JP2024539502A - 製剤 - Google Patents

製剤 Download PDF

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Publication number
JP2024539502A
JP2024539502A JP2024547821A JP2024547821A JP2024539502A JP 2024539502 A JP2024539502 A JP 2024539502A JP 2024547821 A JP2024547821 A JP 2024547821A JP 2024547821 A JP2024547821 A JP 2024547821A JP 2024539502 A JP2024539502 A JP 2024539502A
Authority
JP
Japan
Prior art keywords
antibody
arginine
stable liquid
liquid formulation
hcl
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
JP2024547821A
Other languages
English (en)
Japanese (ja)
Other versions
JP2024539502A5 (https=
Inventor
サラ マーケッテ、
クラウデ ピアボーム、
ミカエル ジョゼフ エデュアルド ボーネン、
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
UCB Biopharma SRL
Original Assignee
UCB Biopharma SRL
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 UCB Biopharma SRL filed Critical UCB Biopharma SRL
Publication of JP2024539502A publication Critical patent/JP2024539502A/ja
Publication of JP2024539502A5 publication Critical patent/JP2024539502A5/ja
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2024547821A 2021-10-21 2022-10-20 製剤 Pending JP2024539502A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB2115127.9A GB202115127D0 (en) 2021-10-21 2021-10-21 Formulations
GB2115127.9 2021-10-21
PCT/EP2022/079185 WO2023067051A1 (en) 2021-10-21 2022-10-20 Formulations

Publications (2)

Publication Number Publication Date
JP2024539502A true JP2024539502A (ja) 2024-10-28
JP2024539502A5 JP2024539502A5 (https=) 2025-10-22

Family

ID=78806159

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2024547821A Pending JP2024539502A (ja) 2021-10-21 2022-10-20 製剤

Country Status (17)

Country Link
US (1) US20250281403A1 (https=)
EP (1) EP4419077A1 (https=)
JP (1) JP2024539502A (https=)
KR (1) KR20240099316A (https=)
CN (1) CN118175989A (https=)
AR (1) AR127420A1 (https=)
AU (1) AU2022369042A1 (https=)
CA (1) CA3235492A1 (https=)
CL (1) CL2024001232A1 (https=)
CO (1) CO2024006206A2 (https=)
GB (1) GB202115127D0 (https=)
GE (2) GEAP202416521A (https=)
IL (1) IL312211A (https=)
MX (1) MX2024004873A (https=)
PE (1) PE20241192A1 (https=)
TW (1) TW202330029A (https=)
WO (1) WO2023067051A1 (https=)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006100679A2 (en) 2005-03-22 2006-09-28 Quark Pharmaceuticals, Inc. Recombinant antibodies against human type ii transglutaminase and uses thereof
GB2490655A (en) 2011-04-28 2012-11-14 Univ Aston Modulators of tissue transglutaminase
GB201209096D0 (en) 2012-05-24 2012-07-04 Medical Res Council Technology Compounds
GB201411320D0 (en) 2014-06-25 2014-08-06 Ucb Biopharma Sprl Antibody construct
CN109563161A (zh) * 2016-02-03 2019-04-02 安口生物公司 用于提高抗体稳定性的缓冲制剂

Also Published As

Publication number Publication date
CA3235492A1 (en) 2023-04-27
US20250281403A1 (en) 2025-09-11
IL312211A (en) 2024-06-01
PE20241192A1 (es) 2024-06-03
GEAP202416521A (en) 2024-07-25
CO2024006206A2 (es) 2024-05-30
AR127420A1 (es) 2024-01-24
CL2024001232A1 (es) 2024-09-13
WO2023067051A1 (en) 2023-04-27
KR20240099316A (ko) 2024-06-28
GB202115127D0 (en) 2021-12-08
MX2024004873A (es) 2024-05-06
GEP20257801B (en) 2025-09-25
EP4419077A1 (en) 2024-08-28
TW202330029A (zh) 2023-08-01
CN118175989A (zh) 2024-06-11
AU2022369042A1 (en) 2024-06-06

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A521 Request for written amendment filed

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Effective date: 20251014

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Effective date: 20251014