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EA201900360A1 - WATER PHARMACEUTICAL COMPOSITION OF RECOMBINANT MONOCLONAL ANTIBODY TO TNF - Google Patents

WATER PHARMACEUTICAL COMPOSITION OF RECOMBINANT MONOCLONAL ANTIBODY TO TNF

Info

Publication number
EA201900360A1
EA201900360A1 EA201900360A EA201900360A EA201900360A1 EA 201900360 A1 EA201900360 A1 EA 201900360A1 EA 201900360 A EA201900360 A EA 201900360A EA 201900360 A EA201900360 A EA 201900360A EA 201900360 A1 EA201900360 A1 EA 201900360A1
Authority
EA
Eurasian Patent Office
Prior art keywords
monoclonal antibody
tnf
pharmaceutical composition
recombinant monoclonal
tnfα
Prior art date
Application number
EA201900360A
Other languages
Russian (ru)
Inventor
Екатерина Александровна ЛОМКОВА
Александр Олегович ЯКОВЛЕВ
Виктория Олеговна ШИТИКОВА
Анастасия Михайловна РЯХОВСКАЯ
Дмитрий Валентинович МОРОЗОВ
Original Assignee
Закрытое Акционерное Общество "Биокад"
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 Закрытое Акционерное Общество "Биокад" filed Critical Закрытое Акционерное Общество "Биокад"
Priority claimed from PCT/RU2017/050133 external-priority patent/WO2018124948A1/en
Publication of EA201900360A1 publication Critical patent/EA201900360A1/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
    • 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
    • A61K47/16—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
    • 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
    • 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

Landscapes

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

Abstract

Изобретение относится к улучшенным водным фармацевтическим композициям рекомбинантного моноклонального антитела к ФНОα и способу его получения. Настоящее изобретение также относится к применению улучшенных водных фармацевтических композиций рекомбинантного моноклонального антитела к ФНОα для лечения заболеваний, опосредованных ФНОα. Предложенное изобретение позволяет предотвращать физико-химическую нестабильность, выраженную в образовании агрегатов и фрагментов белков или модификацию белков в растворе, а также предотвращает нестабильность при замораживании-размораживании, перемешивании и встряхивании.The invention relates to improved aqueous pharmaceutical compositions of a recombinant anti-TNFα monoclonal antibody and a method for producing the same. The present invention also relates to the use of improved aqueous pharmaceutical compositions of recombinant anti-TNFα monoclonal antibody for the treatment of diseases mediated by TNFα. The proposed invention makes it possible to prevent physicochemical instability, expressed in the formation of aggregates and fragments of proteins or the modification of proteins in solution, and also prevents instability during freezing-thawing, mixing and shaking.

EA201900360A 2017-12-29 2017-12-29 WATER PHARMACEUTICAL COMPOSITION OF RECOMBINANT MONOCLONAL ANTIBODY TO TNF EA201900360A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RU2017146821A RU2764521C2 (en) 2017-12-29 2017-12-29 AQUEOUS PHARMACEUTICAL COMPOSITION OF A RECOMBINANT MONOCLONAL ANTIBODY TO TNF-α
PCT/RU2017/050133 WO2018124948A1 (en) 2016-12-30 2017-12-29 AQUEOUS PHARMACEUTICAL COMPOSITION OF A RECOMBINANT MONOCLONAL ANTIBODY TO FNOα

Publications (1)

Publication Number Publication Date
EA201900360A1 true EA201900360A1 (en) 2019-12-30

Family

ID=67209836

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201900360A EA201900360A1 (en) 2017-12-29 2017-12-29 WATER PHARMACEUTICAL COMPOSITION OF RECOMBINANT MONOCLONAL ANTIBODY TO TNF

Country Status (2)

Country Link
EA (1) EA201900360A1 (en)
RU (1) RU2764521C2 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024022414A1 (en) * 2022-07-29 2024-02-01 舒泰神（北京）生物制药股份有限公司 High-concentration monoclonal antibody preparation and use thereof

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI0611901A2 (en) * 2005-06-14 2012-08-28 Amgen, Inc composition, lyophilized kit and process for preparing a composition
SG2013054218A (en) * 2008-01-15 2014-10-30 Abbott Gmbh & Co Kg Powdered protein compositions and methods of making same
NZ613809A (en) * 2009-05-04 2015-02-27 Abbvie Biotechnology Ltd Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
CN104707146B (en) * 2013-12-16 2019-04-16 浙江海正药业股份有限公司 A kind of pharmaceutical composition containing adalimumab
HUP1400510A1 (en) * 2014-10-28 2016-05-30 Richter Gedeon Nyrt Pharmaceutical anti-tnfalpha antibody formulation

Also Published As

Publication number Publication date
RU2017146821A (en) 2019-07-01
RU2764521C2 (en) 2022-01-18
RU2017146821A3 (en) 2021-07-09

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