BR112021020509A8 - Glicoproteínas sialiladas - Google Patents

Glicoproteínas sialiladas

Info

Publication number
BR112021020509A8
BR112021020509A8 BR112021020509A BR112021020509A BR112021020509A8 BR 112021020509 A8 BR112021020509 A8 BR 112021020509A8 BR 112021020509 A BR112021020509 A BR 112021020509A BR 112021020509 A BR112021020509 A BR 112021020509A BR 112021020509 A8 BR112021020509 A8 BR 112021020509A8
Authority
BR
Brazil
Prior art keywords
stable
present
sialylated glycoproteins
shear stress
shear
Prior art date
Application number
BR112021020509A
Other languages
English (en)
Other versions
BR112021020509A2 (pt
Inventor
D Patil Siddhesh
Original Assignee
Janssen Biotech Inc
Momenta Pharmaceuticals 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 Janssen Biotech Inc, Momenta Pharmaceuticals Inc filed Critical Janssen Biotech Inc
Publication of BR112021020509A2 publication Critical patent/BR112021020509A2/pt
Publication of BR112021020509A8 publication Critical patent/BR112021020509A8/pt

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
    • A61K47/06—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
    • A61K9/08—Solutions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/524—CH2 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'

Abstract

GLICOPROTEÍNAS SIALILADAS. A presente invenção refere-se a preparações farmacêuticas contendo imunoglobulinas hipersialiladas. As preparações são estáveis à tensão de cisalhamento. As composições farmacêuticas descritas na presente invenção fornecem composições de hsIgG farmaceuticamente aceitáveis que são estáveis à tensão de cisalhamento (por exemplo, um número significativo de partículas subvisíveis não se forma quando a formulação é submetida à tensão de cisalhamento, como agitação, por exemplo, durante o transporte e, assim, pode ser transportada e manuseada na forma líquida.
BR112021020509A 2019-04-18 2020-04-17 Glicoproteínas sialiladas BR112021020509A8 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962836016P 2019-04-18 2019-04-18
PCT/US2020/028863 WO2020215021A1 (en) 2019-04-18 2020-04-17 Sialylated glycoproteins

Publications (2)

Publication Number Publication Date
BR112021020509A2 BR112021020509A2 (pt) 2022-03-15
BR112021020509A8 true BR112021020509A8 (pt) 2023-01-10

Family

ID=72837963

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112021020509A BR112021020509A8 (pt) 2019-04-18 2020-04-17 Glicoproteínas sialiladas

Country Status (20)

Country Link
US (1) US20220211849A1 (pt)
EP (1) EP3955962A4 (pt)
JP (1) JP2022529168A (pt)
KR (1) KR20220002963A (pt)
CN (1) CN113795275A (pt)
AU (1) AU2020259492A1 (pt)
BR (1) BR112021020509A8 (pt)
CA (1) CA3137101A1 (pt)
CL (1) CL2021002668A1 (pt)
CO (1) CO2021013926A2 (pt)
CR (1) CR20210521A (pt)
EA (1) EA202192860A1 (pt)
EC (1) ECSP21078309A (pt)
IL (1) IL287306A (pt)
JO (1) JOP20210281A1 (pt)
MX (1) MX2021012710A (pt)
PE (1) PE20220383A1 (pt)
SG (1) SG11202110942SA (pt)
WO (1) WO2020215021A1 (pt)
ZA (1) ZA202109184B (pt)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2021009851A (es) 2019-02-18 2021-09-10 Lilly Co Eli Formulacion de anticuerpos terapeuticos.
US20230417762A1 (en) 2020-11-20 2023-12-28 Momenta Pharmaceuticals, Inc. Sialylated glycoproteins

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2004248155B2 (en) * 2003-06-09 2008-10-23 Redox-Reactive Reagents L.L.C. Method of altering the binding specificity of plasma proteins by oxidation-reduction reactions
EP1532983A1 (en) * 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
CA2615122A1 (en) * 2005-08-03 2007-02-15 Immunogen, Inc. Immunoconjugate formulations
EP3708581A3 (en) * 2009-05-27 2021-10-20 Takeda Pharmaceutical Company Limited A method to produce a highly concentrated immunoglobulin preparation for subcutaneous use
FR2961107B1 (fr) * 2010-06-15 2012-07-27 Lab Francais Du Fractionnement Composition d'immunoglobulines humaines stabilisee
EP2900264A4 (en) * 2012-09-26 2016-05-25 Momenta Pharmaceuticals Inc GLYKOPROTEINZUBEREITUNGEN
US20160108450A1 (en) * 2013-05-02 2016-04-21 Momenta Pharmaceutcals, Inc. Sialylated glycoproteins
CA2908407C (en) * 2013-05-29 2022-06-14 F. Hoffmann-La Roche Ag Quantitative control of sialylation
WO2018131893A1 (ko) * 2017-01-11 2018-07-19 ㈜셀트리온 안정한 액체 제제

Also Published As

Publication number Publication date
JOP20210281A1 (ar) 2023-01-30
BR112021020509A2 (pt) 2022-03-15
CR20210521A (es) 2022-04-01
EA202192860A1 (ru) 2021-12-23
ECSP21078309A (es) 2021-11-30
PE20220383A1 (es) 2022-03-18
WO2020215021A1 (en) 2020-10-22
CL2021002668A1 (es) 2022-05-27
CN113795275A (zh) 2021-12-14
US20220211849A1 (en) 2022-07-07
SG11202110942SA (en) 2021-11-29
EP3955962A1 (en) 2022-02-23
JP2022529168A (ja) 2022-06-17
KR20220002963A (ko) 2022-01-07
MX2021012710A (es) 2021-11-12
ZA202109184B (en) 2023-04-26
EP3955962A4 (en) 2022-12-14
AU2020259492A1 (en) 2021-11-11
CA3137101A1 (en) 2020-10-22
IL287306A (en) 2021-12-01
CO2021013926A2 (es) 2021-10-29

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Legal Events

Date Code Title Description
B25A Requested transfer of rights approved

Owner name: MOMENTA PHARMACEUTICALS, INC. (US)