EA200600579A1 - Способ получения плазмидной днк фармацевтического качества - Google Patents
Способ получения плазмидной днк фармацевтического качестваInfo
- Publication number
- EA200600579A1 EA200600579A1 EA200600579A EA200600579A EA200600579A1 EA 200600579 A1 EA200600579 A1 EA 200600579A1 EA 200600579 A EA200600579 A EA 200600579A EA 200600579 A EA200600579 A EA 200600579A EA 200600579 A1 EA200600579 A1 EA 200600579A1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- plasmid dna
- order
- purification steps
- pharmaceutical quality
- pdna
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 2
- 239000013612 plasmid Substances 0.000 title 1
- 230000009089 cytolysis Effects 0.000 abstract 2
- 238000000746 purification Methods 0.000 abstract 2
- 108091032973 (ribonucleotides)n+m Proteins 0.000 abstract 1
- 108091092584 GDNA Proteins 0.000 abstract 1
- 238000001042 affinity chromatography Methods 0.000 abstract 1
- 238000005571 anion exchange chromatography Methods 0.000 abstract 1
- 230000001580 bacterial effect Effects 0.000 abstract 1
- 239000000356 contaminant Substances 0.000 abstract 1
- 239000002158 endotoxin Substances 0.000 abstract 1
- 238000001914 filtration Methods 0.000 abstract 1
- 238000003306 harvesting Methods 0.000 abstract 1
- 238000004191 hydrophobic interaction chromatography Methods 0.000 abstract 1
- 239000006166 lysate Substances 0.000 abstract 1
- 102000004169 proteins and genes Human genes 0.000 abstract 1
- 108090000623 proteins and genes Proteins 0.000 abstract 1
- 239000000725 suspension Substances 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
- A61K48/0091—Purification or manufacturing processes for gene therapy compositions
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M47/00—Means for after-treatment of the produced biomass or of the fermentation or metabolic products, e.g. storage of biomass
- C12M47/06—Hydrolysis; Cell lysis; Extraction of intracellular or cell wall material
-
- 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
- C12N1/00—Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
- C12N1/06—Lysis of microorganisms
-
- 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
- C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
- C12N15/09—Recombinant DNA-technology
- C12N15/10—Processes for the isolation, preparation or purification of DNA or RNA
- C12N15/1003—Extracting or separating nucleic acids from biological samples, e.g. pure separation or isolation methods; Conditions, buffers or apparatuses therefor
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Genetics & Genomics (AREA)
- Biotechnology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Biomedical Technology (AREA)
- General Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Microbiology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Medicinal Chemistry (AREA)
- Tropical Medicine & Parasitology (AREA)
- Virology (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Manufacturing & Machinery (AREA)
- Cell Biology (AREA)
- Sustainable Development (AREA)
- Analytical Chemistry (AREA)
- Crystallography & Structural Chemistry (AREA)
- Physics & Mathematics (AREA)
- Biophysics (AREA)
- Plant Pathology (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Saccharide Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
Abstract
Согласно данному изобретению предложен способ непрерывного щелочного лизиса бактериальной суспензии для получения пДНК. Согласно ему дополнительно предложены возможные дополнительные стадии, включающие фильтрацию лизата, анионообменную хроматографию, аффинную хроматографию с образованием тройной спирали и гидрофобную хроматографию. Эти возможные стадии очистки можно комбинировать с непрерывным лизисом для того, чтобы получить продукт высокоочищенной плазмидной пДНК, по существу лишенной гДНК, РНК, белка, эндотоксина и других примесей.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US50346403P | 2003-09-17 | 2003-09-17 | |
US56300804P | 2004-04-19 | 2004-04-19 | |
PCT/EP2004/011437 WO2005026331A2 (en) | 2003-09-17 | 2004-09-17 | Method of preparation of pharmaceutically grade plasmid dna |
Publications (2)
Publication Number | Publication Date |
---|---|
EA200600579A1 true EA200600579A1 (ru) | 2006-10-27 |
EA009447B1 EA009447B1 (ru) | 2007-12-28 |
Family
ID=42827706
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EA200600579A EA009447B1 (ru) | 2003-09-17 | 2004-09-17 | Способ получения плазмидной днк фармацевтического качества |
Country Status (17)
Country | Link |
---|---|
US (1) | US20070111221A1 (ru) |
EP (1) | EP1664277B1 (ru) |
JP (1) | JP2007505613A (ru) |
KR (1) | KR101094032B1 (ru) |
CN (1) | CN1882682B (ru) |
AT (1) | ATE532853T1 (ru) |
AU (2) | AU2004272748C1 (ru) |
BR (1) | BRPI0413907A (ru) |
CA (1) | CA2536931A1 (ru) |
EA (1) | EA009447B1 (ru) |
ES (1) | ES2376173T3 (ru) |
IL (1) | IL174147A0 (ru) |
MX (1) | MXPA06003004A (ru) |
NO (1) | NO20061659L (ru) |
NZ (1) | NZ545449A (ru) |
PT (1) | PT1664277E (ru) |
WO (1) | WO2005026331A2 (ru) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
RU2489168C1 (ru) * | 2012-02-28 | 2013-08-10 | Общество с ограниченной ответственностью "НТфарма" | Фармацевтическая композиция, продуцирующая антиоксидантный, антимикробный, антитоксический белок - лактоферрин человека, способ ее получения и способ терапии |
Families Citing this family (25)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2005100542A1 (en) * | 2004-04-19 | 2005-10-27 | Centelion | Method for purifying plasmid dna |
ES2529675T3 (es) * | 2004-11-30 | 2015-02-24 | Merial Ltd. | Dispositivos de mezclado para la lisis química de células |
US20090233348A1 (en) * | 2006-08-15 | 2009-09-17 | Basf Se | Method for isolating proteins from production cells |
EP2081442B1 (en) * | 2006-10-10 | 2016-08-10 | TrovaGene, Inc. | Compositions, methods and kits for isolating nucleic acids from body fluids using anion exchange media |
EP2409995A3 (en) | 2007-02-28 | 2012-08-15 | Lipoxen Technologies Limited | Reduction of endotoxin in polysialic acids |
US9017966B2 (en) | 2007-05-23 | 2015-04-28 | Nature Technology Corporation | E. coli plasmid DNA production |
US20090004716A1 (en) * | 2007-05-23 | 2009-01-01 | Vgx Pharmaceuticlas, Inc. | Compositions comprising high concentration of biologically active molecules and processes for preparing the same |
WO2008150838A1 (en) * | 2007-05-31 | 2008-12-11 | Ge Healthcare Uk Limited | Improved miniprep system for simple and rapid plasmid dna extraction |
US20090258932A1 (en) * | 2008-04-09 | 2009-10-15 | Viromed Co., Ltd. | Lyophilized DNA Formulations for Enhanced Expression of Plasmid DNA |
WO2011057199A1 (en) * | 2009-11-06 | 2011-05-12 | Adenios, Inc. | Compositions for treating cns disorders |
RU2488406C1 (ru) * | 2012-02-16 | 2013-07-27 | Общество с ограниченной ответственностью "НТфарма" | Фармацевтическая композиция для терапии острых токсических состояний |
EP2682168A1 (en) | 2012-07-02 | 2014-01-08 | Millipore Corporation | Purification of biological molecules |
CN104099321A (zh) * | 2014-07-10 | 2014-10-15 | 广州市军科泰特医药科技有限公司 | 抗肺癌T-VISA-BikDD质粒的制备方法 |
MX383367B (es) * | 2014-12-29 | 2025-03-13 | Toray Ind Inc Star | Composición que contiene establemente una molécula de ácido nucleico. |
CN106884011B (zh) * | 2015-12-16 | 2020-11-17 | 固安鼎泰海规生物科技有限公司 | 一种规模化质粒纯化的联合液相层析分离方法 |
EP3452574A1 (en) | 2016-05-06 | 2019-03-13 | Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V. | Plug flow tubular bioreactor, system containing the same and method for production of virus |
US20210207075A1 (en) * | 2018-05-31 | 2021-07-08 | Vgxi Inc. | Lysis coil apparatus and uses thereof for isolation and purification of polynucleotides |
IL296722A (en) | 2020-03-31 | 2022-11-01 | Richter Helm Biologics Gmbh & Co Kg | Methods for the production of plasmid DNA |
CN111394427B (zh) * | 2020-04-22 | 2023-04-11 | 宁波市博坤生物科技有限公司 | 一种含泥土检材中微量dna的提取方法 |
EP3906982B1 (de) | 2020-05-08 | 2022-03-16 | AXAGARIUS GmbH & Co. KG | Verfahren zur plasmidreinigung unter gleichzeitiger abreicherung von endotoxinen |
JP2021074018A (ja) * | 2021-02-12 | 2021-05-20 | マックス−プランク−ゲゼルシャフト・ツア・フェルデルング・デア・ヴィッセンシャフテン・エー・ファオ | プラグフローチューブ型バイオリアクター、それを含むシステム、およびウイルスの調製のための方法 |
CN115404232A (zh) * | 2021-05-10 | 2022-11-29 | 艾棣维欣(苏州)生物制品有限公司 | 用于提取细菌中质粒dna的方法 |
CN113332869B (zh) * | 2021-06-23 | 2022-12-23 | 苏州沃美生物有限公司 | 混合装置和方法以及重组大肠杆菌质粒提取方法 |
WO2024086213A2 (en) * | 2022-10-19 | 2024-04-25 | Abec, Inc. | Cell lysis and plasmid isolation system |
CN117187069B (zh) * | 2023-09-18 | 2024-04-05 | 苏州依科赛生物科技股份有限公司 | 一种碱裂解工艺的大肠杆菌hcp检测方法 |
Family Cites Families (22)
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US2692764A (en) * | 1951-01-19 | 1954-10-26 | Howe Baker Corp | Mixing apparatus |
JPS5321458A (en) * | 1976-08-11 | 1978-02-27 | Hitachi Ltd | Device for mixing fluids |
US4737349A (en) * | 1985-11-01 | 1988-04-12 | Ciba-Geigy Corporation | Tubular reactor for heterogeneous reactions |
US5096818A (en) * | 1990-06-04 | 1992-03-17 | Autogen Instruments, Inc. | Nucleic acid separation method |
US5561064A (en) * | 1994-02-01 | 1996-10-01 | Vical Incorporated | Production of pharmaceutical-grade plasmid DNA |
US6197553B1 (en) * | 1994-07-15 | 2001-03-06 | Merck & Co., Inc. | Method for large scale plasmid purification |
US5837529A (en) * | 1994-10-17 | 1998-11-17 | Genzyme Corporation | Method for lysing cells |
FR2728264B1 (fr) * | 1994-12-16 | 1997-01-31 | Rhone Poulenc Rorer Sa | Purification d'adn par formation de triple helice avec un oligonucleotide immobilise |
US5840254A (en) * | 1995-06-02 | 1998-11-24 | Cdc Technologies, Inc. | Apparatus for mixing fluids for analysis |
AU706857B2 (en) * | 1995-12-21 | 1999-06-24 | Genzyme Corporation | Method for lysing cells |
FR2746412B1 (fr) * | 1996-03-21 | 1998-06-12 | Rhone Poulenc Rorer Sa | Purification d'adn plasmidique de qualite pharmaceutique |
US7026468B2 (en) * | 1996-07-19 | 2006-04-11 | Valentis, Inc. | Process and equipment for plasmid purification |
US7807822B2 (en) * | 1996-08-01 | 2010-10-05 | Robert Bridenbaugh | Methods for purifying nucleic acids |
US5721120A (en) * | 1996-10-02 | 1998-02-24 | Merck & Co., Inc. | Method of disrupting cultured cells using an impinging jet device |
FR2773818B1 (fr) * | 1998-01-21 | 2000-02-18 | Pasteur Merieux Serums Vacc | Procede et dispositif de lyse de bacteries |
GB2338236B (en) * | 1998-06-13 | 2003-04-09 | Aea Technology Plc | Microbiological cell processing |
US6664049B1 (en) * | 1999-01-20 | 2003-12-16 | Aventis Pasteur S.A. | Method and device for cell lysis |
DE60042366D1 (de) * | 1999-05-28 | 2009-07-23 | Lonza Biolog Inc | Methoden zur reinigung von dns |
AU7688900A (en) * | 1999-10-02 | 2001-05-10 | Bioneer Corporation | Automatic dna purification apparatus |
JP2004509335A (ja) * | 2000-09-18 | 2004-03-25 | ユニバーシティ オブ ワシントン | 複数のフローストリーム間の流体界面の回転操作のための微小流体デバイス |
JP2005538717A (ja) * | 2002-09-13 | 2005-12-22 | ヴァレンティス,インコーポレイテッド | 核酸のプレパラティブスケールの精製のための装置および方法 |
WO2004060277A2 (en) * | 2002-12-23 | 2004-07-22 | Vical Incorporated | Process for purification of plasmid dna |
-
2004
- 2004-09-17 BR BRPI0413907-0A patent/BRPI0413907A/pt not_active Application Discontinuation
- 2004-09-17 CN CN2004800338652A patent/CN1882682B/zh not_active Expired - Fee Related
- 2004-09-17 EP EP04787081A patent/EP1664277B1/en not_active Expired - Lifetime
- 2004-09-17 JP JP2006526618A patent/JP2007505613A/ja active Pending
- 2004-09-17 PT PT04787081T patent/PT1664277E/pt unknown
- 2004-09-17 KR KR1020067005411A patent/KR101094032B1/ko not_active Expired - Fee Related
- 2004-09-17 MX MXPA06003004A patent/MXPA06003004A/es active IP Right Grant
- 2004-09-17 AT AT04787081T patent/ATE532853T1/de active
- 2004-09-17 WO PCT/EP2004/011437 patent/WO2005026331A2/en active Application Filing
- 2004-09-17 NZ NZ545449A patent/NZ545449A/en not_active IP Right Cessation
- 2004-09-17 EA EA200600579A patent/EA009447B1/ru not_active IP Right Cessation
- 2004-09-17 ES ES04787081T patent/ES2376173T3/es not_active Expired - Lifetime
- 2004-09-17 AU AU2004272748A patent/AU2004272748C1/en not_active Ceased
- 2004-09-17 CA CA002536931A patent/CA2536931A1/en not_active Abandoned
-
2006
- 2006-03-06 IL IL174147A patent/IL174147A0/en unknown
- 2006-03-17 US US11/384,191 patent/US20070111221A1/en not_active Abandoned
- 2006-04-11 NO NO20061659A patent/NO20061659L/no not_active Application Discontinuation
-
2010
- 2010-03-03 AU AU2010200801A patent/AU2010200801A1/en not_active Abandoned
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
RU2489168C1 (ru) * | 2012-02-28 | 2013-08-10 | Общество с ограниченной ответственностью "НТфарма" | Фармацевтическая композиция, продуцирующая антиоксидантный, антимикробный, антитоксический белок - лактоферрин человека, способ ее получения и способ терапии |
WO2013129960A1 (ru) * | 2012-02-28 | 2013-09-06 | Общество с ограниченной ответственностью "НТфарма" | Фармацевтическая композиция, продуцирующая лактоферрин человека, способ её получения и способ терапии |
Also Published As
Publication number | Publication date |
---|---|
CN1882682B (zh) | 2010-06-16 |
EA009447B1 (ru) | 2007-12-28 |
HK1096994A1 (en) | 2007-06-15 |
AU2004272748C1 (en) | 2010-07-08 |
BRPI0413907A (pt) | 2006-10-24 |
EP1664277B1 (en) | 2011-11-09 |
AU2004272748B2 (en) | 2009-12-03 |
NZ545449A (en) | 2009-07-31 |
MXPA06003004A (es) | 2006-06-23 |
ES2376173T3 (es) | 2012-03-09 |
PT1664277E (pt) | 2012-01-17 |
CA2536931A1 (en) | 2005-03-24 |
AU2010200801A1 (en) | 2010-03-25 |
KR20060086941A (ko) | 2006-08-01 |
CN1882682A (zh) | 2006-12-20 |
US20070111221A1 (en) | 2007-05-17 |
KR101094032B1 (ko) | 2011-12-19 |
JP2007505613A (ja) | 2007-03-15 |
AU2004272748A1 (en) | 2005-03-24 |
ATE532853T1 (de) | 2011-11-15 |
WO2005026331A3 (en) | 2005-11-17 |
IL174147A0 (en) | 2006-08-01 |
WO2005026331A2 (en) | 2005-03-24 |
NO20061659L (no) | 2006-06-13 |
EP1664277A2 (en) | 2006-06-07 |
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Legal Events
Date | Code | Title | Description |
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MM4A | Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s) |
Designated state(s): AM AZ KZ KG MD TJ TM |
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MM4A | Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s) |
Designated state(s): BY RU |