AU2012278802B2 - Assays for detecting neutralizing autoantibodies to biologic therapy with TNF alpha - Google Patents

Assays for detecting neutralizing autoantibodies to biologic therapy with TNF alpha Download PDF

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Publication number
AU2012278802B2
AU2012278802B2 AU2012278802A AU2012278802A AU2012278802B2 AU 2012278802 B2 AU2012278802 B2 AU 2012278802B2 AU 2012278802 A AU2012278802 A AU 2012278802A AU 2012278802 A AU2012278802 A AU 2012278802A AU 2012278802 B2 AU2012278802 B2 AU 2012278802B2
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AU
Australia
Prior art keywords
tnfa
labeled
autoantibody
drug
neutralizing
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Ceased
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AU2012278802A
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AU2012278802A1 (en
Inventor
Scott Hauenstein
Linda Ohrmund
Sharat Singh
Shui Long Wang
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Societe des Produits Nestle SA
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Societe des Produits Nestle SA
Nestle SA
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Publication of AU2012278802A1 publication Critical patent/AU2012278802A1/en
Assigned to NESTEC S.A. reassignment NESTEC S.A. Amend patent request/document other than specification (104) Assignors: NESTEC SA
Application granted granted Critical
Publication of AU2012278802B2 publication Critical patent/AU2012278802B2/en
Priority to AU2016201196A priority Critical patent/AU2016201196B2/en
Assigned to Société des Produits Nestlé S.A. reassignment Société des Produits Nestlé S.A. Request for Assignment Assignors: NESTEC S.A.
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/536Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase
    • G01N33/537Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody
    • G01N33/538Immunoassay; 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
    • 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
    • G01N33/564Immunoassay; 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/34Size-selective separation, e.g. size-exclusion chromatography; Gel filtration; Permeation
    • 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
    • G01N33/5308Immunoassay; Biospecific binding assay; Materials therefor for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites
    • 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
    • G01N2333/525Tumor necrosis factor [TNF]
    • 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
    • G01N33/6854Immunoglobulins

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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)
AU2012278802A 2011-07-06 2012-07-06 Assays for detecting neutralizing autoantibodies to biologic therapy with TNF alpha Ceased AU2012278802B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2016201196A AU2016201196B2 (en) 2011-07-06 2016-02-25 Assays for detecting neutralizing autoantibodies to biologic therapy with TNF alpha

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

Related Child Applications (1)

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AU2016201196A Division AU2016201196B2 (en) 2011-07-06 2016-02-25 Assays for detecting neutralizing autoantibodies to biologic therapy with TNF alpha

Publications (2)

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AU2012278802A1 AU2012278802A1 (en) 2013-05-02
AU2012278802B2 true AU2012278802B2 (en) 2015-11-26

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AU2016201196A Ceased AU2016201196B2 (en) 2011-07-06 2016-02-25 Assays for detecting neutralizing autoantibodies to biologic therapy with TNF alpha

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US (2) US9465027B2 (cg-RX-API-DMAC7.html)
EP (2) EP3130921B1 (cg-RX-API-DMAC7.html)
JP (1) JP6181646B2 (cg-RX-API-DMAC7.html)
KR (1) KR20140047628A (cg-RX-API-DMAC7.html)
CN (1) CN103782172A (cg-RX-API-DMAC7.html)
AU (2) AU2012278802B2 (cg-RX-API-DMAC7.html)
CA (1) CA2840232A1 (cg-RX-API-DMAC7.html)
MX (1) MX343324B (cg-RX-API-DMAC7.html)
RU (1) RU2013158256A (cg-RX-API-DMAC7.html)
SG (1) SG10201605516YA (cg-RX-API-DMAC7.html)
WO (1) WO2013006810A1 (cg-RX-API-DMAC7.html)
ZA (1) ZA201309703B (cg-RX-API-DMAC7.html)

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EP3130921B1 (en) 2011-07-06 2018-09-12 Nestec S.A. Assays for detecting neutralizing autoantibodies to biologic therapy with tnf alpha
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CN107250798A (zh) * 2014-12-05 2017-10-13 雀巢产品技术援助有限公司 用于检测患者样品中的生物制品的间接均相迁移率变动试验
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
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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
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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