DK3209767T3 - Hidtil ukendt oprensningsfremgangsmåde til isolering og kommerciel fremstilling af rekombinant tnk-tpa (tenecteplase) - Google Patents

Hidtil ukendt oprensningsfremgangsmåde til isolering og kommerciel fremstilling af rekombinant tnk-tpa (tenecteplase) Download PDF

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Publication number
DK3209767T3
DK3209767T3 DK15852227.6T DK15852227T DK3209767T3 DK 3209767 T3 DK3209767 T3 DK 3209767T3 DK 15852227 T DK15852227 T DK 15852227T DK 3209767 T3 DK3209767 T3 DK 3209767T3
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DK
Denmark
Prior art keywords
tenecte
plase
tpa
insulation
purification procedure
Prior art date
Application number
DK15852227.6T
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English (en)
Inventor
Arjun Raghuwanshi
Kumar Shrawan Singh
Ankit Kumar
Ranjan Mihir Sahoo
Sanjay Singh
Original Assignee
Gennova Biopharmaceuticals Ltd
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Application filed by Gennova Biopharmaceuticals Ltd filed Critical Gennova Biopharmaceuticals Ltd
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Publication of DK3209767T3 publication Critical patent/DK3209767T3/da

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    • 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)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (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)
DK15852227.6T 2014-10-21 2015-10-19 Hidtil ukendt oprensningsfremgangsmåde til isolering og kommerciel fremstilling af rekombinant tnk-tpa (tenecteplase) DK3209767T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2343MU2014 2014-10-21
PCT/IN2015/050137 WO2016063299A2 (en) 2014-10-21 2015-10-19 A novel purification process for isolation and commercial production of recombinant tnk-tpa (tenecteplase)

Publications (1)

Publication Number Publication Date
DK3209767T3 true DK3209767T3 (da) 2020-11-02

Family

ID=55761711

Family Applications (1)

Application Number Title Priority Date Filing Date
DK15852227.6T DK3209767T3 (da) 2014-10-21 2015-10-19 Hidtil ukendt oprensningsfremgangsmåde til isolering og kommerciel fremstilling af rekombinant tnk-tpa (tenecteplase)

Country Status (16)

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

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
WO2019086463A1 (en) 2017-10-30 2019-05-09 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
ES3014697T3 (en) * 2018-07-19 2025-04-24 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
CA2368797C (en) * 1999-04-26 2010-08-17 Genentech, Inc. Cell culture process
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
TWI439282B (zh) * 2006-08-29 2014-06-01 Genentech Inc 以血栓溶解劑治療中風之方法
WO2008070353A2 (en) * 2006-11-07 2008-06-12 Genentech, Inc. Tissue plasminogen activator variant uses
WO2011015922A1 (en) * 2009-08-03 2011-02-10 Avesthagen Limited A highly efficient process of purification and production of recombinant tnk-tpa (tenecteplase)
EP4786482A2 (en) * 2009-08-06 2026-08-05 F. Hoffmann-La Roche AG Virus filtration methods
US9540426B2 (en) * 2009-10-06 2017-01-10 Bristol-Myers Squibb Company Mammalian cell culture processes for protein production
ES2635595T3 (es) * 2010-11-16 2017-10-04 Cadila Healthcare Limited Un nuevo procedimiento para la purificación del activador tisular del plasminógeno
EP2654770B1 (en) * 2010-12-23 2018-07-11 Gennova Biopharmaceuticals Ltd. Pharmaceutical compositions of tenecteplase

Also Published As

Publication number Publication date
BR112017006294A2 (pt) 2017-12-12
SA517381361B1 (ar) 2021-07-17
LT3209767T (lt) 2020-11-25
US10544408B2 (en) 2020-01-28
US20180223270A1 (en) 2018-08-09
AU2015334455B2 (en) 2020-05-21
MX383595B (es) 2025-03-14
NZ731196A (en) 2020-09-25
JP2018504366A (ja) 2018-02-15
EP3209767A2 (en) 2017-08-30
CL2017000952A1 (es) 2018-05-25
PE20171131A1 (es) 2017-08-09
WO2016063299A2 (en) 2016-04-28
WO2016063299A3 (en) 2016-06-09
JP7086601B2 (ja) 2022-06-20
ES2829923T3 (es) 2021-06-02
CO2017004931A2 (es) 2017-08-10
PT3209767T (pt) 2020-11-09
EP3209767B1 (en) 2020-08-05
PL3209767T3 (pl) 2021-01-11
AU2015334455A1 (en) 2017-05-18
EA038482B1 (ru) 2021-09-03
EA201700217A1 (ru) 2017-10-31
MX2017004470A (es) 2017-11-20
EP3209767A4 (en) 2018-03-07

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