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CL2017000952A1 - Proceso novedoso de purificación para el aislamiento y producción comercial de tnk-tpa recombinante (tenecteplasa) - Google Patents

Proceso novedoso de purificación para el aislamiento y producción comercial de tnk-tpa recombinante (tenecteplasa)

Info

Publication number
CL2017000952A1
CL2017000952A1 CL2017000952A CL2017000952A CL2017000952A1 CL 2017000952 A1 CL2017000952 A1 CL 2017000952A1 CL 2017000952 A CL2017000952 A CL 2017000952A CL 2017000952 A CL2017000952 A CL 2017000952A CL 2017000952 A1 CL2017000952 A1 CL 2017000952A1
Authority
CL
Chile
Prior art keywords
tpa
tenecteplase
isolation
tnk
purification process
Prior art date
Application number
CL2017000952A
Other languages
English (en)
Inventor
Sanjay Singh
Arjun Raghuwanshi
Kumar Shrawan Singh
Ankit Kumar
Ranjan Mihir Sahoo
Original Assignee
Gennova Biopharmaceuticals 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=55761711&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CL2017000952(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Gennova Biopharmaceuticals Ltd filed Critical Gennova Biopharmaceuticals Ltd
Publication of CL2017000952A1 publication Critical patent/CL2017000952A1/es

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/6456—Plasminogen activators
    • C12N9/6459—Plasminogen activators t-plasminogen activator (3.4.21.68), i.e. tPA
    • 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)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • 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
    • A61K47/16—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6402—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from non-mammals
    • C12N9/6405—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from non-mammals not being snakes
    • C12N9/6408—Serine endopeptidases (3.4.21)
    • 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)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21068—Tissue plasminogen activator (3.4.21.68), i.e. tPA

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Cardiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Peptides Or Proteins (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

<p>La presente invención se refiere a un nuevo proceso para aislar y purificar activador de plasminógeno tisular y sus variantes, más específicamente TNK-tPA, a partir de células CHO y describe un proceso de purificación de TNK-tPA aplicable en la industria, simple, rentable, robusto y muy eficiente.</p>
CL2017000952A 2014-10-21 2017-04-17 Proceso novedoso de purificación para el aislamiento y producción comercial de tnk-tpa recombinante (tenecteplasa) CL2017000952A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN2343MU2014 2014-10-21

Publications (1)

Publication Number Publication Date
CL2017000952A1 true CL2017000952A1 (es) 2018-05-25

Family

ID=55761711

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2017000952A CL2017000952A1 (es) 2014-10-21 2017-04-17 Proceso novedoso de purificación para el aislamiento y producción comercial de tnk-tpa recombinante (tenecteplasa)

Country Status (16)

Country Link
US (1) US10544408B2 (es)
EP (1) EP3209767B1 (es)
JP (1) JP7086601B2 (es)
AU (1) AU2015334455B2 (es)
CL (1) CL2017000952A1 (es)
CO (1) CO2017004931A2 (es)
DK (1) DK3209767T3 (es)
EA (1) EA038482B1 (es)
ES (1) ES2829923T3 (es)
LT (1) LT3209767T (es)
MX (1) MX383595B (es)
PE (1) PE20171131A1 (es)
PL (1) PL3209767T3 (es)
PT (1) PT3209767T (es)
SA (1) SA517381361B1 (es)
WO (1) WO2016063299A2 (es)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201603291D0 (en) * 2016-02-25 2016-04-13 Binding Site Group The Ltd Antibodies
GB201708262D0 (en) * 2017-05-23 2017-07-05 Binding Site Group Ltd Assay for plasma cell associated disease
SG11202003793WA (en) 2017-10-30 2020-05-28 Baxalta GmbH Environmentally compatible detergents for inactivation of lipid-enveloped viruses
WO2019229764A1 (en) * 2018-06-01 2019-12-05 Gennova Biopharmaceuticals Limited Process for production of recombinant tnk-tpa by packed-bed perfusion system
EP3823594B1 (en) 2018-07-19 2025-02-05 Ichnos Sciences S.A. Liquid antibody formulation
CN113337490B (zh) * 2021-06-18 2022-01-07 广州铭康生物工程有限公司 一种大规模快速分离纯化rhTNK-tPA I/II型的方法
CN115161308A (zh) * 2022-06-13 2022-10-11 江苏丰华生物制药有限公司 一种注射用替奈普酶上清液的纯化方法
CN115400089A (zh) * 2022-08-19 2022-11-29 上海丰华天力通生物医药有限公司 一种含有组织型纤溶酶原激活剂改构体的药物组合物及其制备方法
CN115386562A (zh) * 2022-09-01 2022-11-25 江苏丰华生物制药有限公司 一种重组蛋白内毒素的去除方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1171615B1 (en) 1999-04-26 2006-12-13 Genentech, Inc. Cell culture process for glycoproteins
US20070014779A1 (en) * 2002-11-14 2007-01-18 Genentech, Inc. Plasminogen activator variant formulations
WO2005014655A2 (en) * 2003-08-08 2005-02-17 Fresenius Kabi Deutschland Gmbh Conjugates of hydroxyalkyl starch and a protein
CN101505785A (zh) 2006-08-29 2009-08-12 健泰科生物技术公司 替奈普酶用于治疗急性缺血性中风的用途
JP5871449B2 (ja) 2006-11-07 2016-03-01 ジェネンテック， インコーポレイテッド 組織プラスミノゲン活性化因子バリアントの使用
WO2011015922A1 (en) 2009-08-03 2011-02-10 Avesthagen Limited A highly efficient process of purification and production of recombinant tnk-tpa (tenecteplase)
PT2462158T (pt) 2009-08-06 2018-02-23 H Hoffnabb La Roche Ag Método para melhorar a remoção de vírus na purificação de proteínas
US9540426B2 (en) * 2009-10-06 2017-01-10 Bristol-Myers Squibb Company Mammalian cell culture processes for protein production
EP2640834B1 (en) 2010-11-16 2017-06-28 Cadila Healthcare Limited A novel process for the purification of tissue plasminogen activator
CN103391785A (zh) 2010-12-23 2013-11-13 热诺瓦生物制药有限公司 替萘普酶的药用组合物

Also Published As

Publication number Publication date
DK3209767T3 (da) 2020-11-02
US10544408B2 (en) 2020-01-28
ES2829923T3 (es) 2021-06-02
PT3209767T (pt) 2020-11-09
NZ731196A (en) 2020-09-25
BR112017006294A2 (pt) 2017-12-12
SA517381361B1 (ar) 2021-07-17
EP3209767A4 (en) 2018-03-07
JP2018504366A (ja) 2018-02-15
WO2016063299A2 (en) 2016-04-28
US20180223270A1 (en) 2018-08-09
EP3209767B1 (en) 2020-08-05
WO2016063299A3 (en) 2016-06-09
JP7086601B2 (ja) 2022-06-20
LT3209767T (lt) 2020-11-25
CO2017004931A2 (es) 2017-08-10
AU2015334455B2 (en) 2020-05-21
PE20171131A1 (es) 2017-08-09
AU2015334455A1 (en) 2017-05-18
EP3209767A2 (en) 2017-08-30
EA201700217A1 (ru) 2017-10-31
MX2017004470A (es) 2017-11-20
PL3209767T3 (pl) 2021-01-11
MX383595B (es) 2025-03-14
EA038482B1 (ru) 2021-09-03

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