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)
  • Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (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)

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

Publications (2)

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

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AU2012278802A Ceased AU2012278802B2 (en) 2011-07-06 2012-07-06 Assays for detecting neutralizing autoantibodies to biologic therapy with TNF alpha
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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Country Status (12)

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US (2) US9465027B2 (enExample)
EP (2) EP2729807B1 (enExample)
JP (1) JP6181646B2 (enExample)
KR (1) KR20140047628A (enExample)
CN (1) CN103782172A (enExample)
AU (2) AU2012278802B2 (enExample)
CA (1) CA2840232A1 (enExample)
MX (1) MX343324B (enExample)
RU (1) RU2013158256A (enExample)
SG (1) SG10201605516YA (enExample)
WO (1) WO2013006810A1 (enExample)
ZA (1) ZA201309703B (enExample)

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RU2013158256A (ru) 2011-07-06 2015-07-10 Нестек С.А. АНАЛИЗЫ ДЛЯ ОБНАРУЖЕНИЯ НЕЙТРАЛИЗУЮЩИХ АУТОАНТИТЕЛ ДЛЯ БИОЛОГИЧЕСКОЙ ТЕРАПИИ TNFα
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WO2015110989A1 (en) 2014-01-23 2015-07-30 Nestec S.A. Biomarker panel for assessment of mucosal healing
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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
EP3482199A1 (en) * 2016-07-08 2019-05-15 Atonomics A/S A universal assay for determining the quantity of therapeutic monoclonal antibodies and their corresponding anti-drug-antibodies in samples
WO2020263450A1 (en) * 2019-06-25 2020-12-30 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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