CO2021013926A2 - Glicoproteínas sialiladas - Google Patents

Glicoproteínas sialiladas

Info

Publication number
CO2021013926A2
CO2021013926A2 CONC2021/0013926A CO2021013926A CO2021013926A2 CO 2021013926 A2 CO2021013926 A2 CO 2021013926A2 CO 2021013926 A CO2021013926 A CO 2021013926A CO 2021013926 A2 CO2021013926 A2 CO 2021013926A2
Authority
CO
Colombia
Prior art keywords
shear stress
stable
sialylated glycoproteins
pharmaceutical
preparations
Prior art date
Application number
CONC2021/0013926A
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 CO2021013926A2 publication Critical patent/CO2021013926A2/es

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'

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

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.
CONC2021/0013926A 2019-04-18 2021-10-15 Glicoproteínas sialiladas CO2021013926A2 (es)

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 (1)

Publication Number Publication Date
CO2021013926A2 true CO2021013926A2 (es) 2021-10-29

Family

ID=72837963

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2021/0013926A CO2021013926A2 (es) 2019-04-18 2021-10-15 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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11634485B2 (en) 2019-02-18 2023-04-25 Eli Lilly And Company Therapeutic antibody formulation
WO2022109327A1 (en) 2020-11-20 2022-05-27 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
JP4662557B2 (ja) * 2003-06-09 2011-03-30 レドックス−リアクティブ リエイジェンツ リミテッド ライアビリティー カンパニー 酸化還元反応による血漿タンパク質の結合特異性の改変方法
EP1532983A1 (en) * 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
NZ599176A (en) * 2005-08-03 2014-04-30 Immunogen Inc Immunoconjugate formulations
SG176256A1 (en) * 2009-05-27 2012-01-30 Baxter Int 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
US20150252108A1 (en) * 2012-09-26 2015-09-10 Momenta Pharmaceuticals, Inc. Glycoprotein preparations
ES2802274T3 (es) * 2013-05-02 2021-01-18 Momenta Pharmaceuticals Inc Glicoproteínas sialiladas
WO2014191240A1 (en) * 2013-05-29 2014-12-04 F. Hoffmann-La Roche Ag Quantitative control of sialylation
CN110167531A (zh) * 2017-01-11 2019-08-23 赛特瑞恩股份有限公司 稳定的液体调配物

Also Published As

Publication number Publication date
ZA202109184B (en) 2023-04-26
CL2021002668A1 (es) 2022-05-27
US20220211849A1 (en) 2022-07-07
KR20220002963A (ko) 2022-01-07
EA202192860A1 (ru) 2021-12-23
AU2020259492A1 (en) 2021-11-11
JP2022529168A (ja) 2022-06-17
WO2020215021A1 (en) 2020-10-22
JOP20210281A1 (ar) 2023-01-30
BR112021020509A8 (pt) 2023-01-10
SG11202110942SA (en) 2021-11-29
CN113795275A (zh) 2021-12-14
MX2021012710A (es) 2021-11-12
IL287306A (en) 2021-12-01
EP3955962A4 (en) 2022-12-14
ECSP21078309A (es) 2021-11-30
BR112021020509A2 (pt) 2022-03-15
CR20210521A (es) 2022-04-01
PE20220383A1 (es) 2022-03-18
CA3137101A1 (en) 2020-10-22
EP3955962A1 (en) 2022-02-23

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