-17
US8053200B2 (en) 2011-11-08
AU2006330562A1 (en) 2007-07-05
CN101346630B (zh) 2013-07-17
MX2008008138A (es) 2008-11-28
US7736863B2 (en) 2010-06-15
US20150285819A1 (en) 2015-10-08
EP2360479A3 (en) 2011-08-31
US8058021B2 (en) 2011-11-15
US9671411B2 (en) 2017-06-06
WO2007076411A1 (en) 2007-07-05
PL2360479T3 (pl) 2014-09-30
HK1199753A1 (en) 2015-07-17
PT1977252E (pt) 2013-01-28
DK2360479T3 (da) 2014-04-07
JP2009521690A (ja) 2009-06-04
EP1977252B1 (en) 2012-12-05
ES2400965T3 (es) 2013-04-15

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