MX2022003461A - Metodos de produccion de composiciones de anticuerpos. - Google Patents

Metodos de produccion de composiciones de anticuerpos.

Info

Publication number
MX2022003461A
MX2022003461A MX2022003461A MX2022003461A MX2022003461A MX 2022003461 A MX2022003461 A MX 2022003461A MX 2022003461 A MX2022003461 A MX 2022003461A MX 2022003461 A MX2022003461 A MX 2022003461A MX 2022003461 A MX2022003461 A MX 2022003461A
Authority
MX
Mexico
Prior art keywords
methods
antibody composition
product quality
determining
antibody compositions
Prior art date
Application number
MX2022003461A
Other languages
English (en)
Inventor
Robert J Duff
Zhe Huang
Jose G Ramirez
Original Assignee
Amgen Inc
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 Amgen Inc filed Critical Amgen Inc
Publication of MX2022003461A publication Critical patent/MX2022003461A/es

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16BBIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY
    • G16B5/00ICT specially adapted for modelling or simulations in systems biology, e.g. gene-regulatory networks, protein interaction networks or metabolic networks
    • G16B5/20Probabilistic models
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/10Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14Specific host cells or culture conditions, e.g. components, pH or temperature
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/40Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41Glycosylation, sialylation, or fucosylation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732Antibody-dependent cellular cytotoxicity [ADCC]
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2400/00Assays, e.g. immunoassays or enzyme assays, involving carbohydrates
    • G01N2400/10Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Genetics & Genomics (AREA)
  • Biotechnology (AREA)
  • Food Science & Technology (AREA)
  • Analytical Chemistry (AREA)
  • Microbiology (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Cell Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physiology (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Evolutionary Biology (AREA)
  • Medical Informatics (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Theoretical Computer Science (AREA)
  • Probability & Statistics with Applications (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

En el presente documento se proporcionan métodos para determinar la calidad del producto de una composición de anticuerpo, en donde el nivel de actividad de ADCC de la composición de anticuerpo es un criterio en el que se basa la calidad del producto de la composición de anticuerpo. En realizaciones ilustrativas, el método comprende (i) determinar el contenido de glucano afucosilado total (TAF) de una muestra de una composición de anticuerpo; y (ii) determinar la calidad del producto como aceptable y/o lograr el criterio del nivel de actividad de la ADCC usando el contenido de glucano TAF determinado en (i) está dentro de un intervalo diana. En el presente documento se proporcionan además métodos relacionados para monitorizar la calidad del producto y métodos para producir una composición de anticuerpo.
MX2022003461A 2019-09-26 2020-09-28 Metodos de produccion de composiciones de anticuerpos. MX2022003461A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962906709P 2019-09-26 2019-09-26
PCT/US2020/053090 WO2021062372A1 (en) 2019-09-26 2020-09-28 Methods of producing antibody compositions

Publications (1)

Publication Number Publication Date
MX2022003461A true MX2022003461A (es) 2022-04-19

Family

ID=73014594

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2022003461A MX2022003461A (es) 2019-09-26 2020-09-28 Metodos de produccion de composiciones de anticuerpos.

Country Status (11)

Country Link
US (1) US20220349898A1 (es)
EP (1) EP4034556A1 (es)
JP (1) JP2022549329A (es)
KR (1) KR20220069982A (es)
CN (1) CN114450593A (es)
AU (1) AU2020355251A1 (es)
BR (1) BR112022005583A2 (es)
CA (1) CA3152547A1 (es)
IL (1) IL290825A (es)
MX (1) MX2022003461A (es)
WO (1) WO2021062372A1 (es)

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BR112023022493A2 (pt) * 2021-04-28 2024-02-15 Univ Columbia Anticorpos para tratamento e prevenção de covid-19 e variantes emergentes
AU2022361382A1 (en) * 2021-10-05 2024-03-28 Amgen Inc. Fc-gamma receptor ii binding and glycan content

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Also Published As

Publication number Publication date
EP4034556A1 (en) 2022-08-03
AU2020355251A1 (en) 2022-04-21
BR112022005583A2 (pt) 2022-09-20
US20220349898A1 (en) 2022-11-03
CA3152547A1 (en) 2021-04-01
WO2021062372A1 (en) 2021-04-01
KR20220069982A (ko) 2022-05-27
JP2022549329A (ja) 2022-11-24
IL290825A (en) 2022-04-01
CN114450593A (zh) 2022-05-06

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