BR112015028411B1 - Formulações estáveis de domínios variáveis únicos de imunoglobulina e uso destas - Google Patents

Formulações estáveis de domínios variáveis únicos de imunoglobulina e uso destas Download PDF

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Publication number
BR112015028411B1
BR112015028411B1 BR112015028411-6A BR112015028411A BR112015028411B1 BR 112015028411 B1 BR112015028411 B1 BR 112015028411B1 BR 112015028411 A BR112015028411 A BR 112015028411A BR 112015028411 B1 BR112015028411 B1 BR 112015028411B1
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BR
Brazil
Prior art keywords
formulation
concentration
formulations
vwf
storage
Prior art date
Application number
BR112015028411-6A
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English (en)
Portuguese (pt)
Other versions
BR112015028411A2 (pt
Inventor
Yves Meyvis
Veronique De Brabandere
Hans Ulrichts
Ann Brige
Filip Callewaert
Original Assignee
Ablynx Nv
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Publication date
Application filed by Ablynx Nv filed Critical Ablynx Nv
Publication of BR112015028411A2 publication Critical patent/BR112015028411A2/pt
Publication of BR112015028411B1 publication Critical patent/BR112015028411B1/pt

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    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/36—Immunoglobulins [IG], 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
    • 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

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  • 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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Diabetes (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (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)
BR112015028411-6A 2013-05-17 2014-05-16 Formulações estáveis de domínios variáveis únicos de imunoglobulina e uso destas BR112015028411B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361824523P 2013-05-17 2013-05-17
US61/824,523 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
BR112015028411A2 BR112015028411A2 (pt) 2017-12-12
BR112015028411B1 true BR112015028411B1 (pt) 2023-01-10

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BR112015028411-6A BR112015028411B1 (pt) 2013-05-17 2014-05-16 Formulações estáveis de domínios variáveis únicos de imunoglobulina e uso destas

Country Status (25)

Country Link
US (2) US10035862B2 (https=)
EP (2) EP3511018B1 (https=)
JP (2) JP6433986B2 (https=)
KR (1) KR102166399B1 (https=)
CN (3) CN105339003B (https=)
AU (3) AU2014267222B2 (https=)
BR (1) BR112015028411B1 (https=)
CA (1) CA2912670A1 (https=)
CY (1) CY1122090T1 (https=)
DK (1) DK2996720T3 (https=)
ES (2) ES2731922T3 (https=)
HR (1) HRP20190954T1 (https=)
HU (1) HUE044392T2 (https=)
LT (1) LT2996720T (https=)
MX (2) MX387527B (https=)
NL (1) NL1040254C2 (https=)
PH (1) PH12015502591B1 (https=)
PL (2) PL3511018T3 (https=)
PT (2) PT3511018T (https=)
RS (1) RS58857B1 (https=)
RU (1) RU2671977C2 (https=)
SI (1) SI2996720T1 (https=)
SM (1) SMT201900359T1 (https=)
TR (1) TR201908663T4 (https=)
WO (1) WO2014184352A1 (https=)

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CN113908254B (zh) * 2021-10-19 2024-05-28 山西锦波生物医药股份有限公司 一种干粉吸入剂及其制备方法和用途
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Publication number Publication date
US10035862B2 (en) 2018-07-31
MX2019005269A (es) 2019-09-04
RU2671977C2 (ru) 2018-11-08
RS58857B1 (sr) 2019-07-31
HK1218258A1 (zh) 2017-02-10
MX387527B (es) 2025-03-12
ES2895150T3 (es) 2022-02-17
TR201908663T4 (tr) 2019-07-22
JP2019034967A (ja) 2019-03-07
US20190010249A1 (en) 2019-01-10
ES2731922T3 (es) 2019-11-19
EP3511018B1 (en) 2021-07-28
PL3511018T3 (pl) 2022-01-10
KR102166399B1 (ko) 2020-10-16
MX364664B (es) 2019-05-03
PL2996720T3 (pl) 2019-09-30
MX2015015722A (es) 2016-03-16
CN110063935B (zh) 2021-11-09
LT2996720T (lt) 2019-07-10
JP2016520075A (ja) 2016-07-11
AU2019201307B2 (en) 2021-01-28
EP2996720B1 (en) 2019-03-27
AU2014267222A1 (en) 2015-11-12
CN110037983A (zh) 2019-07-23
SI2996720T1 (sl) 2019-07-31
PH12015502591A1 (en) 2016-02-29
CN105339003A (zh) 2016-02-17
CN110063935A (zh) 2019-07-30
EP2996720A1 (en) 2016-03-23
BR112015028411A2 (pt) 2017-12-12
US20160090424A1 (en) 2016-03-31
DK2996720T3 (da) 2019-06-24
NL1040254C2 (en) 2014-11-24
WO2014184352A1 (en) 2014-11-20
PH12015502591B1 (en) 2016-02-29
RU2015154214A (ru) 2017-06-22
CN105339003B (zh) 2018-11-20
HRP20190954T1 (hr) 2019-07-26
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HUE044392T2 (hu) 2019-10-28
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