CN112243379A - 稳定的抗体制剂 - Google Patents

稳定的抗体制剂 Download PDF

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Publication number
CN112243379A
CN112243379A CN201980038032.1A CN201980038032A CN112243379A CN 112243379 A CN112243379 A CN 112243379A CN 201980038032 A CN201980038032 A CN 201980038032A CN 112243379 A CN112243379 A CN 112243379A
Authority
CN
China
Prior art keywords
formulation
antibody
formulations
stable
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.)
Pending
Application number
CN201980038032.1A
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English (en)
Chinese (zh)
Inventor
M·贾亚拉曼
A·钱德拉塞卡尔
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=CN112243379(A) "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 CN112243379A publication Critical patent/CN112243379A/zh
Pending legal-status Critical Current

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    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
CN201980038032.1A 2018-04-10 2019-04-10 稳定的抗体制剂 Pending CN112243379A (zh)

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 (1)

Publication Number Publication Date
CN112243379A true CN112243379A (zh) 2021-01-19

Family

ID=68164052

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201980038032.1A Pending CN112243379A (zh) 2018-04-10 2019-04-10 稳定的抗体制剂

Country Status (10)

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

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4720125A1 (en) 2023-05-30 2026-04-08 Paragon Therapeutics, Inc. Alpha4beta7 integrin antibody compositions and methods of use
EP4762093A1 (en) 2023-08-14 2026-06-24 Paragon Therapeutics, Inc. Alpha 4 beta 7 integrin binding proteins and methods of use

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100098712A1 (en) * 2008-05-20 2010-04-22 Michael Adler Pharmaceutical formulation of an antibody against OX40L
WO2010102241A1 (en) * 2009-03-06 2010-09-10 Genentech, Inc. Antibody formulation
CN103533959A (zh) * 2011-05-02 2014-01-22 米伦纽姆医药公司 抗α4β7抗体的制剂

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103040732B (zh) * 2003-02-10 2015-04-01 伊兰药品公司 免疫球蛋白制剂及其制备方法
US20090208492A1 (en) * 2007-06-14 2009-08-20 Elan Pharmaceuticals, Inc. Lyophilized Immunoglobulin Formulations and Methods of Preparation
UA116189C2 (uk) * 2011-05-02 2018-02-26 Мілленніум Фармасьютікалз, Інк. КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА
CN112292146A (zh) * 2018-04-10 2021-01-29 雷迪博士实验室有限公司 治疗性抗体的稳定的制剂
SG11202009874QA (en) * 2018-04-10 2020-11-27 Dr Reddys Laboratories Ltd Antibody formulation
AR119268A1 (es) * 2019-06-10 2021-12-09 Millennium Pharm Inc Métodos de purificación de anticuerpos y composiciones de estos
CA3143167A1 (en) * 2019-06-10 2020-12-17 Takeda Pharmaceutical Company Limited Methods of producing an anti-.alpha.4.beta.7 antibody

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100098712A1 (en) * 2008-05-20 2010-04-22 Michael Adler Pharmaceutical formulation of an antibody against OX40L
WO2010102241A1 (en) * 2009-03-06 2010-09-10 Genentech, Inc. Antibody formulation
CN102414221A (zh) * 2009-03-06 2012-04-11 健泰科生物技术公司 抗体配制剂
CN103533959A (zh) * 2011-05-02 2014-01-22 米伦纽姆医药公司 抗α4β7抗体的制剂

Also Published As

Publication number Publication date
WO2019198099A1 (en) 2019-10-17
EP3773695A1 (en) 2021-02-17
JP2021521168A (ja) 2021-08-26
AU2019251452A2 (en) 2020-12-03
CO2020013545A2 (es) 2021-01-18
EP3773695A4 (en) 2021-12-22
SG11202009872YA (en) 2020-11-27
ZA202006262B (en) 2023-01-25
BR112020020741A2 (pt) 2021-01-19
US12024561B2 (en) 2024-07-02
AU2019251452A1 (en) 2020-11-26
US20210253714A1 (en) 2021-08-19

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Application publication date: 20210119