SI3060229T1 - Stabilne vodne formulacije protiteles - Google Patents

Stabilne vodne formulacije protiteles

Info

Publication number
SI3060229T1
SI3060229T1 SI201431876T SI201431876T SI3060229T1 SI 3060229 T1 SI3060229 T1 SI 3060229T1 SI 201431876 T SI201431876 T SI 201431876T SI 201431876 T SI201431876 T SI 201431876T SI 3060229 T1 SI3060229 T1 SI 3060229T1
Authority
SI
Slovenia
Prior art keywords
stable
antibody formulations
aqueous antibody
aqueous
formulations
Prior art date
Application number
SI201431876T
Other languages
English (en)
Inventor
William Leach
Rachael Lewus
James Mcgivney
Kelcy Newell
Kevin Douglas Stewart
Original Assignee
Astrazeneca Ab
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 Astrazeneca Ab filed Critical Astrazeneca Ab
Publication of SI3060229T1 publication Critical patent/SI3060229T1/sl

Links

Classifications

    • 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
    • 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]

Landscapes

  • 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)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)
SI201431876T 2013-10-24 2014-10-23 Stabilne vodne formulacije protiteles SI3060229T1 (sl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361895143P 2013-10-24 2013-10-24
PCT/US2014/061997 WO2015061584A1 (en) 2013-10-24 2014-10-23 Stable, aqueous antibody formulations
EP14855343.1A EP3060229B1 (en) 2013-10-24 2014-10-23 Stable, aqueous antibody formulations

Publications (1)

Publication Number Publication Date
SI3060229T1 true SI3060229T1 (sl) 2021-11-30

Family

ID=52993565

Family Applications (1)

Application Number Title Priority Date Filing Date
SI201431876T SI3060229T1 (sl) 2013-10-24 2014-10-23 Stabilne vodne formulacije protiteles

Country Status (23)

Country Link
US (3) US20150118249A1 (sl)
EP (2) EP3060229B1 (sl)
JP (3) JP6483673B2 (sl)
KR (3) KR20210041101A (sl)
CN (3) CN113350278B (sl)
AU (3) AU2014339984B2 (sl)
BR (1) BR112016008576B1 (sl)
CA (1) CA2926089C (sl)
CY (1) CY1125697T1 (sl)
DK (1) DK3060229T3 (sl)
ES (1) ES2893861T3 (sl)
HK (1) HK1221900A1 (sl)
HR (1) HRP20211371T1 (sl)
HU (1) HUE055919T2 (sl)
LT (1) LT3060229T (sl)
MX (2) MX2016004605A (sl)
PL (1) PL3060229T3 (sl)
PT (1) PT3060229T (sl)
RS (1) RS62419B1 (sl)
RU (2) RU2763787C2 (sl)
SG (2) SG10201803178UA (sl)
SI (1) SI3060229T1 (sl)
WO (1) WO2015061584A1 (sl)

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TWI660972B (zh) 2012-09-10 2019-06-01 愛爾蘭商尼歐托普生物科學公司 抗ｍｃａｍ抗體及相關使用方法
JP6483673B2 (ja) * 2013-10-24 2019-03-13 アストラゼネカ アクチボラグ 安定した水性抗体製剤
CA2938946A1 (en) 2014-03-12 2015-09-17 Prothena Biosciences Limited Anti-mcam antibodies and associated methods of use
US10059761B2 (en) 2014-03-12 2018-08-28 Prothena Biosciences Limited Anti-Laminin4 antibodies specific for LG4-5
EP3350226A2 (en) * 2015-09-16 2018-07-25 Prothena Biosciences Limited Use of anti-mcam antibodies for treatment or prophylaxis of giant cell arteritis, polymyalgia rheumatica or takayasu's arteritis
WO2017095848A1 (en) * 2015-11-30 2017-06-08 Medimmune, Llc Optimized ratios of amino acids and sugars as amorphous stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
CN109803640B (zh) * 2016-08-10 2022-01-04 赛特瑞恩股份有限公司 稳定的液体抗流感病毒抗体医药调配物
CN114917185B (zh) 2016-10-21 2023-11-14 美国安进公司 药物配制品及其制备方法
CR20210435A (es) 2019-02-18 2021-09-20 Lilly Co Eli Formulación de anticuerpos terapéuticos
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
JPWO2021124793A1 (sl) * 2019-12-16 2021-06-24
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
US20230115267A1 (en) * 2020-03-13 2023-04-13 Samsung Bioepis Co., Ltd. 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
KR20230121797A (ko) * 2020-12-17 2023-08-21 아스트라제네카 아베 항-il5r 항체 제형

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Also Published As

Publication number Publication date
AU2014339984A1 (en) 2016-04-28
RU2763787C2 (ru) 2022-01-11
KR20200051844A (ko) 2020-05-13
WO2015061584A1 (en) 2015-04-30
CN105611938A (zh) 2016-05-25
RU2016119755A (ru) 2017-11-27
KR20210041101A (ko) 2021-04-14
KR20160068946A (ko) 2016-06-15
MX2021015825A (es) 2022-02-03
AU2014339984B2 (en) 2020-04-09
CA2926089C (en) 2022-08-30
DK3060229T3 (da) 2021-10-11
PL3060229T3 (pl) 2021-12-27
EP3060229A4 (en) 2017-08-16
US20150118249A1 (en) 2015-04-30
AU2020204608A1 (en) 2020-07-30
AU2022291595A1 (en) 2023-03-16
PT3060229T (pt) 2021-10-07
JP2016535020A (ja) 2016-11-10
RU2016119755A3 (sl) 2018-04-28
US20190201535A1 (en) 2019-07-04
CN113350278A (zh) 2021-09-07
CN113350278B (zh) 2023-03-24
EP3892288A1 (en) 2021-10-13
BR112016008576A2 (pt) 2017-10-03
US20200297855A1 (en) 2020-09-24
EP3060229B1 (en) 2021-08-25
ES2893861T3 (es) 2022-02-10
BR112016008576B1 (pt) 2023-03-07
KR102238065B1 (ko) 2021-04-07
JP6896781B2 (ja) 2021-06-30
HK1221900A1 (zh) 2017-06-16
LT3060229T (lt) 2021-09-27
JP2019116480A (ja) 2019-07-18
JP6483673B2 (ja) 2019-03-13
SG11201603206UA (en) 2016-05-30
HRP20211371T1 (hr) 2021-11-26
RU2021137159A (ru) 2022-01-11
CY1125697T1 (el) 2024-02-16
CA2926089A1 (en) 2015-04-30
HUE055919T2 (hu) 2022-01-28
JP2021152034A (ja) 2021-09-30
EP3060229A1 (en) 2016-08-31
MX2016004605A (es) 2016-11-14
RS62419B1 (sr) 2021-10-29
CN112107538A (zh) 2020-12-22
KR102109053B1 (ko) 2020-05-13
SG10201803178UA (en) 2018-05-30

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