MX2018012648A - Preparaciones que contienen anticuerpos. - Google Patents

Preparaciones que contienen anticuerpos.

Info

Publication number
MX2018012648A
MX2018012648A MX2018012648A MX2018012648A MX2018012648A MX 2018012648 A MX2018012648 A MX 2018012648A MX 2018012648 A MX2018012648 A MX 2018012648A MX 2018012648 A MX2018012648 A MX 2018012648A MX 2018012648 A MX2018012648 A MX 2018012648A
Authority
MX
Mexico
Prior art keywords
antibody
containing liquid
aforementioned
liquid preparation
relates
Prior art date
Application number
MX2018012648A
Other languages
English (en)
Inventor
Saeki Atsushi
Nishizawa Shaw
Sasaki Hitoshi
Imai Chifumi
Igawa Tomoyuki
Original Assignee
Chugai Pharmaceutical Co Ltd
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 Chugai Pharmaceutical Co Ltd filed Critical Chugai Pharmaceutical Co Ltd
Publication of MX2018012648A publication Critical patent/MX2018012648A/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
    • 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
    • C07K16/36—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
    • 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
    • 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
    • A61K47/30—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
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • 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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • 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 preparación líquida que contiene un anticuerpo estable que raramente sufre la formación de agregados de Emicizumab (ACE910) que es un anticuerpo biespecífico que tiene una función alternativa a la función del FVIII. Más específicamente, la presente invención se refiere se refiere a la preparación líquida que contiene el anticuerpo antes mencionado que contiene entre 20 y 180 mg/ml del anticuerpo biespecífico mencionado con anterioridad, un amortiguador de histidina-aspartato entre 10 mM y 40 mM, entre 0.2 y 1 mg/ml de Poloxámero 188 y arginina entre 100 mM y 300 mM y tiene un valor de pH de 4.5 a 6.5.
MX2018012648A 2016-04-28 2017-04-27 Preparaciones que contienen anticuerpos. MX2018012648A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2016090590 2016-04-28
PCT/JP2017/016658 WO2017188356A1 (ja) 2016-04-28 2017-04-27 抗体含有製剤

Publications (1)

Publication Number Publication Date
MX2018012648A true MX2018012648A (es) 2019-01-30

Family

ID=60160798

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2018012648A MX2018012648A (es) 2016-04-28 2017-04-27 Preparaciones que contienen anticuerpos.

Country Status (21)

Country Link
US (1) US20210189006A1 (es)
EP (1) EP3449940A4 (es)
JP (3) JP7320943B2 (es)
KR (1) KR102456742B1 (es)
CN (2) CN108883178B (es)
AR (1) AR108240A1 (es)
AU (1) AU2017255077A1 (es)
BR (1) BR112018067792A2 (es)
CA (1) CA3016301A1 (es)
CL (1) CL2018003022A1 (es)
CR (1) CR20180554A (es)
HK (1) HK1257953A1 (es)
IL (1) IL262589A (es)
MA (1) MA44780A (es)
MX (1) MX2018012648A (es)
PE (1) PE20181889A1 (es)
RU (1) RU2748046C2 (es)
SG (1) SG11201807765PA (es)
TW (2) TW202402326A (es)
UA (1) UA126900C2 (es)
WO (1) WO2017188356A1 (es)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2006232287B2 (en) 2005-03-31 2011-10-06 Chugai Seiyaku Kabushiki Kaisha Methods for producing polypeptides by regulating polypeptide association
JP5144499B2 (ja) 2006-03-31 2013-02-13 中外製薬株式会社 二重特異性抗体を精製するための抗体改変方法
EP4342995A2 (en) 2006-03-31 2024-03-27 Chugai Seiyaku Kabushiki Kaisha Methods for controlling blood pharmacokinetics of antibodies
EP3127921A1 (en) 2007-09-26 2017-02-08 Chugai Seiyaku Kabushiki Kaisha Method of modifying isoelectric point of antibody via amino acid substition in cdr
TWI505838B (zh) 2010-01-20 2015-11-01 Chugai Pharmaceutical Co Ltd Stabilized antibody solution containing
MX355060B (es) 2010-11-17 2018-04-03 Chugai Pharmaceutical Co Ltd Molecula multiespecifica de union a antigeno que tiene funcion alternativa a la funcion del factor viii de coagulacion sanguinea.
JP6534615B2 (ja) 2013-09-27 2019-06-26 中外製薬株式会社 ポリペプチド異種多量体の製造方法
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
US11142587B2 (en) 2015-04-01 2021-10-12 Chugai Seiyaku Kabushiki Kaisha Method for producing polypeptide hetero-oligomer
SG11201803989WA (en) 2015-12-28 2018-06-28 Chugai Pharmaceutical Co Ltd Method for promoting efficiency of purification of fc region-containing polypeptide
MA46200A (fr) 2016-09-06 2019-07-17 Chugai Pharmaceutical Co Ltd Procédés d'utilisation d'un anticorps bispécifique qui reconnaît le facteur de coagulation ix et/ou le facteur de coagulation ix activé et le facteur de coagulation x et/ou le facteur de coagulation x activé
PE20210005A1 (es) 2017-09-29 2021-01-05 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
FR3082427B1 (fr) 2018-06-14 2020-09-25 Lab Francais Du Fractionnement Combinaison de facteur vii et d'un anticorps bispecifique anti-facteurs ix et x
EP3849513A1 (en) * 2018-09-11 2021-07-21 Ichnos Sciences SA Compositions comprising a bispecific antibody, bufffer and one or more stabilizing agents
CN111665352A (zh) * 2020-06-23 2020-09-15 广州市丹蓝生物科技有限公司 一种储存剂及由其制备的抗体溶液制剂及其应用
US20240115698A1 (en) * 2021-02-05 2024-04-11 Bio-Thera Solutions, Ltd. Anti-il-5 antibody formulation, preparation method therefor and use thereof
WO2023058723A1 (ja) * 2021-10-08 2023-04-13 中外製薬株式会社 プレフィルドシリンジ製剤の調製方法
KR20240011866A (ko) 2021-12-01 2024-01-26 추가이 세이야쿠 가부시키가이샤 항체 함유 제제의 조제 방법
CN114544839A (zh) * 2022-01-20 2022-05-27 未名生物医药有限公司 一种抗人神经生长因子抗体的电荷变异体检测方法

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU1344102A (en) 2000-10-12 2002-04-22 Genentech Inc Reduced-viscosity concentrated protein formulations
WO2005035753A1 (ja) 2003-10-10 2005-04-21 Chugai Seiyaku Kabushiki Kaisha 機能蛋白質を代替する二重特異性抗体
WO2006109592A1 (ja) 2005-04-08 2006-10-19 Chugai Seiyaku Kabushiki Kaisha 血液凝固第viii因子の機能代替抗体
PE20091174A1 (es) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
TWI505838B (zh) * 2010-01-20 2015-11-01 Chugai Pharmaceutical Co Ltd Stabilized antibody solution containing
MX355060B (es) 2010-11-17 2018-04-03 Chugai Pharmaceutical Co Ltd Molecula multiespecifica de union a antigeno que tiene funcion alternativa a la funcion del factor viii de coagulacion sanguinea.
US20150030589A1 (en) 2012-03-08 2015-01-29 Hoffmann-La Roche Inc. Abeta antibody formulation
TW201625299A (zh) * 2014-06-20 2016-07-16 Chugai Pharmaceutical Co Ltd 用於因第ｖｉｉｉ凝血因子及／或活化的第ｖｉｉｉ凝血因子的活性降低或欠缺而發病及／或進展的疾病之預防及／或治療之醫藥組成物

Also Published As

Publication number Publication date
CL2018003022A1 (es) 2019-01-18
TWI820000B (zh) 2023-11-01
RU2018141173A3 (es) 2020-06-11
EP3449940A1 (en) 2019-03-06
JP7320943B2 (ja) 2023-08-04
RU2018141173A (ru) 2020-05-28
CN108883178B (zh) 2023-03-14
UA126900C2 (uk) 2023-02-22
SG11201807765PA (en) 2018-10-30
AU2017255077A1 (en) 2018-10-04
US20210189006A1 (en) 2021-06-24
CN116059353A (zh) 2023-05-05
PE20181889A1 (es) 2018-12-11
KR102456742B1 (ko) 2022-10-19
CN108883178A (zh) 2018-11-23
AR108240A1 (es) 2018-08-01
RU2748046C2 (ru) 2021-05-19
TW202402326A (zh) 2024-01-16
CR20180554A (es) 2019-01-10
TW201737942A (zh) 2017-11-01
JP2022037069A (ja) 2022-03-08
JP2023145766A (ja) 2023-10-11
CA3016301A1 (en) 2017-11-02
IL262589A (en) 2018-12-31
MA44780A (fr) 2019-03-06
WO2017188356A1 (ja) 2017-11-02
JPWO2017188356A1 (ja) 2019-03-07
KR20190003596A (ko) 2019-01-09
BR112018067792A2 (pt) 2019-02-12
EP3449940A4 (en) 2020-01-22
HK1257953A1 (zh) 2019-11-01

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