KR20190027878A - 치료 단백질 제제용 안정화 부형제 - Google Patents

치료 단백질 제제용 안정화 부형제 Download PDF

Info

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
Authority
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
Other languages
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

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/54Medicinal 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
    • A61K47/543Lipids, e.g. triglycerides; Polyamines, e.g. spermine or spermidine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1774Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/04Drugs for genital or sexual disorders; Contraceptives for inducing labour or abortion; Uterotonics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08GMACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G73/00Macromolecular 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
    • C08G73/02Polyamines
    • C08G73/0233Polyamines derived from (poly)oxazolines, (poly)oxazines or having pendant acyl groups
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863Immunoglobulins [IGs], 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)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (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)
  • 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)
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 (enExample)
EP (1) EP3484520A4 (enExample)
JP (1) JP2019527729A (enExample)
KR (1) KR20190027878A (enExample)
CA (1) CA3030422C (enExample)
WO (1) WO2018013673A1 (enExample)

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
US20160074515A1 (en) 2014-06-20 2016-03-17 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
KR20230018549A (ko) * 2018-03-07 2023-02-07 코메라 라이프 사이언시스, 인코포레이티드 단백질 제형을 위한 부형제 화합물
WO2019180561A1 (en) 2018-03-20 2019-09-26 Mankind Pharma Ltd. Stable pharmaceutical composition of vasopressin
NZ770284A (en) 2018-05-10 2025-11-28 Regeneron Pharma High concentration vegf receptor fusion protein containing formulations
EP3852723B1 (en) 2018-09-20 2025-11-05 ACADIA Pharmaceuticals Inc. Stable intranasal formulations of carbetocin
AU2019345313A1 (en) 2018-09-20 2021-03-18 Levo Therapeutics, Inc. Carbetocin drug product and process for preparing same
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
EP4178529A1 (en) * 2020-07-07 2023-05-17 F. Hoffmann-La Roche AG Alternative surfactants as stabilizers for therapeutic protein formulations
TW202408580A (zh) * 2022-04-22 2024-03-01 愛爾蘭商健生科學愛爾蘭無限公司 冷凍乾燥組成物(二)

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
CA2439097C (en) * 2001-03-26 2010-10-12 Novartis Ag Pharmaceutical compositions
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
WO2009055427A2 (en) 2007-10-22 2009-04-30 Becton, Dickinson And Company Methods for evaluating the aggregation of a protein in a suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution
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
CA2792965A1 (en) * 2010-04-27 2011-11-03 Scil Technology Gmbh Stable aqueous mia/cd-rap formulations
US8802603B2 (en) 2010-06-17 2014-08-12 Becton, Dickinson And Company Medical components having coated surfaces exhibiting low friction and low reactivity
MY161390A (en) 2010-06-24 2017-04-14 Genentech Inc Compositions and methods containing alkylglycosides for stabilizing protein-containing formulations
WO2012135035A1 (en) * 2011-03-25 2012-10-04 Amgen Inc. Anti - sclerostin antibody crystals and formulations thereof
SG11201407812SA (en) 2012-05-31 2014-12-30 Agency Science Tech & Res 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
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
HK1220120A1 (zh) 2013-03-15 2017-04-28 Ansun Biopharma, Inc. 制造注射蛋白质微粒悬浮液的方法
CN105229030A (zh) * 2013-04-22 2016-01-06 葛莱高托普有限公司 用具有低岩藻糖基化的抗-egfr抗体的抗-癌治疗
US20160074515A1 (en) * 2014-06-20 2016-03-17 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations

Also Published As

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

Similar Documents

Publication Publication Date Title
US10610600B2 (en) Stabilizing excipients for therapeutic protein formulations
US20240058263A1 (en) Formulations of antibody
EP3160484B1 (en) Viscosity-reducing excipient compounds for protein formulations
US20200316196A1 (en) Stabilizing excipients for therapeutic protein formulations
US11806399B2 (en) Excipient compounds for biopolymer formulations
CA3129181C (en) Excipient compounds for biopolymer formulations
AU2011207915A1 (en) Liquid formulations for long-acting G-CSF conjugate
KR102572453B1 (ko) 단백질 가공 처리를 위한 부형제 화합물
US20230065872A1 (en) Excipient compounds for protein processing
KR20200128717A (ko) 단백질 제형을 위한 부형제 화합물
EP3886909A1 (en) Excipient compounds for protein processing
US20210379185A1 (en) Excipient compounds for protein processing
US20250255966A1 (en) Corn phytoglycogen formulations for stabilizing proteins
JP6527697B2 (ja) タンパク質を安定化させたゲル状製剤
HK1172552A (en) Formulations of antibody

Legal Events

Date Code Title Description
PA0105 International application

Patent event date: 20190208

Patent event code: PA01051R01D

Comment text: International Patent Application

PG1501 Laying open of application
A201 Request for examination
PA0201 Request for examination

Patent event code: PA02012R01D

Patent event date: 20200630

Comment text: Request for Examination of Application

E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

Comment text: Notification of reason for refusal

Patent event date: 20220106

Patent event code: PE09021S01D

E601 Decision to refuse application
PE0601 Decision on rejection of patent

Patent event date: 20220715

Comment text: Decision to Refuse Application

Patent event code: PE06012S01D

Patent event date: 20220106

Comment text: Notification of reason for refusal

Patent event code: PE06011S01I