CN118175989A - 制剂 - Google Patents

制剂 Download PDF

Info

Publication number
CN118175989A
CN118175989A CN202280070452.XA CN202280070452A CN118175989A CN 118175989 A CN118175989 A CN 118175989A CN 202280070452 A CN202280070452 A CN 202280070452A CN 118175989 A CN118175989 A CN 118175989A
Authority
CN
China
Prior art keywords
antibody
arginine
liquid formulation
stable liquid
histidine
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
CN202280070452.XA
Other languages
English (en)
Chinese (zh)
Inventor
S·马凯特
C·皮尔布姆
M·J·E·博南
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 CN118175989A publication Critical patent/CN118175989A/zh
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • A61K47/16—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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [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)
CN202280070452.XA 2021-10-21 2022-10-20 制剂 Pending CN118175989A (zh)

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 (1)

Publication Number Publication Date
CN118175989A true CN118175989A (zh) 2024-06-11

Family

ID=78806159

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202280070452.XA Pending CN118175989A (zh) 2021-10-21 2022-10-20 制剂

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
JP2024539502A (ja) 2024-10-28
GEP20257801B (en) 2025-09-25
EP4419077A1 (en) 2024-08-28
TW202330029A (zh) 2023-08-01
AU2022369042A1 (en) 2024-06-06

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