KR102238065B1 - 안정한 수성 항체 제제 - Google Patents

안정한 수성 항체 제제 Download PDF

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KR102238065B1
KR102238065B1 KR1020207012828A KR20207012828A KR102238065B1 KR 102238065 B1 KR102238065 B1 KR 102238065B1 KR 1020207012828 A KR1020207012828 A KR 1020207012828A KR 20207012828 A KR20207012828 A KR 20207012828A KR 102238065 B1 KR102238065 B1 KR 102238065B1
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antibody
formulation
seq
cdr2
nos
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KR20200051844A (ko
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윌리엄 리치
레이첼 루이스
제임스 맥기브니
켈시 뉴웰
케빈 더글라스 스튜어트
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아스트라제네카 아베
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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
    • 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
    • A61K9/0012—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
    • 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)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (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)
KR1020207012828A 2013-10-24 2014-10-23 안정한 수성 항체 제제 Active KR102238065B1 (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)

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KR1020167012565A Division KR102109053B1 (ko) 2013-10-24 2014-10-23 안정한 수성 항체 제제

Related Child Applications (1)

Application Number Title Priority Date Filing Date
KR1020217009731A Division KR20210041101A (ko) 2013-10-24 2014-10-23 안정한 수성 항체 제제

Publications (2)

Publication Number Publication Date
KR20200051844A KR20200051844A (ko) 2020-05-13
KR102238065B1 true KR102238065B1 (ko) 2021-04-07

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ID=52993565

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

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KR1020217009731A Ceased KR20210041101A (ko) 2013-10-24 2014-10-23 안정한 수성 항체 제제

Country Status (23)

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US (4) US20150118249A1 (enExample)
EP (2) EP3060229B1 (enExample)
JP (3) JP6483673B2 (enExample)
KR (3) KR102238065B1 (enExample)
CN (4) CN113350278B (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) RU2763787C2 (enExample)
SG (2) SG10201803178UA (enExample)
SI (1) SI3060229T1 (enExample)
SM (1) SMT202100580T1 (enExample)
WO (1) WO2015061584A1 (enExample)

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HRP20211371T1 (hr) * 2013-10-24 2021-11-26 Astrazeneca Ab Stabilne, vodene formulacije protutijela
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CN111511800B (zh) 2017-10-30 2023-11-28 武田药品工业株式会社 灭活脂包膜病毒的环境相容性去污剂
CA3100035A1 (en) 2018-08-27 2020-03-05 Regeneron Pharmaceuticals, Inc. Use of raman spectroscopy in downstream purification
JP7266108B2 (ja) 2019-02-18 2023-04-27 イーライ リリー アンド カンパニー 治療用抗体製剤
KR20210145187A (ko) * 2019-03-29 2021-12-01 지앙수 헨그루이 메디슨 컴퍼니 리미티드 Il-5에 대한 항체를 함유하는 약학적 조성물 및 이의 용도
TW202126688A (zh) 2019-09-27 2021-07-16 瑞典商阿斯特捷利康公司 使用貝那利珠單抗治療遲發性氣喘之方法
US20230041642A1 (en) * 2019-12-16 2023-02-09 Nipro Corporation Aggregation Inhibitory Agent and Medical Composition and Medical Device Including Same
CN111024963A (zh) * 2019-12-27 2020-04-17 桂林英美特生物技术研究所 一种液体稳定、抗冰冻的免疫比浊法载脂蛋白b单试剂
CA3169901A1 (en) * 2020-03-13 2021-09-16 Mi Gyeong Kim Pharmaceutical liquid composition having increased stability
CN113769081A (zh) * 2020-06-10 2021-12-10 三生国健药业（上海）股份有限公司 一种稳定的高浓度抗人il-5单克隆抗体液体制剂
JP2023553641A (ja) * 2020-12-17 2023-12-25 アストラゼネカ アクチボラグ 抗ｉｌ５ｒ抗体製剤

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US20070048304A1 (en) 1995-09-11 2007-03-01 Kyowa Hakko Kogyo Co., Ltd. Method of treating allergy using antibody against human interleukin-5 receptor alpha chain
US20090304706A1 (en) 2006-04-21 2009-12-10 Novartis Ag Antagonist anti-cd40 antibody pharmaceutical compositions
US20100074903A1 (en) 2008-09-19 2010-03-25 Ulla Grauschopf Novel antibody formulation

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CA2926089A1 (en) 2015-04-30
CA2926089C (en) 2022-08-30
CN105611938B (zh) 2024-12-31
US20250170245A1 (en) 2025-05-29
EP3892288A1 (en) 2021-10-13
JP2019116480A (ja) 2019-07-18
RU2021137159A (ru) 2022-01-11
PT3060229T (pt) 2021-10-07
AU2022291595B2 (en) 2025-06-12
US20200297855A1 (en) 2020-09-24
EP3060229A4 (en) 2017-08-16
JP6896781B2 (ja) 2021-06-30
AU2014339984B2 (en) 2020-04-09
SI3060229T1 (sl) 2021-11-30
SG10201803178UA (en) 2018-05-30
JP6483673B2 (ja) 2019-03-13
MX2016004605A (es) 2016-11-14
CN112107538A (zh) 2020-12-22
JP2016535020A (ja) 2016-11-10
AU2020204608A1 (en) 2020-07-30
HK1221900A1 (zh) 2017-06-16
SMT202100580T1 (it) 2021-11-12
AU2014339984A1 (en) 2016-04-28
JP2021152034A (ja) 2021-09-30
HUE055919T2 (hu) 2022-01-28
SG11201603206UA (en) 2016-05-30
CY1125697T1 (el) 2024-02-16
RU2016119755A (ru) 2017-11-27
US20190201535A1 (en) 2019-07-04
US20150118249A1 (en) 2015-04-30
MX2021015825A (es) 2022-02-03
BR112016008576B1 (pt) 2023-03-07
CN119971024A (zh) 2025-05-13
RU2763787C2 (ru) 2022-01-11
CN113350278A (zh) 2021-09-07
KR20200051844A (ko) 2020-05-13
EP3060229B1 (en) 2021-08-25
ES2893861T3 (es) 2022-02-10
RS62419B1 (sr) 2021-10-29
KR102109053B1 (ko) 2020-05-13
AU2025230794A1 (en) 2025-10-02
KR20210041101A (ko) 2021-04-14
EP3060229A1 (en) 2016-08-31
PL3060229T3 (pl) 2021-12-27
DK3060229T3 (da) 2021-10-11
CN105611938A (zh) 2016-05-25
CN113350278B (zh) 2023-03-24
HRP20211371T1 (hr) 2021-11-26
AU2022291595A1 (en) 2023-03-16
RU2016119755A3 (enExample) 2018-04-28
MX388893B (es) 2025-03-20
WO2015061584A1 (en) 2015-04-30
LT3060229T (lt) 2021-09-27
KR20160068946A (ko) 2016-06-15
BR112016008576A2 (pt) 2017-10-03

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