CL2018003022A1 - Preparaciones que contienen anticuerpos. - Google Patents

Preparaciones que contienen anticuerpos.

Info

Publication number
CL2018003022A1
CL2018003022A1 CL2018003022A CL2018003022A CL2018003022A1 CL 2018003022 A1 CL2018003022 A1 CL 2018003022A1 CL 2018003022 A CL2018003022 A CL 2018003022A CL 2018003022 A CL2018003022 A CL 2018003022A CL 2018003022 A1 CL2018003022 A1 CL 2018003022A1
Authority
CL
Chile
Prior art keywords
antibody
preparations containing
containing antibodies
invention refers
liquid preparation
Prior art date
Application number
CL2018003022A
Other languages
English (en)
Inventor
Tomoyuki Igawa
Atsushi Saeki
Shaw Nishizawa
Hitoshi Sasaki
Chifumi Imai
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 CL2018003022A1 publication Critical patent/CL2018003022A1/es

Links

Classifications

    • 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
    • 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
    • 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]

Landscapes

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

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.
CL2018003022A 2016-04-28 2018-10-24 Preparaciones que contienen anticuerpos. CL2018003022A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP2016090590 2016-04-28

Publications (1)

Publication Number Publication Date
CL2018003022A1 true CL2018003022A1 (es) 2019-01-18

Family

ID=60160798

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2018003022A CL2018003022A1 (es) 2016-04-28 2018-10-24 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) CN116059353A (es)
AR (1) AR108240A1 (es)
AU (1) AU2017255077B2 (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
JP5620626B2 (ja) 2005-03-31 2014-11-05 中外製薬株式会社 会合制御によるポリペプチド製造方法
US9670269B2 (en) 2006-03-31 2017-06-06 Chugai Seiyaku Kabushiki Kaisha Methods of modifying antibodies for purification of bispecific antibodies
EP4001409A1 (en) 2006-03-31 2022-05-25 Chugai Seiyaku Kabushiki Kaisha Methods for controlling blood pharmacokinetics of antibodies
DK2202245T3 (en) 2007-09-26 2016-11-21 Chugai Pharmaceutical Co Ltd A method of modifying an antibody isoelectric point VIA amino acid substitution in CDR
TWI505838B (zh) 2010-01-20 2015-11-01 Chugai Pharmaceutical Co Ltd Stabilized antibody solution containing
US9334331B2 (en) 2010-11-17 2016-05-10 Chugai Seiyaku Kabushiki Kaisha Bispecific antibodies
RU2758952C1 (ru) 2013-09-27 2021-11-03 Чугаи Сейяку Кабусики Кайся Способ получения полипептидного гетеромультимера
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
JP7082484B2 (ja) 2015-04-01 2022-06-08 中外製薬株式会社 ポリペプチド異種多量体の製造方法
KR20180091918A (ko) 2015-12-28 2018-08-16 추가이 세이야쿠 가부시키가이샤 Fc 영역 함유 폴리펩타이드의 정제를 효율화하기 위한 방법
MX2019002510A (es) 2016-09-06 2019-06-24 Chugai Pharmaceutical Co Ltd Metodos para usar un anticuerpo biespecifico que reconoce el factor de coagulacion ix y/o el factor de coagulacion ix activado y el factor de coagulacion x y/o factor de coagulacion x activado.
CR20210381A (es) 2017-09-29 2021-09-09 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 (Divisional Exp. 2020-0158)
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
WO2020053301A1 (en) * 2018-09-11 2020-03-19 Ichnos Sciences S.A. Compositions comprising a bispecific antibody, bufffer and one or more stabilizing agents
CN111665352B (zh) * 2020-06-23 2024-05-17 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
WO2023058705A1 (ja) * 2021-10-08 2023-04-13 中外製薬株式会社 抗ｈｌａ－ｄｑ２．５抗体の製剤
WO2023100975A1 (ja) * 2021-12-01 2023-06-08 中外製薬株式会社 抗体含有製剤の調製方法
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
DK1324776T4 (en) 2000-10-12 2018-05-28 Genentech Inc CONCENTRATED PROTEIN FORMULATIONS WITH REDUCED VISCOSITY
AU2003271174A1 (en) 2003-10-10 2005-04-27 Chugai Seiyaku Kabushiki Kaisha Double specific antibodies substituting for functional protein
EP2824183B1 (en) 2005-04-08 2020-07-29 Chugai Seiyaku Kabushiki Kaisha Methods for producing bispecific antibodies
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
US9334331B2 (en) 2010-11-17 2016-05-10 Chugai Seiyaku Kabushiki Kaisha Bispecific antibodies
JP5859148B2 (ja) 2012-03-08 2016-02-10 エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ Ａβ抗体製剤
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
RU2018141173A3 (es) 2020-06-11
RU2748046C2 (ru) 2021-05-19
JPWO2017188356A1 (ja) 2019-03-07
TW202402326A (zh) 2024-01-16
HK1257953A1 (zh) 2019-11-01
MX2018012648A (es) 2019-01-30
BR112018067792A2 (pt) 2019-02-12
SG11201807765PA (en) 2018-10-30
KR20190003596A (ko) 2019-01-09
AR108240A1 (es) 2018-08-01
JP2023145766A (ja) 2023-10-11
PE20181889A1 (es) 2018-12-11
RU2018141173A (ru) 2020-05-28
MA44780A (fr) 2019-03-06
IL262589A (en) 2018-12-31
UA126900C2 (uk) 2023-02-22
CN116059353A (zh) 2023-05-05
AU2017255077A1 (en) 2018-10-04
TW201737942A (zh) 2017-11-01
CR20180554A (es) 2019-01-10
AU2017255077B2 (en) 2024-05-16
EP3449940A1 (en) 2019-03-06
EP3449940A4 (en) 2020-01-22
JP2022037069A (ja) 2022-03-08
CA3016301A1 (en) 2017-11-02
KR102456742B1 (ko) 2022-10-19
CN108883178B (zh) 2023-03-14
US20210189006A1 (en) 2021-06-24
CN108883178A (zh) 2018-11-23
WO2017188356A1 (ja) 2017-11-02
JP7320943B2 (ja) 2023-08-04
TWI820000B (zh) 2023-11-01

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