JP2016502091A - 生物学的治療に対する中和自己抗体の検出のためのアッセイ - Google Patents

生物学的治療に対する中和自己抗体の検出のためのアッセイ Download PDF

Info

Publication number
JP2016502091A
JP2016502091A JP2015544592A JP2015544592A JP2016502091A JP 2016502091 A JP2016502091 A JP 2016502091A JP 2015544592 A JP2015544592 A JP 2015544592A JP 2015544592 A JP2015544592 A JP 2015544592A JP 2016502091 A JP2016502091 A JP 2016502091A
Authority
JP
Japan
Prior art keywords
tnfα
labeled
drug
sample
neutralizing
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.)
Pending
Application number
JP2015544592A
Other languages
English (en)
Japanese (ja)
Other versions
JP2016502091A5 (enExample
Inventor
スコット ハウエンシュタイン，
スコット ハウエンシュタイン，
シャラット シング，
シャラット シング，
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.)
Nestec SA
Original Assignee
Nestec SA
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
Priority claimed from US13/802,117 external-priority patent/US20130266963A1/en
Application filed by Nestec SA filed Critical Nestec SA
Publication of JP2016502091A publication Critical patent/JP2016502091A/ja
Publication of JP2016502091A5 publication Critical patent/JP2016502091A5/ja
Pending legal-status Critical Current

Links

Images

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
    • G01N33/53—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
    • 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
    • G01N33/502—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 for testing non-proliferative effects
    • 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
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • General Physics & Mathematics (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Pathology (AREA)
  • Microbiology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Rehabilitation Therapy (AREA)
  • Rheumatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Toxicology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
JP2015544592A 2012-11-30 2013-11-27 生物学的治療に対する中和自己抗体の検出のためのアッセイ Pending JP2016502091A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201261732251P 2012-11-30 2012-11-30
US61/732,251 2012-11-30
US13/802,117 US20130266963A1 (en) 2011-07-06 2013-03-13 Assay for detecting neutralizing autoantibodies to biologic therapy
US13/802,117 2013-03-13
PCT/IB2013/060458 WO2014083520A2 (en) 2012-11-30 2013-11-27 Assays for detecting neutralizing autoantibodies to biologic therapy

Publications (2)

Publication Number Publication Date
JP2016502091A true JP2016502091A (ja) 2016-01-21
JP2016502091A5 JP2016502091A5 (enExample) 2017-01-05

Family

ID=50828561

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2015544592A Pending JP2016502091A (ja) 2012-11-30 2013-11-27 生物学的治療に対する中和自己抗体の検出のためのアッセイ

Country Status (13)

Country Link
EP (1) EP2926136A2 (enExample)
JP (1) JP2016502091A (enExample)
KR (1) KR20150088890A (enExample)
CN (1) CN105074461A (enExample)
AU (1) AU2013350817A1 (enExample)
BR (1) BR112015012482A2 (enExample)
CA (1) CA2892766A1 (enExample)
HK (1) HK1215969A1 (enExample)
IL (1) IL238995A0 (enExample)
MX (1) MX2015006852A (enExample)
RU (1) RU2015125739A (enExample)
SG (2) SG11201504097PA (enExample)
WO (1) WO2014083520A2 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023509435A (ja) * 2020-01-02 2023-03-08 エフ． ホフマン－ラ ロシュ アーゲー Ａｄａ応答特定アッセイ

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2010315547C1 (en) 2009-10-26 2015-06-04 Société des Produits Nestlé S.A. Assays for the detection of anti-TNF drugs and autoantibodies
AU2011317149B2 (en) 2010-10-18 2015-05-07 Société des Produits Nestlé S.A. Methods for determining anti-drug antibody isotypes
RU2013158256A (ru) 2011-07-06 2015-07-10 Нестек С.А. АНАЛИЗЫ ДЛЯ ОБНАРУЖЕНИЯ НЕЙТРАЛИЗУЮЩИХ АУТОАНТИТЕЛ ДЛЯ БИОЛОГИЧЕСКОЙ ТЕРАПИИ TNFα
ES2735085T3 (es) 2014-12-05 2019-12-16 Nestle Sa Ensayos de cambio de movilidad homogéneos indirectos para la detección de agentes biológicos en muestras de pacientes
US11085931B2 (en) 2015-01-09 2021-08-10 W. Health L.P. Universal assay for determining the quantity of TNFα inhibitory drugs and their corresponding anti-drug-antibodies
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
AU2018241286B2 (en) 2017-03-31 2025-03-13 Ablynx N.V. Improved immunogenicity assays
CN111024958B (zh) * 2020-03-11 2020-06-23 同昕生物技术（北京）有限公司 用于检测单抗药物和抗单抗药物抗体的试剂及其应用
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
CN114047343B (zh) * 2022-01-13 2022-05-31 美迪西普亚医药科技(上海)有限公司 双耐受型抗IgE单抗药物的免疫原性分析试剂盒及其使用方法和应用
CN117871856A (zh) * 2023-12-15 2024-04-12 首都医科大学附属北京地坛医院 可溶性因子在无症状神经梅毒检测中的应用

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011056590A1 (en) * 2009-10-26 2011-05-12 Prometheus Laboratories Inc. Assays for the detection of anti-tnf drugs and autoantibodies
WO2012154253A1 (en) * 2011-02-17 2012-11-15 Prometheus Laboratories Inc. ASSAYS FOR DETECTING AUTOANTIBODIES TO ANTI-TNFα DRUGS

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102884433A (zh) * 2010-04-29 2013-01-16 塞拉蒂亚戈公司 用于检测抗体的方法
AU2011317149B2 (en) * 2010-10-18 2015-05-07 Société des Produits Nestlé S.A. Methods for determining anti-drug antibody isotypes
RU2013158256A (ru) * 2011-07-06 2015-07-10 Нестек С.А. АНАЛИЗЫ ДЛЯ ОБНАРУЖЕНИЯ НЕЙТРАЛИЗУЮЩИХ АУТОАНТИТЕЛ ДЛЯ БИОЛОГИЧЕСКОЙ ТЕРАПИИ TNFα

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011056590A1 (en) * 2009-10-26 2011-05-12 Prometheus Laboratories Inc. Assays for the detection of anti-tnf drugs and autoantibodies
WO2012154253A1 (en) * 2011-02-17 2012-11-15 Prometheus Laboratories Inc. ASSAYS FOR DETECTING AUTOANTIBODIES TO ANTI-TNFα DRUGS

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023509435A (ja) * 2020-01-02 2023-03-08 エフ． ホフマン－ラ ロシュ アーゲー Ａｄａ応答特定アッセイ
JP7570421B2 (ja) 2020-01-02 2024-10-21 エフ． ホフマン－ラ ロシュ アーゲー Ａｄａ応答特定アッセイ

Also Published As

Publication number Publication date
WO2014083520A3 (en) 2014-07-31
RU2015125739A (ru) 2017-01-13
IL238995A0 (en) 2015-07-30
MX2015006852A (es) 2015-09-16
WO2014083520A2 (en) 2014-06-05
BR112015012482A2 (pt) 2017-07-11
CN105074461A (zh) 2015-11-18
KR20150088890A (ko) 2015-08-03
SG11201504097PA (en) 2015-06-29
AU2013350817A1 (en) 2015-06-11
SG10201703210XA (en) 2017-06-29
CA2892766A1 (en) 2014-06-05
EP2926136A2 (en) 2015-10-07
HK1215969A1 (zh) 2016-09-30

Similar Documents

Publication Publication Date Title
JP6181646B2 (ja) Ｔｎｆアルファによる生物学的治療に対する中和自己抗体の検出のためのアッセイ
JP2016502091A (ja) 生物学的治療に対する中和自己抗体の検出のためのアッセイ
CN103299190B (zh) 确定抗药物抗体同种型的方法
JP6063398B2 (ja) 抗ＴＮＦα薬に対する自己抗体を検出するためのアッセイ
US20130266963A1 (en) Assay for detecting neutralizing autoantibodies to biologic therapy
RU2574976C2 (ru) Способы определения изотипа антител против лекарственных препаратов
HK1194467B (en) Assays for detecting neutralizing autoantibodies to biologic therapy with tnf alpha
HK1191688B (en) ASSAYS FOR DETECTING AUTOANTIBODIES TO ANTI-TNFα DRUGS

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20161114

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20161114

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20170906

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20170912

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20171212

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20180417