DK2705365T3 - Immunoassay til direkte bestemmelse af antigenindhold i produkter indeholdende adjuvans-koblede antigenpartikler - Google Patents

Immunoassay til direkte bestemmelse af antigenindhold i produkter indeholdende adjuvans-koblede antigenpartikler Download PDF

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Publication number
DK2705365T3
DK2705365T3 DK12705431.0T DK12705431T DK2705365T3 DK 2705365 T3 DK2705365 T3 DK 2705365T3 DK 12705431 T DK12705431 T DK 12705431T DK 2705365 T3 DK2705365 T3 DK 2705365T3
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DK
Denmark
Prior art keywords
antigen
immunoglobulin
particles
coupled
adjuvant
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DK12705431.0T
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English (en)
Inventor
Erica Helena Maria Kerkvliet
Original Assignee
Hal Allergy Holding B V
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Publication of DK2705365T3 publication Critical patent/DK2705365T3/da

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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
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54313Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
    • 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
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54393Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding

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  • Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Microbiology (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Claims (10)

1
1. Fremgangsmåde til bestemmelse af styrken af et produkt indeholdende antigen-koblede adjuvanspartikler, hvilken fremgangsmåde omfatter trinene: a) kontakt mellem produktet indeholdende antigen-koblede adjuvanspartikler og immunglobulinmolekyler, der kan genkende antigenet under betingelser, der tillader antigen-immunglobulin-binding; b) tilvejebringelse af en overflade med antigenet, uden adjuvanset, immobili-seret derpå; c) kontakt mellem det immunglobulin-kontaktede produkt fra trin (a) og overfladen i trin (b) under betingelser, der tillader antigen-immunglobulin-binding; d) fjernelse af ikke-bundne immunglobulinmolekyler og antigen-koblede ad-juvanspartikler-bundne immunglobulinmolekyler; e) detektering af antigen-bundne immunglobulinmolekyler for derved at bestemme styrken af et produkt indeholdende antigen-koblede adjuvanspartikler ved bestemmelse af 50% IgG-inhiberingen under anvendelse af en dosis-re-spons-kurve; hvor de antigen-koblede adjuvanspartikler er antigen-koblede aluminiumpartikler eller antigen-koblede tyrosi nparti kier, og hvor immunglobulinet er IgG.
2. Fremgangsmåde ifølge krav 1, hvor produktet er en vaccine eller et immunterapeutisk middel.
3. Fremgangsmåde ifølge krav 1, hvor det nævnte aluminium er valgt fra gruppen bestående af aluminiumhydroxid, alhydrogel, aluminiumphosphat, kalium-aluminiumsulfat og alun.
4. Fremgangsmåde ifølge ethvert af kravene 1 til 3, hvor antigenet er et allergen.
5. Fremgangsmåde ifølge ethvert af kravene 1 til 4, hvor trin (e) omfatter kontakt mellem de antigen-bundne immunglobulinmolekyler og et andet immun-globulinmolekyle, der kan genkende det antigen-bundne immunglobulinmolekyle 2 under betingelser, der tillader antigen-bundet immunglobulinmolekyle-andet im-munglobulinmolekyle-binding og detektering af antigen-bundet immunglobulinmolekyle-andet immunglobulinmolekyle-binding.
6. Fremgangsmåde ifølge krav 5, hvor det andet immunglobulin omfatter en detekterbar mærkning.
7. Fremgangsmåde ifølge krav 6, hvor mærkningen er et enzym, fortrinsvis HRP.
8. Fremgangsmåde ifølge ethvert af kravene 1 til 7, hvor overfladen er tilvejebragt med en ELISA-plade.
9. Fremgangsmåde ifølge ethvert af kravene 1 til 8, hvor produktet indeholdende antigen-koblede adjuvanspartikler er en suspension.
10. Fremgangsmåde ifølge ethvert af kravene 1 til 9, hvor trin (d) omfatter én eller flere ganges vask af overfladen.
DK12705431.0T 2011-01-14 2012-01-31 Immunoassay til direkte bestemmelse af antigenindhold i produkter indeholdende adjuvans-koblede antigenpartikler DK2705365T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP2011050433 2011-01-14
PCT/IB2012/050447 WO2012095834A1 (en) 2011-01-14 2012-01-31 Immunoassay for direct determination of antigen content of products comprising adjuvant-coupled-antigen particles

Publications (1)

Publication Number Publication Date
DK2705365T3 true DK2705365T3 (da) 2016-10-24

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Application Number Title Priority Date Filing Date
DK12705431.0T DK2705365T3 (da) 2011-01-14 2012-01-31 Immunoassay til direkte bestemmelse af antigenindhold i produkter indeholdende adjuvans-koblede antigenpartikler

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Country Link
US (1) US20130302837A1 (da)
DK (1) DK2705365T3 (da)
ES (1) ES2594895T3 (da)
PT (1) PT2705365T (da)
WO (1) WO2012095834A1 (da)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2715899C1 (ru) * 2019-02-21 2020-03-04 Федеральное государственное бюджетное научное учреждение "Научно-исследовательский институт вакцин и сывороток им. И.И. Мечникова" (ФГБНУ НИИВС им. И.И. Мечникова) Способ количественного определения в вакцинном препарате антигена, адсорбированного на частицах гидроксида алюминия
CN112798787A (zh) * 2019-11-14 2021-05-14 安徽智飞龙科马生物制药有限公司 狂犬病疫苗抗原含量检测方法及试剂或试剂盒

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5643933A (en) * 1995-06-02 1997-07-01 G. D. Searle & Co. Substituted sulfonylphenylheterocycles as cyclooxygenase-2 and 5-lipoxygenase inhibitors
AU2770001A (en) * 2000-01-07 2001-07-24 Aventis Pasteur Competitive enzyme immunoassay for assessing total antigen content of aluminum-adsorbed antigens
UA79735C2 (uk) * 2000-08-10 2007-07-25 Глаксосмітклайн Байолоджікалз С.А. Очищення антигенів вірусу гепатиту b (hbv) для використання у вакцинах
CA2464527A1 (en) * 2001-10-26 2003-08-14 Id Biomedical Corporation Of Washington Multivalent streptococcal vaccine compositions and methods for use
US7867715B2 (en) * 2003-08-05 2011-01-11 Alk-Abello A/S Method of evaluating the immunological activity of a vaccine
US20080254041A1 (en) * 2003-09-11 2008-10-16 Novozymes A/S Method for Selecting an Immunotherapeutic Preparation

Also Published As

Publication number Publication date
WO2012095834A1 (en) 2012-07-19
US20130302837A1 (en) 2013-11-14
PT2705365T (pt) 2016-09-19
ES2594895T3 (es) 2016-12-23

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