BR112016011224A2 - Formulação líquida de uma proteína de fusão que compreende tnfr e região de fc - Google Patents

Formulação líquida de uma proteína de fusão que compreende tnfr e região de fc

Info

Publication number
BR112016011224A2
BR112016011224A2 BR112016011224A BR112016011224A BR112016011224A2 BR 112016011224 A2 BR112016011224 A2 BR 112016011224A2 BR 112016011224 A BR112016011224 A BR 112016011224A BR 112016011224 A BR112016011224 A BR 112016011224A BR 112016011224 A2 BR112016011224 A2 BR 112016011224A2
Authority
BR
Brazil
Prior art keywords
tnfr
fusion protein
liquid formulation
region
formulation
Prior art date
Application number
BR112016011224A
Other languages
English (en)
Inventor
Tae Lee Jung
Hyuk Kim In
Keun Yu Jae
Yim Yim Jung
Hyeon Jeong Myeong
Ho Ahn Yong
Original Assignee
Ares Trading Sa
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 Ares Trading Sa filed Critical Ares Trading Sa
Publication of BR112016011224A2 publication Critical patent/BR112016011224A2/pt

Links

Classifications

    • 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
    • A61K38/1793—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/16—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
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70578—NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Abstract

FORMULAÇÃO LÍQUIDA DE UMA PROTEÍNA DE FUSÃO QUE COMPREENDE TNFR E REGIÃO DE FC. A presente invenção se refere a uma formulação líquida que compreende uma proteína de fusão TNFR-Fc e um estabilizador, na qual a proteína de fusão compreende TNFR (receptor do fator de necrose tumoral) ou um fragmento do mesmo e uma região de Fc de imunoglobulina, e o estabilizador compreende um ou mais aminoácidos selecionados entre o grupo consistindo de prolina e histidina, uma solução tampão, e um agente isotônico que contém cloreto de sódio (NaCl) e sacarose, e um método para a preparação da formulação líquida. A formulação líquida de acordo com a presente invenção proporciona excelente estabilidade de armazenagem porque é possível armazenagem por longo tempo da proteína de fusão TNFR-Fc (etanercept) e não são necessárias condições particulares de armazenagem. Como a formulação líquida da presente invenção apresenta excelente estabilidade de armazenagem muito embora a formulação seja simples, é mais econômica do que outras formulações liofilizadas ou de estabilizadores, e, portanto, a formulação pode ser aplicada de modo eficaz para utilizações em que é benéfico o tratamento de proteína de fusão TNFR-Fc (etanercept).
BR112016011224A 2013-11-29 2014-11-28 Formulação líquida de uma proteína de fusão que compreende tnfr e região de fc BR112016011224A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20130148028 2013-11-29
PCT/KR2014/011540 WO2015080513A1 (en) 2013-11-29 2014-11-28 A liquid formulation of a fusion protein comprising tnfr and fc region

Publications (1)

Publication Number Publication Date
BR112016011224A2 true BR112016011224A2 (pt) 2017-09-19

Family

ID=53199391

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112016011224A BR112016011224A2 (pt) 2013-11-29 2014-11-28 Formulação líquida de uma proteína de fusão que compreende tnfr e região de fc

Country Status (10)

Country Link
US (1) US9700595B2 (pt)
EP (1) EP3073992A4 (pt)
JP (2) JP6798882B2 (pt)
KR (1) KR101712245B1 (pt)
CN (1) CN106061468B (pt)
AU (1) AU2014354384B2 (pt)
BR (1) BR112016011224A2 (pt)
CA (1) CA2930227C (pt)
IL (1) IL245754B (pt)
WO (1) WO2015080513A1 (pt)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG162788A1 (en) 2005-06-14 2010-07-29 Amgen Inc Self-buffering protein formulations
AU2014354384B2 (en) 2013-11-29 2018-11-08 Ares Trading S.A. A liquid formulation of a fusion protein comprising TNFR and Fc region
BR112017013269A2 (pt) * 2014-12-22 2018-02-27 Ares Trading S.A. ?composição farmacêutica líquida?
KR101808234B1 (ko) * 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
CN109982685B (zh) * 2016-10-21 2022-03-11 美国安进公司 药物配制品及其制备方法
US11236146B2 (en) * 2016-10-28 2022-02-01 Celltrion Inc. Stable pharmaceutical formulation
CN106800598B (zh) * 2017-02-09 2020-08-07 广州桂雨生物科技有限公司 一种抗体保存液及其制备方法
US11603407B2 (en) 2017-04-06 2023-03-14 Regeneron Pharmaceuticals, Inc. Stable antibody formulation
CN108853482A (zh) * 2017-05-12 2018-11-23 上海复旦张江生物医药股份有限公司 一种重组人TNFR-Fc融合蛋白突变体的用途
US11253569B2 (en) 2018-05-03 2022-02-22 Seattle Children's Hospital Methods of treating Kawasaki Disease
CN111228225B (zh) * 2018-11-28 2022-08-26 鲁南制药集团股份有限公司 一种重组人肿瘤坏死因子受体-Fc融合蛋白冻干制剂
WO2020138517A1 (ko) * 2018-12-24 2020-07-02 삼성바이오에피스 주식회사 항-TNFα 항체를 포함하는 약제학적 조성물
US20240059768A1 (en) * 2021-01-14 2024-02-22 Hanall Biopharma Co., Ltd. A stable ophthalmic composition comprising tanfanercept, which is free of stabilizer or substantially free of stabilizer
CN115919761B (zh) * 2023-01-29 2023-07-21 浙江莎普爱思药业股份有限公司 一种甲磺酸帕珠沙星液体制剂及其制备方法

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4037837A1 (de) * 1990-11-28 1992-06-04 Behringwerke Ag Zellfreie rezeptorbindungsteste, ihre herstellung und verwendung
JP2007521315A (ja) 2003-08-01 2007-08-02 アムジェン インコーポレイテッド 結晶性腫瘍壊死因子レセプター２ポリペプチド
AU2007307107B2 (en) * 2006-10-06 2011-11-03 Amgen Inc. Stable antibody formulations
CA2760185A1 (en) * 2009-05-04 2010-11-11 Abbott Biotechnology Ltd. Stable high protein concentration formulations of human anti-tnf-alpha antibodies
TWI505838B (zh) * 2010-01-20 2015-11-01 Chugai Pharmaceutical Co Ltd Stabilized antibody solution containing
WO2011141926A2 (en) * 2010-05-10 2011-11-17 Intas Biopharmaceuticals Limited Liquid formulation of polypeptides containing an fc domain of an immunoglobulin
WO2012111762A1 (ja) * 2011-02-17 2012-08-23 協和発酵キリン株式会社 抗ｃｄ４０抗体の高濃度製剤
KR101673654B1 (ko) * 2011-04-20 2016-11-07 산도즈 아게 융합 단백질 TNFR:Fc의 안정한 제약 액체 제제
CN107998388B (zh) * 2011-05-02 2023-07-14 千禧制药公司 抗α4β7抗体的制剂
UY34105A (es) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd Formulación líquida estable de etanercept
CA2851646A1 (en) 2011-10-18 2013-04-25 Coherus Biosciences, Inc. Etanercept formulations stabilized with meglumine
US9649383B2 (en) * 2012-11-19 2017-05-16 Merck Sharp & Dohme Corp. Liquid formulations for TNFR:Fc fusion proteins
AU2014354384B2 (en) 2013-11-29 2018-11-08 Ares Trading S.A. A liquid formulation of a fusion protein comprising TNFR and Fc region

Also Published As

Publication number Publication date
US9700595B2 (en) 2017-07-11
JP2020063261A (ja) 2020-04-23
AU2014354384A1 (en) 2016-06-02
EP3073992A1 (en) 2016-10-05
KR20150063305A (ko) 2015-06-09
IL245754B (en) 2020-01-30
US20170028020A1 (en) 2017-02-02
JP2016539947A (ja) 2016-12-22
CA2930227C (en) 2021-09-28
WO2015080513A1 (en) 2015-06-04
CN106061468A (zh) 2016-10-26
KR101712245B1 (ko) 2017-03-06
EP3073992A4 (en) 2017-09-13
JP6798882B2 (ja) 2020-12-09
CN106061468B (zh) 2020-10-02
CA2930227A1 (en) 2015-06-04
IL245754A0 (en) 2016-08-31
AU2014354384B2 (en) 2018-11-08

Similar Documents

Publication Publication Date Title
BR112016011224A2 (pt) Formulação líquida de uma proteína de fusão que compreende tnfr e região de fc
CL2018000238A1 (es) Mezcla de péptidos (divisional solicitud 201601405)
BR112015022978A2 (pt) agente de ligação biespecífico, seu método de produção composição farmacêutica, proteína de fusão, uso, sequência de ácido nucleico, vetor, célula hospedeira, método de matar células tumorais e de inibir o crescimento tumoral
PE20191033A1 (es) PROTEINAS DE FUSION FC HETERODIMERICAS IL 15/IL 15R(alfa)
BR112018072946A2 (pt) proteínas de fusão a gdf15 e usos das mesmas
CY1123307T1 (el) Πρωτεϊνες συγχωνευσης fgf21 μακρας δρασης και φαρμακευτικες συνθεσεις που τις περιλαμβανουν
AR106752A1 (es) Proteínas de unión a pd1 / ctla4
BR112015020235A2 (pt) fragmento biologicamente ativo de proteína csf-1 ou um seu homólogo, ácido nucléico, proteína de fusão, ácido nucléico isolado, vetor, célula hospedeira, método de realização da proteína de fusão do primeiro aspeto da invenção, composição, utilização de uma proteína de fusão, método de tratamento para um indivíduo sofrendo de cancro do fígado e que irá ser submetido a cirurgia, método de tratamento para um indivíduo que irá ser submetido a cirurgia de transplante de fígado, e, kit
BR112016002614A8 (pt) Imunocitoquina, ácido nucleico, vetor, célula hospedeira e composição farmacêutica
BR112015022210A2 (pt) formulações farmacêuticas aquosas estáveis, seu uso, artigo de manufatura, métodos de redução da agregação de um anticorpo monoclonal terapêutico e método de produção de uma formulação farmacêutica.
BRPI0614761A2 (pt) proteìnas de fusão de albumina
EA201001204A1 (ru) Методы и композиции, в которых применяют слитые полипептиды klotho-fgf
ECSP17061751A (es) Nuevas proteínas específicas para pioverdina y pioquelina
EA201490815A1 (ru) Составы этанерцепта, стабилизированные с помощью аминокислот
EA201690377A1 (ru) Антитела к ингибитору активатора плазминогена 1 (pai-1) и пути их применения
EA201201047A1 (ru) Способы и композиции, в которых применяют слитые полипептиды fgf 23
MX2009002816A (es) Proteinas de fusion de albumina.
BR112016015187A2 (pt) proteína de fusão para inibição da angiogênese ou do crescimento e uso da mesma
EA201991409A2 (ru) Антитела к ингибитору активатора плазминогена 1 (pai-1) и пути их применения
MX2015005231A (es) Composicion farmaceutica estable de la proteina de fusion tnfr:fc.
PE20152020A1 (es) Dominios gla como agentes de direccionamiento
BR112018007960A2 (pt) conjugado, proteína pcrv, composição imunogênica, métodos de preparação de uma composição imunogênica, de tratamento e de produção de um bioconjugado, polinucleotídeo, vetor, célula hospedeira, e, bioconjugado.
BR112016014913A8 (pt) anticorpo, ou um fragmento de ligação ao antígeno do mesmo, conjugado, ácido nucléico, vetor, célula hospedeira, composição farmacêutica, método de preparo de uma cadeia leve de um anticorpo ou fragmento de ligação ao antígeno e método de preparo de um conjugado
BR112014006929A2 (pt) agentes anti-fator de necrose tumoral-alfa e seus usos
AR091155A1 (es) Composicion farmaceutica acuosa que contiene un agente terapeutico biologico y guanidina o un derivado de guanidina y una inyeccion que incluye la composicion

Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07G Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]

Free format text: NOTIFICACAO DE DEVOLUCAO DO PEDIDO EM FUNCAO DA REVOGACAO DO ART. 229-C DA LEI NO 9.279, DE 1996, POR FORCA DA LEI NO 14.195, DE 2021

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09B Patent application refused [chapter 9.2 patent gazette]