DK2256132T3 - Fremgangsmåde til påvisning af probnp med et monoklonalt antistof - Google Patents

Fremgangsmåde til påvisning af probnp med et monoklonalt antistof Download PDF

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Publication number
DK2256132T3
DK2256132T3 DK10172014.2T DK10172014T DK2256132T3 DK 2256132 T3 DK2256132 T3 DK 2256132T3 DK 10172014 T DK10172014 T DK 10172014T DK 2256132 T3 DK2256132 T3 DK 2256132T3
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Denmark
Prior art keywords
probnp
antibody
native
native probnp
mab
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DK10172014.2T
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English (en)
Inventor
Volker Klemt
Anneliese Borgya
Andreas Gallusser
Michael Grol
Christoph Seidel
Klaus Hallermayer
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Roche Diagnostics Gmbh
Hoffmann La Roche
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Application filed by Roche Diagnostics Gmbh, Hoffmann La Roche filed Critical Roche Diagnostics Gmbh
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Publication of DK2256132T3 publication Critical patent/DK2256132T3/da

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/26—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/58—Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Cardionatrin; Cardiodilatin
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/10—Cells modified by introduction of foreign genetic material
    • C12N5/12—Fused cells, e.g. hybridomas
    • C12N5/16—Animal cells
    • 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
    • G01N33/531—Production of immunochemical test 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
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/975—Kit
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/811—Test for named disease, body condition or organ function

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Endocrinology (AREA)
  • Biophysics (AREA)
  • Zoology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pathology (AREA)
  • Cardiology (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Toxicology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Wood Science & Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Claims (7)

1
1. Antistof, som specifikt binder sig til nativt proBNP, hvor antistoffet, som specifikt binder sig til nativt proBNP, er et monoklonalt antistof, som binder sig til syntetiske peptider bestående af aminosyrerne henholdsvis 39 til 46, 40 til 47, 41 til 48 og 42 til 49 fra NT-proBNP og med hensyn til værdierne for proBNP som bestemt i patientprøver ved anvendelse af antistoffet korrelerer med en r-værdi på mindst r=0,95 eller derover med værdierne for proBNP som bestemt i prøverne ved anvendelse af det monoklonale antistof MAB 1.21.3 produceret af den hybridomcellelinje, som er deponeret under DSM ACC 2650 hos DSMZ, og hvor r-værdien bestemmes ved hjælp af lineær regressionsanalyse.
2. Fremgangsmåde til specifik påvisning af nativt proBNP in vitro, hvilken fremgangsmåde omfatter trinene etablering af kontakt mellem en prøve, som mistænkes for eller vides at indeholde proBNP, og et antistof mod nativt proBNP ifølge krav 1 under betingelser, som muliggør dannelse af et antistof mod nativt proBNP-nativt proBNP-kompleks og påvisning af det dannede kompleks.
3. Fremgangsmåde ifølge krav 2, hvor påvisningen gennemføres ved hjælp af et kompetitivt immunassay.
4. Fremgangsmåde ifølge krav 2, hvor påvisningen gennemføres ved hjælp af et sandwich-immunassay, hvor der også anvendes et andet antistof mod proBNP, og hvor det andet antistof mod proBNP og antistoffet mod nativt proBNP begge binder sig til nativt proBNP og således danner et andet anti-proBNP-antistof-nativt proBNP-anti-nativt proBNP-antistof-kompleks.
5. Fremgangsmåde ifølge krav 4, hvor det andet antistof er valgt fra gruppen bestående af henholdsvis MAB 17.3.1, MAB 18.4.34 og MAB 18.29.23, der er produceret af de hybridomcellelinjer, som er deponeret hos DSM under henholdsvis DSM ACC 2591, DSM ACC 2592 og DSM ACC 2593. 2
6. Fremgangsmåde til at skelne NYHA-klasserne O og I fra klasserne II, III og IV in vitro, hvilken fremgangsmåde omfatter specifik påvisning af nativt proBNP ved anvendelse af et antistof ifølge krav 1 og korrelering af niveauet af nativt proBNP med hjerteinsufficiens.
7. Kit til måling af nativt proBNP, hvilket kit omfatter et antistof ifølge krav 1 og hjælpereagenser til påvisning af nativt proBNP.
DK10172014.2T 2003-05-12 2004-05-12 Fremgangsmåde til påvisning af probnp med et monoklonalt antistof DK2256132T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP03010591 2003-05-12
EP04732282A EP1625164B1 (en) 2003-05-12 2004-05-12 Method of detecting probnp with a monoclonal antibody binding to the amino acids 42-46

Publications (1)

Publication Number Publication Date
DK2256132T3 true DK2256132T3 (da) 2015-07-13

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ID=33427054

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Application Number Title Priority Date Filing Date
DK04732278.9T DK1625163T3 (da) 2003-05-12 2004-05-12 Fremgangsmåde til at påvise proBNP med en monoklonal antistofbinding til aminosyrerne 38-43
DK10172014.2T DK2256132T3 (da) 2003-05-12 2004-05-12 Fremgangsmåde til påvisning af probnp med et monoklonalt antistof
DK04732282.1T DK1625164T3 (da) 2003-05-12 2004-05-12 Fremgangsmåde til at påvise proBNP med et monoklonalt antistof, som binder til aminosyrerne 42-46

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DK04732278.9T DK1625163T3 (da) 2003-05-12 2004-05-12 Fremgangsmåde til at påvise proBNP med en monoklonal antistofbinding til aminosyrerne 38-43

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DK04732282.1T DK1625164T3 (da) 2003-05-12 2004-05-12 Fremgangsmåde til at påvise proBNP med et monoklonalt antistof, som binder til aminosyrerne 42-46

Country Status (15)

Country Link
US (4) US7264938B2 (da)
EP (4) EP1625163B8 (da)
JP (4) JP4430066B2 (da)
KR (2) KR100857752B1 (da)
CN (3) CN101967190A (da)
AT (2) ATE517124T1 (da)
AU (1) AU2004235974B2 (da)
BR (1) BRPI0410261B8 (da)
CA (2) CA2522747C (da)
DK (3) DK1625163T3 (da)
ES (3) ES2369008T3 (da)
HU (1) HUE025169T2 (da)
MX (1) MXPA05011826A (da)
PL (3) PL2256132T3 (da)
WO (2) WO2004099253A1 (da)

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ATE522546T1 (de) 2011-09-15
DK1625163T3 (da) 2011-12-05
JP4430066B2 (ja) 2010-03-10
WO2004099253A1 (en) 2004-11-18
JP5128125B2 (ja) 2013-01-23
ES2369008T3 (es) 2011-11-24
CN1832964A (zh) 2006-09-13
JP2013018784A (ja) 2013-01-31
KR100857752B1 (ko) 2008-09-11
MXPA05011826A (es) 2006-01-26
EP1625164B1 (en) 2011-07-20
EP1625164A1 (en) 2006-02-15
AU2004235974B2 (en) 2008-02-14
BRPI0410261B8 (pt) 2021-07-27
CA2522747C (en) 2012-08-14
CA2522378A1 (en) 2004-11-18
EP2949669A1 (en) 2015-12-02
CN101967190A (zh) 2011-02-09
DK1625164T3 (da) 2011-10-31
KR20080011467A (ko) 2008-02-04
US20070117156A1 (en) 2007-05-24
EP1625163A1 (en) 2006-02-15
EP1625163B1 (en) 2011-08-31
US7811770B2 (en) 2010-10-12
ATE517124T1 (de) 2011-08-15
CN100497393C (zh) 2009-06-10
PL2256132T3 (pl) 2016-08-31
JP2010011860A (ja) 2010-01-21
ES2372282T3 (es) 2012-01-18
JP4834136B2 (ja) 2011-12-14
ES2548327T3 (es) 2015-10-15
CA2522747A1 (en) 2004-11-18
PL1625164T3 (pl) 2011-12-30
HUE025169T2 (en) 2016-02-29
US20060110776A1 (en) 2006-05-25
EP2256132B1 (en) 2015-04-01
US7264939B2 (en) 2007-09-04
AU2004235974A1 (en) 2004-11-18
US7807380B2 (en) 2010-10-05
BRPI0410261A (pt) 2006-05-16
HK1097855A1 (zh) 2007-07-06
US7264938B2 (en) 2007-09-04
EP2256132A1 (en) 2010-12-01
JP2007525427A (ja) 2007-09-06
KR20060003905A (ko) 2006-01-11
WO2004099252A1 (en) 2004-11-18
JP2007535470A (ja) 2007-12-06
JP5649631B2 (ja) 2015-01-07
US20070099241A1 (en) 2007-05-03
EP1625163B8 (en) 2011-11-02
BRPI0410261B1 (pt) 2020-03-10
PL1625163T3 (pl) 2012-01-31
CA2522378C (en) 2011-03-29
CN1784425A (zh) 2006-06-07
US20060110775A1 (en) 2006-05-25

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