EA033387B1 - СТАБИЛИЗИРОВАННЫЕ СОСТАВЫ, СОДЕРЖАЩИЕ АНТИТЕЛА ПРОТИВ Ang-2 - Google Patents

СТАБИЛИЗИРОВАННЫЕ СОСТАВЫ, СОДЕРЖАЩИЕ АНТИТЕЛА ПРОТИВ Ang-2

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Publication number
EA033387B1
EA033387B1 EA201491414A EA201491414A EA033387B1 EA 033387 B1 EA033387 B1 EA 033387B1 EA 201491414 A EA201491414 A EA 201491414A EA 201491414 A EA201491414 A EA 201491414A EA 033387 B1 EA033387 B1 EA 033387B1
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EA
Eurasian Patent Office
Prior art keywords
concentration
formulation
formulations containing
containing anti
stabilized formulations
Prior art date
Application number
EA201491414A
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English (en)
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EA201491414A1 (ru
Inventor
Scott Walsh
Daniel Dix
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Regeneron Pharma
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Application filed by Regeneron Pharma filed Critical Regeneron Pharma
Publication of EA201491414A1 publication Critical patent/EA201491414A1/ru
Publication of EA033387B1 publication Critical patent/EA033387B1/ru

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    • 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
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • 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
    • A61K47/26—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
    • A61K9/0012—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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D85/00—Containers, packaging elements or packages, specially adapted for particular articles or materials
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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

Abstract

Настоящее изобретение относится к стабильному фармацевтическому составу, содержащему (i) антитело в концентрации от 20±3 до 60±9 мг/мл, которое специфически связывается с ангиопоэтином-2 человека (Ang-2 человека), причем антитело содержит вариабельную область тяжелой цепи (HCVR) с аминокислотной последовательностью SEQ ID NO:18 и вариабельную область легкой цепи (LCVR) с аминокислотной последовательностью SEQ ID NO:20; (ii) гистидин в концентрации 10±1,5 мМ; (iii) полисорбат в концентрации 0,2±0,03% мас./об.; и (iv) сахарозу в концентрации 10±1,5% мас./об., где pH состава составляет 6±0,3. Также изобретение относится к набору, содержащему указанный состав, для лечения, профилактики или облечения течения заболевания или нарушения, опосредованного Ang-2.
EA201491414A 2012-01-23 2013-01-22 СТАБИЛИЗИРОВАННЫЕ СОСТАВЫ, СОДЕРЖАЩИЕ АНТИТЕЛА ПРОТИВ Ang-2 EA033387B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261589427P 2012-01-23 2012-01-23
PCT/US2013/022473 WO2013112438A1 (en) 2012-01-23 2013-01-22 Stabilized formulations containing anti-ang2 antibodies

Publications (2)

Publication Number Publication Date
EA201491414A1 EA201491414A1 (ru) 2014-12-30
EA033387B1 true EA033387B1 (ru) 2019-10-31

Family

ID=47633582

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201491414A EA033387B1 (ru) 2012-01-23 2013-01-22 СТАБИЛИЗИРОВАННЫЕ СОСТАВЫ, СОДЕРЖАЩИЕ АНТИТЕЛА ПРОТИВ Ang-2

Country Status (23)

Country Link
US (1) US9402898B2 (ru)
EP (1) EP2807190B1 (ru)
JP (1) JP6113756B2 (ru)
KR (1) KR102063028B1 (ru)
CN (1) CN104169299B (ru)
AR (1) AR089787A1 (ru)
AU (1) AU2013212587B2 (ru)
BR (1) BR112014017882A2 (ru)
CA (1) CA2861062A1 (ru)
CL (1) CL2014001930A1 (ru)
EA (1) EA033387B1 (ru)
HK (1) HK1204631A1 (ru)
IL (1) IL233482B (ru)
JO (1) JO3533B1 (ru)
MA (1) MA35904B1 (ru)
MX (1) MX357393B (ru)
MY (1) MY164611A (ru)
NZ (1) NZ627859A (ru)
PH (1) PH12014501628B1 (ru)
SG (1) SG11201403792TA (ru)
TW (1) TWI615149B (ru)
UY (1) UY34587A (ru)
WO (1) WO2013112438A1 (ru)

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