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CY1122090T1 - Σταθερες φαρμακοτεχνικες μορφες μονων μεταβλητων περιοχων ανοσοσφαιρινης και χρησεις αυτων - Google Patents

Σταθερες φαρμακοτεχνικες μορφες μονων μεταβλητων περιοχων ανοσοσφαιρινης και χρησεις αυτων

Info

Publication number
CY1122090T1
CY1122090T1 CY20191100669T CY191100669T CY1122090T1 CY 1122090 T1 CY1122090 T1 CY 1122090T1 CY 20191100669 T CY20191100669 T CY 20191100669T CY 191100669 T CY191100669 T CY 191100669T CY 1122090 T1 CY1122090 T1 CY 1122090T1
Authority
CY
Cyprus
Prior art keywords
single variable
immunospherein
pharmaceutical
variable region
stable pharmaceutical
Prior art date
Application number
CY20191100669T
Other languages
English (en)
Inventor
Yves Meyvis
Veronique De Brabandere
Hans Ulrichts
Ann Brige
Filip CALLEWAERT
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 CY1122090T1 publication Critical patent/CY1122090T1/el

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    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/36Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/22Immunoglobulins specific features characterized by taxonomic origin from camelids, e.g. camel, llama or dromedary
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/569Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, 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)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Diabetes (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (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

Η παρούσα εφεύρεση αναφέρεται σε σταθερές φαρμακοτεχνικές μορφές πολυπεπτιδίων, π.χ. μονές μεταβλητές περιοχές ανοσοσφαιρίνης, συγκεκριμένα μονές μεταβλητές περιοχές ανοσοσφαιρίνης οι οποίες κατευθύνονται έναντι Παράγοντα von Willebrand (vWF). Η εφεύρεση παρέχει φαρμακοτεχνικές μορφές που είναι σταθερές κατά την αποθήκευση για παρατεταμένες χρονικές περιόδους και σε ένα ευρύ φάσμα θερμοκρασιών. Οι φαρμακοτεχνικές μορφές της εφεύρεσης εξασφαλίζουν υψηλή σταθερότητα του πολυπεπτιδίου, επιτρέποντας πολλαπλούς κύκλους ψύξης-τήξης χωρίς χημική ή φυσική αλλοίωση, και παρέχουν σταθερότητα σε σχέση με μηχανική καταπόνηση, όπως καταπόνηση ανακίνησης, διάτμησης ή ανάδευσης. Είναι κατάλληλες για φαρμακευτικές και διαγνωστικές παρασκευές και συμβατές με φαρμακευτικώς αποδεκτά αραιωτικά.
CY20191100669T 2013-05-17 2019-06-26 Σταθερες φαρμακοτεχνικες μορφες μονων μεταβλητων περιοχων ανοσοσφαιρινης και χρησεις αυτων CY1122090T1 (el)

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 (1)

Publication Number Publication Date
CY1122090T1 true CY1122090T1 (el) 2020-11-25

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CY20191100669T CY1122090T1 (el) 2013-05-17 2019-06-26 Σταθερες φαρμακοτεχνικες μορφες μονων μεταβλητων περιοχων ανοσοσφαιρινης και χρησεις αυτων

Country Status (26)

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US (2) US10035862B2 (el)
EP (2) EP3511018B1 (el)
JP (2) JP6433986B2 (el)
KR (1) KR102166399B1 (el)
CN (3) CN110037983A (el)
AU (3) AU2014267222B2 (el)
BR (1) BR112015028411B1 (el)
CA (1) CA2912670A1 (el)
CY (1) CY1122090T1 (el)
DK (1) DK2996720T3 (el)
ES (2) ES2895150T3 (el)
HK (1) HK1218258A1 (el)
HR (1) HRP20190954T1 (el)
HU (1) HUE044392T2 (el)
LT (1) LT2996720T (el)
MX (2) MX364664B (el)
NL (1) NL1040254C2 (el)
PH (1) PH12015502591B1 (el)
PL (2) PL2996720T3 (el)
PT (2) PT3511018T (el)
RS (1) RS58857B1 (el)
RU (1) RU2671977C2 (el)
SI (1) SI2996720T1 (el)
SM (1) SMT201900359T1 (el)
TR (1) TR201908663T4 (el)
WO (1) WO2014184352A1 (el)

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Also Published As

Publication number Publication date
DK2996720T3 (da) 2019-06-24
MX2019005269A (es) 2019-09-04
CN105339003A (zh) 2016-02-17
JP2019034967A (ja) 2019-03-07
US10035862B2 (en) 2018-07-31
KR102166399B1 (ko) 2020-10-16
NL1040254C2 (en) 2014-11-24
AU2014267222A1 (en) 2015-11-12
AU2019201307B2 (en) 2021-01-28
JP2016520075A (ja) 2016-07-11
PH12015502591A1 (en) 2016-02-29
AU2014267222B2 (en) 2018-12-13
US20190010249A1 (en) 2019-01-10
AU2019201307A1 (en) 2019-03-14
PT3511018T (pt) 2021-10-15
ES2731922T3 (es) 2019-11-19
US20160090424A1 (en) 2016-03-31
EP2996720A1 (en) 2016-03-23
MX2015015722A (es) 2016-03-16
KR20160007657A (ko) 2016-01-20
CN110063935A (zh) 2019-07-30
JP6433986B2 (ja) 2018-12-05
MX364664B (es) 2019-05-03
PT2996720T (pt) 2019-07-04
PH12015502591B1 (en) 2016-02-29
RU2018137504A3 (el) 2021-12-28
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BR112015028411A2 (pt) 2017-12-12
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SMT201900359T1 (it) 2019-07-11
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EP3511018A1 (en) 2019-07-17
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JP6952019B2 (ja) 2021-10-20
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CA2912670A1 (en) 2014-11-20
RU2671977C2 (ru) 2018-11-08
WO2014184352A1 (en) 2014-11-20
AU2021200035A1 (en) 2021-02-25
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