AU2019251453A1 - Stable formulations of therapeutic antibody - Google Patents

Stable formulations of therapeutic antibody Download PDF

Info

Publication number
AU2019251453A1
AU2019251453A1 AU2019251453A AU2019251453A AU2019251453A1 AU 2019251453 A1 AU2019251453 A1 AU 2019251453A1 AU 2019251453 A AU2019251453 A AU 2019251453A AU 2019251453 A AU2019251453 A AU 2019251453A AU 2019251453 A1 AU2019251453 A1 AU 2019251453A1
Authority
AU
Australia
Prior art keywords
antibody
formulation
vedolizumab
formulations
buffer
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
AU2019251453A
Other languages
English (en)
Other versions
AU2019251453A2 (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
Application filed by Dr Reddys Laboratories Ltd filed Critical Dr Reddys Laboratories Ltd
Publication of AU2019251453A1 publication Critical patent/AU2019251453A1/en
Publication of AU2019251453A2 publication Critical patent/AU2019251453A2/en
Abandoned legal-status Critical Current

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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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
    • 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
    • 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
    • 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

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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
AU2019251453A 2018-04-10 2019-04-10 Stable formulations of therapeutic antibody Abandoned AU2019251453A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201841013647 2018-04-10
IN201841013647 2018-04-10
PCT/IN2019/050293 WO2019198101A1 (en) 2018-04-10 2019-04-10 Stable formulations of therapeutic antibody

Publications (2)

Publication Number Publication Date
AU2019251453A1 true AU2019251453A1 (en) 2020-11-26
AU2019251453A2 AU2019251453A2 (en) 2020-12-03

Family

ID=68164106

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2019251453A Abandoned AU2019251453A1 (en) 2018-04-10 2019-04-10 Stable formulations of therapeutic antibody

Country Status (10)

Country Link
US (1) US12433947B2 (https=)
EP (1) EP3773696A4 (https=)
JP (1) JP2021521171A (https=)
CN (1) CN112292146A (https=)
AU (1) AU2019251453A1 (https=)
BR (1) BR112020020703A2 (https=)
CO (1) CO2020013571A2 (https=)
SG (1) SG11202009876TA (https=)
WO (1) WO2019198101A1 (https=)
ZA (1) ZA202006264B (https=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022253994A1 (en) * 2021-06-04 2022-12-08 Polpharma Biologics S.A. Vedolizumab formulation

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG10202012778YA (en) 2015-12-18 2021-01-28 Astellas Pharma Inc Pharmaceutical composition comprising anti-human tslp receptor antibody
WO2019198099A1 (en) * 2018-04-10 2019-10-17 Dr. Reddy's Laboratories Limited Stable antibody formulation
WO2024098180A1 (en) * 2022-11-07 2024-05-16 Wuxi Biologics (Hong Kong) Limited Pharmaceutical compositions comprising anti-human tslp receptor antibodies and methods of using the same
EP4259192A4 (en) * 2020-12-09 2024-11-20 Dr. Reddy's Laboratories Limited STABLE AQUEOUS BUFFER-FREE FORMULATION OF AN INTEGRIN ANTIBODY
EP4717712A2 (en) * 2021-12-27 2026-04-01 Polpharma Biologics S.A. Vedolizumab formulation
TW202432601A (zh) 2022-11-07 2024-08-16 美商上游生物公司 包含抗人類ｔｓｌｐ受體抗體之醫藥組成物及其使用方法
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 (8)

* 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
NZ595526A (en) * 2007-06-14 2013-03-28 Biogen Idec Inc Pharmaceutical composition comprising a vla-4 binding antibody, a phosphate buffer and a surfactant
US20090208492A1 (en) * 2007-06-14 2009-08-20 Elan Pharmaceuticals, Inc. Lyophilized Immunoglobulin Formulations and Methods of Preparation
BRPI0820819B1 (pt) * 2007-12-21 2021-06-08 F. Hoffmann-La Roche Ag formulação de anticorpos humanizados b-ly 1 e seu uso
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.
TWI752912B (zh) 2015-07-17 2022-01-21 美商寇西勒斯生物科技股份有限公司 那他珠單抗的穩定水性調配物
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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022253994A1 (en) * 2021-06-04 2022-12-08 Polpharma Biologics S.A. Vedolizumab formulation

Also Published As

Publication number Publication date
EP3773696A1 (en) 2021-02-17
CN112292146A (zh) 2021-01-29
JP2021521171A (ja) 2021-08-26
US12433947B2 (en) 2025-10-07
US20210401982A1 (en) 2021-12-30
WO2019198101A1 (en) 2019-10-17
ZA202006264B (en) 2022-09-28
CO2020013571A2 (es) 2021-01-18
BR112020020703A2 (pt) 2021-01-12
EP3773696A4 (en) 2021-12-29
AU2019251453A2 (en) 2020-12-03
SG11202009876TA (en) 2020-11-27

Similar Documents

Publication Publication Date Title
US12030948B2 (en) Antibody formulation
US12433947B2 (en) Stable formulations of therapeutic antibody
WO2021070203A1 (en) Stable formulation of integrin antibody
EP4243859A1 (en) Stable aqueous high concentration formulation of integrin antibody
WO2022123603A1 (en) Stable aqueous buffer free formulation of an integrin antibody
US12024561B2 (en) Stable antibody formulation
WO2023031970A1 (en) A pharmaceutical formulation of immune check point inhibitors
EP4398932A1 (en) Formulations of immune check point inhibitors or like
WO2024023843A1 (en) A pharmaceutical formulation of a therapeuticantibody and preparations thereof
WO2025037335A1 (en) Formulations of anti-cd20 antibody
EP4251197A1 (en) Stable therapeutic protein formulation and methods of making the same
WO2025037336A1 (en) Pharmaceutical formulations of anti-cd 20 antibody and methods of preparing the same

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