KR20190027878A - 치료 단백질 제제용 안정화 부형제 - Google Patents

치료 단백질 제제용 안정화 부형제 Download PDF

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Publication number
KR20190027878A
KR20190027878A KR1020197003892A KR20197003892A KR20190027878A KR 20190027878 A KR20190027878 A KR 20190027878A KR 1020197003892 A KR1020197003892 A KR 1020197003892A KR 20197003892 A KR20197003892 A KR 20197003892A KR 20190027878 A KR20190027878 A KR 20190027878A
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KR
South Korea
Prior art keywords
formulation
stabilizing excipient
protein
excipient
stabilizing
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.)
Ceased
Application number
KR1020197003892A
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English (en)
Korean (ko)
Inventor
데이비드 에스. 숀
로버트 피. 마호니
필립 위스리치
다니엘 지. 그린
Original Assignee
리폼 바이오로직스, 엘엘씨
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 리폼 바이오로직스, 엘엘씨 filed Critical 리폼 바이오로직스, 엘엘씨
Publication of KR20190027878A publication Critical patent/KR20190027878A/ko
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61K47/50—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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Diabetes (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (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)
KR1020197003892A 2016-07-13 2017-07-12 치료 단백질 제제용 안정화 부형제 Ceased KR20190027878A (ko)

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 (1)

Publication Number Publication Date
KR20190027878A true KR20190027878A (ko) 2019-03-15

Family

ID=60941865

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020197003892A Ceased KR20190027878A (ko) 2016-07-13 2017-07-12 치료 단백질 제제용 안정화 부형제

Country Status (6)

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

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
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
WO2019036619A1 (en) * 2017-08-18 2019-02-21 Reform Biologics, Llc STABILIZING EXCIPIENTS FOR FORMULATIONS OF THERAPEUTIC PROTEIN
EP3761962A4 (en) * 2018-03-07 2021-12-15 ReForm Biologics, Inc. EXCIPIENT COMPOUNDS FOR PROTEIN-BASED FORMULATIONS
WO2019180561A1 (en) 2018-03-20 2019-09-26 Mankind Pharma Ltd. Stable pharmaceutical composition of vasopressin
US11103552B2 (en) 2018-05-10 2021-08-31 Regeneron Pharmaceuticals, Inc. High concentration VEGF receptor fusion protein containing formulations
EP3852724A4 (en) 2018-09-20 2022-07-06 Levo Therapeutics, Inc. CARBETOCIN DRUG PRODUCT AND PROCESS FOR ITS MANUFACTURE
TW202031283A (zh) 2018-09-20 2020-09-01 馬克 Ｃ 曼寧 穩定卡貝縮宮素鼻內製劑
GB201904741D0 (en) * 2019-04-04 2019-05-22 Glaxosmithkline Ip Dev Ltd Novel process
CN113710794B (zh) 2019-04-19 2024-08-09 富士胶片株式会社 细胞外囊泡的保存稳定化剂及保存稳定化方法
CN116133689A (zh) * 2020-07-07 2023-05-16 豪夫迈·罗氏有限公司 作为治疗性蛋白质制剂的稳定剂的替代表面活性剂
US20250275967A1 (en) * 2022-04-22 2025-09-04 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
EP1372611B1 (en) * 2001-03-26 2006-05-17 Novartis AG Pharmaceutical composition comprising a poorly water-soluble staurosporine, 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
CN101889209A (zh) 2007-10-22 2010-11-17 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和用含蛋白质溶液的有机基聚硅氧烷涂布的医疗制品
WO2009065126A2 (en) 2007-11-16 2009-05-22 Boston Protein Solutions Excipients for protein stabilization
AU2010277559B2 (en) * 2009-07-31 2016-08-11 Sanofi-Aventis Deutschland Gmbh Prodrugs comprising an insulin linker conjugate
BR112012027361A2 (pt) * 2010-04-27 2021-04-27 Scil Technology Gmbh formulação mia/cd-rap estável.
US8802603B2 (en) 2010-06-17 2014-08-12 Becton, Dickinson And Company Medical components having coated surfaces exhibiting low friction and low reactivity
SG186783A1 (en) 2010-06-24 2013-02-28 Genentech Inc Compositions and methods containing alkylgycosides for stabilizing protein- containing formulations
WO2012135035A1 (en) * 2011-03-25 2012-10-04 Amgen Inc. Anti - sclerostin antibody crystals and formulations thereof
SG10201606990TA (en) 2012-05-31 2016-10-28 Agency Science Tech & Res Methods for reducing levels of protein-contaminant complexes and aggregates in protein preparations by treatment with electropositive organic additives
US9119858B2 (en) * 2012-08-21 2015-09-01 Genesys Research Institute, Inc. Compositions and methods for treating or preventing anthracycline induced cardiotoxicity
US9592297B2 (en) * 2012-08-31 2017-03-14 Bayer Healthcare Llc Antibody and protein formulations
JP6026002B2 (ja) 2012-11-27 2016-11-16 アルテオジェン インコーポレイテッド タンパク質とＦｃドメインを融合した融合タンパク質の安定化用組成物
US20140342006A1 (en) 2013-03-15 2014-11-20 Ansun Biopharma, Inc. Methods for Preparing Injectable Protein Microparticle Suspensions
US20160068609A1 (en) * 2013-04-22 2016-03-10 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

Also Published As

Publication number Publication date
US20180015168A1 (en) 2018-01-18
US10016513B2 (en) 2018-07-10
US10279048B2 (en) 2019-05-07
CA3030422C (en) 2021-10-26
EP3484520A4 (en) 2020-07-29
US20200282065A1 (en) 2020-09-10
US20190275159A1 (en) 2019-09-12
WO2018013673A1 (en) 2018-01-18
US10610600B2 (en) 2020-04-07
US20180015169A1 (en) 2018-01-18
JP2019527729A (ja) 2019-10-03
EP3484520A1 (en) 2019-05-22
CA3030422A1 (en) 2018-01-18

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