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SI3586826T1 - Sestavki in postopki za stabilizacijo formulacij, ki vsebujejo beljakovine - Google Patents

Sestavki in postopki za stabilizacijo formulacij, ki vsebujejo beljakovine

Info

Publication number
SI3586826T1
SI3586826T1 SI201131987T SI201131987T SI3586826T1 SI 3586826 T1 SI3586826 T1 SI 3586826T1 SI 201131987 T SI201131987 T SI 201131987T SI 201131987 T SI201131987 T SI 201131987T SI 3586826 T1 SI3586826 T1 SI 3586826T1
Authority
SI
Slovenia
Prior art keywords
compositions
methods
containing formulations
stabilizing protein
stabilizing
Prior art date
Application number
SI201131987T
Other languages
English (en)
Inventor
Osigwe Esue
Vikas K. Sharma
Original Assignee
F. Hoffmann-La Roche Ag
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 F. Hoffmann-La Roche Ag filed Critical F. Hoffmann-La Roche Ag
Publication of SI3586826T1 publication Critical patent/SI3586826T1/sl

Links

Classifications

    • 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
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • C07K16/2845Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily against integrin beta2-subunit-containing molecules, e.g. CD11, CD18
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3076Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells against structure-related tumour-associated moieties
    • C07K16/3092Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells against structure-related tumour-associated moieties against tumour-associated mucins
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, 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)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Cell Biology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preventing Corrosion Or Incrustation Of Metals (AREA)
  • Anti-Oxidant Or Stabilizer Compositions (AREA)
  • Saccharide Compounds (AREA)
SI201131987T 2010-06-24 2011-06-23 Sestavki in postopki za stabilizacijo formulacij, ki vsebujejo beljakovine SI3586826T1 (sl)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US35810510P 2010-06-24 2010-06-24
EP19167191.6A EP3586826B1 (en) 2010-06-24 2011-06-23 Compositions and methods for stabilizing protein-containing formulations

Publications (1)

Publication Number Publication Date
SI3586826T1 true SI3586826T1 (sl) 2021-09-30

Family

ID=44628056

Family Applications (2)

Application Number Title Priority Date Filing Date
SI201131803T SI2585045T1 (sl) 2010-06-24 2011-06-23 Sestavki in postopki, ki vsebujejo alkilglikozide za stabilizacijo formulacij, ki vsebujejo beljakovine
SI201131987T SI3586826T1 (sl) 2010-06-24 2011-06-23 Sestavki in postopki za stabilizacijo formulacij, ki vsebujejo beljakovine

Family Applications Before (1)

Application Number Title Priority Date Filing Date
SI201131803T SI2585045T1 (sl) 2010-06-24 2011-06-23 Sestavki in postopki, ki vsebujejo alkilglikozide za stabilizacijo formulacij, ki vsebujejo beljakovine

Country Status (19)

Country Link
US (4) US9254321B2 (sl)
EP (3) EP4008313A1 (sl)
JP (1) JP5894154B2 (sl)
KR (2) KR102058307B1 (sl)
CN (1) CN103068367B (sl)
AU (1) AU2011270828B2 (sl)
BR (1) BR112012033002B1 (sl)
CA (2) CA2802756C (sl)
ES (2) ES2880802T3 (sl)
HR (2) HRP20191878T1 (sl)
IL (2) IL223651A (sl)
MX (1) MX339666B (sl)
MY (2) MY161390A (sl)
NZ (1) NZ605147A (sl)
PL (2) PL3586826T3 (sl)
SG (1) SG186783A1 (sl)
SI (2) SI2585045T1 (sl)
WO (1) WO2011163458A2 (sl)
ZA (1) ZA201209539B (sl)

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PL3586826T3 (pl) * 2010-06-24 2021-10-25 F. Hoffmann-La Roche Ag Kompozycje i sposoby stabilizowania preparatów zawierających białka
US20140314778A1 (en) 2013-03-13 2014-10-23 Genentech, Inc. Formulations with reduced oxidation
MY174679A (en) * 2013-03-13 2020-05-06 Genentech Inc Formulations with reduced oxidation
WO2015032972A1 (en) * 2013-09-09 2015-03-12 Lek Pharmaceuticals D.D. Nanoformulation of g-csf for non-parenteral delivery
WO2015032981A1 (en) * 2013-09-09 2015-03-12 Lek Pharmaceuticals D.D. Erythropoietin conjugates having oral bioavailability
EP3052604B1 (en) * 2013-09-30 2023-05-31 Enza Biotech AB Use of alkylglycosides surfactants
CN104707146B (zh) * 2013-12-16 2019-04-16 浙江海正药业股份有限公司 一种含有阿达木单抗的药物组合物
US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
US20160074515A1 (en) 2014-06-20 2016-03-17 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
WO2018013673A1 (en) 2016-07-13 2018-01-18 Reform Biologics, Llc Stabilizing excipients for therapeutic protein formulations
WO2019036619A1 (en) * 2017-08-18 2019-02-21 Reform Biologics, Llc STABILIZING EXCIPIENTS FOR FORMULATIONS OF THERAPEUTIC PROTEIN
WO2020205716A1 (en) 2019-04-01 2020-10-08 Genentech, Inc. Compositions and methods for stabilizing protein-containing formulations
WO2021107033A1 (ja) * 2019-11-29 2021-06-03 千寿製薬株式会社 医薬組成物
CN117599193A (zh) * 2023-11-24 2024-02-27 皓阳生物科技(上海)有限公司 包含抗原和表面活性剂的物质组合物及其制备方法与应用

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Also Published As

Publication number Publication date
JP2013533244A (ja) 2013-08-22
CA2802756C (en) 2021-05-04
CN103068367A (zh) 2013-04-24
CA3111727C (en) 2022-07-26
MX339666B (es) 2016-06-03
PL2585045T3 (pl) 2020-01-31
JP5894154B2 (ja) 2016-03-23
KR20180130590A (ko) 2018-12-07
HRP20191878T1 (hr) 2019-12-27
HRP20211056T1 (hr) 2021-10-01
BR112012033002B1 (pt) 2021-10-13
AU2011270828B2 (en) 2015-09-24
ES2751381T3 (es) 2020-03-31
US20130224213A1 (en) 2013-08-29
US10188735B2 (en) 2019-01-29
ES2880802T3 (es) 2021-11-25
EP4008313A1 (en) 2022-06-08
MY184736A (en) 2021-04-20
EP3586826A1 (en) 2020-01-01
KR102058307B1 (ko) 2019-12-20
NZ605147A (en) 2014-12-24
MX2012014862A (es) 2013-03-25
BR112012033002A2 (pt) 2016-12-20
KR101924653B1 (ko) 2018-12-03
WO2011163458A2 (en) 2011-12-29
ZA201209539B (en) 2015-03-25
MY161390A (en) 2017-04-14
EP3586826B1 (en) 2021-05-12
PL3586826T3 (pl) 2021-10-25
US11103584B2 (en) 2021-08-31
EP2585045B1 (en) 2019-08-21
EP2585045A2 (en) 2013-05-01
KR20130098283A (ko) 2013-09-04
IL254354B (en) 2021-05-31
IL254354A0 (en) 2017-11-30
AU2011270828A1 (en) 2013-01-17
SG186783A1 (en) 2013-02-28
CA2802756A1 (en) 2011-12-29
RU2013103025A (ru) 2014-07-27
AU2011270828A2 (en) 2013-02-07
SI2585045T1 (sl) 2019-11-29
IL223651A (en) 2017-09-28
WO2011163458A3 (en) 2012-06-07
US20190216929A1 (en) 2019-07-18
CA3111727A1 (en) 2011-12-29
US20160199494A1 (en) 2016-07-14
US9254321B2 (en) 2016-02-09
US11938189B2 (en) 2024-03-26
CN103068367B (zh) 2016-09-07
US20210353756A1 (en) 2021-11-18

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