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JOP20210152A1 - صياغة محلول بروتيني محتوية على تركيز عالٍ من جسم مضاد لـ vegf - Google Patents

صياغة محلول بروتيني محتوية على تركيز عالٍ من جسم مضاد لـ vegf

Info

Publication number
JOP20210152A1
JOP20210152A1 JOP/2021/0152A JOP20210152A JOP20210152A1 JO P20210152 A1 JOP20210152 A1 JO P20210152A1 JO P20210152 A JOP20210152 A JO P20210152A JO P20210152 A1 JOP20210152 A1 JO P20210152A1
Authority
JO
Jordan
Prior art keywords
high concentration
protein solution
antibody
formulation containing
containing high
Prior art date
Application number
JOP/2021/0152A
Other languages
English (en)
Inventor
Moor Pamela De
Juergen Sigg
Original Assignee
Novartis Ag
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 Novartis Ag filed Critical Novartis Ag
Publication of JOP20210152A1 publication Critical patent/JOP20210152A1/ar

Links

Classifications

    • 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
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Ophthalmology & Optometry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Indicating Or Recording The Presence, Absence, Or Direction Of Movement (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
  • Magnetic Resonance Imaging Apparatus (AREA)

Abstract

يتعلق الاختراع الحالي بتوفير أجسام مضادة لـ VEGF تمت صياغتها كتركيبات صيدلانية مائية، عالية التركيز، مناسبة للحقن، يفضل للحقن داخل الجسم الزجاجي. تكون التركيبات الصيدلانية المائية مفيدة لتوصيل تركيز عالٍ من المقوم النشط للجسم المضاد إلى مريض من دون مستويات عالية من تراكم الجسم المضاد ومن دون مستوى عالٍ من مادة دقائقية دون المرئية. تشتمل تركيبة مائية من الاختراع على جسم مضاد له تركيز على الأقل 50 مجم/ ملليلتر. تتضمن تركيبة صيدلانية مائية من الاختراع سكر، عامل مُنظم، ومنشط سطح.
JOP/2021/0152A 2018-12-18 2019-12-16 صياغة محلول بروتيني محتوية على تركيز عالٍ من جسم مضاد لـ vegf JOP20210152A1 (ar)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862781003P 2018-12-18 2018-12-18
PCT/IB2019/060859 WO2020128792A1 (en) 2018-12-18 2019-12-16 Protein solution formulation containing high concentration of an anti-vegf antibody

Publications (1)

Publication Number Publication Date
JOP20210152A1 true JOP20210152A1 (ar) 2023-01-30

Family

ID=69165422

Family Applications (1)

Application Number Title Priority Date Filing Date
JOP/2021/0152A JOP20210152A1 (ar) 2018-12-18 2019-12-16 صياغة محلول بروتيني محتوية على تركيز عالٍ من جسم مضاد لـ vegf

Country Status (23)

Country Link
US (2) US11945859B2 (ar)
EP (1) EP3897714A1 (ar)
JP (2) JP7089121B2 (ar)
KR (1) KR20210106476A (ar)
CN (1) CN113194993A (ar)
AR (1) AR117707A1 (ar)
AU (1) AU2019407063B2 (ar)
BR (1) BR112021011290A2 (ar)
CA (1) CA3119241A1 (ar)
CL (1) CL2021001587A1 (ar)
CO (1) CO2021007830A2 (ar)
CR (1) CR20210318A (ar)
EC (1) ECSP21043639A (ar)
IL (1) IL283456A (ar)
JO (1) JOP20210152A1 (ar)
MX (1) MX2021007393A (ar)
NZ (1) NZ775956A (ar)
PE (1) PE20211602A1 (ar)
PH (1) PH12021551307A1 (ar)
SG (1) SG11202104653XA (ar)
TW (1) TWI857996B (ar)
WO (1) WO2020128792A1 (ar)
ZA (1) ZA202102986B (ar)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101834797B1 (ko) 2008-06-25 2018-03-07 에스바테크 - 어 노바티스 컴파니 엘엘씨 보편적 항체 프레임워크를 사용한 래빗 항체의 인간화
WO2009155723A2 (en) 2008-06-25 2009-12-30 Esbatech, An Alcon Biomedical Research Unit Llc STABLE AND SOLUBLE ANTIBODIES INHIBITING TNFα
TWI761959B (zh) 2014-11-07 2022-04-21 瑞士商諾華公司 治療眼部疾病之方法
CN117820474A (zh) * 2023-04-25 2024-04-05 南京贝思奥生物科技有限公司 改善眼部血管新生相关疾病的药物及其应用

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
WO2009155723A2 (en) 2008-06-25 2009-12-30 Esbatech, An Alcon Biomedical Research Unit Llc STABLE AND SOLUBLE ANTIBODIES INHIBITING TNFα
KR101834797B1 (ko) 2008-06-25 2018-03-07 에스바테크 - 어 노바티스 컴파니 엘엘씨 보편적 항체 프레임워크를 사용한 래빗 항체의 인간화
ES2793008T3 (es) 2008-06-25 2020-11-12 Novartis Ag Anticuerpos estables y solubles que inhiben VEGF
WO2012076670A2 (en) * 2010-12-10 2012-06-14 Novartis Ag Antibody formulation
CN103764666A (zh) 2011-06-16 2014-04-30 隆沙有限公司 萃取胜肽的方法及其在液相胜肽合成的应用
BR112013030472A2 (pt) 2011-06-30 2019-09-24 Genentech Inc formulação farmacêutica, artigo de fabricação e método
US20140004131A1 (en) 2012-05-04 2014-01-02 Novartis Ag Antibody formulation
US9216219B2 (en) 2012-06-12 2015-12-22 Novartis Ag Anti-BAFFR antibody formulation
JOP20200175A1 (ar) 2012-07-03 2017-06-16 Novartis Ag حقنة
US9388239B2 (en) 2014-05-01 2016-07-12 Consejo Nacional De Investigation Cientifica Anti-human VEGF antibodies with unusually strong binding affinity to human VEGF-A and cross reactivity to human VEGF-B
TWI761959B (zh) * 2014-11-07 2022-04-21 瑞士商諾華公司 治療眼部疾病之方法
US20160144025A1 (en) 2014-11-25 2016-05-26 Regeneron Pharmaceuticals, Inc. Methods and formulations for treating vascular eye diseases
AU2019235577B2 (en) 2018-03-16 2021-09-30 Novartis Ag Methods for treating ocular diseases

Also Published As

Publication number Publication date
ZA202102986B (en) 2024-08-28
AU2019407063A1 (en) 2021-05-27
JP2022513253A (ja) 2022-02-07
IL283456A (en) 2021-07-29
AR117707A1 (es) 2021-08-25
AU2019407063B2 (en) 2024-07-04
PE20211602A1 (es) 2021-08-18
SG11202104653XA (en) 2021-07-29
US20200190179A1 (en) 2020-06-18
CO2021007830A2 (es) 2021-06-21
TW202031289A (zh) 2020-09-01
CR20210318A (es) 2021-07-14
CL2021001587A1 (es) 2022-02-11
TWI857996B (zh) 2024-10-11
KR20210106476A (ko) 2021-08-30
WO2020128792A1 (en) 2020-06-25
NZ775956A (en) 2024-12-20
JP7089121B2 (ja) 2022-06-21
CA3119241A1 (en) 2020-06-25
EP3897714A1 (en) 2021-10-27
BR112021011290A2 (pt) 2021-11-03
US11945859B2 (en) 2024-04-02
MX2021007393A (es) 2021-09-23
US20240182554A1 (en) 2024-06-06
ECSP21043639A (es) 2021-07-30
PH12021551307A1 (en) 2022-05-16
CN113194993A (zh) 2021-07-30
JP2022105056A (ja) 2022-07-12

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