CO2023015509A2 - Un método para mejorar la estabilidad de una formulación de anticuerpos - Google Patents

Un método para mejorar la estabilidad de una formulación de anticuerpos

Info

Publication number
CO2023015509A2
CO2023015509A2 CONC2023/0015509A CO2023015509A CO2023015509A2 CO 2023015509 A2 CO2023015509 A2 CO 2023015509A2 CO 2023015509 A CO2023015509 A CO 2023015509A CO 2023015509 A2 CO2023015509 A2 CO 2023015509A2
Authority
CO
Colombia
Prior art keywords
antibody
formulations
stability
improve
antibody formulation
Prior art date
Application number
CONC2023/0015509A
Other languages
English (en)
Inventor
Murali Jayaraman
Pakhale Swapnil Vasudeo
Shrija Ghosh
L Shri Ranga Priya R
Ananya Saha
Suman Labala
Mahesh Ingale
Original Assignee
Dr Reddys Laboratories Ltd
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 Dr Reddys Laboratories Ltd filed Critical Dr Reddys Laboratories Ltd
Publication of CO2023015509A2 publication Critical patent/CO2023015509A2/es

Links

Classifications

    • 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
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La presente invención divulga una formulación estable de un anticuerpo α4β7, en la que la formulación comprende un anticuerpo α4β7, un aminoácido, un ácido monocarboxílico o ácido dicarboxílico y un tensioactivo. Las formulaciones de anticuerpos divulgadas son formulaciones líquidas de alta concentración que también son adecuadas para diferentes modos de administración (subcutánea/intravenosa). Las formulaciones divulgadas exhiben estabilidad bajo diversas condiciones de estrés acelerado.
CONC2023/0015509A 2021-05-07 2023-11-17 Un método para mejorar la estabilidad de una formulación de anticuerpos CO2023015509A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202141020878 2021-05-07
PCT/IN2022/050430 WO2022234594A1 (en) 2021-05-07 2022-05-05 A method of improving stability of an antibody formulation

Publications (1)

Publication Number Publication Date
CO2023015509A2 true CO2023015509A2 (es) 2023-11-30

Family

ID=83932659

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2023/0015509A CO2023015509A2 (es) 2021-05-07 2023-11-17 Un método para mejorar la estabilidad de una formulación de anticuerpos

Country Status (7)

Country Link
EP (1) EP4333878A1 (es)
JP (1) JP2024516293A (es)
CN (1) CN117545501A (es)
AU (1) AU2022271025A1 (es)
BR (1) BR112023022811A2 (es)
CO (1) CO2023015509A2 (es)
WO (1) WO2022234594A1 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116466092A (zh) * 2023-03-21 2023-07-21 浙江夸克生物科技有限公司 定量测定尿视黄醇结合蛋白的试剂盒

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4317010B2 (ja) * 2001-07-25 2009-08-19 ピーディーエル バイオファーマ,インコーポレイティド IgG抗体の安定な凍結乾燥医薬製剤
JP5231810B2 (ja) * 2005-12-28 2013-07-10 中外製薬株式会社 抗体含有安定化製剤
UA116189C2 (uk) * 2011-05-02 2018-02-26 Мілленніум Фармасьютікалз, Інк. КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА

Also Published As

Publication number Publication date
CN117545501A (zh) 2024-02-09
AU2022271025A1 (en) 2023-12-14
JP2024516293A (ja) 2024-04-12
EP4333878A1 (en) 2024-03-13
BR112023022811A2 (pt) 2024-01-16
WO2022234594A1 (en) 2022-11-10

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