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WO2023067031A3 - In vitro potency assay for protein-based meningococcal vaccines using a plurality of monoclonal antibodies and antigens immobilized to colour-coded beads - Google Patents

In vitro potency assay for protein-based meningococcal vaccines using a plurality of monoclonal antibodies and antigens immobilized to colour-coded beads Download PDF

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Publication number
WO2023067031A3
WO2023067031A3 PCT/EP2022/079144 EP2022079144W WO2023067031A3 WO 2023067031 A3 WO2023067031 A3 WO 2023067031A3 EP 2022079144 W EP2022079144 W EP 2022079144W WO 2023067031 A3 WO2023067031 A3 WO 2023067031A3
Authority
WO
WIPO (PCT)
Prior art keywords
monoclonal antibodies
colour
protein
vitro potency
potency assay
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.)
Ceased
Application number
PCT/EP2022/079144
Other languages
French (fr)
Other versions
WO2023067031A2 (en
Inventor
Marta BACCONI
Monia BARDELLI
Brunella Brunelli
Vincent DEWAR
Elisabetta Frigimelica
Carmine MALZONE
Werner Pansegrau
Daniele Veggi
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.)
GlaxoSmithKline Biologicals SA
Original Assignee
GlaxoSmithKline Biologicals 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
Application filed by GlaxoSmithKline Biologicals SA filed Critical GlaxoSmithKline Biologicals SA
Publication of WO2023067031A2 publication Critical patent/WO2023067031A2/en
Publication of WO2023067031A3 publication Critical patent/WO2023067031A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • G01N33/536—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase
    • G01N33/537—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/12—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • C07K16/1203—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-negative bacteria
    • C07K16/1217—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-negative bacteria from Neisseriaceae (F)
    • 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
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56911—Bacteria
    • 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
    • G01N33/577—Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies; monoclonal antibodies per se are classified with their corresponding antigens
    • 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
    • G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
    • G01N33/585—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances with a particulate label, e.g. coloured latex
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Analytical Chemistry (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Pathology (AREA)
  • Microbiology (AREA)
  • General Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Virology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

This invention provides a multiplex binding assay for analysing a meningococcal vaccine and assessing in vitro relative potency of the same (IVRP). The invention also provides monoclonal antibodies which bind to meningococcal proteins within the vaccine, and in particular monoclonal antibodies which are bactericidal for meningococcus and/or which recognise conformational epitopes within the meningococcal proteins.
PCT/EP2022/079144 2021-10-21 2022-10-19 Assay Ceased WO2023067031A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB2115077.6A GB202115077D0 (en) 2021-10-21 2021-10-21 Assay
GB2115077.6 2021-10-21

Publications (2)

Publication Number Publication Date
WO2023067031A2 WO2023067031A2 (en) 2023-04-27
WO2023067031A3 true WO2023067031A3 (en) 2023-06-01

Family

ID=78805967

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2022/079144 Ceased WO2023067031A2 (en) 2021-10-21 2022-10-19 Assay

Country Status (2)

Country Link
GB (1) GB202115077D0 (en)
WO (1) WO2023067031A2 (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009143168A2 (en) * 2008-05-19 2009-11-26 Novartis Ag Vaccine assays
WO2012031271A1 (en) * 2010-09-04 2012-03-08 Novartis Ag Bactericidal antibody assays to assess immunogenicity and potency of meningococcal capsular saccharide vaccines
WO2013132040A2 (en) * 2012-03-08 2013-09-12 Novartis Ag In vitro potency assay for protein-based meningococcal vaccines

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2848965A1 (en) 1978-11-11 1980-05-22 Behringwerke Ag METHOD FOR PRODUCING MEMBRANE PROTEINS FROM NEISSERIA MENINGITIDIS AND VACCINE CONTAINING THEM
US5698438A (en) 1994-10-18 1997-12-16 Oregon Health Sciences University Bacterial hemoglobin receptor gene
IL117483A (en) 1995-03-17 2008-03-20 Bernard Brodeur Proteinase k resistant surface protein of neisseria meningitidis
US6180111B1 (en) 1995-05-18 2001-01-30 University Of Maryland Vaccine delivery system
MX343744B (en) 1998-05-01 2016-11-22 J Craig Venter Inst Inc Neisseria meningitidis antigens and compositions.
EP1741784B1 (en) 1999-11-29 2010-03-10 Novartis Vaccines and Diagnostics S.r.l. 85kDa neisserial antigen
BRPI0112928B1 (en) 2000-07-27 2017-08-29 Children's Hospital & Research Center At Oakland A composition comprising preparations comprising outer membrane vesicles (OMV), microvesicles (MV) or both MVO and MV
MX339524B (en) 2001-10-11 2016-05-30 Wyeth Corp Novel immunogenic compositions for the prevention and treatment of meningococcal disease.
GB0213622D0 (en) 2002-06-13 2002-07-24 Glaxosmithkline Biolog Sa Vaccine Corporation
GB0220194D0 (en) 2002-08-30 2002-10-09 Chiron Spa Improved vesicles
GB0227346D0 (en) 2002-11-22 2002-12-31 Chiron Spa 741
GB0316560D0 (en) 2003-07-15 2003-08-20 Chiron Srl Vesicle filtration
GB0419627D0 (en) 2004-09-03 2004-10-06 Chiron Srl Immunogenic bacterial vesicles with outer membrane proteins
GB0424092D0 (en) 2004-10-29 2004-12-01 Chiron Srl Immunogenic bacterial vesicles with outer membrane proteins
NZ593674A (en) 2008-12-17 2013-03-28 Novartis Ag Meningococcal vaccines including hemoglobin receptor
GB0917003D0 (en) 2009-09-28 2009-11-11 Novartis Vaccines Inst For Global Health Srl Purification of bacterial vesicles
EP3607967A1 (en) 2018-08-09 2020-02-12 GlaxoSmithKline Biologicals S.A. Modified meningococcal fhbp polypeptides

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009143168A2 (en) * 2008-05-19 2009-11-26 Novartis Ag Vaccine assays
WO2012031271A1 (en) * 2010-09-04 2012-03-08 Novartis Ag Bactericidal antibody assays to assess immunogenicity and potency of meningococcal capsular saccharide vaccines
WO2013132040A2 (en) * 2012-03-08 2013-09-12 Novartis Ag In vitro potency assay for protein-based meningococcal vaccines

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
BANDIERA SILVIO ET AL: "A single immunogenicity assay for testing potency of combination DTaP vaccines: Simultaneous quantitation of anti-DT, anti-TT, anti-PTxd and anti-FHA antibodies in Guinea-pig serum with a Luminex -xMAP bead-based serological assay", BIOLOGICALS, ACADEMIC PRESS LTD., LONDON, GB, vol. 61, 23 August 2019 (2019-08-23), pages 15 - 21, XP085813642, ISSN: 1045-1056, [retrieved on 20190823], DOI: 10.1016/J.BIOLOGICALS.2019.08.002 *
MASDOR NOOR AZLINA ET AL: "Subtractive inhibition assay for the detection of Campylobacter jejuni in chicken samples using surface plasmon resonance", SCIENTIFIC REPORTS, vol. 9, no. 1, 1 January 2019 (2019-01-01), pages 13642, XP093022376, Retrieved from the Internet <URL:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6754509/pdf/41598_2019_Article_49672.pdf> DOI: 10.1038/s41598-019-49672-2 *
SKOTTRUP ET AL: "Monoclonal antibodies for the detection of Puccinia striiformis urediniospores", MYCOLOGICAL RESEARCH, ELSEVIER, GB, vol. 111, no. 3, 1 March 2007 (2007-03-01), pages 332 - 338, XP022015904, ISSN: 0953-7562, DOI: 10.1016/J.MYCRES.2006.11.010 *
SKOTTRUP ET AL: "Rapid determination of Phytophthora infestans sporangia using a surface plasmon resonance immunosensor", JOURNAL OF MICROBIOLOGICAL METHODS, ELSEVIER, AMSTERDAM, NL, vol. 68, no. 3, 16 February 2007 (2007-02-16), pages 507 - 515, XP005892088, ISSN: 0167-7012, DOI: 10.1016/J.MIMET.2006.10.011 *
YIXIAN WANG ET AL: "Subtractive inhibition assay for the detection of E.coli O157:H7 using surface plasmon resonance", vol. 11, no. 3, 1 January 2011 (2011-01-01), pages 2728 - 2739, XP003029230, ISSN: 1424-8220, Retrieved from the Internet <URL:http://www.mdpi.com/1424-8220/11/3/2728> [retrieved on 20110301], DOI: 10.3390/S110302728 *

Also Published As

Publication number Publication date
GB202115077D0 (en) 2021-12-08
WO2023067031A2 (en) 2023-04-27

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