EA202091373A1 - Стабилизированные составы, содержащие антитела анти-pcsk9 - Google Patents

Стабилизированные составы, содержащие антитела анти-pcsk9

Info

Publication number
EA202091373A1
EA202091373A1 EA202091373A EA202091373A EA202091373A1 EA 202091373 A1 EA202091373 A1 EA 202091373A1 EA 202091373 A EA202091373 A EA 202091373A EA 202091373 A EA202091373 A EA 202091373A EA 202091373 A1 EA202091373 A1 EA 202091373A1
Authority
EA
Eurasian Patent Office
Prior art keywords
formulations containing
pcsk9
antibody
containing anti
pcsk9 antibodies
Prior art date
Application number
EA202091373A
Other languages
English (en)
Inventor
Скотт Уолш
Дэниел Дикс
Original Assignee
Ридженерон Фармасьютикалз, Инк.
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=46889415&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EA202091373(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ридженерон Фармасьютикалз, Инк. filed Critical Ридженерон Фармасьютикалз, Инк.
Publication of EA202091373A1 publication Critical patent/EA202091373A1/ru

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • 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
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/22—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513—Piston constructions to improve sealing or sliding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • 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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Chemical & Material Sciences (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

В настоящем изобретении предлагаются фармацевтические составы, содержащие человеческое антитело, которое специфически связывает человеческую пропротеин конвертазу субтилизин/кексин тип 9 протеазу (PCSK9). Составы, кроме антитела анти-PCSK9, могут содержать по крайней мере одну аминокислоту, по крайней мере один сахар или по крайней мере одно неионогенное поверхностно-активное вещество. Фармацевтические составы настоящего изобретения демонстрируют значительный уровень стабильности антитела после хранения в течение нескольких месяцев.
EA202091373A 2011-07-28 2012-07-27 Стабилизированные составы, содержащие антитела анти-pcsk9 EA202091373A1 (ru)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201161512666P 2011-07-28 2011-07-28

Publications (1)

Publication Number Publication Date
EA202091373A1 true EA202091373A1 (ru) 2021-07-30

Family

ID=46889415

Family Applications (3)

Application Number Title Priority Date Filing Date
EA201791185A EA036042B1 (ru) 2011-07-28 2012-07-27 Стабилизированные составы, содержащие антитела анти-pcsk9
EA201490370A EA028227B1 (ru) 2011-07-28 2012-07-27 Стабилизированные составы, содержащие антитела к человеческой пропротеиновой конвертазе субтилизин/кексин типа 9 (pcsk9)
EA202091373A EA202091373A1 (ru) 2011-07-28 2012-07-27 Стабилизированные составы, содержащие антитела анти-pcsk9

Family Applications Before (2)

Application Number Title Priority Date Filing Date
EA201791185A EA036042B1 (ru) 2011-07-28 2012-07-27 Стабилизированные составы, содержащие антитела анти-pcsk9
EA201490370A EA028227B1 (ru) 2011-07-28 2012-07-27 Стабилизированные составы, содержащие антитела к человеческой пропротеиновой конвертазе субтилизин/кексин типа 9 (pcsk9)

Country Status (19)

Country Link
US (7) US8795669B2 (ru)
EP (2) EP2736529A2 (ru)
JP (3) JP6045583B2 (ru)
KR (1) KR102001818B1 (ru)
CN (2) CN108420788A (ru)
AR (1) AR087305A1 (ru)
AU (2) AU2012286663B2 (ru)
BR (1) BR112014001712B1 (ru)
CA (1) CA2841588C (ru)
CL (1) CL2014000183A1 (ru)
CO (1) CO6862108A2 (ru)
EA (3) EA036042B1 (ru)
IL (1) IL230282B (ru)
MA (1) MA35355B1 (ru)
MX (2) MX352529B (ru)
MY (1) MY165156A (ru)
TW (1) TWI586366B (ru)
UY (1) UY34228A (ru)
WO (1) WO2013016648A2 (ru)

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