TWI847980B - 厄瑞努單抗組成物及其用途 - Google Patents

厄瑞努單抗組成物及其用途 Download PDF

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Publication number
TWI847980B
TWI847980B TW108111646A TW108111646A TWI847980B TW I847980 B TWI847980 B TW I847980B TW 108111646 A TW108111646 A TW 108111646A TW 108111646 A TW108111646 A TW 108111646A TW I847980 B TWI847980 B TW I847980B
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Taiwan
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composition
variants
errenumumab
hplc
amount
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TW108111646A
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English (en)
Chinese (zh)
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TW202003572A (zh
Inventor
凱尼斯 羅森
諾耶 萊德
蘇明達 哈普阿瑞奇
約瑟 桂格里歐 瑞米瑞茲
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美商安進公司
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2869Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against hormone receptors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/06Antimigraine agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • 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
    • 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
    • G01N30/26Conditioning of the fluid carrier; Flow patterns
    • G01N30/38Flow patterns
    • G01N30/46Flow patterns using more than one column
    • G01N30/461Flow patterns using more than one column with serial coupling of separation columns
    • G01N30/463Flow patterns using more than one column with serial coupling of separation columns for multidimensional chromatography
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51Complete heavy chain or Fd fragment, i.e. VH + CH1
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515Complete light chain, i.e. VL + CL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Neurology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Endocrinology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
TW108111646A 2018-04-02 2019-04-02 厄瑞努單抗組成物及其用途 TWI847980B (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862651651P 2018-04-02 2018-04-02
US62/651,651 2018-04-02

Publications (2)

Publication Number Publication Date
TW202003572A TW202003572A (zh) 2020-01-16
TWI847980B true TWI847980B (zh) 2024-07-11

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Family Applications (1)

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TW108111646A TWI847980B (zh) 2018-04-02 2019-04-02 厄瑞努單抗組成物及其用途

Country Status (19)

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US (2) US11407838B2 (enExample)
EP (1) EP3774881A1 (enExample)
JP (3) JP7840636B2 (enExample)
KR (1) KR20200139720A (enExample)
CN (1) CN111954678A (enExample)
AR (1) AR114722A1 (enExample)
AU (1) AU2019246983B2 (enExample)
BR (1) BR112020019882A2 (enExample)
CA (1) CA3095899A1 (enExample)
CL (2) CL2020002519A1 (enExample)
EA (1) EA202092335A1 (enExample)
IL (1) IL277663A (enExample)
MA (1) MA52202A (enExample)
MX (1) MX2020010320A (enExample)
PH (1) PH12020551618A1 (enExample)
SA (1) SA520420261B1 (enExample)
SG (1) SG11202009629YA (enExample)
TW (1) TWI847980B (enExample)
WO (1) WO2019195185A1 (enExample)

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JO3382B1 (ar) * 2008-12-23 2019-03-13 Amgen Inc أجسام مضادة ترتبط مع مستقبل cgrp بشري
WO2022232376A1 (en) * 2021-04-29 2022-11-03 Amgen Inc. Methods for reducing low molecular weight species of recombinantly-produced proteins
EP4455163A4 (en) * 2021-12-22 2025-12-24 Chugai Pharmaceutical Co Ltd REDUCED BIOLOGICALLY ACTIVE ANTIBODY VARIANT
CN115819589A (zh) * 2022-10-19 2023-03-21 武汉人福创新药物研发中心有限公司 一种培养基及生产抗cgrpr抗体的方法

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Also Published As

Publication number Publication date
EP3774881A1 (en) 2021-02-17
US11407838B2 (en) 2022-08-09
BR112020019882A2 (pt) 2021-01-05
TW202003572A (zh) 2020-01-16
WO2019195185A1 (en) 2019-10-10
AU2019246983B2 (en) 2025-12-18
PH12020551618A1 (en) 2021-08-16
US20220348673A1 (en) 2022-11-03
AR114722A1 (es) 2020-10-07
US20190300617A1 (en) 2019-10-03
SA520420261B1 (ar) 2024-05-23
MA52202A (fr) 2021-02-17
JP2023103323A (ja) 2023-07-26
JP2026034591A (ja) 2026-02-27
CA3095899A1 (en) 2019-10-10
KR20200139720A (ko) 2020-12-14
AU2019246983A1 (en) 2020-10-29
CL2023000491A1 (es) 2023-10-13
JP2021519790A (ja) 2021-08-12
SG11202009629YA (en) 2020-10-29
JP7840636B2 (ja) 2026-04-06
MX2020010320A (es) 2021-01-08
EA202092335A1 (ru) 2021-01-22
CN111954678A (zh) 2020-11-17
IL277663A (en) 2020-11-30
CL2020002519A1 (es) 2021-04-05

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