MX388893B - Formulaciones de anticuerpos estables acuosas. - Google Patents

Formulaciones de anticuerpos estables acuosas.

Info

Publication number
MX388893B
MX388893B MX2016004605A MX2016004605A MX388893B MX 388893 B MX388893 B MX 388893B MX 2016004605 A MX2016004605 A MX 2016004605A MX 2016004605 A MX2016004605 A MX 2016004605A MX 388893 B MX388893 B MX 388893B
Authority
MX
Mexico
Prior art keywords
antibody formulations
stable antibody
aqueous stable
aqueous
formulations
Prior art date
Application number
MX2016004605A
Other languages
English (en)
Spanish (es)
Other versions
MX2016004605A (es
Inventor
James Mcgivney
Kelcy Newell
Kevin Douglas Stewart
Rachael Lewus
William Leach
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 MX2016004605A publication Critical patent/MX2016004605A/es
Publication of MX388893B publication Critical patent/MX388893B/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • 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
    • 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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/14Antitussive agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866Immunoglobulins [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
    • 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
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Endocrinology (AREA)
  • Inorganic Chemistry (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)
MX2016004605A 2013-10-24 2014-10-23 Formulaciones de anticuerpos estables acuosas. MX388893B (es)

Applications Claiming Priority (2)

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

Publications (2)

Publication Number Publication Date
MX2016004605A MX2016004605A (es) 2016-11-14
MX388893B true MX388893B (es) 2025-03-20

Family

ID=52993565

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2016004605A MX388893B (es) 2013-10-24 2014-10-23 Formulaciones de anticuerpos estables acuosas.
MX2021015825A MX2021015825A (es) 2013-10-24 2016-04-11 Formulaciones de anticuerpos estables acuosas.

Family Applications After (1)

Application Number Title Priority Date Filing Date
MX2021015825A MX2021015825A (es) 2013-10-24 2016-04-11 Formulaciones de anticuerpos estables acuosas.

Country Status (23)

Country Link
US (4) US20150118249A1 (enExample)
EP (2) EP3892288A1 (enExample)
JP (3) JP6483673B2 (enExample)
KR (3) KR20210041101A (enExample)
CN (4) CN105611938B (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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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
EP3892288A1 (en) * 2013-10-24 2021-10-13 Astrazeneca AB Stable, aqueous antibody formulations
CA2938933A1 (en) 2014-03-12 2015-09-17 Prothena Biosciences Limited Anti-laminin4 antibodies specific for lg4-5
ES2744526T3 (es) 2014-03-12 2020-02-25 Prothena Biosciences Ltd Anticuerpos anti-MCAM y métodos de uso asociados
WO2017046776A2 (en) * 2015-09-16 2017-03-23 Prothena Biosciences Limited Use of anti-mcam antibodies for treatment or prophylaxis of giant cell arteritis, polymyalgia rheumatica or takayasu's arteritis
EP4606820A3 (en) * 2015-11-30 2025-10-29 Medimmune, LLC Optimized ratios of amino acids and sugars as amorphous stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
ES2968923T3 (es) 2016-08-10 2024-05-14 Celltrion Inc Preparación farmacéutica líquida estable de anticuerpo contra el virus de la gripe
AU2017345490B2 (en) 2016-10-21 2022-07-07 Amgen Inc. Pharmaceutical formulations and methods of making the same
CA3080656A1 (en) 2017-10-30 2019-05-09 Baxalta GmbH Environmentally compatible detergents for inactivation of lipid-enveloped viruses
IL280880B2 (en) 2018-08-27 2025-04-01 Regeneron Pharma Using Raman Spectroscopy in Downstream Purification
MX2021009851A (es) 2019-02-18 2021-09-10 Lilly Co Eli Formulacion de anticuerpos terapeuticos.
CN113507938B (zh) * 2019-03-29 2024-04-16 广东恒瑞医药有限公司 包含抗il-5抗体的药物组合物及其用途
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
JP7718272B2 (ja) * 2019-12-16 2025-08-05 ニプロ株式会社 凝集防止剤ならびにそれを用いた医薬組成物および医療用デバイス
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
KR20220152540A (ko) * 2020-03-13 2022-11-16 삼성바이오에피스 주식회사 안정성이 증진된 액상 약제학적 조성물
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
CA3204307A1 (en) * 2020-12-17 2022-06-23 Astrazeneca Ab Anti-il5r antibody formulations

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EP3892288A1 (en) * 2013-10-24 2021-10-13 Astrazeneca AB Stable, aqueous antibody formulations

Also Published As

Publication number Publication date
CN105611938B (zh) 2024-12-31
CN105611938A (zh) 2016-05-25
AU2022291595B2 (en) 2025-06-12
LT3060229T (lt) 2021-09-27
JP2019116480A (ja) 2019-07-18
AU2014339984A1 (en) 2016-04-28
AU2022291595A1 (en) 2023-03-16
CA2926089C (en) 2022-08-30
MX2021015825A (es) 2022-02-03
HUE055919T2 (hu) 2022-01-28
KR20210041101A (ko) 2021-04-14
BR112016008576B1 (pt) 2023-03-07
BR112016008576A2 (pt) 2017-10-03
CN113350278B (zh) 2023-03-24
RU2021137159A (ru) 2022-01-11
SG10201803178UA (en) 2018-05-30
US20200297855A1 (en) 2020-09-24
KR20160068946A (ko) 2016-06-15
CA2926089A1 (en) 2015-04-30
EP3892288A1 (en) 2021-10-13
ES2893861T3 (es) 2022-02-10
PT3060229T (pt) 2021-10-07
PL3060229T3 (pl) 2021-12-27
RU2016119755A3 (enExample) 2018-04-28
KR102238065B1 (ko) 2021-04-07
KR102109053B1 (ko) 2020-05-13
JP2021152034A (ja) 2021-09-30
HK1221900A1 (zh) 2017-06-16
AU2014339984B2 (en) 2020-04-09
CN113350278A (zh) 2021-09-07
AU2025230794A1 (en) 2025-10-02
JP2016535020A (ja) 2016-11-10
US20150118249A1 (en) 2015-04-30
EP3060229B1 (en) 2021-08-25
JP6896781B2 (ja) 2021-06-30
KR20200051844A (ko) 2020-05-13
AU2020204608A1 (en) 2020-07-30
CN119971024A (zh) 2025-05-13
US20250170245A1 (en) 2025-05-29
CN112107538A (zh) 2020-12-22
JP6483673B2 (ja) 2019-03-13
EP3060229A4 (en) 2017-08-16
SG11201603206UA (en) 2016-05-30
WO2015061584A1 (en) 2015-04-30
RS62419B1 (sr) 2021-10-29
EP3060229A1 (en) 2016-08-31
MX2016004605A (es) 2016-11-14
HRP20211371T1 (hr) 2021-11-26
RU2016119755A (ru) 2017-11-27
SI3060229T1 (sl) 2021-11-30
US20190201535A1 (en) 2019-07-04
DK3060229T3 (da) 2021-10-11
CY1125697T1 (el) 2024-02-16
SMT202100580T1 (it) 2021-11-12
RU2763787C2 (ru) 2022-01-11

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