AR108240A1 - Formulaciones que contienen anticuerpos - Google Patents

Formulaciones que contienen anticuerpos

Info

Publication number
AR108240A1
AR108240A1 ARP170101082A ARP170101082A AR108240A1 AR 108240 A1 AR108240 A1 AR 108240A1 AR P170101082 A ARP170101082 A AR P170101082A AR P170101082 A ARP170101082 A AR P170101082A AR 108240 A1 AR108240 A1 AR 108240A1
Authority
AR
Argentina
Prior art keywords
formulations containing
containing antibodies
formulations
antibody
bispecific antibody
Prior art date
Application number
ARP170101082A
Other languages
English (en)
Inventor
Tomoyuki Igawa
Chifumi Imai
Hitoshi Sasaki
Shaw Nishizawa
Atsushi Saeki
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 AR108240A1 publication Critical patent/AR108240A1/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]

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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Formulaciones de soluciones de anticuerpos estables donde se suprime la formación de agregados de Emicizumab (ACE910), un anticuerpo biespecífico con el que puede sustituirse funcionalmente el FVIII. Formulaciones de soluciones de anticuerpos con un pH de entre 4,5 y 6,5, que contienen 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.
ARP170101082A 2016-04-28 2017-04-27 Formulaciones que contienen anticuerpos AR108240A1 (es)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
AR108240A1 true AR108240A1 (es) 2018-08-01

Family

ID=60160798

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP170101082A AR108240A1 (es) 2016-04-28 2017-04-27 Formulaciones 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) TWI820000B (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
WO2006106905A1 (ja) 2005-03-31 2006-10-12 Chugai Seiyaku Kabushiki Kaisha 会合制御によるポリペプチド製造方法
DK2009101T3 (en) 2006-03-31 2018-01-15 Chugai Pharmaceutical Co Ltd Antibody modification method for purification of a bispecific antibody
US11046784B2 (en) 2006-03-31 2021-06-29 Chugai Seiyaku Kabushiki Kaisha Methods for controlling blood pharmacokinetics of antibodies
SI2202245T1 (sl) 2007-09-26 2016-10-28 Chugai Seiyaku Kabushiki Kaisha Postopek modificiranja izoelektrične točke protitelesa preko aminokislinske substitucije v CDR
AR080428A1 (es) 2010-01-20 2012-04-11 Chugai Pharmaceutical Co Ltd Formulaciones liquidas estabilizadas contentivas de anticuerpos
CN105859889B (zh) 2010-11-17 2020-01-07 中外制药株式会社 具有代替凝血因子viii的功能的功能的多特异性抗原结合分子
BR112016006197B1 (pt) 2013-09-27 2023-04-11 Chugai Seiyaku Kabushiki Kaisha Método para produzir um anticorpo biespecífico de polipeptídeos
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
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
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
EP3398965A4 (en) 2015-12-28 2019-09-18 Chugai Seiyaku Kabushiki Kaisha METHOD FOR PROMOTING THE EFFICACY OF PURIFYING A POLYPEPTIDE CONTAINING AN FC REGION
EP3509637A4 (en) 2016-09-06 2020-05-27 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
CA3071236A1 (en) 2017-09-29 2019-04-04 Chugai Seiyaku Kabushiki Kaisha Multispecific antigen-binding molecule having blood coagulation factor viii (fviii) cofactor function-substituting activity, and pharmaceutical formulation containing said molecule as active ingredient
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
EP4272756A1 (en) * 2021-02-05 2023-11-08 Bio-Thera Solutions, Ltd. Anti-il-5 antibody formulation, preparation method therefor and use thereof
TW202333781A (zh) * 2021-10-08 2023-09-01 日商中外製藥股份有限公司 抗ｈｌａ－ｄｑ２﹒５抗體製劑
TW202333787A (zh) 2021-12-01 2023-09-01 日商中外製藥股份有限公司 含抗體製劑的調製方法
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
AU2002213441B2 (en) 2000-10-12 2006-10-26 Genentech, Inc. Reduced-viscosity concentrated protein formulations
AU2003271174A1 (en) 2003-10-10 2005-04-27 Chugai Seiyaku Kabushiki Kaisha Double specific antibodies substituting for functional protein
PL1876236T3 (pl) 2005-04-08 2015-01-30 Chugai Pharmaceutical Co Ltd Przeciwciała zastępujące czynność czynnika krzepnięcia VIII
PE20091174A1 (es) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
AR080428A1 (es) * 2010-01-20 2012-04-11 Chugai Pharmaceutical Co Ltd Formulaciones liquidas estabilizadas contentivas de anticuerpos
CN105859889B (zh) 2010-11-17 2020-01-07 中外制药株式会社 具有代替凝血因子viii的功能的功能的多特异性抗原结合分子
KR101666289B1 (ko) 2012-03-08 2016-10-13 에프. 호프만-라 로슈 아게 아밀로이드-베타 펩타이드 항체 제형
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
UA126900C2 (uk) 2023-02-22
TWI820000B (zh) 2023-11-01
MX2018012648A (es) 2019-01-30
EP3449940A4 (en) 2020-01-22
CN108883178B (zh) 2023-03-14
RU2748046C2 (ru) 2021-05-19
CR20180554A (es) 2019-01-10
CN116059353A (zh) 2023-05-05
WO2017188356A1 (ja) 2017-11-02
KR102456742B1 (ko) 2022-10-19
RU2018141173A (ru) 2020-05-28
CN108883178A (zh) 2018-11-23
AU2017255077B2 (en) 2024-05-16
JP2023145766A (ja) 2023-10-11
IL262589A (en) 2018-12-31
HK1257953A1 (zh) 2019-11-01
KR20190003596A (ko) 2019-01-09
TW202402326A (zh) 2024-01-16
SG11201807765PA (en) 2018-10-30
JP7320943B2 (ja) 2023-08-04
MA44780A (fr) 2019-03-06
JP2022037069A (ja) 2022-03-08
CL2018003022A1 (es) 2019-01-18
TW201737942A (zh) 2017-11-01
BR112018067792A2 (pt) 2019-02-12
AU2017255077A1 (en) 2018-10-04
JPWO2017188356A1 (ja) 2019-03-07
CA3016301A1 (en) 2017-11-02
EP3449940A1 (en) 2019-03-06
US20210189006A1 (en) 2021-06-24
PE20181889A1 (es) 2018-12-11
RU2018141173A3 (es) 2020-06-11

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