JP2015519382A - 治療用抗体のための医薬処方物 - Google Patents

治療用抗体のための医薬処方物 Download PDF

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Publication number
JP2015519382A
JP2015519382A JP2015516595A JP2015516595A JP2015519382A JP 2015519382 A JP2015519382 A JP 2015519382A JP 2015516595 A JP2015516595 A JP 2015516595A JP 2015516595 A JP2015516595 A JP 2015516595A JP 2015519382 A JP2015519382 A JP 2015519382A
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antibody
concentration
pharmaceutical composition
formulation
buffer
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JP2015519382A5 (enExample
Inventor
フランク ミカエル
フランク ミカエル
シュテファン バサラブ
シュテファン バサラブ
アンナ マリア アイボフナー
アンナ マリア アイボフナー
シルケ ミューラウ
シルケ ミューラウ
マルクス ウォルフラム
マルクス ウォルフラム
Original Assignee
ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング
ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング
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Publication of JP2015519382A publication Critical patent/JP2015519382A/ja
Publication of JP2015519382A5 publication Critical patent/JP2015519382A5/ja
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    • 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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/22—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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'

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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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Transplantation (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2015516595A 2012-06-12 2013-06-12 治療用抗体のための医薬処方物 Pending JP2015519382A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP12171617 2012-06-12
EP12171617.9 2012-06-12
PCT/EP2013/062063 WO2013186230A1 (en) 2012-06-12 2013-06-12 Pharmaceutical formulation for a therapeutic antibody

Publications (2)

Publication Number Publication Date
JP2015519382A true JP2015519382A (ja) 2015-07-09
JP2015519382A5 JP2015519382A5 (enExample) 2016-03-24

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JP2015516595A Pending JP2015519382A (ja) 2012-06-12 2013-06-12 治療用抗体のための医薬処方物

Country Status (4)

Country Link
US (1) US20150150982A1 (enExample)
EP (1) EP2863951A1 (enExample)
JP (1) JP2015519382A (enExample)
WO (1) WO2013186230A1 (enExample)

Cited By (2)

* Cited by examiner, † Cited by third party
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JP2019525902A (ja) * 2016-06-30 2019-09-12 セルトリオン・インコーポレイテッド 安定な液体医薬製剤
JP2021120393A (ja) * 2016-10-21 2021-08-19 アムジエン・インコーポレーテツド 医薬製剤及びその製造方法

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US9062106B2 (en) 2011-04-27 2015-06-23 Abbvie Inc. Methods for controlling the galactosylation profile of recombinantly-expressed proteins
US10093728B2 (en) 2012-03-07 2018-10-09 Cadila Healthcare Limited Pharmaceutical formulations of TNF-alpha antibodies
WO2013158279A1 (en) 2012-04-20 2013-10-24 Abbvie Inc. Protein purification methods to reduce acidic species
US9067990B2 (en) 2013-03-14 2015-06-30 Abbvie, Inc. Protein purification using displacement chromatography
WO2013158273A1 (en) 2012-04-20 2013-10-24 Abbvie Inc. Methods to modulate c-terminal lysine variant distribution
US20140142500A1 (en) * 2012-04-23 2014-05-22 Zogenix, Inc. Piston closures for drug delivery capsules
CN104507497B (zh) * 2012-05-03 2018-10-19 勃林格殷格翰国际有限公司 抗IL-23p19抗体
US9249182B2 (en) 2012-05-24 2016-02-02 Abbvie, Inc. Purification of antibodies using hydrophobic interaction chromatography
US9512214B2 (en) 2012-09-02 2016-12-06 Abbvie, Inc. Methods to control protein heterogeneity
MX2015003007A (es) 2012-09-07 2015-06-05 Coherus Biosciences Inc Formulaciones acuosas estables de adalimumab.
SG11201507230PA (en) 2013-03-12 2015-10-29 Abbvie Inc Human antibodies that bind human tnf-alpha and methods of preparing the same
US9017687B1 (en) 2013-10-18 2015-04-28 Abbvie, Inc. Low acidic species compositions and methods for producing and using the same using displacement chromatography
WO2014151878A2 (en) 2013-03-14 2014-09-25 Abbvie Inc. Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosacharides
EP3052640A2 (en) 2013-10-04 2016-08-10 AbbVie Inc. Use of metal ions for modulation of protein glycosylation profiles of recombinant proteins
JP6526025B2 (ja) 2013-10-16 2019-06-05 オンコバイオロジクス，インコーポレイティド 抗体安定性を増強する緩衝液製剤
US9181337B2 (en) 2013-10-18 2015-11-10 Abbvie, Inc. Modulated lysine variant species compositions and methods for producing and using the same
US9085618B2 (en) 2013-10-18 2015-07-21 Abbvie, Inc. Low acidic species compositions and methods for producing and using the same
WO2015073884A2 (en) 2013-11-15 2015-05-21 Abbvie, Inc. Glycoengineered binding protein compositions
ES2572919T3 (es) * 2014-05-23 2016-06-03 Ares Trading S.A. Composición farmacéutica líquida
PL2946765T3 (pl) 2014-05-23 2017-08-31 Ares Trading S.A. Ciekła kompozycja farmaceutyczna
EP2946767B1 (en) 2014-05-23 2016-10-05 Ares Trading S.A. Liquid pharmaceutical composition
KR20170018810A (ko) 2014-06-10 2017-02-20 메이지 세이카 파루마 가부시키가이샤 안정한 아달리무맙 수성 제제
IL287947B2 (en) 2014-10-23 2024-08-01 Amgen Inc Viscosity reduction of pharmaceutical preparations
HUP1400510A1 (hu) 2014-10-28 2016-05-30 Richter Gedeon Nyrt Gyógyászati TNFalfa ellenes antitest készítmény
US10696735B2 (en) 2015-01-21 2020-06-30 Outlook Therapeutics, Inc. Modulation of charge variants in a monoclonal antibody composition
AR103544A1 (es) * 2015-01-28 2017-05-17 Mabxience S A FORMULACIONES FARMACÉUTICAS PARA ANTICUERPOS ANTI-TNF-a
SG10202103879YA (en) 2015-02-04 2021-05-28 Boehringer Ingelheim Int Methods of treating inflammatory diseases
EP3289092B1 (en) * 2015-04-27 2020-02-12 Momenta Pharmaceuticals, Inc. Method of manufacturing a therapeutic protein
US11229702B1 (en) 2015-10-28 2022-01-25 Coherus Biosciences, Inc. High concentration formulations of adalimumab
CN109563161A (zh) 2016-02-03 2019-04-02 安口生物公司 用于提高抗体稳定性的缓冲制剂
WO2017184880A1 (en) 2016-04-20 2017-10-26 Coherus Biosciences, Inc. A method of filling a container with no headspace
US20200087390A1 (en) 2016-12-21 2020-03-19 Amgen Inc. Anti-tnf alpha antibody formulations
JP7377596B2 (ja) 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法
CN108686204A (zh) * 2017-04-07 2018-10-23 浙江海正药业股份有限公司 包含组氨酸缓冲体系的英夫利西单抗组合物
JP7235770B2 (ja) 2018-05-10 2023-03-08 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 高濃度ｖｅｇｆ受容体融合タンパク質を含む製剤
WO2020138517A1 (ko) * 2018-12-24 2020-07-02 삼성바이오에피스 주식회사 항-TNFα 항체를 포함하는 약제학적 조성물
SG11202108627SA (en) 2019-02-18 2021-09-29 Lilly Co Eli Therapeutic antibody formulation
TW202123965A (zh) 2019-09-09 2021-07-01 德商百靈佳殷格翰國際股份有限公司 抗-il-23p19抗體調配物
CN113546252A (zh) * 2020-04-24 2021-10-26 上海君实生物医药科技股份有限公司 抗pcsk9抗体的药物递送装置

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019525902A (ja) * 2016-06-30 2019-09-12 セルトリオン・インコーポレイテッド 安定な液体医薬製剤
JP7082070B2 (ja) 2016-06-30 2022-06-07 セルトリオン・インコーポレイテッド 安定な液体医薬製剤
JP2022122941A (ja) * 2016-06-30 2022-08-23 セルトリオン・インコーポレイテッド 安定な液体医薬製剤
JP7405324B2 (ja) 2016-06-30 2023-12-26 セルトリオン・インコーポレイテッド 安定な液体医薬製剤
US11951207B2 (en) 2016-06-30 2024-04-09 Celltrion Inc. Stable liquid pharmaceutical preparation
JP2021120393A (ja) * 2016-10-21 2021-08-19 アムジエン・インコーポレーテツド 医薬製剤及びその製造方法
JP2024010026A (ja) * 2016-10-21 2024-01-23 アムジエン・インコーポレーテツド 医薬製剤及びその製造方法
US12214013B2 (en) 2016-10-21 2025-02-04 Amgen Inc. Methods of treatment of arthritis and/or psoriasis with pharmaceutical formulations of etanercept
JP7754903B2 (ja) 2016-10-21 2025-10-15 アムジエン・インコーポレーテツド 医薬製剤及びその製造方法

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WO2013186230A1 (en) 2013-12-19
EP2863951A1 (en) 2015-04-29
US20150150982A1 (en) 2015-06-04

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