AR122746A2 - Una formulación farmacéutica líquida estable de anticuerpo - Google Patents

Una formulación farmacéutica líquida estable de anticuerpo

Info

Publication number
AR122746A2
AR122746A2 ARP210101758A ARP210101758A AR122746A2 AR 122746 A2 AR122746 A2 AR 122746A2 AR P210101758 A ARP210101758 A AR P210101758A AR P210101758 A ARP210101758 A AR P210101758A AR 122746 A2 AR122746 A2 AR 122746A2
Authority
AR
Argentina
Prior art keywords
pharmaceutical formulation
stable liquid
antibody pharmaceutical
liquid antibody
stable
Prior art date
Application number
ARP210101758A
Other languages
English (en)
Inventor
Pierre Goldbach
Hanns Mahler
- Mueller Robert Christian
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 AR122746A2 publication Critical patent/AR122746A2/es

Links

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
    • 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
    • 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
    • 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
    • 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
    • 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]

Abstract

La presente invención se refiere a una formulación farmacéutica que contiene aproximadamente de 50 mg/ml a 200 mg/ml de un anticuerpo Ab, del 0,01% al 0,1% de poloxámero, de 5 mM a 50 mM de un tampón, de 100 mM a 300 mM de un estabilizante, y tiene un pH comprendido aprox. entre 4,5 y 7,0.
ARP210101758A 2012-03-08 2021-06-25 Una formulación farmacéutica líquida estable de anticuerpo AR122746A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP12158602 2012-03-08

Publications (1)

Publication Number Publication Date
AR122746A2 true AR122746A2 (es) 2022-10-05

Family

ID=47780075

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP130100743A AR090272A1 (es) 2012-03-08 2013-03-07 FORMULACION DE ANTICUERPOS Ab
ARP210101758A AR122746A2 (es) 2012-03-08 2021-06-25 Una formulación farmacéutica líquida estable de anticuerpo

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ARP130100743A AR090272A1 (es) 2012-03-08 2013-03-07 FORMULACION DE ANTICUERPOS Ab

Country Status (26)

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

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10011858B2 (en) 2005-03-31 2018-07-03 Chugai Seiyaku Kabushiki Kaisha Methods for producing polypeptides by regulating polypeptide association
ES2654040T3 (es) 2006-03-31 2018-02-12 Chugai Seiyaku Kabushiki Kaisha Método de modificación de anticuerpos para la purificación de anticuerpos biespecíficos
DK3056568T3 (da) 2006-03-31 2021-11-01 Chugai Pharmaceutical Co Ltd Fremgangsmåder til kontrollering af antistoffers blodfarmakokinetik
CN106519025B (zh) 2007-09-26 2021-04-23 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
NZ609557A (en) * 2010-10-06 2014-12-24 Regeneron Pharma Stabilized formulations containing anti-interleukin-4 receptor (il-4r) antibodies
TR201802772T4 (tr) 2010-11-17 2018-03-21 Chugai Pharmaceutical Co Ltd Kan pıhtılaşma faktörü VIII in işlevi için alternatif işleve sahip multi-spesifik antijen bağlayıcı molekül.
AR087305A1 (es) 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
BR112016006197B1 (pt) 2013-09-27 2023-04-11 Chugai Seiyaku Kabushiki Kaisha Método para produzir um anticorpo biespecífico de polipeptídeos
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
EP3279216A4 (en) 2015-04-01 2019-06-19 Chugai Seiyaku Kabushiki Kaisha PROCESS FOR PREPARING POLYPEPTIDE HETERO OLIGOMER
DK3313879T3 (da) 2015-06-24 2022-03-14 Hoffmann La Roche Anti-transferrinreceptor-antistoffer med tilpasset affinitet
CA2995645A1 (en) 2015-08-18 2017-02-23 Regeneron Pharmaceuticals, Inc. Anti-pcsk9 inhibitory antibodies for treating patients with hyperlipidemia undergoing lipoprotein apheresis
CN114014936A (zh) 2015-10-02 2022-02-08 豪夫迈·罗氏有限公司 双特异性抗人cd20/人转铁蛋白受体抗体及使用方法
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
WO2017115773A1 (ja) 2015-12-28 2017-07-06 中外製薬株式会社 Ｆｃ領域含有ポリペプチドの精製を効率化するための方法
RU2748046C2 (ru) 2016-04-28 2021-05-19 Чугаи Сейяку Кабусики Кайся Препарат, содержащий антитело
CA3035327A1 (en) 2016-09-06 2018-03-15 Chugai Seiyaku Kabushiki Kaisha Methods of using a bispecific antibody that recognizes coagulation factor ix and/or activated coagulation factor ix and coagulation factor x and/or activated coagulation factor x
US20200113854A1 (en) * 2017-05-30 2020-04-16 Morinaga Milk Industry Co., Ltd. Composition for Improving Brain Function
JP7263320B2 (ja) 2017-08-22 2023-04-24 バイオジェン・エムエイ・インコーポレイテッド 抗ベータアミロイド抗体を含有する医薬組成物
MX2020002710A (es) 2017-09-29 2020-07-20 Chugai Pharmaceutical Co Ltd Molecula de union al antigeno multiespecifica que tiene actividad de sustitucion de la funcion de cofactor del factor viii de coagulacion de sangre (fviii) y formulacion farmaceutica que contiene tal molecula como ingrediente activo.
KR20230035355A (ko) * 2020-07-03 2023-03-13 씨에스엘 이노베이션 피티와이 엘티디 인자 xii 항원 결합 단백질의 고농도 제형
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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US5202238A (en) 1987-10-27 1993-04-13 Oncogen Production of chimeric antibodies by homologous recombination
US5204244A (en) 1987-10-27 1993-04-20 Oncogen Production of chimeric antibodies by homologous recombination
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Also Published As

Publication number Publication date
CN104159613A (zh) 2014-11-19
HUE028440T2 (en) 2016-12-28
RU2014140137A (ru) 2016-04-27
CY1117363T1 (el) 2017-04-26
DK2822587T3 (en) 2016-02-29
MX2014009662A (es) 2014-09-25
SI2822587T1 (sl) 2016-04-29
IL234120B (en) 2019-03-31
AU2013229613A1 (en) 2014-07-24
JP5859148B2 (ja) 2016-02-10
KR20140120942A (ko) 2014-10-14
MY166045A (en) 2018-05-22
CN104159613B (zh) 2016-11-23
BR112014019667A2 (pt) 2017-06-27
NZ626955A (en) 2016-01-29
EP2822587B1 (en) 2016-02-03
ES2564281T3 (es) 2016-03-21
CA2860543A1 (en) 2013-09-12
KR101666289B1 (ko) 2016-10-13
EP2822587A1 (en) 2015-01-14
HK1200717A1 (en) 2015-08-14
BR112014019667B1 (pt) 2022-11-01
US20150030589A1 (en) 2015-01-29
SG11201404481RA (en) 2014-09-26
MX351148B (es) 2017-10-04
WO2013131866A1 (en) 2013-09-12
AU2013229613B2 (en) 2015-07-30
JP2015510871A (ja) 2015-04-13
CA2860543C (en) 2018-04-24
ZA201405103B (en) 2015-04-29
HRP20160434T1 (hr) 2016-05-20
PL2822587T3 (pl) 2016-07-29
AR090272A1 (es) 2014-10-29
RS54644B1 (en) 2016-08-31

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