CN115812080A - 含有抗ctla-4抗体的稳定调配物 - Google Patents

含有抗ctla-4抗体的稳定调配物 Download PDF

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Publication number
CN115812080A
CN115812080A CN202180049075.7A CN202180049075A CN115812080A CN 115812080 A CN115812080 A CN 115812080A CN 202180049075 A CN202180049075 A CN 202180049075A CN 115812080 A CN115812080 A CN 115812080A
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CN
China
Prior art keywords
pharmaceutical formulation
antibody
stable pharmaceutical
stable
amino acid
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Pending
Application number
CN202180049075.7A
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English (en)
Chinese (zh)
Inventor
Y·程
D·B·路德维希
X·唐
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Regeneron Pharmaceuticals Inc
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Regeneron Pharmaceuticals Inc
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Filing date
Publication date
Application filed by Regeneron Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Publication of CN115812080A publication Critical patent/CN115812080A/zh
Pending legal-status Critical Current

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    • 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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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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)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
CN202180049075.7A 2020-07-08 2021-07-07 含有抗ctla-4抗体的稳定调配物 Pending CN115812080A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063049540P 2020-07-08 2020-07-08
US63/049,540 2020-07-08
PCT/US2021/040648 WO2022010988A1 (en) 2020-07-08 2021-07-07 Stabilized formulations containing anti-ctla-4 antibodies

Publications (1)

Publication Number Publication Date
CN115812080A true CN115812080A (zh) 2023-03-17

Family

ID=77207237

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180049075.7A Pending CN115812080A (zh) 2020-07-08 2021-07-07 含有抗ctla-4抗体的稳定调配物

Country Status (10)

Country Link
US (1) US20220031843A1 (enExample)
EP (1) EP4178983A1 (enExample)
JP (1) JP2023533963A (enExample)
KR (1) KR20230035595A (enExample)
CN (1) CN115812080A (enExample)
AU (1) AU2021305093A1 (enExample)
CA (1) CA3185091A1 (enExample)
IL (1) IL299152A (enExample)
MX (1) MX2022016218A (enExample)
WO (1) WO2022010988A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2022009558A (es) 2020-02-04 2022-09-09 Regeneron Pharma Contenido de humedad residual objetivo para farmaco liofilizado.

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0747045B2 (ja) 1986-10-15 1995-05-24 株式会社大協精工 積層した注射器用滑栓
JP3100727B2 (ja) 1992-01-23 2000-10-23 株式会社大協精工 変性ポリシロキサン組成物及び該組成物を被覆した衛生ゴム製品
JP3172057B2 (ja) 1995-04-05 2001-06-04 株式会社大協精工 ラミネートゴム栓
JP3512349B2 (ja) 1999-01-29 2004-03-29 株式会社大協精工 柱状ゴム要素の成形型
JP2002209975A (ja) 2001-01-19 2002-07-30 Daikyo Seiko Ltd 医薬バイアル用ラミネートゴム栓
JO3417B1 (ar) * 2010-01-08 2019-10-20 Regeneron Pharma الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r
AU2011312191B2 (en) * 2010-10-06 2015-07-02 Regeneron Pharmaceuticals, Inc. Stabilized formulations containing anti-interleukin-4 receptor (IL-4R) antibodies
AR087305A1 (es) * 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
MY164611A (en) * 2012-01-23 2018-01-30 Regeneron Pharma Stabilized formulations containing anti-ang2 antibodies
EP2633874A1 (en) * 2012-03-02 2013-09-04 Sanofi-Aventis Deutschland GmbH Fixed-dose medicament delivery device
AR092325A1 (es) * 2012-05-31 2015-04-15 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-dll4 y kit
ES2813580T3 (es) * 2015-04-17 2021-03-24 Bristol Myers Squibb Co Composiciones que comprenden una combinación de ipilimumab y nivolumab
MX2019013034A (es) * 2017-05-02 2020-02-05 Merck Sharp & Dohme Formulaciones estables de anticuerpos anti-ctla4 solos y en combinacion con anticuerpos contra el receptor de muerte programasa 1 (pd-1) y metodos para su uso.
TWI799432B (zh) 2017-07-27 2023-04-21 美商再生元醫藥公司 抗ctla-4抗體及其用途
US20210317220A1 (en) * 2018-09-24 2021-10-14 Janssen Biotech, Inc. Method of providing safe administration of an anti-cd154 antibody
CN114793422A (zh) * 2019-12-25 2022-07-26 百奥泰生物制药股份有限公司 抗ctla-4单克隆抗体及其制备方法与应用

Also Published As

Publication number Publication date
KR20230035595A (ko) 2023-03-14
US20220031843A1 (en) 2022-02-03
MX2022016218A (es) 2023-03-31
CA3185091A1 (en) 2022-01-13
AU2021305093A1 (en) 2023-03-09
IL299152A (en) 2023-02-01
WO2022010988A1 (en) 2022-01-13
EP4178983A1 (en) 2023-05-17
JP2023533963A (ja) 2023-08-07

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