PL3060229T3 - Stabilne, wodne formulacje przeciwciała - Google Patents

Stabilne, wodne formulacje przeciwciała

Info

Publication number
PL3060229T3
PL3060229T3 PL14855343T PL14855343T PL3060229T3 PL 3060229 T3 PL3060229 T3 PL 3060229T3 PL 14855343 T PL14855343 T PL 14855343T PL 14855343 T PL14855343 T PL 14855343T PL 3060229 T3 PL3060229 T3 PL 3060229T3
Authority
PL
Poland
Prior art keywords
stable
antibody formulations
aqueous antibody
aqueous
formulations
Prior art date
Application number
PL14855343T
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 PL3060229T3 publication Critical patent/PL3060229T3/pl

Links

Classifications

    • 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
    • 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
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (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)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (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)
PL14855343T 2013-10-24 2014-10-23 Stabilne, wodne formulacje przeciwciała PL3060229T3 (pl)

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
PL3060229T3 true PL3060229T3 (pl) 2021-12-27

Family

ID=52993565

Family Applications (1)

Application Number Title Priority Date Filing Date
PL14855343T PL3060229T3 (pl) 2013-10-24 2014-10-23 Stabilne, wodne formulacje przeciwciała

Country Status (23)

Country Link
US (4) US20150118249A1 (pl)
EP (2) EP3892288A1 (pl)
JP (3) JP6483673B2 (pl)
KR (3) KR102109053B1 (pl)
CN (4) CN113350278B (pl)
AU (4) AU2014339984B2 (pl)
BR (1) BR112016008576B1 (pl)
CA (1) CA2926089C (pl)
CY (1) CY1125697T1 (pl)
DK (1) DK3060229T3 (pl)
ES (1) ES2893861T3 (pl)
HR (1) HRP20211371T1 (pl)
HU (1) HUE055919T2 (pl)
LT (1) LT3060229T (pl)
MX (2) MX388893B (pl)
PL (1) PL3060229T3 (pl)
PT (1) PT3060229T (pl)
RS (1) RS62419B1 (pl)
RU (2) RU2763787C2 (pl)
SG (2) SG10201803178UA (pl)
SI (1) SI3060229T1 (pl)
SM (1) SMT202100580T1 (pl)
WO (1) WO2015061584A1 (pl)

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WO2006138181A2 (en) 2005-06-14 2006-12-28 Amgen Inc. Self-buffering protein formulations
CA2870149A1 (en) * 2012-05-03 2013-11-07 Medimmune, Llc Method for analyzing sample components
TW201922795A (zh) 2012-09-10 2019-06-16 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
CA2926089C (en) * 2013-10-24 2022-08-30 Medimmune, Llc Stable, aqueous antibody formulations
CA2938933A1 (en) 2014-03-12 2015-09-17 Prothena Biosciences Limited Anti-laminin4 antibodies specific for lg4-5
DK3116911T3 (da) 2014-03-12 2019-09-30 Prothena Biosciences Ltd Anti-mcam-antistoffer og tilhørende fremgangsmåder til anvendelse
JP2018530540A (ja) * 2015-09-16 2018-10-18 プロセナ バイオサイエンシーズ リミテッド 巨細胞動脈炎、リウマチ性多発筋痛症又は高安動脈炎の処置又は予防のための抗mcam抗体の使用
EP3383435A4 (en) * 2015-11-30 2019-07-10 Medimmune, LLC OPTIMIZED RATES OF AMINO ACIDS AND SUGARS AS AMORPHOUS STABILIZING COMPOUNDS IN PHARMACEUTICAL COMPOSITIONS HAVING HIGH CONCENTRATIONS IN PROTEIN-BASED THERAPEUTICS
TWI656882B (zh) 2016-08-10 2019-04-21 南韓商賽特瑞恩股份有限公司 穩定的液體抗流感病毒抗體醫藥調配物
US20180110856A1 (en) * 2016-10-21 2018-04-26 Amgen Inc. Pharmaceutical Formulations and Methods of Making the Same
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MY204234A (en) 2018-08-27 2024-08-16 Regeneron Pharma Use of raman spectroscopy in downstream purification
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CA3134401A1 (en) * 2019-03-29 2020-10-08 Jiangsu Hengrui Medicine Co., Ltd. Pharmaceutical composition containing antibody against il-5 and use thereof
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
AU2021233503A1 (en) * 2020-03-13 2022-09-22 Samsung Bioepis Co., Ltd. Liquid pharmaceutical composition having improved stability
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CA2926089C (en) * 2013-10-24 2022-08-30 Medimmune, Llc Stable, aqueous antibody formulations

Also Published As

Publication number Publication date
KR20210041101A (ko) 2021-04-14
CN112107538A (zh) 2020-12-22
US20250170245A1 (en) 2025-05-29
DK3060229T3 (da) 2021-10-11
MX388893B (es) 2025-03-20
RU2016119755A3 (pl) 2018-04-28
RU2763787C2 (ru) 2022-01-11
EP3060229A1 (en) 2016-08-31
JP2021152034A (ja) 2021-09-30
AU2022291595A1 (en) 2023-03-16
WO2015061584A1 (en) 2015-04-30
HK1221900A1 (zh) 2017-06-16
CY1125697T1 (el) 2024-02-16
KR20200051844A (ko) 2020-05-13
CN105611938A (zh) 2016-05-25
CA2926089A1 (en) 2015-04-30
ES2893861T3 (es) 2022-02-10
CN105611938B (zh) 2024-12-31
RU2016119755A (ru) 2017-11-27
MX2016004605A (es) 2016-11-14
SI3060229T1 (sl) 2021-11-30
BR112016008576B1 (pt) 2023-03-07
KR102109053B1 (ko) 2020-05-13
US20150118249A1 (en) 2015-04-30
AU2014339984A1 (en) 2016-04-28
SG11201603206UA (en) 2016-05-30
KR102238065B1 (ko) 2021-04-07
CN113350278B (zh) 2023-03-24
AU2025230794A1 (en) 2025-10-02
AU2014339984B2 (en) 2020-04-09
RS62419B1 (sr) 2021-10-29
JP6483673B2 (ja) 2019-03-13
KR20160068946A (ko) 2016-06-15
JP6896781B2 (ja) 2021-06-30
CN119971024A (zh) 2025-05-13
US20200297855A1 (en) 2020-09-24
JP2019116480A (ja) 2019-07-18
CA2926089C (en) 2022-08-30
LT3060229T (lt) 2021-09-27
AU2020204608A1 (en) 2020-07-30
JP2016535020A (ja) 2016-11-10
PT3060229T (pt) 2021-10-07
SG10201803178UA (en) 2018-05-30
SMT202100580T1 (it) 2021-11-12
EP3892288A1 (en) 2021-10-13
MX2021015825A (es) 2022-02-03
EP3060229B1 (en) 2021-08-25
EP3060229A4 (en) 2017-08-16
RU2021137159A (ru) 2022-01-11
BR112016008576A2 (pt) 2017-10-03
HUE055919T2 (hu) 2022-01-28
US20190201535A1 (en) 2019-07-04
HRP20211371T1 (hr) 2021-11-26
CN113350278A (zh) 2021-09-07
AU2022291595B2 (en) 2025-06-12

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