MX2022016218A - Formulaciones estabilizadas que contienen anticuerpos anti-ctla-4. - Google Patents

Formulaciones estabilizadas que contienen anticuerpos anti-ctla-4.

Info

Publication number
MX2022016218A
MX2022016218A MX2022016218A MX2022016218A MX2022016218A MX 2022016218 A MX2022016218 A MX 2022016218A MX 2022016218 A MX2022016218 A MX 2022016218A MX 2022016218 A MX2022016218 A MX 2022016218A MX 2022016218 A MX2022016218 A MX 2022016218A
Authority
MX
Mexico
Prior art keywords
ctla
antibody
antibodies
formulations containing
containing anti
Prior art date
Application number
MX2022016218A
Other languages
English (en)
Inventor
Yuan Cheng
Xiaolin Tang
Ludwig David B
Original Assignee
Regeneron Pharma
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 Regeneron Pharma filed Critical Regeneron Pharma
Publication of MX2022016218A publication Critical patent/MX2022016218A/es

Links

Classifications

    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], 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 [IG], 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
    • 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
    • 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

Landscapes

  • 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)

Abstract

La presente invención proporciona formulaciones farmacéuticas líquidas y liofilizadas que comprenden un anticuerpo que se une específicamente a la proteína 4 asociada a linfocitos T citotóxicos (hCTLA-4). Las formulaciones pueden contener, además de un anticuerpo anti-CTLA-4, un regulador, al menos un azúcar o al menos un surfactante no iónico. Las formulaciones farmacéuticas de la presente invención exhiben un grado sustancial de estabilidad del anticuerpo después del almacenamiento durante varios meses y después de someterse a estrés térmico y otros estreses físicos.
MX2022016218A 2020-07-08 2021-07-07 Formulaciones estabilizadas que contienen anticuerpos anti-ctla-4. MX2022016218A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063049540P 2020-07-08 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
MX2022016218A true MX2022016218A (es) 2023-03-31

Family

ID=77207237

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2022016218A MX2022016218A (es) 2020-07-08 2021-07-07 Formulaciones estabilizadas que contienen anticuerpos anti-ctla-4.

Country Status (10)

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

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115151772B (zh) 2020-02-04 2024-11-15 瑞泽恩制药公司 冻干药物产品的目标残留水分含量

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
CN106267189B (zh) * 2010-10-06 2021-02-26 瑞泽恩制药公司 含有抗白介素-4受体(il-4r)的抗体的稳定制剂
AR087305A1 (es) * 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
NZ627859A (en) * 2012-01-23 2015-09-25 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
MY188749A (en) * 2015-04-17 2021-12-28 Bristol Myers Squibb Co Compositions comprising a combination of nivolumab and ipilimumab
TN2019000294A1 (en) * 2017-05-02 2021-05-07 Merck Sharp & Dohme Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof
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
WO2020068723A1 (en) * 2018-09-24 2020-04-02 Janssen Biotech, Inc. Method of providing safe administration of an anti-cd154 antibody
US20230203164A1 (en) * 2019-12-25 2023-06-29 Bio-Thera Solutions, Ltd. Anti-ctla-4 monoclonal antibody, preparation method therefor, and application thereof

Also Published As

Publication number Publication date
CN115812080A (zh) 2023-03-17
CA3185091A1 (en) 2022-01-13
IL299152A (en) 2023-02-01
EP4178983A1 (en) 2023-05-17
WO2022010988A1 (en) 2022-01-13
AU2021305093A1 (en) 2023-03-09
US20220031843A1 (en) 2022-02-03
JP2023533963A (ja) 2023-08-07
KR20230035595A (ko) 2023-03-14

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