CL2021002668A1 - Glicoproteínas sialiladas. - Google Patents

Glicoproteínas sialiladas.

Info

Publication number
CL2021002668A1
CL2021002668A1 CL2021002668A CL2021002668A CL2021002668A1 CL 2021002668 A1 CL2021002668 A1 CL 2021002668A1 CL 2021002668 A CL2021002668 A CL 2021002668A CL 2021002668 A CL2021002668 A CL 2021002668A CL 2021002668 A1 CL2021002668 A1 CL 2021002668A1
Authority
CL
Chile
Prior art keywords
shear stress
stable
sialylated glycoproteins
pharmaceutical
preparations
Prior art date
Application number
CL2021002668A
Other languages
English (en)
Inventor
Siddhesh D Patil
Original Assignee
Janssen Biotech 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 filed Critical Janssen Biotech Inc
Publication of CL2021002668A1 publication Critical patent/CL2021002668A1/es

Links

Classifications

    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/40Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41Glycosylation, sialylation, or fucosylation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/524CH2 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55Fab or Fab'

Abstract

Se describen preparaciones farmacéuticas que contienen inmunoglobulinas hipersialiladas. Las preparaciones son estables al esfuerzo de cizalla. Las composiciones farmacéuticas descritas en la presente descripción proporcionan composiciones de hsIgG farmacéuticamente aceptables que son estables contra el esfuerzo de cizalla (p. ej., no se forman un número significativo de partículas subvisibles cuando la formulación se somete a esfuerzo de cizalla, tal como agitación, por ejemplo, durante el envío) y, por lo tanto, pueden enviarse y manipularse en forma líquida.
CL2021002668A 2019-04-18 2021-10-12 Glicoproteínas sialiladas. CL2021002668A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201962836016P 2019-04-18 2019-04-18

Publications (1)

Publication Number Publication Date
CL2021002668A1 true CL2021002668A1 (es) 2022-05-27

Family

ID=72837963

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2021002668A CL2021002668A1 (es) 2019-04-18 2021-10-12 Glicoproteínas sialiladas.

Country Status (20)

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

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
CN113795275A (zh) 2021-12-14
BR112021020509A8 (pt) 2023-01-10
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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