ES2400965T8 - Ensayo mejorado de activación de monocitos con mayor capacidad para detectar contaminantes pirogénicos no endotoxínicos en productos médicos - Google Patents

Ensayo mejorado de activación de monocitos con mayor capacidad para detectar contaminantes pirogénicos no endotoxínicos en productos médicos Download PDF

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Publication number
ES2400965T8
ES2400965T8 ES06846727T ES06846727T ES2400965T8 ES 2400965 T8 ES2400965 T8 ES 2400965T8 ES 06846727 T ES06846727 T ES 06846727T ES 06846727 T ES06846727 T ES 06846727T ES 2400965 T8 ES2400965 T8 ES 2400965T8
Authority
ES
Spain
Prior art keywords
medical products
activation assay
greater ability
detect non
monocyte activation
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
ES06846727T
Other languages
English (en)
Other versions
ES2400965T3 (es
Inventor
Stephen Poole
Mehul Patel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter Healthcare SA
Public Health England
Baxter International Inc
Original Assignee
Baxter Healthcare SA
Health Protection Agency
Baxter International Inc
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 Baxter Healthcare SA, Health Protection Agency, Baxter International Inc filed Critical Baxter Healthcare SA
Application granted granted Critical
Publication of ES2400965T3 publication Critical patent/ES2400965T3/es
Publication of ES2400965T8 publication Critical patent/ES2400965T8/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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)
ES06846727T 2005-12-22 2006-12-20 Ensayo mejorado de activación de monicitos con mayor capacidad para detectar contaminantes pirotécnicos no endotoxínicos en productos médicos Active ES2400965T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US75297005P 2005-12-22 2005-12-22
US752970P 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 (2)

Publication Number Publication Date
ES2400965T3 ES2400965T3 (es) 2013-04-15
ES2400965T8 true ES2400965T8 (es) 2013-06-04

Family

ID=37913652

Family Applications (2)

Application Number Title Priority Date Filing Date
ES06846727T Active ES2400965T3 (es) 2005-12-22 2006-12-20 Ensayo mejorado de activación de monicitos con mayor capacidad para detectar contaminantes pirotécnicos no endotoxínicos en productos médicos
ES11003878.3T Active ES2477588T3 (es) 2005-12-22 2006-12-20 Ensayo de activación de monocitos perfeccionado capaz de detectar contaminantes pirogénicos no endotoxínicos en productos médicos

Family Applications After (1)

Application Number Title Priority Date Filing Date
ES11003878.3T Active ES2477588T3 (es) 2005-12-22 2006-12-20 Ensayo de activación de monocitos perfeccionado capaz de detectar contaminantes pirogénicos no endotoxínicos en productos médicos

Country Status (16)

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

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT1977252E (pt) * 2005-12-22 2013-01-28 Baxter Int Teste de activação de monócitos melhorado mais capaz de detectar contaminantes pirogénicos sem serem endotoxinas em produtos médicos
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
US20090239819A1 (en) * 2008-03-20 2009-09-24 Run Wang Peritoneal dialysis solution test method
JP5438751B2 (ja) 2008-03-20 2014-03-12 バクスター・インターナショナル・インコーポレイテッド 酵素消化による微生物生成物の破壊
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
EP2694961B2 (fr) * 2011-04-08 2022-01-05 Roquette Frères Methodes de detection de contaminants dans des solutions contenants des polymeres de glucose
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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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
EP1234181A4 (en) * 1999-12-03 2005-01-26 Baxter Int PYROGENICITY TEST FOR USE WITH AUTOMATED IMMUNOLOGICAL ASSAY SYSTEMS
JP2004524516A (ja) * 2000-12-12 2004-08-12 オーストラリアン インスティチュート オブ マリーン サイエンス 麻痺性貝毒のアッセイ
ATE294235T1 (de) * 2002-02-12 2005-05-15 Biotage Ab Trennverfahren und vorrichtung zur durchführung eines solchen verfahrens
GB0207350D0 (en) * 2002-03-28 2002-05-08 Univ Sheffield Surface
PT1977252E (pt) * 2005-12-22 2013-01-28 Baxter Int Teste de activação de monócitos melhorado mais capaz de detectar contaminantes pirogénicos sem serem endotoxinas em produtos médicos

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
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
DK2360479T3 (da) 2014-04-07
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

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