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MA46169A1 - Aqueous pharmaceutical composition of a recombinant monoclonal antibody for tumor necrosis factor tnfa - Google Patents

Aqueous pharmaceutical composition of a recombinant monoclonal antibody for tumor necrosis factor tnfa

Info

Publication number
MA46169A1
MA46169A1 MA46169A MA46169A MA46169A1 MA 46169 A1 MA46169 A1 MA 46169A1 MA 46169 A MA46169 A MA 46169A MA 46169 A MA46169 A MA 46169A MA 46169 A1 MA46169 A1 MA 46169A1
Authority
MA
Morocco
Prior art keywords
monoclonal antibody
tnfa
recombinant monoclonal
pharmaceutical composition
necrosis factor
Prior art date
Application number
MA46169A
Other languages
French (fr)
Other versions
MA46169B2 (en
Inventor
Ekaterina Aleksandrovna Lomkova
Dmitry Valentinovich Morozov
Aleksandr Olegovich Iakolev
Viktoriya Olegovna Shitikova
Anastasiya Mikhajlovna Tyakhovskaya
Original Assignee
Biocad Cjsc
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 Biocad Cjsc filed Critical Biocad Cjsc
Priority claimed from PCT/RU2017/050133 external-priority patent/WO2018124948A1/en
Publication of MA46169A1 publication Critical patent/MA46169A1/en
Publication of MA46169B2 publication Critical patent/MA46169B2/en

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
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K47/26—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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La présente invention des compositions pharmaceutiques d'un anticorps monoclonal recombinant pour le facteur tnfa et un procédé de sa production. La présente invention concerne également l'utilisation de compositions pharmaceutiques améliorées d'un anticorps monoclonal recombinant pour le facteur tnfa dans le traitement de maladies à médiation par tnfa. La présente invention permet de prévenir toute instabilité physico-chimique exprimée dans la formation d'agglomérés et de fragments de protéines ou une modification de protéines dans une solution et empêche l'instabilité lorsqu'elle est congelée / décongelée, mélangée ou secouée.The present invention provides pharmaceutical compositions of a recombinant monoclonal antibody to factor tnfa and a method for its production. The present invention also relates to the use of improved pharmaceutical compositions of a recombinant monoclonal antibody for tnfa factor in the treatment of tnfa-mediated diseases. The present invention helps prevent any physicochemical instability expressed in the formation of agglomerates and protein fragments or modification of proteins in a solution and prevents instability when frozen / thawed, mixed or shaken.

MA46169A 2016-12-30 2017-12-29 Aqueous pharmaceutical composition of a recombinant monoclonal antibody for tumor necrosis factor tnfa MA46169B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RU2016152691A RU2665966C2 (en) 2016-12-30 2016-12-30 Recombinant monoclonal antibody to tnf-alpha aqueous pharmaceutical composition
PCT/RU2017/050133 WO2018124948A1 (en) 2016-12-30 2017-12-29 AQUEOUS PHARMACEUTICAL COMPOSITION OF A RECOMBINANT MONOCLONAL ANTIBODY TO FNOα

Publications (2)

Publication Number Publication Date
MA46169A1 true MA46169A1 (en) 2021-09-30
MA46169B2 MA46169B2 (en) 2022-12-30

Family

ID=62813997

Family Applications (1)

Application Number Title Priority Date Filing Date
MA46169A MA46169B2 (en) 2016-12-30 2017-12-29 Aqueous pharmaceutical composition of a recombinant monoclonal antibody for tumor necrosis factor tnfa

Country Status (3)

Country Link
CN (1) CN110536698B (en)
MA (1) MA46169B2 (en)
RU (1) RU2665966C2 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2754760C2 (en) * 2019-04-02 2021-09-07 Закрытое Акционерное Общество "Биокад" Aqueous pharmaceutical composition of anti-il17a antibody and its application
CN116510006A (en) * 2022-01-31 2023-08-01 拜奥卡德联合股份公司 Pharmaceutical composition of anti-TRBV 9 antibody and application thereof

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2473360C2 (en) * 2007-11-30 2013-01-27 Эббот Лэборетриз Protein compositions and methods for preparing them
EP2419448A1 (en) * 2009-04-16 2012-02-22 Abbott Biotherapeutics Corp. Anti-tnf- antibodies and their uses
WO2010129469A1 (en) * 2009-05-04 2010-11-11 Abbott Biotechnology Ltd. Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
HRP20161753T1 (en) * 2010-11-11 2017-02-10 Abbvie Biotechnology Ltd LIQUID HIGH-CONCENTRATION ANTI-TNF-ALPHA ANTIBODICAL FORMULATIONS
KR101730694B1 (en) * 2012-03-07 2017-04-27 카딜라 핼쓰캐어 리미티드 Pharmaceutical Formulations of TNF-Alpha Antibodies
RU2589691C2 (en) * 2014-06-16 2016-07-10 Общество с ограниченной ответственностью "Промоген-МАТ" Stable composition of antibody specifically bound with her2 receptors and preparation method thereof
TW201636047A (en) * 2015-01-28 2016-10-16 麥博賽恩斯有限公司 Pharmaceutical formulations for anti-TNF-alpha antibodies

Also Published As

Publication number Publication date
CN110536698A (en) 2019-12-03
CN110536698B (en) 2024-02-13
RU2665966C2 (en) 2018-09-05
MA46169B2 (en) 2022-12-30
RU2016152691A3 (en) 2018-07-02
RU2016152691A (en) 2018-07-02

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