EA202191699A1 - Способы для охарактеризования дисульфидных связей - Google Patents

Способы для охарактеризования дисульфидных связей

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Publication number
EA202191699A1
EA202191699A1 EA202191699A EA202191699A EA202191699A1 EA 202191699 A1 EA202191699 A1 EA 202191699A1 EA 202191699 A EA202191699 A EA 202191699A EA 202191699 A EA202191699 A EA 202191699A EA 202191699 A1 EA202191699 A1 EA 202191699A1
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EA
Eurasian Patent Office
Prior art keywords
peptides
drug product
protein drug
peptide standards
disulfide bonds
Prior art date
Application number
EA202191699A
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English (en)
Inventor
Шунхай Ванг
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Ридженерон Фармасьютикалз, Инк.
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Application filed by Ридженерон Фармасьютикалз, Инк. filed Critical Ридженерон Фармасьютикалз, Инк.
Publication of EA202191699A1 publication Critical patent/EA202191699A1/ru

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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/04Preparation or injection of sample to be analysed
    • G01N30/06Preparation
    • 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
    • G01N33/6803General methods of protein analysis not limited to specific proteins or families of proteins
    • G01N33/6806Determination of free amino acids
    • G01N33/6812Assays for specific amino acids
    • G01N33/6815Assays for specific amino acids containing sulfur, e.g. cysteine, cystine, methionine, homocysteine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/28Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/62Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating the ionisation of gases, e.g. aerosols; by investigating electric discharges, e.g. emission of cathode
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/62Detectors specially adapted therefor
    • G01N30/72Mass spectrometers
    • G01N30/7233Mass spectrometers interfaced to liquid or supercritical fluid chromatograph
    • 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
    • G01N33/6803General methods of protein analysis not limited to specific proteins or families of proteins
    • G01N33/6848Methods of protein analysis involving mass spectrometry
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N2030/022Column chromatography characterised by the kind of separation mechanism
    • G01N2030/027Liquid chromatography
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/88Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
    • G01N2030/8813Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials
    • G01N2030/8831Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials involving peptides or proteins
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2458/00Labels used in chemical analysis of biological material
    • G01N2458/15Non-radioactive isotope labels, e.g. for detection by mass spectrometry

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Food Science & Technology (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Cell Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biotechnology (AREA)
  • Biophysics (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Mycology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Electrochemistry (AREA)
  • Peptides Or Proteins (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

Предлагаются композиции и способы для анализа дисульфидных связей. Иллюстративный способ включает в себя приготовление пептидных стандартов, не имеющих дисульфидных связей, пептидных стандартов с скремблированными дисульфидными связями, и пептидных стандартов с нативными дисульфидными связями, в соответствии с последовательностью области белкового лекарственного продукта, которая включает в себя дисульфидную связь, расщепление образца белкового лекарственного продукта на пептиды, разделение пептидов белкового лекарственного продукта, анализ пептидов белкового лекарственного продукта и пептидных стандартов, идентификацию пептидов с скремблированными и нативными дисульфидными связями по времени удерживания, и количественное определение уровня пептидов с скремблированными дисульфидными связями.
EA202191699A 2019-01-16 2020-01-16 Способы для охарактеризования дисульфидных связей EA202191699A1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962792994P 2019-01-16 2019-01-16
PCT/US2020/013907 WO2020150491A1 (en) 2019-01-16 2020-01-16 Methods for characterizing disulfide bonds

Publications (1)

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EA202191699A1 true EA202191699A1 (ru) 2021-10-11

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EA202191841A EA202191841A1 (ru) 2019-01-16 2020-01-16 Способы для идентификации свободных тиолов в белках
EA202191699A EA202191699A1 (ru) 2019-01-16 2020-01-16 Способы для охарактеризования дисульфидных связей

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US (4) US11674968B2 (ru)
EP (3) EP3857237B1 (ru)
JP (2) JP2022517721A (ru)
KR (2) KR20210114927A (ru)
CN (3) CN113272650A (ru)
AU (2) AU2020208396A1 (ru)
BR (2) BR112021009544A2 (ru)
CA (2) CA3116735A1 (ru)
DK (1) DK3857237T3 (ru)
EA (2) EA202191841A1 (ru)
ES (1) ES2942024T3 (ru)
FI (1) FI3857237T3 (ru)
HU (1) HUE061783T2 (ru)
IL (2) IL284471A (ru)
MX (2) MX2021008589A (ru)
PL (1) PL3857237T3 (ru)
SG (2) SG11202104103XA (ru)
WO (2) WO2020150492A1 (ru)
ZA (2) ZA202102546B (ru)

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CN113272650A (zh) 2021-08-17
US20200225245A1 (en) 2020-07-16
CA3116735A1 (en) 2020-07-23
EP4220173A3 (en) 2023-10-18
US11579150B2 (en) 2023-02-14
CA3116732A1 (en) 2020-07-23
JP2022517721A (ja) 2022-03-10
CN113272651A (zh) 2021-08-17
BR112021009543A2 (pt) 2021-08-17
FI3857237T3 (fi) 2023-05-03
KR20210114927A (ko) 2021-09-24
MX2021008590A (es) 2021-08-11
US12000839B2 (en) 2024-06-04
KR20210114926A (ko) 2021-09-24
MX2021008589A (es) 2021-08-11
CN113272651B (zh) 2023-06-16
JP2022517720A (ja) 2022-03-10
HUE061783T2 (hu) 2023-08-28
SG11202104103XA (en) 2021-05-28
AU2020208395A1 (en) 2021-05-20
BR112021009544A2 (pt) 2021-10-26
EP4220173A2 (en) 2023-08-02
IL284471A (en) 2021-08-31
EP3857236A1 (en) 2021-08-04
ZA202102546B (en) 2023-10-25
ES2942024T3 (es) 2023-05-29
US11674968B2 (en) 2023-06-13
PL3857237T3 (pl) 2023-07-10
ZA202102547B (en) 2023-10-25
DK3857237T3 (da) 2023-05-01
EP3857237A1 (en) 2021-08-04
US20200225243A1 (en) 2020-07-16
WO2020150491A1 (en) 2020-07-23
CN117110492A (zh) 2023-11-24
US20230280354A1 (en) 2023-09-07
EA202191841A1 (ru) 2021-10-07
SG11202104237YA (en) 2021-05-28
WO2020150492A1 (en) 2020-07-23
AU2020208396A1 (en) 2021-05-20
US20230273216A1 (en) 2023-08-31
EP3857237B1 (en) 2023-03-01
IL284473A (en) 2021-08-31
WO2020150492A8 (en) 2021-05-06

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