BR112014019667A2 - formulação de anticorpo abeta - Google Patents

formulação de anticorpo abeta

Info

Publication number
BR112014019667A2
BR112014019667A2 BR112014019667A BR112014019667A BR112014019667A2 BR 112014019667 A2 BR112014019667 A2 BR 112014019667A2 BR 112014019667 A BR112014019667 A BR 112014019667A BR 112014019667 A BR112014019667 A BR 112014019667A BR 112014019667 A2 BR112014019667 A2 BR 112014019667A2
Authority
BR
Brazil
Prior art keywords
abeta antibody
antibody formulation
approximately
formulation
abeta
Prior art date
Application number
BR112014019667A
Other languages
English (en)
Other versions
BR112014019667B1 (pt
Inventor
Christian Mahler Hanns
Goldbach Pierre
Mueller Robert
Original Assignee
Hoffmann La Roche
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 Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of BR112014019667A2 publication Critical patent/BR112014019667A2/pt
Publication of BR112014019667B1 publication Critical patent/BR112014019667B1/pt

Links

Classifications

    • 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
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/16—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
    • A61K47/26—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Endocrinology (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)

Abstract

resumo patente de invenção: "formulação de anticorpo abeta". a presente invenção refere-se a uma formulação farmacêutica que compreende aproximadamente 50 mg/ml-200 mg/ml de um anticorpo abeta, poloxâmero de aproximadamente 0,01%-0,1%, aproximadamente 5 mm-50 mm de um tampão, aproximadamente 100 mm-300 mm de um estabilizante em um ph de aproximadamente 4,5-7,0.
BR112014019667-2A 2012-03-08 2013-03-05 Formulação farmacêutica líquida estável de anticorpo abeta BR112014019667B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP12158602 2012-03-08
EP12158602.8 2012-03-08
PCT/EP2013/054313 WO2013131866A1 (en) 2012-03-08 2013-03-05 Abeta antibody formulation

Publications (2)

Publication Number Publication Date
BR112014019667A2 true BR112014019667A2 (pt) 2017-06-27
BR112014019667B1 BR112014019667B1 (pt) 2022-11-01

Family

ID=47780075

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112014019667-2A BR112014019667B1 (pt) 2012-03-08 2013-03-05 Formulação farmacêutica líquida estável de anticorpo abeta

Country Status (26)

Country Link
US (1) US20150030589A1 (pt)
EP (1) EP2822587B1 (pt)
JP (1) JP5859148B2 (pt)
KR (1) KR101666289B1 (pt)
CN (1) CN104159613B (pt)
AR (2) AR090272A1 (pt)
AU (1) AU2013229613B2 (pt)
BR (1) BR112014019667B1 (pt)
CA (1) CA2860543C (pt)
CY (1) CY1117363T1 (pt)
DK (1) DK2822587T3 (pt)
ES (1) ES2564281T3 (pt)
HK (1) HK1200717A1 (pt)
HR (1) HRP20160434T1 (pt)
HU (1) HUE028440T2 (pt)
IL (1) IL234120B (pt)
MX (1) MX351148B (pt)
MY (1) MY166045A (pt)
NZ (1) NZ626955A (pt)
PL (1) PL2822587T3 (pt)
RS (1) RS54644B1 (pt)
RU (1) RU2014140137A (pt)
SG (1) SG11201404481RA (pt)
SI (1) SI2822587T1 (pt)
WO (1) WO2013131866A1 (pt)
ZA (1) ZA201405103B (pt)

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ES2592271T3 (es) 2005-03-31 2016-11-29 Chugai Seiyaku Kabushiki Kaisha Métodos de producción de polipéptidos mediante la regulación de la asociación de los polipéptidos
US9670269B2 (en) 2006-03-31 2017-06-06 Chugai Seiyaku Kabushiki Kaisha Methods of modifying antibodies for purification of bispecific antibodies
DK3056568T3 (da) 2006-03-31 2021-11-01 Chugai Pharmaceutical Co Ltd Fremgangsmåder til kontrollering af antistoffers blodfarmakokinetik
CN101874042B9 (zh) 2007-09-26 2019-01-01 中外制药株式会社 利用cdr的氨基酸取代来改变抗体等电点的方法
EA034617B1 (ru) * 2010-10-06 2020-02-27 Ридженерон Фармасьютикалз, Инк. Дозированная форма жидкой фармацевтической композиции, содержащей антитела к рецептору интерлейкина-4 (il-4r)
KR102099580B1 (ko) 2010-11-17 2020-04-10 추가이 세이야쿠 가부시키가이샤 혈액응고 제viii 인자의 기능을 대체하는 기능을 갖는 다중특이성 항원 결합 분자
AR087305A1 (es) 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
AU2014325063B2 (en) 2013-09-27 2019-10-31 Chugai Seiyaku Kabushiki Kaisha Method for producing polypeptide heteromultimer
TWI700300B (zh) 2014-09-26 2020-08-01 日商中外製藥股份有限公司 中和具有第ｖｉｉｉ凝血因子（ｆｖｉｉｉ）機能替代活性的物質之抗體
TWI701435B (zh) 2014-09-26 2020-08-11 日商中外製藥股份有限公司 測定ｆｖｉｉｉ的反應性之方法
WO2016159213A1 (ja) 2015-04-01 2016-10-06 中外製薬株式会社 ポリペプチド異種多量体の製造方法
PE20221007A1 (es) 2015-06-24 2022-06-15 Hoffmann La Roche Anticuerpos anti-receptor de transferrina con afinidad disenada
MX2018002000A (es) 2015-08-18 2018-06-19 Regeneron Pharma Anticuerpos inhibidores de anti-pcsk9 para el tratamiento de pacientes con hiperlipidemia que se someten aferesis de lipoproteina.
AR106189A1 (es) 2015-10-02 2017-12-20 Hoffmann La Roche ANTICUERPOS BIESPECÍFICOS CONTRA EL A-b HUMANO Y EL RECEPTOR DE TRANSFERRINA HUMANO Y MÉTODOS DE USO
UA127887C2 (uk) 2015-10-02 2024-02-07 Ф. Хоффманн-Ля Рош Аг Біспецифічне антитіло до людського cd20/людського рецептора трансферину та способи його застосування
KR20180091918A (ko) 2015-12-28 2018-08-16 추가이 세이야쿠 가부시키가이샤 Fc 영역 함유 폴리펩타이드의 정제를 효율화하기 위한 방법
CR20180554A (es) 2016-04-28 2019-01-10 Chugai Pharmaceutical Co Ltd Preparaciones que contienen anticuerpos
JP7125932B2 (ja) 2016-09-06 2022-08-25 中外製薬株式会社 凝固第ｉｘ因子および／または活性化凝固第ｉｘ因子ならびに凝固第ｘ因子および／または活性化凝固第ｘ因子を認識する二重特異性抗体の使用法
CN110691592A (zh) * 2017-05-30 2020-01-14 森永乳业株式会社 脑功能改善用组合物
MX2020001855A (es) 2017-08-22 2020-08-13 Biogen Ma Inc Composiciones farmacéuticas que contienen anticuerpos anti-beta-amiloides.
CR20200158A (es) 2017-09-29 2020-06-14 Chugai Pharmaceutical Co Ltd Molécula de unión al antígeno multiespecífica que tiene actividad de sustitución de la función de cofactor del factor viii de coagulación de sangre (fviii) y formulación farmacéutica que contiene tal molécula como ingrediente
WO2022000046A1 (en) * 2020-07-03 2022-01-06 CSL Innovation Pty Ltd High concentration formulation of factor xii antigen binding proteins
WO2023115112A1 (en) * 2021-12-20 2023-06-29 CSL Innovation Pty Ltd Protein formulations and uses thereof
WO2023215267A1 (en) * 2022-05-02 2023-11-09 Regeneron Pharmaceuticals, Inc. Anti-interleukin-4 receptor (il-4r) antibody formulations

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Also Published As

Publication number Publication date
CN104159613A (zh) 2014-11-19
HUE028440T2 (en) 2016-12-28
JP5859148B2 (ja) 2016-02-10
JP2015510871A (ja) 2015-04-13
EP2822587A1 (en) 2015-01-14
CN104159613B (zh) 2016-11-23
WO2013131866A1 (en) 2013-09-12
AR122746A2 (es) 2022-10-05
CA2860543A1 (en) 2013-09-12
ES2564281T3 (es) 2016-03-21
RS54644B1 (en) 2016-08-31
NZ626955A (en) 2016-01-29
BR112014019667B1 (pt) 2022-11-01
MX2014009662A (es) 2014-09-25
MY166045A (en) 2018-05-22
ZA201405103B (en) 2015-04-29
SG11201404481RA (en) 2014-09-26
IL234120B (en) 2019-03-31
AU2013229613B2 (en) 2015-07-30
KR101666289B1 (ko) 2016-10-13
SI2822587T1 (sl) 2016-04-29
US20150030589A1 (en) 2015-01-29
RU2014140137A (ru) 2016-04-27
CY1117363T1 (el) 2017-04-26
HRP20160434T1 (hr) 2016-05-20
PL2822587T3 (pl) 2016-07-29
MX351148B (es) 2017-10-04
EP2822587B1 (en) 2016-02-03
AU2013229613A1 (en) 2014-07-24
DK2822587T3 (en) 2016-02-29
HK1200717A1 (en) 2015-08-14
AR090272A1 (es) 2014-10-29
CA2860543C (en) 2018-04-24
KR20140120942A (ko) 2014-10-14

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

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]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 05/03/2013, OBSERVADAS AS CONDICOES LEGAIS