CR20210318A - Formulación de solución de proteínas que contiene una alta concentración de un anticuerpo anti-vegf - Google Patents

Formulación de solución de proteínas que contiene una alta concentración de un anticuerpo anti-vegf

Info

Publication number
CR20210318A
CR20210318A CR20210318A CR20210318A CR20210318A CR 20210318 A CR20210318 A CR 20210318A CR 20210318 A CR20210318 A CR 20210318A CR 20210318 A CR20210318 A CR 20210318A CR 20210318 A CR20210318 A CR 20210318A
Authority
CR
Costa Rica
Prior art keywords
high concentration
antibody
protein solution
formulation containing
vegf antibody
Prior art date
Application number
CR20210318A
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=69165422&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CR20210318(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of CR20210318A publication Critical patent/CR20210318A/es

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
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/0048Eye, e.g. artificial tears
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, 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)
  • Public Health (AREA)
  • Animal Behavior & Ethology (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)
  • Oil, Petroleum & Natural Gas (AREA)
  • Ophthalmology & Optometry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (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

La presente divulgación proporciona anticuerpos anti-VEGF formulados como alta concentración, composiciones farmacéuticas acuosas, adecuadas para una inyección, con preferencia una inyección intravítrea. Las composiciones farmacéuticas acuosas son útiles para el suministro de una alta concentración del ingrediente activo del anticuerpo a un paciente sin altos niveles de agregación de anticuerpos y sin un alto nivel de material particulado sub-visible. Una composición acuosa de la divulgación comprende un anticuerpo que tiene una concentración de al menos 50 mg/ml. Una composición farmacéutica acuosa de la divulgación incluye un azúcar, un agente tamponador, y un surfactante
CR20210318A 2018-12-18 2019-12-16 Formulación de solución de proteínas que contiene una alta concentración de un anticuerpo anti-vegf CR20210318A (es)

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
CR20210318A true CR20210318A (es) 2021-07-14

Family

ID=69165422

Family Applications (1)

Application Number Title Priority Date Filing Date
CR20210318A CR20210318A (es) 2018-12-18 2019-12-16 Formulación de solución de proteínas que contiene una alta concentración de un anticuerpo anti-vegf

Country Status (24)

Country Link
US (2) US11945859B2 (es)
EP (1) EP3897714A1 (es)
JP (2) JP7089121B2 (es)
KR (1) KR20210106476A (es)
CN (1) CN113194993A (es)
AR (1) AR117707A1 (es)
AU (1) AU2019407063B2 (es)
BR (1) BR112021011290A2 (es)
CA (1) CA3119241A1 (es)
CL (1) CL2021001587A1 (es)
CO (1) CO2021007830A2 (es)
CR (1) CR20210318A (es)
EC (1) ECSP21043639A (es)
IL (1) IL283456A (es)
JO (1) JOP20210152A1 (es)
MX (1) MX2021007393A (es)
MY (1) MY206282A (es)
NZ (1) NZ775956A (es)
PE (1) PE20211602A1 (es)
PH (1) PH12021551307A1 (es)
SG (1) SG11202104653XA (es)
TW (1) TWI857996B (es)
WO (1) WO2020128792A1 (es)
ZA (1) ZA202102986B (es)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104004094B (zh) 2008-06-25 2017-09-22 艾斯巴技术-诺华有限责任公司 使用通用抗体构架进行的兔抗体的人源化
RU2653753C1 (ru) 2008-06-25 2018-05-14 ИЭсБиЭйТЕК, ЭН АЛЬКОН БАЙОМЕДИКАЛ РИСЕРЧ ЮНИТ ЭлЭлСи СТАБИЛЬНЫЕ И РАСТВОРИМЫЕ АНТИТЕЛА, ИНГИБИРУЮЩИЕ 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
KR20250051157A (ko) 2019-06-05 2025-04-16 리제너론 파아마슈티컬스, 인크. 정밀 투여량 전달을 위한 디바이스 및 방법
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 .
RU2653753C1 (ru) 2008-06-25 2018-05-14 ИЭсБиЭйТЕК, ЭН АЛЬКОН БАЙОМЕДИКАЛ РИСЕРЧ ЮНИТ ЭлЭлСи СТАБИЛЬНЫЕ И РАСТВОРИМЫЕ АНТИТЕЛА, ИНГИБИРУЮЩИЕ TNFα
HUE032894T2 (hu) 2008-06-25 2017-11-28 Esbatech Alcon Biomed Res Unit VEGF-gátló, stabilis és oldható antitestek
CN104004094B (zh) 2008-06-25 2017-09-22 艾斯巴技术-诺华有限责任公司 使用通用抗体构架进行的兔抗体的人源化
US9458240B2 (en) * 2010-12-10 2016-10-04 Novartis Pharma Ag Anti-BAFFR antibody formulations
JP2014519520A (ja) 2011-06-16 2014-08-14 ロンザ・リミテッド ペプチドの抽出方法および液相ペプチド合成におけるその使用
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
DE202013000688U1 (de) 2012-07-03 2013-03-05 Novartis Ag Glas-Spritze
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
PH12021551307A1 (en) 2022-05-16
KR20210106476A (ko) 2021-08-30
WO2020128792A1 (en) 2020-06-25
JP2022105056A (ja) 2022-07-12
JP2022513253A (ja) 2022-02-07
MX2021007393A (es) 2021-09-23
CL2021001587A1 (es) 2022-02-11
AU2019407063B2 (en) 2024-07-04
BR112021011290A2 (pt) 2021-11-03
AU2019407063A1 (en) 2021-05-27
ECSP21043639A (es) 2021-07-30
CA3119241A1 (en) 2020-06-25
CO2021007830A2 (es) 2021-06-21
JOP20210152A1 (ar) 2023-01-30
CN113194993A (zh) 2021-07-30
US20240182554A1 (en) 2024-06-06
US11945859B2 (en) 2024-04-02
EP3897714A1 (en) 2021-10-27
SG11202104653XA (en) 2021-07-29
US20200190179A1 (en) 2020-06-18
PE20211602A1 (es) 2021-08-18
TWI857996B (zh) 2024-10-11
JP7089121B2 (ja) 2022-06-21
IL283456A (en) 2021-07-29
AR117707A1 (es) 2021-08-25
NZ775956A (en) 2024-12-20
TW202031289A (zh) 2020-09-01
MY206282A (en) 2024-12-06
ZA202102986B (en) 2024-08-28

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