JP2019527729A - 治療用タンパク質製剤のための安定化賦形剤 - Google Patents

治療用タンパク質製剤のための安定化賦形剤 Download PDF

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Publication number
JP2019527729A
JP2019527729A JP2019522614A JP2019522614A JP2019527729A JP 2019527729 A JP2019527729 A JP 2019527729A JP 2019522614 A JP2019522614 A JP 2019522614A JP 2019522614 A JP2019522614 A JP 2019522614A JP 2019527729 A JP2019527729 A JP 2019527729A
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formulation
stabilizing excipient
ppm
therapeutic
protein
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Japanese (ja)
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JP2019527729A5 (enExample
Inventor
ソーン、デイヴィッド、エス．
マホーニー、ロバート、ピー．
ビュートリッヒ、フィリップ
グリーン、ダニエル、ジー．
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リフォーム バイオロジクス、エルエルシー
リフォーム バイオロジクス、エルエルシー
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Publication of JP2019527729A publication Critical patent/JP2019527729A/ja
Publication of JP2019527729A5 publication Critical patent/JP2019527729A5/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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
    • A61K47/543—Lipids, e.g. triglycerides; Polyamines, e.g. spermine or spermidine
    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1774—Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/08—Solutions
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/04—Drugs for genital or sexual disorders; Contraceptives for inducing labour or abortion; Uterotonics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G73/00—Macromolecular compounds obtained by reactions forming a linkage containing nitrogen with or without oxygen or carbon in the main chain of the macromolecule, not provided for in groups C08G12/00 - C08G71/00
    • C08G73/02—Polyamines
    • C08G73/0233—Polyamines derived from (poly)oxazolines, (poly)oxazines or having pendant acyl groups
    • 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
    • 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
    • C07K16/2863—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Polymers & Plastics (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Cell Biology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2019522614A 2016-07-13 2017-07-12 治療用タンパク質製剤のための安定化賦形剤 Pending JP2019527729A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662361793P 2016-07-13 2016-07-13
US62/361,793 2016-07-13
PCT/US2017/041691 WO2018013673A1 (en) 2016-07-13 2017-07-12 Stabilizing excipients for therapeutic protein formulations

Publications (2)

Publication Number Publication Date
JP2019527729A true JP2019527729A (ja) 2019-10-03
JP2019527729A5 JP2019527729A5 (enExample) 2020-08-06

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JP2019522614A Pending JP2019527729A (ja) 2016-07-13 2017-07-12 治療用タンパク質製剤のための安定化賦形剤

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Country Link
US (4) US10279048B2 (enExample)
EP (1) EP3484520A4 (enExample)
JP (1) JP2019527729A (enExample)
KR (1) KR20190027878A (enExample)
CA (1) CA3030422C (enExample)
WO (1) WO2018013673A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023532764A (ja) * 2020-07-07 2023-07-31 エフ． ホフマン－ラ ロシュ アーゲー 治療用タンパク質製剤の安定剤としての代替界面活性剤

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. Excipient compounds for protein processing
WO2015196091A1 (en) 2014-06-20 2015-12-23 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
WO2019036619A1 (en) * 2017-08-18 2019-02-21 Reform Biologics, Llc STABILIZING EXCIPIENTS FOR FORMULATIONS OF THERAPEUTIC PROTEIN
JP7256816B2 (ja) * 2018-03-07 2023-04-12 コメラ ライフ サイエンシズ，インコーポレイテッド タンパク質製剤用の賦形剤化合物
US11318183B2 (en) 2018-03-20 2022-05-03 Mankind Pharma Ltd. Stable pharmaceutical composition of vasopressin
RS67656B1 (sr) 2018-05-10 2026-02-27 Regeneron Pharma Formulacije koje sadrže visoke koncentracije fuzionog proteina vegf receptora
US20200093884A1 (en) 2018-09-20 2020-03-26 Mark C. Manning Stable intranasal formulations of carbetocin
EP3852724A4 (en) 2018-09-20 2022-07-06 Levo Therapeutics, Inc. CARBETOCIN DRUG PRODUCT AND PROCESS FOR ITS MANUFACTURE
GB201904741D0 (en) * 2019-04-04 2019-05-22 Glaxosmithkline Ip Dev Ltd Novel process
WO2020213682A1 (ja) * 2019-04-19 2020-10-22 富士フイルム和光純薬株式会社 細胞外小胞の保存安定化剤及び保存安定化方法
WO2023203257A1 (en) * 2022-04-22 2023-10-26 Janssen Sciences Ireland Unlimited Company Freeze dried compositions

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2510633C3 (de) * 1975-03-12 1978-07-13 Boehringer Mannheim Gmbh, 6800 Mannheim Diagnostisches Mittel zum Nachweis von Eiweiß in Körperflüssigkeiten und dafür geeignete Indikatorfarbstoffe
US5183746A (en) * 1986-10-27 1993-02-02 Schering Aktiengesellschaft Formulation processes for pharmaceutical compositions of recombinant β-
US6039977A (en) * 1997-12-09 2000-03-21 Alza Corporation Pharmaceutical hydrogel formulations, and associated drug delivery devices and methods
WO2002076432A2 (en) * 2001-03-26 2002-10-03 Novartis Ag Pharmaceutical composition comprising a poorly water-soluble active ingredient, a surfactant and a water-soluble polymer
US7041088B2 (en) 2002-10-11 2006-05-09 Ethicon, Inc. Medical devices having durable and lubricious polymeric coating
DE10325198B4 (de) 2003-06-04 2007-10-25 Clariant Produkte (Deutschland) Gmbh Verwendung von alkoxylierten vernetzten Polyglycerinen als biologisch abbaubare Emulsionsspalter
US8025915B2 (en) 2006-01-11 2011-09-27 Schott Ag Method of preparing a macromolecule deterrent surface on a pharmaceutical package
CN106443002A (zh) 2007-10-22 2017-02-22 贝克顿·迪金森公司 评价在含有机基聚硅氧烷的悬浮液中蛋白质聚集的方法
CN101795680A (zh) * 2007-11-16 2010-08-04 波苏蛋白试剂公司 稳定蛋白质的辅剂
KR20120089843A (ko) * 2009-07-31 2012-08-14 사노피-아벤티스 도이칠란트 게엠베하 인슐린 링커 접합체를 포함한 프로드럭
WO2011134979A2 (en) * 2010-04-27 2011-11-03 Scil Technology Gmbh Stable mia/cd-rap formulation
US8802603B2 (en) 2010-06-17 2014-08-12 Becton, Dickinson And Company Medical components having coated surfaces exhibiting low friction and low reactivity
KR101924653B1 (ko) 2010-06-24 2018-12-03 제넨테크, 인크. 단백질-함유 제제를 안정화시키기 위한 알킬글리코시드 함유 조성물 및 방법
US9145457B2 (en) * 2011-03-25 2015-09-29 Amgen Inc. Sclerostin antibody crystals and formulations thereof
WO2013180650A1 (en) 2012-05-31 2013-12-05 Agency For Science, Technology And Research Methods for reducing levels of protein-contaminant complexes and aggregates in protein preparations by treatment with electropositive organic additives
JP2015526471A (ja) * 2012-08-21 2015-09-10 ジェネシス リサーチ インスティチュート アントラサイクリン誘発性心毒性を治療または予防するための組成物および方法
US9592297B2 (en) 2012-08-31 2017-03-14 Bayer Healthcare Llc Antibody and protein formulations
CN104870019A (zh) 2012-11-27 2015-08-26 阿特根公司 用于稳定蛋白质和Fc结构域融合的融合蛋白的组合物
EP2968189A4 (en) 2013-03-15 2016-11-16 Ansun Biopharma Inc METHOD FOR PRODUCING INJECTABLE PROTEIN MICROPARTICLE SUSPENSIONS
CA2908819A1 (en) * 2013-04-22 2014-10-30 Glycotope Gmbh Anti-cancer treatments with anti-egfr antibodies having a low fucosylation
WO2015196091A1 (en) 2014-06-20 2015-12-23 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BIOTECHNOLOGY AND BIOENGINEERING, vol. 59, no. 4, JPN6021026949, 1998, pages 517 - 519, ISSN: 0004706046 *
油化学, vol. 第33巻第3号, JPN6021026950, 1984, pages 148 - 150, ISSN: 0004706045 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023532764A (ja) * 2020-07-07 2023-07-31 エフ． ホフマン－ラ ロシュ アーゲー 治療用タンパク質製剤の安定剤としての代替界面活性剤
JP7898238B2 (ja) 2020-07-07 2026-07-31 エフ． ホフマン－ラ ロシュ アーゲー 治療用タンパク質製剤の安定剤としての代替界面活性剤

Also Published As

Publication number Publication date
US20200282065A1 (en) 2020-09-10
WO2018013673A1 (en) 2018-01-18
US10016513B2 (en) 2018-07-10
US20190275159A1 (en) 2019-09-12
CA3030422A1 (en) 2018-01-18
US10279048B2 (en) 2019-05-07
EP3484520A1 (en) 2019-05-22
EP3484520A4 (en) 2020-07-29
US10610600B2 (en) 2020-04-07
US20180015168A1 (en) 2018-01-18
CA3030422C (en) 2021-10-26
US20180015169A1 (en) 2018-01-18
KR20190027878A (ko) 2019-03-15

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