BR112012021873B8 - composição de matéria, artigo de manufatura, métodos para preparar uma composição, para aumentar a estabilidade de uma proteína em solução aquosa livre de polissorbato e para prevenir ou reduzir a agregação de uma proteína em solução aquosa livre de polissorbato - Google Patents

composição de matéria, artigo de manufatura, métodos para preparar uma composição, para aumentar a estabilidade de uma proteína em solução aquosa livre de polissorbato e para prevenir ou reduzir a agregação de uma proteína em solução aquosa livre de polissorbato

Info

Publication number
BR112012021873B8
BR112012021873B8 BR112012021873A BR112012021873A BR112012021873B8 BR 112012021873 B8 BR112012021873 B8 BR 112012021873B8 BR 112012021873 A BR112012021873 A BR 112012021873A BR 112012021873 A BR112012021873 A BR 112012021873A BR 112012021873 B8 BR112012021873 B8 BR 112012021873B8
Authority
BR
Brazil
Prior art keywords
protein
aqueous solution
polysorbate
composition
free aqueous
Prior art date
Application number
BR112012021873A
Other languages
English (en)
Other versions
BR112012021873A2 (pt
BR112012021873B1 (pt
Inventor
Junyan Ji
Jun Liu
Yuchang John Wang
Original Assignee
Genentech Inc
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 Genentech Inc filed Critical Genentech Inc
Publication of BR112012021873A2 publication Critical patent/BR112012021873A2/pt
Publication of BR112012021873B1 publication Critical patent/BR112012021873B1/pt
Publication of BR112012021873B8 publication Critical patent/BR112012021873B8/pt

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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • 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
    • A61K39/39591—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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4283—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
    • C07K16/4291—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig against IgE
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • 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

Abstract

composições de matéria, artigo de manufatura, método de preparação de uma formulação contendo proteína estabilizada, método para aumentar a estabilidade de uma proteína em solução aquosa e método de prevenção ou redução da agregação de uma proteína em solução aquosa. a invenção refere-se à utilização de compostos não tensoativos, incluindo, por exemplo, polioxietileno (poe) sorbitanos e polietileno-glicóis (pegs), para a estabilização de formulações contendo proteínas e para a prevenção da agregação de proteínas em tais formulações.
BR112012021873A 2010-03-22 2011-03-21 composição de matéria, artigo de manufatura, métodos para preparar uma composição, para aumentar a estabilidade de uma proteína em solução aquosa livre de polissorbato e para prevenir ou reduzir a agregação de uma proteína em solução aquosa livre de polissorbato BR112012021873B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US31632610P 2010-03-22 2010-03-22
US61/316,326 2010-03-22
PCT/US2011/029206 WO2011119487A2 (en) 2010-03-22 2011-03-21 Compositions and methods useful for stabilizing protein-containing formulations

Publications (3)

Publication Number Publication Date
BR112012021873A2 BR112012021873A2 (pt) 2016-05-24
BR112012021873B1 BR112012021873B1 (pt) 2021-05-11
BR112012021873B8 true BR112012021873B8 (pt) 2021-09-14

Family

ID=43977896

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112012021873A BR112012021873B8 (pt) 2010-03-22 2011-03-21 composição de matéria, artigo de manufatura, métodos para preparar uma composição, para aumentar a estabilidade de uma proteína em solução aquosa livre de polissorbato e para prevenir ou reduzir a agregação de uma proteína em solução aquosa livre de polissorbato

Country Status (16)

Country Link
US (3) US9662395B2 (pt)
EP (2) EP3513810A1 (pt)
JP (3) JP5937059B2 (pt)
KR (3) KR101878369B1 (pt)
CN (3) CN103124564B (pt)
BR (1) BR112012021873B8 (pt)
CA (2) CA2792125C (pt)
ES (1) ES2722201T3 (pt)
HK (1) HK1216842A1 (pt)
HR (1) HRP20190751T1 (pt)
MX (1) MX354867B (pt)
PL (1) PL2550018T3 (pt)
RU (1) RU2584232C2 (pt)
SI (1) SI2550018T1 (pt)
TR (1) TR201905081T4 (pt)
WO (1) WO2011119487A2 (pt)

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Also Published As

Publication number Publication date
RU2584232C2 (ru) 2016-05-20
CA3027749A1 (en) 2011-09-29
CN104998269A (zh) 2015-10-28
WO2011119487A2 (en) 2011-09-29
JP6742805B2 (ja) 2020-08-19
EP2550018B1 (en) 2019-02-27
CN104998269B (zh) 2019-06-11
KR101878369B1 (ko) 2018-07-16
EP2550018A1 (en) 2013-01-30
JP6791929B2 (ja) 2020-11-25
JP5937059B2 (ja) 2016-06-22
TR201905081T4 (tr) 2019-05-21
KR20130010466A (ko) 2013-01-28
US20170224820A1 (en) 2017-08-10
KR20190104254A (ko) 2019-09-06
JP2013527832A (ja) 2013-07-04
RU2012144626A (ru) 2014-04-27
US9662395B2 (en) 2017-05-30
BR112012021873A2 (pt) 2016-05-24
PL2550018T3 (pl) 2019-08-30
ES2722201T3 (es) 2019-08-08
JP2016193909A (ja) 2016-11-17
CA2792125C (en) 2019-02-12
HK1216842A1 (zh) 2016-12-09
SI2550018T1 (sl) 2019-05-31
MX354867B (es) 2018-03-23
HRP20190751T1 (hr) 2019-06-14
US20200023063A1 (en) 2020-01-23
EP3513810A1 (en) 2019-07-24
JP2019048831A (ja) 2019-03-28
WO2011119487A3 (en) 2013-05-10
KR102218495B1 (ko) 2021-02-19
BR112012021873B1 (pt) 2021-05-11
CN103124564A (zh) 2013-05-29
CN106983862A (zh) 2017-07-28
US20130078232A1 (en) 2013-03-28
MX2012010612A (es) 2012-10-03
CN103124564B (zh) 2016-11-09
KR20180000342A (ko) 2018-01-02
CA2792125A1 (en) 2011-09-29

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