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MX2019005269A - Formulaciones estables de dominios variables sencillos de inmunoglobulina y usos de las mismas. - Google Patents

Formulaciones estables de dominios variables sencillos de inmunoglobulina y usos de las mismas.

Info

Publication number
MX2019005269A
MX2019005269A MX2019005269A MX2019005269A MX2019005269A MX 2019005269 A MX2019005269 A MX 2019005269A MX 2019005269 A MX2019005269 A MX 2019005269A MX 2019005269 A MX2019005269 A MX 2019005269A MX 2019005269 A MX2019005269 A MX 2019005269A
Authority
MX
Mexico
Prior art keywords
variable domains
formulations
immunoglobulin
shaking
same
Prior art date
Application number
MX2019005269A
Other languages
English (en)
Other versions
MX387527B (es
Inventor
Meyvis Yves
De Brabandere Veronique
Ulrichts Hans
Brige Ann
Callewaert Filip
Original Assignee
Ablynx Nv
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 Ablynx Nv filed Critical Ablynx Nv
Publication of MX2019005269A publication Critical patent/MX2019005269A/es
Publication of MX387527B publication Critical patent/MX387527B/es

Links

Classifications

    • 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
    • C07K16/36—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
    • 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
    • A61K47/12—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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/22—Immunoglobulins specific features characterized by taxonomic origin from camelids, e.g. camel, llama or dromedary
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Diabetes (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

La presente invención se refiere a formulaciones estables de polipéptidos, por ejemplo, dominios variables sencillos de inmunoglobulina, en particular dominios variables sencillos de inmunoglobulina dirigidos contra el Factor de von Willebrand (vWF). La invención proporciona formulaciones las cuales son estables durante el almacenamiento por periodos prolongados de tiempo y sobre un intervalo amplio de temperaturas. Las formulaciones de la invención aseguran una estabilidad alta del polipéptido, permitiendo ciclos de congelación-descongelación múltiples sin deterioro químico o físico, y proporcionan estabilidad con relación a la tensión mecánica, tal como tensión por sacudida, corte o agitación. Son adecuadas para preparaciones de diagnóstico y farmacéuticas y compatibles con diluyentes farmacéuticamente aceptables.
MX2019005269A 2013-05-17 2014-05-16 Formulaciones estables de dominios variables sencillos de inmunoglobulina y usos de las mismas. MX387527B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361824523P 2013-05-17 2013-05-17
PCT/EP2014/060107 WO2014184352A1 (en) 2013-05-17 2014-05-16 Stable formulations of immunoglobulin single variable domains and uses thereof

Publications (2)

Publication Number Publication Date
MX2019005269A true MX2019005269A (es) 2019-09-04
MX387527B MX387527B (es) 2025-03-12

Family

ID=49304267

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2019005269A MX387527B (es) 2013-05-17 2014-05-16 Formulaciones estables de dominios variables sencillos de inmunoglobulina y usos de las mismas.
MX2015015722A MX364664B (es) 2013-05-17 2014-05-16 Formulaciones estables de dominios variables sencillos de inmunoglobulina y usos de las mismas.

Family Applications After (1)

Application Number Title Priority Date Filing Date
MX2015015722A MX364664B (es) 2013-05-17 2014-05-16 Formulaciones estables de dominios variables sencillos de inmunoglobulina y usos de las mismas.

Country Status (25)

Country Link
US (2) US10035862B2 (es)
EP (2) EP2996720B1 (es)
JP (2) JP6433986B2 (es)
KR (1) KR102166399B1 (es)
CN (3) CN110063935B (es)
AU (3) AU2014267222B2 (es)
BR (1) BR112015028411B1 (es)
CA (1) CA2912670A1 (es)
CY (1) CY1122090T1 (es)
DK (1) DK2996720T3 (es)
ES (2) ES2731922T3 (es)
HR (1) HRP20190954T1 (es)
HU (1) HUE044392T2 (es)
LT (1) LT2996720T (es)
MX (2) MX387527B (es)
NL (1) NL1040254C2 (es)
PH (1) PH12015502591A1 (es)
PL (2) PL3511018T3 (es)
PT (2) PT2996720T (es)
RS (1) RS58857B1 (es)
RU (1) RU2671977C2 (es)
SI (1) SI2996720T1 (es)
SM (1) SMT201900359T1 (es)
TR (1) TR201908663T4 (es)
WO (1) WO2014184352A1 (es)

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Also Published As

Publication number Publication date
KR20160007657A (ko) 2016-01-20
CA2912670A1 (en) 2014-11-20
RU2018137504A (ru) 2018-12-14
KR102166399B1 (ko) 2020-10-16
RU2018137504A3 (es) 2021-12-28
RU2015154214A (ru) 2017-06-22
CN110063935B (zh) 2021-11-09
AU2019201307B2 (en) 2021-01-28
US10035862B2 (en) 2018-07-31
JP6433986B2 (ja) 2018-12-05
ES2731922T3 (es) 2019-11-19
JP2019034967A (ja) 2019-03-07
CN110037983A (zh) 2019-07-23
TR201908663T4 (tr) 2019-07-22
RU2671977C2 (ru) 2018-11-08
PL3511018T3 (pl) 2022-01-10
MX2015015722A (es) 2016-03-16
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CN105339003A (zh) 2016-02-17
SI2996720T1 (sl) 2019-07-31
EP3511018B1 (en) 2021-07-28
CY1122090T1 (el) 2020-11-25
BR112015028411B1 (pt) 2023-01-10
AU2014267222B2 (en) 2018-12-13
SMT201900359T1 (it) 2019-07-11
CN105339003B (zh) 2018-11-20
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US20160090424A1 (en) 2016-03-31
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PT3511018T (pt) 2021-10-15
RS58857B1 (sr) 2019-07-31
AU2019201307A1 (en) 2019-03-14
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AU2021200035A1 (en) 2021-02-25
HK1218258A1 (zh) 2017-02-10
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DK2996720T3 (da) 2019-06-24
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BR112015028411A2 (pt) 2017-12-12
MX387527B (es) 2025-03-12
AU2014267222A1 (en) 2015-11-12
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JP2016520075A (ja) 2016-07-11
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