AU2019251452A1 - Stable antibody formulation - Google Patents

Stable antibody formulation Download PDF

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Publication number
AU2019251452A1
AU2019251452A1 AU2019251452A AU2019251452A AU2019251452A1 AU 2019251452 A1 AU2019251452 A1 AU 2019251452A1 AU 2019251452 A AU2019251452 A AU 2019251452A AU 2019251452 A AU2019251452 A AU 2019251452A AU 2019251452 A1 AU2019251452 A1 AU 2019251452A1
Authority
AU
Australia
Prior art keywords
formulation
antibody
stable
buffer
salt
Prior art date
Legal status (The legal status 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 status listed.)
Abandoned
Application number
AU2019251452A
Other languages
English (en)
Other versions
AU2019251452A2 (en
Inventor
Anuja CHANDRASEKAR
Murali JAYARAMAN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Dr Reddys Laboratories Ltd
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=68164052&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2019251452(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Dr Reddys Laboratories Ltd filed Critical Dr Reddys Laboratories Ltd
Publication of AU2019251452A1 publication Critical patent/AU2019251452A1/en
Publication of AU2019251452A2 publication Critical patent/AU2019251452A2/en
Abandoned legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, 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)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
AU2019251452A 2018-04-10 2019-04-10 Stable antibody formulation Abandoned AU2019251452A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201841013645 2018-04-10
IN201841013645 2018-04-10
PCT/IN2019/050291 WO2019198099A1 (en) 2018-04-10 2019-04-10 Stable antibody formulation

Publications (2)

Publication Number Publication Date
AU2019251452A1 true AU2019251452A1 (en) 2020-11-26
AU2019251452A2 AU2019251452A2 (en) 2020-12-03

Family

ID=68164052

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2019251452A Abandoned AU2019251452A1 (en) 2018-04-10 2019-04-10 Stable antibody formulation

Country Status (10)

Country Link
US (1) US12024561B2 (https=)
EP (1) EP3773695A4 (https=)
JP (1) JP2021521168A (https=)
CN (1) CN112243379A (https=)
AU (1) AU2019251452A1 (https=)
BR (1) BR112020020741A2 (https=)
CO (1) CO2020013545A2 (https=)
SG (1) SG11202009872YA (https=)
WO (1) WO2019198099A1 (https=)
ZA (1) ZA202006262B (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024249568A1 (en) 2023-05-30 2024-12-05 Paragon Therapeutics, Inc. Alpha4beta7 integrin antibody compositions and methods of use
CN121889424A (zh) 2023-08-14 2026-04-17 派拉冈医疗公司 α4β7整联蛋白结合蛋白及使用方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK2236154T3 (en) * 2003-02-10 2018-06-25 Biogen Ma Inc IMMUNOGLOBULIN INFORMATION AND METHOD OF PREPARING IT
US20090208492A1 (en) * 2007-06-14 2009-08-20 Elan Pharmaceuticals, Inc. Lyophilized Immunoglobulin Formulations and Methods of Preparation
WO2009141239A1 (en) * 2008-05-20 2009-11-26 F. Hoffmann-La Roche Ag A pharmaceutical formulation comprising an antibody against ox40l, uses thereof
AU2010221156A1 (en) * 2009-03-06 2011-09-22 Genentech, Inc. Antibody formulation
UA116189C2 (uk) * 2011-05-02 2018-02-26 Мілленніум Фармасьютікалз, Інк. КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА
MX367097B (es) * 2011-05-02 2019-08-05 Millennium Pharm Inc FORMULACION PARA ANTICUERPO ANTI-A4ß7.
US12433947B2 (en) * 2018-04-10 2025-10-07 Dr. Reddy's Laboratories Limited Stable formulations of therapeutic antibody
WO2019198100A1 (en) * 2018-04-10 2019-10-17 Dr. Reddy's Laboratories Limited Antibody formulation
CN114375307B (zh) * 2019-06-10 2025-12-05 武田药品工业株式会社 产生抗α4β7抗体的方法
EP3980119A4 (en) * 2019-06-10 2023-06-07 Takeda Pharmaceutical Company Limited METHODS FOR PURIFYING ANTIBODIES AND ASSOCIATED COMPOSITIONS

Also Published As

Publication number Publication date
WO2019198099A1 (en) 2019-10-17
SG11202009872YA (en) 2020-11-27
US20210253714A1 (en) 2021-08-19
CN112243379A (zh) 2021-01-19
EP3773695A4 (en) 2021-12-22
EP3773695A1 (en) 2021-02-17
US12024561B2 (en) 2024-07-02
CO2020013545A2 (es) 2021-01-18
BR112020020741A2 (pt) 2021-01-19
JP2021521168A (ja) 2021-08-26
AU2019251452A2 (en) 2020-12-03
ZA202006262B (en) 2023-01-25

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Legal Events

Date Code Title Description
DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS AS SHOWN IN THE STATEMENT FILED 10 NOV 2020

MK1 Application lapsed section 142(2)(a) - no request for examination in relevant period