BR112021020509A2 - Glicoproteínas sialiladas - Google Patents

Glicoproteínas sialiladas

Info

Publication number
BR112021020509A2
BR112021020509A2 BR112021020509A BR112021020509A BR112021020509A2 BR 112021020509 A2 BR112021020509 A2 BR 112021020509A2 BR 112021020509 A BR112021020509 A BR 112021020509A BR 112021020509 A BR112021020509 A BR 112021020509A BR 112021020509 A2 BR112021020509 A2 BR 112021020509A2
Authority
BR
Brazil
Prior art keywords
shear stress
stable
sialylated glycoproteins
present
pharmaceutical
Prior art date
Application number
BR112021020509A
Other languages
English (en)
Other versions
BR112021020509A8 (pt
Inventor
D Patil Siddhesh
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 BR112021020509A2 publication Critical patent/BR112021020509A2/pt
Publication of BR112021020509A8 publication Critical patent/BR112021020509A8/pt

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'

Landscapes

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

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 true BR112021020509A2 (pt) 2022-03-15
BR112021020509A8 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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MA55033A (fr) 2019-02-18 2021-12-29 Lilly Co Eli Formulation d'anticorps thérapeutique
EP4248218A1 (en) 2020-11-20 2023-09-27 Momenta Pharmaceuticals, Inc. Sialylated glycoproteins
US11735303B2 (en) * 2021-06-22 2023-08-22 David Haase Apparatus and method for determining a composition of a replacement therapy treatment

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE518886T1 (de) * 2003-06-09 2011-08-15 Redox Reactive Reagents L L C Verfahren zur änderung der bindungsspezifität von plasmaproteinen durch oxidations- reduktionsreaktionen
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
MY157239A (en) * 2009-05-27 2016-05-13 Baxalta Inc 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
EP3719122A1 (en) * 2013-05-02 2020-10-07 Momenta Pharmaceuticals, Inc. Sialylated glycoproteins
JP6594860B2 (ja) * 2013-05-29 2019-10-23 エフ.ホフマン−ラ ロシュ アーゲー シアル酸付加の定量的調節
WO2018131893A1 (ko) * 2017-01-11 2018-07-19 ㈜셀트리온 안정한 액체 제제

Also Published As

Publication number Publication date
CO2021013926A2 (es) 2021-10-29
SG11202110942SA (en) 2021-11-29
IL287306A (en) 2021-12-01
MX2021012710A (es) 2021-11-12
BR112021020509A8 (pt) 2023-01-10
KR20220002963A (ko) 2022-01-07
AU2020259492A1 (en) 2021-11-11
EP3955962A4 (en) 2022-12-14
EP3955962A1 (en) 2022-02-23
EA202192860A1 (ru) 2021-12-23
ZA202109184B (en) 2023-04-26
CA3137101A1 (en) 2020-10-22
US20220211849A1 (en) 2022-07-07
ECSP21078309A (es) 2021-11-30
CN113795275A (zh) 2021-12-14
CL2021002668A1 (es) 2022-05-27
JOP20210281A1 (ar) 2023-01-30
PE20220383A1 (es) 2022-03-18
WO2020215021A1 (en) 2020-10-22
JP2022529168A (ja) 2022-06-17
CR20210521A (es) 2022-04-01

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Legal Events

Date Code Title Description
B25A Requested transfer of rights approved

Owner name: MOMENTA PHARMACEUTICALS, INC. (US)