TWI893018B - 抗體配製物 - Google Patents

抗體配製物

Info

Publication number
TWI893018B
TWI893018B TW109137726A TW109137726A TWI893018B TW I893018 B TWI893018 B TW I893018B TW 109137726 A TW109137726 A TW 109137726A TW 109137726 A TW109137726 A TW 109137726A TW I893018 B TWI893018 B TW I893018B
Authority
TW
Taiwan
Prior art keywords
pharmaceutical composition
rizanlizumab
suitably
concentration
months
Prior art date
Application number
TW109137726A
Other languages
English (en)
Chinese (zh)
Other versions
TW202128221A (zh
Inventor
法比安 比克爾
查維斯 莉娜 瑪麗亞 博阿多
德克 切利爾斯
法蘭科斯 格勞德
卡洛琳 希爾伯特
弗里德 克勒納
裘根 瑟吉
拉吉瑟克哈爾 保羅
馬亞 安科
阿爾奧薩 耶倫科
Original Assignee
瑞士商諾華公司
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 瑞士商諾華公司 filed Critical 瑞士商諾華公司
Publication of TW202128221A publication Critical patent/TW202128221A/zh
Application granted granted Critical
Publication of TWI893018B publication Critical patent/TWI893018B/zh

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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • 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
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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
    • A61P7/06—Antianaemics
    • 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
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2851—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72
    • C07K16/2854—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72 against selectins, e.g. CD62
    • 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
    • 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
    • C07K2317/50—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]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
TW109137726A 2019-10-30 2020-10-29 抗體配製物 TWI893018B (zh)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US201962927720P 2019-10-30 2019-10-30
US201962927716P 2019-10-30 2019-10-30
US62/927,716 2019-10-30
US62/927,720 2019-10-30
US201962933692P 2019-11-11 2019-11-11
US62/933,692 2019-11-11
US201962936269P 2019-11-15 2019-11-15
US62/936,269 2019-11-15

Publications (2)

Publication Number Publication Date
TW202128221A TW202128221A (zh) 2021-08-01
TWI893018B true TWI893018B (zh) 2025-08-11

Family

ID=73544317

Family Applications (1)

Application Number Title Priority Date Filing Date
TW109137726A TWI893018B (zh) 2019-10-30 2020-10-29 抗體配製物

Country Status (19)

Country Link
US (1) US20220378912A1 (enExample)
EP (1) EP4051236A1 (enExample)
JP (1) JP2023501155A (enExample)
KR (1) KR20220092917A (enExample)
CN (1) CN114828826A (enExample)
AU (1) AU2020373017B2 (enExample)
BR (1) BR112022008097A2 (enExample)
CA (1) CA3158921A1 (enExample)
CL (1) CL2022001085A1 (enExample)
CO (1) CO2022005207A2 (enExample)
EC (1) ECSP22033601A (enExample)
IL (1) IL292403A (enExample)
JO (1) JOP20220097A1 (enExample)
MX (1) MX2022005044A (enExample)
MY (1) MY209141A (enExample)
PE (1) PE20221276A1 (enExample)
PH (1) PH12022551041A1 (enExample)
TW (1) TWI893018B (enExample)
WO (1) WO2021087050A1 (enExample)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018083645A1 (en) * 2016-11-03 2018-05-11 Novartis Ag Treatment regimens
WO2018211517A1 (en) * 2017-05-16 2018-11-22 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
WO2019171326A1 (en) * 2018-03-08 2019-09-12 Novartis Ag Use of an anti-p-selectin antibody

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUE041957T2 (hu) 2006-12-01 2019-06-28 Novartis Ag Anti-P-szelektin antitestek és eljárások azok alkalmazására gyulladásos betegségek kezelésére

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018083645A1 (en) * 2016-11-03 2018-05-11 Novartis Ag Treatment regimens
WO2018211517A1 (en) * 2017-05-16 2018-11-22 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
WO2019171326A1 (en) * 2018-03-08 2019-09-12 Novartis Ag Use of an anti-p-selectin antibody

Also Published As

Publication number Publication date
IL292403A (en) 2022-06-01
TW202128221A (zh) 2021-08-01
WO2021087050A1 (en) 2021-05-06
CN114828826A (zh) 2022-07-29
MX2022005044A (es) 2022-05-16
ECSP22033601A (es) 2022-05-31
CA3158921A1 (en) 2021-05-06
AU2020373017B2 (en) 2024-06-06
PH12022551041A1 (en) 2023-04-24
CO2022005207A2 (es) 2022-05-10
BR112022008097A2 (pt) 2022-08-02
KR20220092917A (ko) 2022-07-04
JOP20220097A1 (ar) 2023-01-30
EP4051236A1 (en) 2022-09-07
JP2023501155A (ja) 2023-01-18
US20220378912A1 (en) 2022-12-01
CL2022001085A1 (es) 2023-02-03
AU2020373017A1 (en) 2022-05-19
MY209141A (en) 2025-06-24
PE20221276A1 (es) 2022-09-05

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