CN103782172A - 检测针对使用TNFα的生物疗法的中和性自体抗体的测定法 - Google Patents

检测针对使用TNFα的生物疗法的中和性自体抗体的测定法 Download PDF

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Publication number
CN103782172A
CN103782172A CN201280043142.5A CN201280043142A CN103782172A CN 103782172 A CN103782172 A CN 103782172A CN 201280043142 A CN201280043142 A CN 201280043142A CN 103782172 A CN103782172 A CN 103782172A
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antibody
tnf
sample
tnfα
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Chinese (zh)
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S·豪恩施泰因
L·奥尔穆德
S·辛格
S·L·王
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Nestec SA
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Societe dAssistance Technique pour Produits Nestle SA
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    • 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
    • G01N33/536—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase
    • G01N33/537—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody
    • G01N33/538—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody by sorbent column, particles or resin strip, i.e. sorbent materials
    • 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
    • G01N33/564—Immunoassay; Biospecific binding assay; Materials therefor for pre-existing immune complex or autoimmune disease, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/34—Size-selective separation, e.g. size-exclusion chromatography; Gel filtration; Permeation
    • 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
    • G01N33/5308—Immunoassay; Biospecific binding assay; Materials therefor for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites
    • 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
    • G01N2333/525—Tumor necrosis factor [TNF]
    • 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
    • G01N33/6854—Immunoglobulins

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Pathology (AREA)
  • Biotechnology (AREA)
  • Rheumatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Rehabilitation Therapy (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
CN201280043142.5A 2011-07-06 2012-07-06 检测针对使用TNFα的生物疗法的中和性自体抗体的测定法 Pending CN103782172A (zh)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201161505031P 2011-07-06 2011-07-06
US61/505,031 2011-07-06
US201161528072P 2011-08-26 2011-08-26
US61/528,072 2011-08-26
US201161535884P 2011-09-16 2011-09-16
US61/535,884 2011-09-16
PCT/US2012/045794 WO2013006810A1 (en) 2011-07-06 2012-07-06 Assays for detecting neutralizing autoantibodies to biologic therapy with tnf alpha

Publications (1)

Publication Number Publication Date
CN103782172A true CN103782172A (zh) 2014-05-07

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CN201280043142.5A Pending CN103782172A (zh) 2011-07-06 2012-07-06 检测针对使用TNFα的生物疗法的中和性自体抗体的测定法

Country Status (12)

Country Link
US (2) US9465027B2 (https=)
EP (2) EP3130921B1 (https=)
JP (1) JP6181646B2 (https=)
KR (1) KR20140047628A (https=)
CN (1) CN103782172A (https=)
AU (2) AU2012278802B2 (https=)
CA (1) CA2840232A1 (https=)
MX (1) MX343324B (https=)
RU (1) RU2013158256A (https=)
SG (1) SG10201605516YA (https=)
WO (1) WO2013006810A1 (https=)
ZA (1) ZA201309703B (https=)

Cited By (8)

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CN105074461A (zh) * 2012-11-30 2015-11-18 雀巢产品技术援助有限公司 用于检测抗生物制品治疗的中和性自身抗体的测定
CN105277682A (zh) * 2015-11-17 2016-01-27 苏州浩欧博生物医药有限公司 一种抗TNF-α单抗药物抗体检测试剂盒
US9784748B2 (en) 2010-10-18 2017-10-10 Nestec S.A. Methods for determining anti-drug antibody isotypes
CN109791142A (zh) * 2016-07-08 2019-05-21 W 健康公司 用于确定样品中治疗性单克隆抗体及其相应抗药物抗体的量的通用测定
US10386366B2 (en) 2009-10-26 2019-08-20 Société des Produits Nestlé S.A. Assays for the detection of anti-TNF drugs and autoantibodies
US10422807B2 (en) 2014-12-05 2019-09-24 Precision Ibd, Inc. Indirect homogeneous mobility shift assays for the detection of biologics in patient samples
US10794906B2 (en) 2011-07-06 2020-10-06 Prometheus Biosciences, Inc. Assays for detecting neutralizing autoantibodies to biologic therapy
CN114236139A (zh) * 2021-12-30 2022-03-25 苏州和锐生物科技有限公司 一种TNF-α生物制剂的抗体检测试剂盒、制备方法

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US9846126B2 (en) 2008-10-27 2017-12-19 Genalyte, Inc. Biosensors based on optical probing and sensing
JP2015532425A (ja) 2012-10-05 2015-11-09 ネステク ソシエテ アノニム 粘膜治癒を予測及びモニタリングするための方法
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CA2932571A1 (en) 2013-12-03 2015-06-11 Nestec S.A. Methods for predicting post-operative recurrence of crohn's disease
WO2015110989A1 (en) 2014-01-23 2015-07-30 Nestec S.A. Biomarker panel for assessment of mucosal healing
EP3990922A1 (en) * 2019-06-25 2022-05-04 ProciseDx Inc. Detection of anti-tnf alpha drug biologics and anti-drug antibodies
KR102626197B1 (ko) * 2020-11-19 2024-01-18 바디텍메드(주) 항 약물 항체의 수준을 정확하게 정량화하는 방법
CN112730846B (zh) * 2020-12-18 2023-12-15 安渡生物医药(杭州)有限公司 一种用于小鼠血样检测免疫复合物的方法

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