KR20210041101A - 안정한 수성 항체 제제 - Google Patents

안정한 수성 항체 제제 Download PDF

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Publication number
KR20210041101A
KR20210041101A KR1020217009731A KR20217009731A KR20210041101A KR 20210041101 A KR20210041101 A KR 20210041101A KR 1020217009731 A KR1020217009731 A KR 1020217009731A KR 20217009731 A KR20217009731 A KR 20217009731A KR 20210041101 A KR20210041101 A KR 20210041101A
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KR
South Korea
Prior art keywords
antibody
seq
formulation
cdr2
nos
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Ceased
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KR1020217009731A
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English (en)
Korean (ko)
Inventor
윌리엄 리치
레이첼 루이스
제임스 맥기브니
켈시 뉴웰
케빈 더글라스 스튜어트
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아스트라제네카 아베
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Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/14—Antitussive agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
KR1020217009731A 2013-10-24 2014-10-23 안정한 수성 항체 제제 Ceased KR20210041101A (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361895143P 2013-10-24 2013-10-24
US61/895,143 2013-10-24
PCT/US2014/061997 WO2015061584A1 (en) 2013-10-24 2014-10-23 Stable, aqueous antibody formulations

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
KR1020207012828A Division KR102238065B1 (ko) 2013-10-24 2014-10-23 안정한 수성 항체 제제

Publications (1)

Publication Number Publication Date
KR20210041101A true KR20210041101A (ko) 2021-04-14

Family

ID=52993565

Family Applications (3)

Application Number Title Priority Date Filing Date
KR1020167012565A Active KR102109053B1 (ko) 2013-10-24 2014-10-23 안정한 수성 항체 제제
KR1020207012828A Active KR102238065B1 (ko) 2013-10-24 2014-10-23 안정한 수성 항체 제제
KR1020217009731A Ceased KR20210041101A (ko) 2013-10-24 2014-10-23 안정한 수성 항체 제제

Family Applications Before (2)

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KR1020167012565A Active KR102109053B1 (ko) 2013-10-24 2014-10-23 안정한 수성 항체 제제
KR1020207012828A Active KR102238065B1 (ko) 2013-10-24 2014-10-23 안정한 수성 항체 제제

Country Status (23)

Country Link
US (4) US20150118249A1 (enExample)
EP (2) EP3892288A1 (enExample)
JP (3) JP6483673B2 (enExample)
KR (3) KR102109053B1 (enExample)
CN (4) CN119971024A (enExample)
AU (4) AU2014339984B2 (enExample)
BR (1) BR112016008576B1 (enExample)
CA (1) CA2926089C (enExample)
CY (1) CY1125697T1 (enExample)
DK (1) DK3060229T3 (enExample)
ES (1) ES2893861T3 (enExample)
HR (1) HRP20211371T1 (enExample)
HU (1) HUE055919T2 (enExample)
LT (1) LT3060229T (enExample)
MX (2) MX388893B (enExample)
PL (1) PL3060229T3 (enExample)
PT (1) PT3060229T (enExample)
RS (1) RS62419B1 (enExample)
RU (2) RU2021137159A (enExample)
SG (2) SG11201603206UA (enExample)
SI (1) SI3060229T1 (enExample)
SM (1) SMT202100580T1 (enExample)
WO (1) WO2015061584A1 (enExample)

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KR102238065B1 (ko) 2021-04-07
HUE055919T2 (hu) 2022-01-28
CA2926089C (en) 2022-08-30
BR112016008576A2 (pt) 2017-10-03
KR20160068946A (ko) 2016-06-15
RU2016119755A (ru) 2017-11-27
EP3892288A1 (en) 2021-10-13
JP2021152034A (ja) 2021-09-30
AU2022291595B2 (en) 2025-06-12
EP3060229A1 (en) 2016-08-31
SI3060229T1 (sl) 2021-11-30
US20200297855A1 (en) 2020-09-24
CN105611938B (zh) 2024-12-31
KR20200051844A (ko) 2020-05-13
ES2893861T3 (es) 2022-02-10
SMT202100580T1 (it) 2021-11-12
LT3060229T (lt) 2021-09-27
JP2016535020A (ja) 2016-11-10
CN119971024A (zh) 2025-05-13
RU2021137159A (ru) 2022-01-11
CN113350278A (zh) 2021-09-07
RU2763787C2 (ru) 2022-01-11
CN105611938A (zh) 2016-05-25
AU2014339984B2 (en) 2020-04-09
DK3060229T3 (da) 2021-10-11
EP3060229A4 (en) 2017-08-16
PL3060229T3 (pl) 2021-12-27
US20190201535A1 (en) 2019-07-04
MX388893B (es) 2025-03-20
US20250170245A1 (en) 2025-05-29
AU2022291595A1 (en) 2023-03-16
AU2020204608A1 (en) 2020-07-30
JP6896781B2 (ja) 2021-06-30
MX2016004605A (es) 2016-11-14
EP3060229B1 (en) 2021-08-25
KR102109053B1 (ko) 2020-05-13
AU2014339984A1 (en) 2016-04-28
CY1125697T1 (el) 2024-02-16
PT3060229T (pt) 2021-10-07
BR112016008576B1 (pt) 2023-03-07
HK1221900A1 (zh) 2017-06-16
MX2021015825A (es) 2022-02-03
JP2019116480A (ja) 2019-07-18
HRP20211371T1 (hr) 2021-11-26
CA2926089A1 (en) 2015-04-30
US20150118249A1 (en) 2015-04-30
RU2016119755A3 (enExample) 2018-04-28
CN113350278B (zh) 2023-03-24
WO2015061584A1 (en) 2015-04-30
JP6483673B2 (ja) 2019-03-13
CN112107538A (zh) 2020-12-22
AU2025230794A1 (en) 2025-10-02
SG11201603206UA (en) 2016-05-30
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