CO2021007830A2 - 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
CO2021007830A2
CO2021007830A2 CONC2021/0007830A CO2021007830A CO2021007830A2 CO 2021007830 A2 CO2021007830 A2 CO 2021007830A2 CO 2021007830 A CO2021007830 A CO 2021007830A CO 2021007830 A2 CO2021007830 A2 CO 2021007830A2
Authority
CO
Colombia
Prior art keywords
high concentration
antibody
protein solution
formulation containing
vegf antibody
Prior art date
Application number
CONC2021/0007830A
Other languages
English (en)
Inventor
Juergen Sigg
Moor Pamela De
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 CO2021007830A2 publication Critical patent/CO2021007830A2/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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22Immunoglobulins [IGs], 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)
  • 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)
  • 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)
  • Peptides Or Proteins (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.
CONC2021/0007830A 2018-12-18 2021-06-15 Formulación de solución de proteínas que contiene una alta concentración de un anticuerpo anti-vegf CO2021007830A2 (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
CO2021007830A2 true CO2021007830A2 (es) 2021-06-21

Family

ID=69165422

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2021/0007830A CO2021007830A2 (es) 2018-12-18 2021-06-15 Formulación de solución de proteínas que contiene una alta concentración de un anticuerpo anti-vegf

Country Status (20)

Country Link
US (1) US11945859B2 (es)
EP (1) EP3897714A1 (es)
JP (2) JP7089121B2 (es)
KR (1) KR20210106476A (es)
CN (1) CN113194993A (es)
AR (1) AR117707A1 (es)
AU (1) AU2019407063A1 (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)
PE (1) PE20211602A1 (es)
SG (1) SG11202104653XA (es)
TW (1) TW202031289A (es)
WO (1) WO2020128792A1 (es)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102164958A (zh) 2008-06-25 2011-08-24 艾斯巴技术,爱尔康生物医药研究装置有限责任公司 使用通用抗体构架进行的兔抗体的人源化
ES2687259T5 (es) 2008-06-25 2022-10-14 Novartis Ag Anticuerpos estables y solubles que inhiben TNF

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 .
ES2687259T5 (es) 2008-06-25 2022-10-14 Novartis Ag Anticuerpos estables y solubles que inhiben TNF
CN102164958A (zh) 2008-06-25 2011-08-24 艾斯巴技术,爱尔康生物医药研究装置有限责任公司 使用通用抗体构架进行的兔抗体的人源化
US8349322B2 (en) 2008-06-25 2013-01-08 ESBATech, an Alcon Biomedical Research Unit, LLC Stable and soluble antibodies inhibiting VEGF
US9458240B2 (en) 2010-12-10 2016-10-04 Novartis Pharma Ag Anti-BAFFR antibody formulations
WO2012171987A1 (en) 2011-06-16 2012-12-20 Lonza Ltd A process for extraction of peptides and its application in liquid phase peptide synthesis
AR086823A1 (es) 2011-06-30 2014-01-22 Genentech Inc Formulaciones de anticuerpo anti-c-met, metodos
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
CN111867631A (zh) 2018-03-16 2020-10-30 诺华股份有限公司 治疗眼部疾病的方法

Also Published As

Publication number Publication date
TW202031289A (zh) 2020-09-01
CR20210318A (es) 2021-07-14
JOP20210152A1 (ar) 2023-01-30
AU2019407063A1 (en) 2021-05-27
ECSP21043639A (es) 2021-07-30
IL283456A (en) 2021-07-29
JP2022513253A (ja) 2022-02-07
BR112021011290A2 (pt) 2021-11-03
US20200190179A1 (en) 2020-06-18
SG11202104653XA (en) 2021-07-29
MX2021007393A (es) 2021-09-23
PE20211602A1 (es) 2021-08-18
KR20210106476A (ko) 2021-08-30
US11945859B2 (en) 2024-04-02
JP7089121B2 (ja) 2022-06-21
CN113194993A (zh) 2021-07-30
EP3897714A1 (en) 2021-10-27
CL2021001587A1 (es) 2022-02-11
JP2022105056A (ja) 2022-07-12
AR117707A1 (es) 2021-08-25
CA3119241A1 (en) 2020-06-25
WO2020128792A1 (en) 2020-06-25

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