CN112218654A - 抗体制剂 - Google Patents

抗体制剂 Download PDF

Info

Publication number
CN112218654A
CN112218654A CN201980037792.0A CN201980037792A CN112218654A CN 112218654 A CN112218654 A CN 112218654A CN 201980037792 A CN201980037792 A CN 201980037792A CN 112218654 A CN112218654 A CN 112218654A
Authority
CN
China
Prior art keywords
antibody
formulation
formulations
sugar
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
CN201980037792.0A
Other languages
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
Application filed by Dr Reddys Laboratories Ltd filed Critical Dr Reddys Laboratories Ltd
Publication of CN112218654A publication Critical patent/CN112218654A/zh
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • A61K47/16—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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839—Immunoglobulins [IGs], 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
    • C07K16/2842—Immunoglobulins [IGs], 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 against integrin beta1-subunit-containing molecules, e.g. CD29, CD49
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839—Immunoglobulins [IGs], 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
    • C07K2317/90—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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
CN201980037792.0A 2018-04-10 2019-04-10 抗体制剂 Pending CN112218654A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201841013646 2018-04-10
IN201841013646 2018-04-10
PCT/IN2019/050292 WO2019198100A1 (en) 2018-04-10 2019-04-10 Antibody formulation

Publications (1)

Publication Number Publication Date
CN112218654A true CN112218654A (zh) 2021-01-12

Family

ID=68163986

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201980037792.0A Pending CN112218654A (zh) 2018-04-10 2019-04-10 抗体制剂

Country Status (10)

Country Link
US (1) US12030948B2 (enExample)
EP (1) EP3773694A4 (enExample)
JP (2) JP2021521159A (enExample)
CN (1) CN112218654A (enExample)
AU (1) AU2019253070A1 (enExample)
BR (1) BR112020020707A2 (enExample)
CO (1) CO2020013552A2 (enExample)
SG (1) SG11202009874QA (enExample)
WO (1) WO2019198100A1 (enExample)
ZA (1) ZA202006263B (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113813377A (zh) * 2021-09-07 2021-12-21 杭州远大生物制药有限公司 抗α4β7抗体制剂及其应用

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6897570B2 (ja) 2015-12-18 2021-06-30 アステラス製薬株式会社 抗ヒトｔｓｌｐ受容体抗体含有医薬組成物
JP2021521168A (ja) * 2018-04-10 2021-08-26 ドクター レディズ ラボラトリーズ リミテッド 安定な抗体製剤
KR20230010239A (ko) * 2020-05-11 2023-01-18 메디뮨 리미티드 항-il-33 항체의 제형물
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
US20230340131A1 (en) * 2020-11-12 2023-10-26 Dr. Reddy’S Laboratories Limited Stable aqueous high concentration formulation of integrin antibody
WO2022157806A1 (en) * 2021-01-20 2022-07-28 Dr. Reddy's Laboratories Limited Freeze dried antibody formulations and methods thereof
EP4333878A4 (en) * 2021-05-07 2025-03-19 Dr. Reddy's Laboratories Limited METHOD FOR IMPROVING THE STABILITY OF AN ANTIBODY FORMULATION
WO2022253994A1 (en) * 2021-06-04 2022-12-08 Polpharma Biologics S.A. Vedolizumab formulation
WO2024102675A1 (en) 2022-11-07 2024-05-16 Upstream Bio, Inc. Pharmaceutical compositions comprising anti-human tslp receptor antibodies and methods of using the same
WO2024249568A1 (en) 2023-05-30 2024-12-05 Paragon Therapeutics, Inc. Alpha4beta7 integrin antibody compositions and methods of use
WO2025041000A1 (en) * 2023-08-21 2025-02-27 Intas Pharmaceuticals Ltd. STABLE LIQUID CITRATE FREE FORMULATION OF AN ANTI-α4β7 ANTIBODY

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101827608A (zh) * 2007-06-14 2010-09-08 伊兰制药公司 冻干的免疫球蛋白制剂和制备方法
CN103533959A (zh) * 2011-05-02 2014-01-22 米伦纽姆医药公司 抗α4β7抗体的制剂
CN103608071A (zh) * 2011-05-02 2014-02-26 米伦纽姆医药公司 抗α4β7抗体的制剂

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004071439A2 (en) * 2003-02-10 2004-08-26 Elan Pharmaceuticals, Inc. Immunoglobulin formulation and method of preparation thereof
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
WO2012076670A2 (en) * 2010-12-10 2012-06-14 Novartis Ag Antibody formulation
WO2017015198A1 (en) * 2015-07-17 2017-01-26 Coherus Biosciences, Inc. Stable aqeous formulations of natalizumab
US20210031012A1 (en) * 2018-01-26 2021-02-04 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with a pde4 inhibitor
US20220364171A1 (en) * 2018-11-23 2022-11-17 Katholieke Universiteit Leuven Predicting a treatment response in inflammatory bowel disease

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101827608A (zh) * 2007-06-14 2010-09-08 伊兰制药公司 冻干的免疫球蛋白制剂和制备方法
CN103533959A (zh) * 2011-05-02 2014-01-22 米伦纽姆医药公司 抗α4β7抗体的制剂
CN103608071A (zh) * 2011-05-02 2014-02-26 米伦纽姆医药公司 抗α4β7抗体的制剂

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
J L CLELAND ET AL.: "A specific molar ratio of stabilizer to protein is required for storage stability of a lyophilized monoclonal antibody", J PHARM SCI, vol. 90, no. 3, pages 310 - 317 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113813377A (zh) * 2021-09-07 2021-12-21 杭州远大生物制药有限公司 抗α4β7抗体制剂及其应用

Also Published As

Publication number Publication date
SG11202009874QA (en) 2020-11-27
EP3773694A1 (en) 2021-02-17
WO2019198100A1 (en) 2019-10-17
BR112020020707A2 (pt) 2021-01-12
JP2024001364A (ja) 2024-01-09
CO2020013552A2 (es) 2021-01-18
EP3773694A4 (en) 2021-12-29
ZA202006263B (en) 2022-01-26
AU2019253070A1 (en) 2020-11-26
US12030948B2 (en) 2024-07-09
AU2019253070A2 (en) 2020-12-03
US20210147555A1 (en) 2021-05-20
JP2021521159A (ja) 2021-08-26

Similar Documents

Publication Publication Date Title
CN112218654A (zh) 抗体制剂
CN112292146A (zh) 治疗性抗体的稳定的制剂
JP2022551622A (ja) インテグリン抗体の安定な製剤
EP4243859A1 (en) Stable aqueous high concentration formulation of integrin antibody
CN117545501A (zh) 改善抗体制剂的稳定性的方法
CN118076380A (zh) 免疫检查点抑制剂的药物配制物
WO2022123603A1 (en) Stable aqueous buffer free formulation of an integrin antibody
CN112243379A (zh) 稳定的抗体制剂
WO2023037384A1 (en) Formulations of immune check point inhibitors or like
WO2024023843A1 (en) A pharmaceutical formulation of a therapeuticantibody and preparations thereof
CN118076381A (zh) 改进免疫检查点抑制剂的稳定性的方法
Ricci aaaaasSampathkumar Krishnan, Monica M. Pallitto, and

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
WD01 Invention patent application deemed withdrawn after publication

Application publication date: 20210112

WD01 Invention patent application deemed withdrawn after publication