KR20230035595A - 항-ctla-4 항체를 함유하는 안정화된 제형 - Google Patents

항-ctla-4 항체를 함유하는 안정화된 제형 Download PDF

Info

Publication number
KR20230035595A
KR20230035595A KR1020237003824A KR20237003824A KR20230035595A KR 20230035595 A KR20230035595 A KR 20230035595A KR 1020237003824 A KR1020237003824 A KR 1020237003824A KR 20237003824 A KR20237003824 A KR 20237003824A KR 20230035595 A KR20230035595 A KR 20230035595A
Authority
KR
South Korea
Prior art keywords
pharmaceutical formulation
antibody
stable
stable pharmaceutical
less
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
KR1020237003824A
Other languages
English (en)
Korean (ko)
Inventor
위안 청
데이비드 비. 루드비히
샤오린 탕
Original Assignee
리제너론 파아마슈티컬스, 인크.
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 리제너론 파아마슈티컬스, 인크. filed Critical 리제너론 파아마슈티컬스, 인크.
Publication of KR20230035595A publication Critical patent/KR20230035595A/ko
Pending legal-status Critical Current

Links

Images

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
    • 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 [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
    • 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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (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)
KR1020237003824A 2020-07-08 2021-07-07 항-ctla-4 항체를 함유하는 안정화된 제형 Pending KR20230035595A (ko)

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
KR20230035595A true KR20230035595A (ko) 2023-03-14

Family

ID=77207237

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020237003824A Pending KR20230035595A (ko) 2020-07-08 2021-07-07 항-ctla-4 항체를 함유하는 안정화된 제형

Country Status (10)

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

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
BR112013008366B1 (pt) * 2010-10-06 2022-02-08 Regeneron Pharmaceuticals, Inc Formulações farmacêuticas líquidas estáveis contendo anticorpos anti-receptor de interleucina-4 humana alfa, e recipiente contendo as referidas formulações
AR087305A1 (es) * 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
AU2013212587B2 (en) * 2012-01-23 2017-07-20 Regeneron Pharmaceuticals, Inc. 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
TN2017000440A1 (en) * 2015-04-17 2019-04-12 Bristol Myers Squibb Co Compositions comprising a combination of an anti-pd-1 antibody and another antibody
SG11201910134SA (en) * 2017-05-02 2019-11-28 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
EP3856246A4 (en) * 2018-09-24 2022-07-20 Janssen Biotech, Inc. METHOD FOR ENSURING SAFE ADMINISTRATION OF 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
CN115812080A (zh) 2023-03-17
WO2022010988A1 (en) 2022-01-13
CA3185091A1 (en) 2022-01-13
EP4178983A1 (en) 2023-05-17
US20220031843A1 (en) 2022-02-03
MX2022016218A (es) 2023-03-31
AU2021305093A1 (en) 2023-03-09
JP2023533963A (ja) 2023-08-07
IL299152A (en) 2023-02-01

Similar Documents

Publication Publication Date Title
US12077593B2 (en) Stabilized formulations containing anti-interleukin-6 receptor (IL-6R) antibodies
CA2805388C (en) Stabilized formulations containing anti-ngf antibodies
US20230346929A1 (en) Stabilized Formulations Containing Anti-IL-33 Antibodies
KR20230035595A (ko) 항-ctla-4 항체를 함유하는 안정화된 제형
US20220332849A1 (en) Stabilized Formulations Containing Anti-MUC16 x Anti-CD3 Bispecific Antibodies
KR20220113417A (ko) 항-CD20 x 항-CD3 이중 특이적 항체를 함유한 안정화 제제
EA051038B1 (ru) Стабилизированные составы, содержащие биспецифические антитела к muc16 и к cd3
CN117320700A (zh) 含有抗muc16 x抗cd3双特异性抗体的稳定制剂
TW202517293A (zh) 含有抗bcmax抗cd3雙特異性抗體之穩定化配製物
HK40000747A (en) Stabilized formulations containing anti-interleukin-6 receptor (il-6r) antibodies
HK40000747B (en) Stabilized formulations containing anti-interleukin-6 receptor (il-6r) antibodies
HK1185258A (en) Stabilized formulations containing anti-ngf antibodies
HK1185258B (en) Stabilized formulations containing anti-ngf antibodies

Legal Events

Date Code Title Description
PA0105 International application

Patent event date: 20230201

Patent event code: PA01051R01D

Comment text: International Patent Application

PG1501 Laying open of application
PA0201 Request for examination

Patent event code: PA02012R01D

Patent event date: 20240704

Comment text: Request for Examination of Application