JP2021521159A - 抗体製剤 - Google Patents

抗体製剤 Download PDF

Info

Publication number
JP2021521159A
JP2021521159A JP2020555387A JP2020555387A JP2021521159A JP 2021521159 A JP2021521159 A JP 2021521159A JP 2020555387 A JP2020555387 A JP 2020555387A JP 2020555387 A JP2020555387 A JP 2020555387A JP 2021521159 A JP2021521159 A JP 2021521159A
Authority
JP
Japan
Prior art keywords
antibody
preparation
sugar
vedolizumab
weeks
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
JP2020555387A
Other languages
English (en)
Japanese (ja)
Other versions
JP2021521159A5 (https=
Inventor
ムラリ ジャヤラマン，
ムラリ ジャヤラマン，
アヌジャ チャンドラセカール，
アヌジャ チャンドラセカール，
Original Assignee
ドクター レディズ ラボラトリーズ リミテッド
ドクター レディズ ラボラトリーズ リミテッド
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 ドクター レディズ ラボラトリーズ リミテッド, ドクター レディズ ラボラトリーズ リミテッド filed Critical ドクター レディズ ラボラトリーズ リミテッド
Publication of JP2021521159A publication Critical patent/JP2021521159A/ja
Publication of JP2021521159A5 publication Critical patent/JP2021521159A5/ja
Priority to JP2023189255A priority Critical patent/JP7793581B2/ja
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 [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
    • C07K16/2842—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 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 [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
    • C07K2317/90—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)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2020555387A 2018-04-10 2019-04-10 抗体製剤 Pending JP2021521159A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2023189255A JP7793581B2 (ja) 2018-04-10 2023-11-06 抗体製剤

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2023189255A Division JP7793581B2 (ja) 2018-04-10 2023-11-06 抗体製剤

Publications (2)

Publication Number Publication Date
JP2021521159A true JP2021521159A (ja) 2021-08-26
JP2021521159A5 JP2021521159A5 (https=) 2022-04-15

Family

ID=68163986

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2020555387A Pending JP2021521159A (ja) 2018-04-10 2019-04-10 抗体製剤
JP2023189255A Active JP7793581B2 (ja) 2018-04-10 2023-11-06 抗体製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2023189255A Active JP7793581B2 (ja) 2018-04-10 2023-11-06 抗体製剤

Country Status (10)

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

Families Citing this family (13)

* 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
JP7804590B2 (ja) * 2020-05-11 2026-01-22 メディミューン リミテッド 抗ｉｌ－３３抗体の処方物
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
EP4243859A4 (en) * 2020-11-12 2024-10-16 Dr. Reddy's Laboratories Ltd. STABLE AQUEOUS FORMULATION WITH HIGH CONCENTRATION OF ANTI-INTEGRIN ANTIBODY
WO2022157806A1 (en) * 2021-01-20 2022-07-28 Dr. Reddy's Laboratories Limited Freeze dried antibody formulations and methods thereof
WO2022234594A1 (en) * 2021-05-07 2022-11-10 Dr. Reddy’S Laboratories Limited A method of improving stability of an antibody formulation
EP4346899A1 (en) * 2021-06-04 2024-04-10 Polpharma Biologics S.A. Vedolizumab formulation
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
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
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
JP2010530003A (ja) * 2007-06-14 2010-09-02 エラン ファーマシューティカルズ，インコーポレイテッド 凍結乾燥免疫グロブリン製剤および調製方法
JP2014514346A (ja) * 2011-05-02 2014-06-19 ミレニアム ファーマシューティカルズ， インコーポレイテッド 抗α４β７抗体のための製剤
JP2014515763A (ja) * 2011-05-02 2014-07-03 ミレニアム ファーマシューティカルズ， インコーポレイテッド 抗α４β７抗体のための製剤

Family Cites Families (6)

* 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
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
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
WO2019147824A1 (en) * 2018-01-26 2019-08-01 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
JP2010530003A (ja) * 2007-06-14 2010-09-02 エラン ファーマシューティカルズ，インコーポレイテッド 凍結乾燥免疫グロブリン製剤および調製方法
JP2014514346A (ja) * 2011-05-02 2014-06-19 ミレニアム ファーマシューティカルズ， インコーポレイテッド 抗α４β７抗体のための製剤
JP2014515763A (ja) * 2011-05-02 2014-07-03 ミレニアム ファーマシューティカルズ， インコーポレイテッド 抗α４β７抗体のための製剤

Also Published As

Publication number Publication date
CO2020013552A2 (es) 2021-01-18
WO2019198100A1 (en) 2019-10-17
BR112020020707A2 (pt) 2021-01-12
JP7793581B2 (ja) 2026-01-05
EP3773694A4 (en) 2021-12-29
AU2019253070A1 (en) 2020-11-26
CN112218654A (zh) 2021-01-12
AU2019253070A2 (en) 2020-12-03
JP2024001364A (ja) 2024-01-09
EP3773694A1 (en) 2021-02-17
SG11202009874QA (en) 2020-11-27
US12030948B2 (en) 2024-07-09
ZA202006263B (en) 2022-01-26
US20210147555A1 (en) 2021-05-20

Similar Documents

Publication Publication Date Title
JP7793581B2 (ja) 抗体製剤
JP2021521171A (ja) 治療用抗体の安定な製剤
JP2022551622A (ja) インテグリン抗体の安定な製剤
WO2022101935A1 (en) Stable aqueous high concentration formulation of integrin antibody
EP4259192A1 (en) Stable aqueous buffer free formulation of an integrin antibody
JP2021521168A (ja) 安定な抗体製剤
EP4395816A1 (en) A pharmaceutical formulation of immune check point inhibitors
WO2024023843A1 (en) A pharmaceutical formulation of a therapeuticantibody and preparations thereof
EP4398932A1 (en) Formulations of immune check point inhibitors or like
WO2025037335A1 (en) Formulations of anti-cd20 antibody
WO2022113105A1 (en) Stable therapeutic protein formulation and methods of making the same

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20220407

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20220407

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20230123

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20230125

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230425

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20230705