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PL3337502T3 - Stabilna formulacja anty-ifnar1 - Google Patents

Stabilna formulacja anty-ifnar1

Info

Publication number
PL3337502T3
PL3337502T3 PL16837818T PL16837818T PL3337502T3 PL 3337502 T3 PL3337502 T3 PL 3337502T3 PL 16837818 T PL16837818 T PL 16837818T PL 16837818 T PL16837818 T PL 16837818T PL 3337502 T3 PL3337502 T3 PL 3337502T3
Authority
PL
Poland
Prior art keywords
ifnar1
formulation
stable anti
stable
ifnar1 formulation
Prior art date
Application number
PL16837818T
Other languages
English (en)
Inventor
Roberto Depaz
Natalie DEJESUS
Jared BEE
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=58052002&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PL3337502(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Astrazeneca Ab filed Critical Astrazeneca Ab
Publication of PL3337502T3 publication Critical patent/PL3337502T3/pl

Links

Classifications

    • 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
    • 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
    • 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
    • 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
    • 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
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/14Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
    • 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
    • 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
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12PFERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00Preparation of peptides or proteins
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/524CH2 domain
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Rheumatology (AREA)
  • Endocrinology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Neurology (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Urology & Nephrology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
PL16837818T 2015-08-19 2016-08-18 Stabilna formulacja anty-ifnar1 PL3337502T3 (pl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562207164P 2015-08-19 2015-08-19
PCT/US2016/047506 WO2017031288A1 (en) 2015-08-19 2016-08-18 Stable anti-ifnar1 formulation
EP16837818.0A EP3337502B1 (en) 2015-08-19 2016-08-18 Stable anti-ifnar1 formulation

Publications (1)

Publication Number Publication Date
PL3337502T3 true PL3337502T3 (pl) 2021-01-11

Family

ID=58052002

Family Applications (2)

Application Number Title Priority Date Filing Date
PL20174805.0T PL3769781T3 (pl) 2015-08-19 2016-08-18 Stabilna formulacja anty-ifnar1
PL16837818T PL3337502T3 (pl) 2015-08-19 2016-08-18 Stabilna formulacja anty-ifnar1

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PL20174805.0T PL3769781T3 (pl) 2015-08-19 2016-08-18 Stabilna formulacja anty-ifnar1

Country Status (25)

Country Link
US (1) US10125195B2 (pl)
EP (3) EP3337502B1 (pl)
JP (4) JP6720293B2 (pl)
KR (4) KR20240090616A (pl)
CN (1) CN107921109A (pl)
AU (3) AU2016308262C1 (pl)
BR (1) BR112018002196A8 (pl)
CA (1) CA2995222C (pl)
CY (2) CY1123657T1 (pl)
DK (2) DK3337502T3 (pl)
ES (2) ES2818229T3 (pl)
FI (1) FI3769781T3 (pl)
HK (1) HK1256195A1 (pl)
HR (2) HRP20230463T1 (pl)
HU (2) HUE061985T2 (pl)
IL (1) IL257279B2 (pl)
LT (2) LT3337502T (pl)
PL (2) PL3769781T3 (pl)
PT (2) PT3337502T (pl)
RS (2) RS60773B1 (pl)
RU (1) RU2731737C2 (pl)
SG (1) SG10202106970XA (pl)
SI (2) SI3769781T1 (pl)
SM (2) SMT202300176T1 (pl)
WO (1) WO2017031288A1 (pl)

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CA3216387A1 (en) 2021-04-23 2022-10-27 Astrazeneca Ab Anti-ifnar1 dosing regime for subcutaneous injection
WO2022238479A1 (en) * 2021-05-12 2022-11-17 Astrazeneca Ab Inhibitor of type 1 interferon receptor steroid sparing in systemic lupus erythematosus patients
CN113527490B (zh) * 2021-07-13 2022-03-01 江苏荃信生物医药股份有限公司 一种抗人ifnar1单克隆抗体浓缩溶液的制备方法
WO2023284073A1 (zh) * 2021-07-13 2023-01-19 江苏荃信生物医药股份有限公司 降低单克隆抗体生产中宿主细胞蛋白含量的亲和纯化方法、抗人ifnar1单克隆抗体浓缩溶液的制备方法以及液体制剂
CN113521276B (zh) * 2021-07-13 2022-04-12 江苏荃信生物医药股份有限公司 包含抗人干扰素α受体1(IFNAR1)单克隆抗体的液体制剂
AU2022317215A1 (en) 2021-07-27 2024-02-29 Astrazeneca Ab Treatment of lupus
AU2022359684A1 (en) * 2021-10-04 2024-05-09 Astrazeneca Ab Treatment of lupus
EP4422674A1 (en) * 2021-10-29 2024-09-04 Intas Pharmaceuticals Ltd. Stable lyophilized formulation of an anti-alpha 4beta7 antibody
TW202337497A (zh) * 2022-02-18 2023-10-01 中國大陸商重慶明道浩悅生物科技有限公司 鼻內調配物及抗sars-cov-2棘蛋白抗體
IN202221038828A (pl) * 2022-07-06 2024-01-12
WO2024079241A1 (en) 2022-10-13 2024-04-18 Astrazeneca Ab Treatment of lupus
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WO2025022280A1 (en) 2023-07-21 2025-01-30 Astrazeneca Ab Treatment of neurodegenerative diseases

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Also Published As

Publication number Publication date
EP3769781A1 (en) 2021-01-27
HUE061985T2 (hu) 2023-09-28
CN107921109A (zh) 2018-04-17
AU2016308262B2 (en) 2020-04-30
AU2020203306C1 (en) 2022-03-31
IL257279A (en) 2018-03-29
EP4233892A2 (en) 2023-08-30
RS60773B1 (sr) 2020-10-30
AU2016308262A1 (en) 2018-03-08
SI3769781T1 (sl) 2023-06-30
KR20200119916A (ko) 2020-10-20
BR112018002196A2 (pt) 2019-04-30
SMT202000483T1 (it) 2020-11-10
EP3337502A1 (en) 2018-06-27
KR20180041173A (ko) 2018-04-23
DK3337502T3 (da) 2020-09-14
AU2020203306B2 (en) 2021-09-09
DK3769781T5 (da) 2024-08-19
AU2016308262C1 (en) 2022-04-21
JP2022066345A (ja) 2022-04-28
KR20240090616A (ko) 2024-06-21
CA2995222C (en) 2021-07-13
SMT202300176T1 (it) 2023-07-20
KR102669174B1 (ko) 2024-06-10
JP2020158527A (ja) 2020-10-01
JP7035119B2 (ja) 2022-03-14
RU2731737C2 (ru) 2020-09-08
AU2021257915A1 (en) 2021-11-18
RU2018107725A (ru) 2019-09-19
CA2995222A1 (en) 2017-02-23
BR112018002196A8 (pt) 2021-05-04
US20170051066A1 (en) 2017-02-23
DK3769781T3 (da) 2023-06-19
PT3769781T (pt) 2023-06-19
HUE051862T2 (hu) 2021-03-29
EP3337502A4 (en) 2019-01-23
HRP20230463T1 (hr) 2023-07-21
LT3337502T (lt) 2020-09-25
WO2017031288A1 (en) 2017-02-23
JP2018523676A (ja) 2018-08-23
ES2818229T3 (es) 2021-04-09
IL257279B2 (en) 2023-04-01
HRP20201297T1 (hr) 2020-11-27
US10125195B2 (en) 2018-11-13
JP2024161043A (ja) 2024-11-15
SG10202106970XA (en) 2021-07-29
RU2018107725A3 (pl) 2019-10-02
FI3769781T3 (fi) 2023-06-07
SI3337502T1 (sl) 2020-10-30
ES2947488T3 (es) 2023-08-10
CY1126062T1 (el) 2023-11-15
EP4233892A3 (en) 2023-10-25
KR20220127378A (ko) 2022-09-19
HK1256195A1 (zh) 2019-09-13
KR102168005B1 (ko) 2020-10-21
IL257279B (en) 2022-12-01
EP3769781B1 (en) 2023-04-19
LT3769781T (lt) 2023-06-12
JP6720293B2 (ja) 2020-07-08
PL3769781T3 (pl) 2023-07-17
EP3337502B1 (en) 2020-06-24
AU2020203306A1 (en) 2020-06-11
RS64263B1 (sr) 2023-07-31
CY1123657T1 (el) 2022-03-24
PT3337502T (pt) 2020-09-23

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