Production of pharmaceutical-grade plasmids at high concentration and high supercoiled percentage
Abstract The increased use of plasmid-based vaccines to replace their more challenging viral counterparts has increased the demand for high purity and high concentration plasmids. Here we report the production of plasmids encoding different transgenes for DNA vaccine candidates at gram scale with an...
Gespeichert in:
| Veröffentlicht in: | Vaccine 2010-02, Vol.28 (8), p.2046-2052 |
|---|---|
| Hauptverfasser: | , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 2052 |
|---|---|
| container_issue | 8 |
| container_start_page | 2046 |
| container_title | Vaccine |
| container_volume | 28 |
| creator | Cai, Ying Rodriguez, Stephen Rameswaran, Ramu Draghia-Akli, Ruxandra Juba, Robert J Hebel, Henry |
| description | Abstract The increased use of plasmid-based vaccines to replace their more challenging viral counterparts has increased the demand for high purity and high concentration plasmids. Here we report the production of plasmids encoding different transgenes for DNA vaccine candidates at gram scale with an integrated process consisting of batch fermentation and limited steps of purification. Plasmid products encoding for eight smallpox antigens that were combined into a bioterrorism DNA vaccine exhibited high purity with undetectable RNA, protein and endotoxin, concentration of up to 13.6 mg/mL and supercoiled percentage of 94.5 ± 1.1% after storage at −80 °C for over 1 year. The process has been scaled up for the cGMP manufacture of pharmaceutical-grade human papillomavirus and influenza DNA vaccines up to a 50 g scale, also demonstrating high purity and high concentration. |
| doi_str_mv | 10.1016/j.vaccine.2009.10.057 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_754566685</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>1_s2_0_S0264410X09015874</els_id><sourcerecordid>3500079061</sourcerecordid><originalsourceid>FETCH-LOGICAL-c575t-ecd082d12286892edc652fcd1faa7f6b57b14df2cfa959150af708bc367ab5423</originalsourceid><addsrcrecordid>eNqFkt-L1DAQgIMo3t7pn6AURHzqmqTNj74ocngqHCio4FuYJtPdrG2zJu3B_fembvHgXu4pYfLNMJNvCHnB6JZRJt8etjdgrR9xyyltcmxLhXpENkyrquSC6cdkQ7msy5rRX2fkPKUDpVRUrHlKzlijG1nXekPgWwxutpMPYxG64riHOIDFefIW-nIXwWFx7CEN3qUCpmLvd_vChtHiOEX4lwajO4XTfMRog-_RFcstI7DDZ-RJB33C5-t5QX5effxx-bm8_vrpy-WH69IKJaYSraOaO8a5lrrh6KwUvLOOdQCqk61QLatdx20HjWiYoNApqltbSQWtqHl1Qd6c6h5j-DNjmszgk8W-hxHDnIwStZBSavEwWVWyoZIv5Kt75CHMccxjGJbfdS0UWyhxomwMKUXszDH6AeKtYdQssszBrLLMImsJZ1k57-VafW4HdHdZq50MvF4BSFlHF2G0Pv3nOBe8qXiVufcnDvP_3niMJlmP2ZHzEe1kXPAPtvLuXgXb-3HZgd94i-luapO4oeb7slnLYtGGMqFVXf0FqabK1A</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1625845715</pqid></control><display><type>article</type><title>Production of pharmaceutical-grade plasmids at high concentration and high supercoiled percentage</title><source>MEDLINE</source><source>ScienceDirect Journals (5 years ago - present)</source><source>ProQuest Central UK/Ireland</source><creator>Cai, Ying ; Rodriguez, Stephen ; Rameswaran, Ramu ; Draghia-Akli, Ruxandra ; Juba, Robert J ; Hebel, Henry</creator><creatorcontrib>Cai, Ying ; Rodriguez, Stephen ; Rameswaran, Ramu ; Draghia-Akli, Ruxandra ; Juba, Robert J ; Hebel, Henry</creatorcontrib><description>Abstract The increased use of plasmid-based vaccines to replace their more challenging viral counterparts has increased the demand for high purity and high concentration plasmids. Here we report the production of plasmids encoding different transgenes for DNA vaccine candidates at gram scale with an integrated process consisting of batch fermentation and limited steps of purification. Plasmid products encoding for eight smallpox antigens that were combined into a bioterrorism DNA vaccine exhibited high purity with undetectable RNA, protein and endotoxin, concentration of up to 13.6 mg/mL and supercoiled percentage of 94.5 ± 1.1% after storage at −80 °C for over 1 year. The process has been scaled up for the cGMP manufacture of pharmaceutical-grade human papillomavirus and influenza DNA vaccines up to a 50 g scale, also demonstrating high purity and high concentration.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2009.10.057</identifier><identifier>PMID: 19896448</identifier><identifier>CODEN: VACCDE</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Allergy and Immunology ; Applied microbiology ; Biological and medical sciences ; Biomass ; Bioterrorism ; Chromatography ; Clinical trials ; Cloning ; Cytomegalovirus ; Deoxyribonucleic acid ; DNA ; DNA - biosynthesis ; DNA - isolation & purification ; DNA vaccine ; Endotoxins ; Fermentation ; Fundamental and applied biological sciences. Psychology ; High concentration ; Human papillomavirus ; Influenza ; Influenza Vaccines - biosynthesis ; Methods ; Microbiology ; Papillomavirus Vaccines - biosynthesis ; Plasmid ; Plasmids ; Production ; Proteins ; Quality Control ; Smallpox Vaccine - biosynthesis ; Studies ; Supercoiled ; Vaccines ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) ; Vaccines, DNA - biosynthesis</subject><ispartof>Vaccine, 2010-02, Vol.28 (8), p.2046-2052</ispartof><rights>Elsevier Ltd</rights><rights>2009 Elsevier Ltd</rights><rights>2015 INIST-CNRS</rights><rights>Copyright 2009 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Feb 23, 2010</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c575t-ecd082d12286892edc652fcd1faa7f6b57b14df2cfa959150af708bc367ab5423</citedby><cites>FETCH-LOGICAL-c575t-ecd082d12286892edc652fcd1faa7f6b57b14df2cfa959150af708bc367ab5423</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1625845715?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>309,310,314,777,781,786,787,3537,23911,23912,25121,27905,27906,45976,64364,64366,64368,72218</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22529323$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19896448$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Cai, Ying</creatorcontrib><creatorcontrib>Rodriguez, Stephen</creatorcontrib><creatorcontrib>Rameswaran, Ramu</creatorcontrib><creatorcontrib>Draghia-Akli, Ruxandra</creatorcontrib><creatorcontrib>Juba, Robert J</creatorcontrib><creatorcontrib>Hebel, Henry</creatorcontrib><title>Production of pharmaceutical-grade plasmids at high concentration and high supercoiled percentage</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>Abstract The increased use of plasmid-based vaccines to replace their more challenging viral counterparts has increased the demand for high purity and high concentration plasmids. Here we report the production of plasmids encoding different transgenes for DNA vaccine candidates at gram scale with an integrated process consisting of batch fermentation and limited steps of purification. Plasmid products encoding for eight smallpox antigens that were combined into a bioterrorism DNA vaccine exhibited high purity with undetectable RNA, protein and endotoxin, concentration of up to 13.6 mg/mL and supercoiled percentage of 94.5 ± 1.1% after storage at −80 °C for over 1 year. The process has been scaled up for the cGMP manufacture of pharmaceutical-grade human papillomavirus and influenza DNA vaccines up to a 50 g scale, also demonstrating high purity and high concentration.</description><subject>Allergy and Immunology</subject><subject>Applied microbiology</subject><subject>Biological and medical sciences</subject><subject>Biomass</subject><subject>Bioterrorism</subject><subject>Chromatography</subject><subject>Clinical trials</subject><subject>Cloning</subject><subject>Cytomegalovirus</subject><subject>Deoxyribonucleic acid</subject><subject>DNA</subject><subject>DNA - biosynthesis</subject><subject>DNA - isolation & purification</subject><subject>DNA vaccine</subject><subject>Endotoxins</subject><subject>Fermentation</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>High concentration</subject><subject>Human papillomavirus</subject><subject>Influenza</subject><subject>Influenza Vaccines - biosynthesis</subject><subject>Methods</subject><subject>Microbiology</subject><subject>Papillomavirus Vaccines - biosynthesis</subject><subject>Plasmid</subject><subject>Plasmids</subject><subject>Production</subject><subject>Proteins</subject><subject>Quality Control</subject><subject>Smallpox Vaccine - biosynthesis</subject><subject>Studies</subject><subject>Supercoiled</subject><subject>Vaccines</subject><subject>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</subject><subject>Vaccines, DNA - biosynthesis</subject><issn>0264-410X</issn><issn>1873-2518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkt-L1DAQgIMo3t7pn6AURHzqmqTNj74ocngqHCio4FuYJtPdrG2zJu3B_fembvHgXu4pYfLNMJNvCHnB6JZRJt8etjdgrR9xyyltcmxLhXpENkyrquSC6cdkQ7msy5rRX2fkPKUDpVRUrHlKzlijG1nXekPgWwxutpMPYxG64riHOIDFefIW-nIXwWFx7CEN3qUCpmLvd_vChtHiOEX4lwajO4XTfMRog-_RFcstI7DDZ-RJB33C5-t5QX5effxx-bm8_vrpy-WH69IKJaYSraOaO8a5lrrh6KwUvLOOdQCqk61QLatdx20HjWiYoNApqltbSQWtqHl1Qd6c6h5j-DNjmszgk8W-hxHDnIwStZBSavEwWVWyoZIv5Kt75CHMccxjGJbfdS0UWyhxomwMKUXszDH6AeKtYdQssszBrLLMImsJZ1k57-VafW4HdHdZq50MvF4BSFlHF2G0Pv3nOBe8qXiVufcnDvP_3niMJlmP2ZHzEe1kXPAPtvLuXgXb-3HZgd94i-luapO4oeb7slnLYtGGMqFVXf0FqabK1A</recordid><startdate>20100223</startdate><enddate>20100223</enddate><creator>Cai, Ying</creator><creator>Rodriguez, Stephen</creator><creator>Rameswaran, Ramu</creator><creator>Draghia-Akli, Ruxandra</creator><creator>Juba, Robert J</creator><creator>Hebel, Henry</creator><general>Elsevier Ltd</general><general>Elsevier</general><general>Elsevier Limited</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7RV</scope><scope>7T2</scope><scope>7T5</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><scope>7QO</scope><scope>8FD</scope><scope>FR3</scope><scope>P64</scope></search><sort><creationdate>20100223</creationdate><title>Production of pharmaceutical-grade plasmids at high concentration and high supercoiled percentage</title><author>Cai, Ying ; Rodriguez, Stephen ; Rameswaran, Ramu ; Draghia-Akli, Ruxandra ; Juba, Robert J ; Hebel, Henry</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c575t-ecd082d12286892edc652fcd1faa7f6b57b14df2cfa959150af708bc367ab5423</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Allergy and Immunology</topic><topic>Applied microbiology</topic><topic>Biological and medical sciences</topic><topic>Biomass</topic><topic>Bioterrorism</topic><topic>Chromatography</topic><topic>Clinical trials</topic><topic>Cloning</topic><topic>Cytomegalovirus</topic><topic>Deoxyribonucleic acid</topic><topic>DNA</topic><topic>DNA - biosynthesis</topic><topic>DNA - isolation & purification</topic><topic>DNA vaccine</topic><topic>Endotoxins</topic><topic>Fermentation</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>High concentration</topic><topic>Human papillomavirus</topic><topic>Influenza</topic><topic>Influenza Vaccines - biosynthesis</topic><topic>Methods</topic><topic>Microbiology</topic><topic>Papillomavirus Vaccines - biosynthesis</topic><topic>Plasmid</topic><topic>Plasmids</topic><topic>Production</topic><topic>Proteins</topic><topic>Quality Control</topic><topic>Smallpox Vaccine - biosynthesis</topic><topic>Studies</topic><topic>Supercoiled</topic><topic>Vaccines</topic><topic>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</topic><topic>Vaccines, DNA - biosynthesis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Cai, Ying</creatorcontrib><creatorcontrib>Rodriguez, Stephen</creatorcontrib><creatorcontrib>Rameswaran, Ramu</creatorcontrib><creatorcontrib>Draghia-Akli, Ruxandra</creatorcontrib><creatorcontrib>Juba, Robert J</creatorcontrib><creatorcontrib>Hebel, Henry</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Nursing & Allied Health Database</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>Biotechnology Research Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Vaccine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cai, Ying</au><au>Rodriguez, Stephen</au><au>Rameswaran, Ramu</au><au>Draghia-Akli, Ruxandra</au><au>Juba, Robert J</au><au>Hebel, Henry</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Production of pharmaceutical-grade plasmids at high concentration and high supercoiled percentage</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2010-02-23</date><risdate>2010</risdate><volume>28</volume><issue>8</issue><spage>2046</spage><epage>2052</epage><pages>2046-2052</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><coden>VACCDE</coden><abstract>Abstract The increased use of plasmid-based vaccines to replace their more challenging viral counterparts has increased the demand for high purity and high concentration plasmids. Here we report the production of plasmids encoding different transgenes for DNA vaccine candidates at gram scale with an integrated process consisting of batch fermentation and limited steps of purification. Plasmid products encoding for eight smallpox antigens that were combined into a bioterrorism DNA vaccine exhibited high purity with undetectable RNA, protein and endotoxin, concentration of up to 13.6 mg/mL and supercoiled percentage of 94.5 ± 1.1% after storage at −80 °C for over 1 year. The process has been scaled up for the cGMP manufacture of pharmaceutical-grade human papillomavirus and influenza DNA vaccines up to a 50 g scale, also demonstrating high purity and high concentration.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>19896448</pmid><doi>10.1016/j.vaccine.2009.10.057</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0264-410X |
| ispartof | Vaccine, 2010-02, Vol.28 (8), p.2046-2052 |
| issn | 0264-410X 1873-2518 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_754566685 |
| source | MEDLINE; ScienceDirect Journals (5 years ago - present); ProQuest Central UK/Ireland |
| subjects | Allergy and Immunology Applied microbiology Biological and medical sciences Biomass Bioterrorism Chromatography Clinical trials Cloning Cytomegalovirus Deoxyribonucleic acid DNA DNA - biosynthesis DNA - isolation & purification DNA vaccine Endotoxins Fermentation Fundamental and applied biological sciences. Psychology High concentration Human papillomavirus Influenza Influenza Vaccines - biosynthesis Methods Microbiology Papillomavirus Vaccines - biosynthesis Plasmid Plasmids Production Proteins Quality Control Smallpox Vaccine - biosynthesis Studies Supercoiled Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vaccines, DNA - biosynthesis |
| title | Production of pharmaceutical-grade plasmids at high concentration and high supercoiled percentage |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-18T01%3A50%3A24IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Production%20of%20pharmaceutical-grade%20plasmids%20at%20high%20concentration%20and%20high%20supercoiled%20percentage&rft.jtitle=Vaccine&rft.au=Cai,%20Ying&rft.date=2010-02-23&rft.volume=28&rft.issue=8&rft.spage=2046&rft.epage=2052&rft.pages=2046-2052&rft.issn=0264-410X&rft.eissn=1873-2518&rft.coden=VACCDE&rft_id=info:doi/10.1016/j.vaccine.2009.10.057&rft_dat=%3Cproquest_cross%3E3500079061%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1625845715&rft_id=info:pmid/19896448&rft_els_id=1_s2_0_S0264410X09015874&rfr_iscdi=true |