FR24C1049I2 - Formulations liquides et lyophilisées stabilisées de adamts13 - Google Patents

Formulations liquides et lyophilisées stabilisées de adamts13

Info

Publication number
FR24C1049I2
FR24C1049I2 FR24C1049C FR24C1049C FR24C1049I2 FR 24C1049 I2 FR24C1049 I2 FR 24C1049I2 FR 24C1049 C FR24C1049 C FR 24C1049C FR 24C1049 C FR24C1049 C FR 24C1049C FR 24C1049 I2 FR24C1049 I2 FR 24C1049I2
Authority
FR
France
Prior art keywords
adamts13
freeze
stabilized liquid
dried formulations
formulations
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
FR24C1049C
Other languages
English (en)
French (fr)
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Takeda Pharmaceutical Co Ltd
Original Assignee
Takeda Pharmaceutical Co Ltd
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 Takeda Pharmaceutical Co Ltd filed Critical Takeda Pharmaceutical Co Ltd
Publication of FR24C1049I1 publication Critical patent/FR24C1049I1/fr
Application granted granted Critical
Publication of FR24C1049I2 publication Critical patent/FR24C1049I2/fr
Active legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/24—Metalloendopeptidases (3.4.24)
    • C12Y304/24087—ADAMTS13 endopeptidase (3.4.24.87)
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • General Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Dermatology (AREA)
  • Dispersion Chemistry (AREA)
  • Peptides Or Proteins (AREA)
FR24C1049C 2009-09-21 2024-12-10 Formulations liquides et lyophilisées stabilisées de adamts13 Active FR24C1049I2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US24435309P 2009-09-21 2009-09-21
PCT/US2010/049723 WO2011035335A2 (en) 2009-09-21 2010-09-21 Stabilized liquid and lyophilized adamts13 formulations
EP10759786.6A EP2480198B9 (en) 2009-09-21 2010-09-21 Stabilized liquid and lyophilized adamts13 formulations
EP15203085.4A EP3167897B1 (en) 2009-09-21 2010-09-21 Stabilized liquid and lyophilized adamts13 formulations

Publications (2)

Publication Number Publication Date
FR24C1049I1 FR24C1049I1 (fr) 2025-01-17
FR24C1049I2 true FR24C1049I2 (fr) 2025-12-12

Family

ID=43598388

Family Applications (1)

Application Number Title Priority Date Filing Date
FR24C1049C Active FR24C1049I2 (fr) 2009-09-21 2024-12-10 Formulations liquides et lyophilisées stabilisées de adamts13

Country Status (21)

Country Link
US (9) US8623352B2 (enExample)
EP (5) EP4218797B9 (enExample)
JP (2) JP5819303B2 (enExample)
KR (6) KR20220139456A (enExample)
CN (2) CN102573792B (enExample)
AU (1) AU2010295299B2 (enExample)
BR (1) BR112012006283B1 (enExample)
CA (1) CA2774556A1 (enExample)
DK (4) DK4218797T5 (enExample)
EA (1) EA024267B1 (enExample)
ES (4) ES2579906T3 (enExample)
FI (2) FI4218797T3 (enExample)
FR (1) FR24C1049I2 (enExample)
HR (1) HRP20160295T1 (enExample)
HU (1) HUE028688T2 (enExample)
IN (1) IN2012DN02645A (enExample)
MX (3) MX362382B (enExample)
NZ (1) NZ598839A (enExample)
PL (4) PL4218797T3 (enExample)
PT (2) PT3834841T (enExample)
WO (1) WO2011035335A2 (enExample)

Families Citing this family (21)

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EP2358895B1 (en) 2008-12-05 2018-05-30 Baxalta GmbH Methods of measuring adamts13-mediated in vivo cleavage of von willebrand factor and uses thereof
PL4218797T3 (pl) * 2009-09-21 2025-02-10 Takeda Pharmaceutical Company Limited Stabilizowane płynne i liofilizowane preparaty adamts13
CN104334196B (zh) * 2012-02-16 2018-04-10 Atyr 医药公司 用于治疗自身免疫疾病和炎性疾病的组氨酰‑tRNA合成酶
CN103566362B (zh) * 2012-07-21 2015-07-29 复旦大学 重组adamts13在制备脑出血药物中的用途
US10441531B2 (en) * 2012-11-09 2019-10-15 Bloodworks Protein stabilizing factors
AU2013203062C1 (en) * 2013-03-15 2018-06-28 Takeda Pharmaceutical Company Limited Subcutaneous administration of adamts13
AU2014233436B2 (en) 2013-03-15 2019-12-05 Atyr Pharma, Inc. Histidyl-tRNA synthetase-Fc conjugates
MX377774B (es) * 2014-06-26 2025-03-11 Amgen Inc Formulaciones de proteinas.
GB201510870D0 (en) * 2015-05-26 2015-08-05 Baxalta Inc And Katholieke Universiteit Leuven And Baxalta Gmbh Treatment of infarction
EP3988938B1 (en) 2016-01-08 2024-06-12 Kyoto University Medicine comprising adamts13 as main ingredient
CN116159130B (zh) 2016-08-04 2025-09-09 武田药品工业株式会社 使用adamts13治疗、改善和/或预防镰状细胞病、急性肺损伤和/或急性呼吸窘迫综合征中的血管阻塞危象
WO2018128689A1 (en) 2016-11-04 2018-07-12 Baxalta Incorporated Adeno-associated virus formulations
JP7679175B2 (ja) 2017-04-20 2025-05-19 エータイアー ファーマ， インコーポレイテッド 肺の炎症を治療するための組成物および方法
UA125971C2 (uk) * 2017-07-25 2022-07-20 Джянгсу Хенгруй Медісін Ко., Лтд. Фармацевтична композиція, яка містить протеїновий комплекс il-15, та її застосування
US20210163990A1 (en) * 2018-07-11 2021-06-03 Baxalta Incorporated Aav compositions
WO2021067668A1 (en) 2019-10-04 2021-04-08 The Children's Medical Center Corporation Adamts13 treatment to enhance graft survival
US20230203469A1 (en) 2020-04-02 2023-06-29 Takeda Pharmaceutical Company Limited Adamts13 variant, compositions, and uses thereof
WO2021234458A1 (en) 2020-05-22 2021-11-25 Takeda Pharmaceutical Company Limited Adamts13 compositions and methods for treating and diagnosing complications of coronavirus disease
EP4196147A4 (en) * 2020-08-13 2024-08-21 Hadasit Medical Research Services and Development Ltd. DISINTEGRIN AND METALLOPROTEINASE WITH THROMBOSPONDIN TYPE 1 MOTIF, MUTANTS OF ELEMENT 13 (ADAMTS-13), COMPOSITIONS AND THERAPEUTIC METHODS THEREFOR
JP2025509154A (ja) 2022-03-08 2025-04-11 エクアシールド メディカル リミテッド ロボット医薬品調製システムにおける流体移送ステーション
WO2024151093A1 (ko) * 2023-01-11 2024-07-18 주식회사 녹십자 혈전성 질환의 예방 또는 치료를 위한 신규한 액상 제형물

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US7037658B2 (en) * 2001-08-16 2006-05-02 Regents Of University Of Michigan Methods and compositions for detecting variant ADAMTS13 genes
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CA2606351C (en) 2005-06-17 2016-12-13 Baxter International Inc. Adamts13-comprising compositions having thrombolytic activity
JP4880997B2 (ja) * 2005-12-28 2012-02-22 アルフレッサファーマ株式会社 Ａｄａｍｔｓ１３の安定化方法
KR101423344B1 (ko) 2006-01-04 2014-07-30 백스터 인터내셔널 인코포레이티드 올리고펩티드-무함유 세포 배양 배지를 이용하여 단백질을 발현시키는 방법
PL4218797T3 (pl) * 2009-09-21 2025-02-10 Takeda Pharmaceutical Company Limited Stabilizowane płynne i liofilizowane preparaty adamts13
US8823352B2 (en) 2011-07-11 2014-09-02 Linear Technology Corporation Switching power supply having separate AC and DC current sensing paths

Also Published As

Publication number Publication date
NZ598839A (en) 2014-03-28
DK3167897T3 (da) 2021-04-19
US20160375111A1 (en) 2016-12-29
US20140178357A1 (en) 2014-06-26
EA024267B1 (ru) 2016-09-30
ES2865250T3 (es) 2021-10-15
US20180207245A1 (en) 2018-07-26
EP2480198A2 (en) 2012-08-01
US20110229455A1 (en) 2011-09-22
EP3167897A1 (en) 2017-05-17
CN104224705B (zh) 2018-02-02
EP4467160A2 (en) 2024-11-27
EP4467160A3 (en) 2025-01-15
EP4218797B1 (en) 2024-09-11
KR20210054598A (ko) 2021-05-13
US20230130866A1 (en) 2023-04-27
US8623352B2 (en) 2014-01-07
US9572778B2 (en) 2017-02-21
WO2011035335A3 (en) 2011-12-01
US10758599B2 (en) 2020-09-01
KR20190137954A (ko) 2019-12-11
KR101891646B1 (ko) 2018-08-27
US20200376098A1 (en) 2020-12-03
US20250099559A1 (en) 2025-03-27
PL3834841T3 (pl) 2023-07-24
EP4218797A1 (en) 2023-08-02
US9937244B2 (en) 2018-04-10
PL2480198T3 (pl) 2016-09-30
KR20250008986A (ko) 2025-01-16
BR112012006283B1 (pt) 2022-03-15
CN104224705A (zh) 2014-12-24
MX362382B (es) 2019-01-14
IN2012DN02645A (enExample) 2015-09-11
BR112012006283A2 (pt) 2016-05-31
DK4218797T5 (da) 2025-07-21
FI4218797T3 (fi) 2024-12-07
AU2010295299A1 (en) 2012-04-12
PL4218797T3 (pl) 2025-02-10
EA201200519A1 (ru) 2012-09-28
EP3834841B1 (en) 2023-05-17
JP5819303B2 (ja) 2015-11-24
ES2948612T3 (es) 2023-09-14
KR20220139456A (ko) 2022-10-14
PT3834841T (pt) 2023-06-19
KR20180095738A (ko) 2018-08-27
ES3001509T3 (en) 2025-03-05
HRP20160295T1 (hr) 2016-05-20
PL3167897T3 (pl) 2021-09-27
ES2579906T3 (es) 2016-08-17
US10238720B2 (en) 2019-03-26
FI3834841T3 (fi) 2023-06-05
MX2019000547A (es) 2020-11-12
JP2013505270A (ja) 2013-02-14
WO2011035335A2 (en) 2011-03-24
US20170112906A1 (en) 2017-04-27
MX339205B (es) 2016-05-16
CN102573792B (zh) 2014-10-15
EP3167897B1 (en) 2021-01-27
EP2480198B1 (en) 2016-03-09
MX2012003414A (es) 2012-06-19
EP2480198B9 (en) 2016-11-23
CA2774556A1 (en) 2011-03-24
DK2480198T3 (en) 2016-03-29
HK1173968A1 (zh) 2013-05-31
EP3834841A1 (en) 2021-06-16
US9351935B2 (en) 2016-05-31
EP4218797B9 (en) 2025-03-05
US11564979B2 (en) 2023-01-31
HUE028688T2 (en) 2017-01-30
DK3834841T3 (da) 2023-06-06
US20190247475A1 (en) 2019-08-15
JP2015063556A (ja) 2015-04-09
FR24C1049I1 (fr) 2025-01-17
PT4218797T (pt) 2024-12-09
KR20120099646A (ko) 2012-09-11
CN102573792A (zh) 2012-07-11
US12178861B2 (en) 2024-12-31
DK4218797T3 (da) 2024-12-09
AU2010295299B2 (en) 2015-12-24

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