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
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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
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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.)
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Publication date
Application filed by Baxter Healthcare SA, Health Protection Agency, Baxter International Inc filed Critical Baxter Healthcare SA
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Publication of ES2400965T3 publication Critical patent/ES2400965T3/es
Publication of ES2400965T8 publication Critical patent/ES2400965T8/es
Active legal-status Critical Current
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    • 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
    • G01N33/5005Chemical 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
    • 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
    • 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)
  • Urology & Nephrology (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Cell Biology (AREA)
  • Medicinal Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Biotechnology (AREA)
  • Food Science & Technology (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (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) EP1977252B1 (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) PL2360479T3 (es)
PT (2) PT2360479E (es)
SG (1) SG179468A1 (es)
WO (1) WO2007076411A1 (es)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
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KR101352222B1 (ko) * 2005-12-22 2014-02-04 백스터 인터내셔널 인코포레이티드 의료용 제품에서 비-내독소 발열성 오염물을 보다 잘검출할 수 있는 개선된 단핵구 활성화 시험
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
MX340916B (es) 2008-01-18 2016-07-29 President And Fellows Of Harvard College * Metodos para detectar señales de identificacion de enfermedad o condiciones en fluidos corporales.
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
US20090239819A1 (en) * 2008-03-20 2009-09-24 Run Wang Peritoneal dialysis solution test method
US20090239238A1 (en) * 2008-03-20 2009-09-24 Baxter International Inc. Methods for measuring pro-inflammatory substance levels in dialysis solutions and dialysis components
EP3309556B1 (en) * 2009-06-25 2020-04-08 Prometheus Biosciences, Inc. Methods for diagnosing irritable bowel syndrome
US20130203624A1 (en) 2010-07-23 2013-08-08 President And Fellows Of Harvard College Methods of Detecting Prenatal or Pregnancy-Related Diseases or Conditions
AU2011280997A1 (en) 2010-07-23 2013-02-28 President And Fellows Of Harvard College Methods of detecting autoimmune or immune-related diseases or conditions
SG194005A1 (en) 2011-04-08 2013-11-29 Roquette Freres Methods for detecting contaminants in solutions containing glucose polymers
FR2978774B1 (fr) * 2011-08-02 2015-02-20 Roquette Freres Methodes de detection des contaminants des circuits de production de 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
CA2845674C (en) 2011-12-21 2018-01-16 Grifols, S.A. Identification of atypical antibodies in human blood and blood products
JP6244356B2 (ja) * 2012-05-29 2017-12-06 ロケット フレールRoquette Freres グルコースポリマーおよびグルコースポリマー加水分解物の製造回路の除染方法
WO2014052593A1 (en) * 2012-09-26 2014-04-03 Cook Biotech Incorporated Medical device design, manufacture and testing systems
EP3119813B1 (fr) 2014-03-21 2023-01-04 Roquette Frères Procede optimise de decontamination de production de polymeres de glucose et d'hydrolysats de polymeres de glucose
BR112017020149A8 (pt) 2015-03-27 2023-05-02 Regeneron Pharma Derivados de maitansinoide, conjugados dos mesmos e métodos de uso
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
ES3046537T3 (en) 2016-11-08 2025-12-02 Regeneron Pharma Steroids and protein-conjugates thereof
WO2021100828A1 (ja) * 2019-11-19 2021-05-27 マイキャン・テクノロジーズ株式会社 ヒト不死化ミエロイド系細胞を使用したin vitroにおける物質の安全性評価方法
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
CA3266655A1 (en) * 2022-09-06 2024-03-14 Mat Research B.V. IMPROVED MONOCYTE ACTIVATION TEST
JPWO2024204725A1 (es) * 2023-03-30 2024-10-03

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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.
JPH07509783A (ja) 1992-10-30 1995-10-26 ティー セル ダイアグノスティックス,インコーポレーテッド 試料中の全分子の測定及びそれに基づく方法
FR2699283B1 (fr) 1992-12-15 1995-03-03 Medgenix Diagnostic Test de pyrogénicite et kit de mise en Óoeuvre.
JPH09510437A (ja) 1993-12-28 1997-10-21 カイロン ミモトープス プロプライエトリー リミテッド T細胞エピトープ
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
CA2430868A1 (en) * 2000-12-12 2002-06-20 Australian Institute Of Marine Science Assay for paralytic shellfish toxin
EP1474511B1 (en) * 2002-02-12 2005-04-27 Biotage AB Separating method and an apparatus performing such a method
GB0207350D0 (en) * 2002-03-28 2002-05-08 Univ Sheffield Surface
KR101352222B1 (ko) * 2005-12-22 2014-02-04 백스터 인터내셔널 인코포레이티드 의료용 제품에서 비-내독소 발열성 오염물을 보다 잘검출할 수 있는 개선된 단핵구 활성화 시험

Also Published As

Publication number Publication date
PL2360479T3 (pl) 2014-09-30
CN101346630A (zh) 2009-01-14
US20150285819A1 (en) 2015-10-08
JP2009521690A (ja) 2009-06-04
PT1977252E (pt) 2013-01-28
BRPI0620434A2 (pt) 2011-11-16
KR20080080400A (ko) 2008-09-03
US8058021B2 (en) 2011-11-15
US9671411B2 (en) 2017-06-06
HK1161638A1 (en) 2012-07-27
US20070184496A1 (en) 2007-08-09
AU2006330562A1 (en) 2007-07-05
CN101346630B (zh) 2013-07-17
EP2360479A3 (en) 2011-08-31
US20120058559A1 (en) 2012-03-08
CN103901208A (zh) 2014-07-02
PT2360479E (pt) 2014-07-10
PL1977252T3 (pl) 2013-07-31
EP2360479A2 (en) 2011-08-24
ES2400965T3 (es) 2013-04-15
US8053200B2 (en) 2011-11-08
ES2477588T3 (es) 2014-07-17
CN103901208B (zh) 2016-08-24
MX2008008138A (es) 2008-11-28
EP2360479B1 (en) 2014-04-02
HK1119243A1 (en) 2009-02-27
DK2360479T3 (da) 2014-04-07
SG179468A1 (en) 2012-04-27
US9023647B2 (en) 2015-05-05
EP1977252B1 (en) 2012-12-05
KR101352222B1 (ko) 2014-02-04
EP1977252A1 (en) 2008-10-08
US20100203557A1 (en) 2010-08-12
HK1199753A1 (en) 2015-07-17
JP4686611B2 (ja) 2011-05-25
WO2007076411A1 (en) 2007-07-05
US7736863B2 (en) 2010-06-15
DK1977252T3 (da) 2013-03-04
CA2633523A1 (en) 2007-07-05
US20100203551A1 (en) 2010-08-12
AU2006330562B2 (en) 2013-05-02

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