PL3449940T3 - Preparat zawierający przeciwciała - Google Patents

Preparat zawierający przeciwciała

Info

Publication number
PL3449940T3
PL3449940T3 PL17789638.8T PL17789638T PL3449940T3 PL 3449940 T3 PL3449940 T3 PL 3449940T3 PL 17789638 T PL17789638 T PL 17789638T PL 3449940 T3 PL3449940 T3 PL 3449940T3
Authority
PL
Poland
Prior art keywords
preparation containing
containing antibodies
antibodies
preparation
Prior art date
Application number
PL17789638.8T
Other languages
English (en)
Inventor
Atsushi Saeki
Shaw NISHIZAWA
Hitoshi Sasaki
Chifumi Imai
Tomoyuki Igawa
Original Assignee
Chugai Seiyaku Kabushiki Kaisha
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 Seiyaku Kabushiki Kaisha filed Critical Chugai Seiyaku Kabushiki Kaisha
Publication of PL3449940T3 publication Critical patent/PL3449940T3/pl

Links

Classifications

    • 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 or 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/36—Immunoglobulins [IG], 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • 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)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
PL17789638.8T 2016-04-28 2017-04-27 Preparat zawierający przeciwciała PL3449940T3 (pl)

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
PL3449940T3 true PL3449940T3 (pl) 2026-03-16

Family

ID=60160798

Family Applications (1)

Application Number Title Priority Date Filing Date
PL17789638.8T PL3449940T3 (pl) 2016-04-28 2017-04-27 Preparat zawierający przeciwciała

Country Status (25)

Country Link
US (1) US12460014B2 (pl)
EP (2) EP4650371A3 (pl)
JP (3) JP7320943B2 (pl)
KR (1) KR102456742B1 (pl)
CN (2) CN116059353B (pl)
AR (1) AR108240A1 (pl)
AU (1) AU2017255077B2 (pl)
BR (1) BR112018067792A2 (pl)
CA (1) CA3016301A1 (pl)
CL (1) CL2018003022A1 (pl)
CR (1) CR20180554A (pl)
ES (1) ES3055961T3 (pl)
HR (1) HRP20251588T1 (pl)
IL (1) IL262589A (pl)
MA (1) MA44780A (pl)
MX (1) MX428477B (pl)
MY (1) MY200833A (pl)
PE (1) PE20181889A1 (pl)
PL (1) PL3449940T3 (pl)
RU (1) RU2748046C2 (pl)
SG (1) SG11201807765PA (pl)
SI (1) SI3449940T1 (pl)
TW (2) TWI820000B (pl)
UA (1) UA126900C2 (pl)
WO (1) WO2017188356A1 (pl)

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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
EP4793360A2 (en) 2006-03-31 2026-08-19 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
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
CA2925256C (en) 2013-09-27 2023-08-15 Chugai Seiyaku Kabushiki Kaisha Method for producing polypeptide heteromultimer
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
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
FR3038517B1 (fr) 2015-07-06 2020-02-28 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Utilisation de fragments fc modifies en immunotherapie
US20200270363A1 (en) 2015-12-25 2020-08-27 Chugai Seiyaku Kabushiki Kaisha Antibody having enhanced activity, and method for modifying same
SG11201803989WA (en) 2015-12-28 2018-06-28 Chugai Pharmaceutical Co Ltd Method for promoting efficiency of purification of fc region-containing polypeptide
CA3027018A1 (en) 2016-07-29 2018-02-01 Chugai Seiyaku Kabushiki Kaisha Bispecific antibody exhibiting increased alternative fviii-cofactor-function activity
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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 moleculeas active ingredient
KR20260090008A (ko) * 2017-11-01 2026-06-16 추가이 세이야쿠 가부시키가이샤 생물 활성이 저하된 항체 배리언트 및 아이소폼
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
AU2020328195A1 (en) * 2019-08-15 2022-03-03 Genmab A/S Pharmaceutical compositions comprising bispecific antibodies directed against CD3 and CD20 and their uses
US12558423B2 (en) * 2020-05-29 2026-02-24 Chugai Seiyaku Kabushiki Kaisha Antibody-containing formulation
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
CN114870008A (zh) * 2021-02-05 2022-08-09 百奥泰生物制药股份有限公司 一种抗il-5抗体制剂及其制备方法和应用
EP4413998A4 (en) * 2021-10-08 2026-02-25 Chugai Pharmaceutical Co Ltd METHOD FOR PREPARING A PRE-FILLED SYRINGE FORMULATION
KR20240011866A (ko) * 2021-12-01 2024-01-26 추가이 세이야쿠 가부시키가이샤 항체 함유 제제의 조제 방법
CN114544839B (zh) * 2022-01-20 2024-08-20 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
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CN119950703B (zh) * 2024-07-08 2025-10-28 武汉友芝友生物制药股份有限公司 抗体制剂
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