Manufacturing genetically modified T cells for clinical trials
Compliance with Food and Drug Administration regulations relating to initiating early phase clinical trials of new cellular therapy products often presents a hurdle to new investigators. One of the biggest obstacles is the requirement to manufacture the therapeutic products under current Good Manufa...
Gespeichert in:
| Veröffentlicht in: | Cancer gene therapy 2015-02, Vol.22 (2), p.67-71 |
|---|---|
| 1. Verfasser: | |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 71 |
|---|---|
| container_issue | 2 |
| container_start_page | 67 |
| container_title | Cancer gene therapy |
| container_volume | 22 |
| creator | Gee, A P |
| description | Compliance with Food and Drug Administration regulations relating to initiating early phase clinical trials of new cellular therapy products often presents a hurdle to new investigators. One of the biggest obstacles is the requirement to manufacture the therapeutic products under current Good Manufacturing Practices—a system that is usually poorly understood by both basic researchers and clinicians. This article reviews the major points that must be addressed when manufacturing genetically modified T cells for therapeutic use. |
| doi_str_mv | 10.1038/cgt.2014.71 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_miscellaneous_1676361731</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A405808434</galeid><sourcerecordid>A405808434</sourcerecordid><originalsourceid>FETCH-LOGICAL-c550t-1ffd3170f20843cef1e2ae112fa306431cfeba493d82cddcb2d4b284622751a23</originalsourceid><addsrcrecordid>eNqNks9rFTEQx4NY7Gv15F0WBBF0n5kkm929CKVULVS81HPIy05eU7KbZ7J76H9vwmtLK0XKMAwkn_nxhS8hb4GugfLui9nOa0ZBrFt4QVYgWlk3DaUvyYr2rK-hp_yQHKV0TTPUtvwVOWSN5Fx0sCJff-ppsdrMS3TTttrihLMz2vubagyDsw6H6rIy6H2qbIiV8W4q_9UcnfbpNTmwueCb23pMfn87uzz9UV_8-n5-enJRm3zKXIO1A4eWWkY7wQ1aQKYRgFnNqRQcjMWNFj0fOmaGwWzYIDasE5KxtgHN-DH5uJ-7i-HPgmlWo0vlKj1hWJIC2UouoeXwLJR2krMmo-__Qa_DEqcsRDHOQQoKPfyPAilBUl7yntpqj8pNNsxRm7JanQjadEW4yNT6CSrHgKMzYULr8vujhg8PGq5Q-_kqBb_MLkzpMfhpD5oYUopo1S66UccbBVQVn6jsE1V8otqi6d2tpmUz4nDP3hkjA5_3QNoVY2B8IPqJeX8By-LBvw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1661603160</pqid></control><display><type>article</type><title>Manufacturing genetically modified T cells for clinical trials</title><source>MEDLINE</source><source>EZB-FREE-00999 freely available EZB journals</source><source>SpringerLink Journals - AutoHoldings</source><creator>Gee, A P</creator><creatorcontrib>Gee, A P</creatorcontrib><description>Compliance with Food and Drug Administration regulations relating to initiating early phase clinical trials of new cellular therapy products often presents a hurdle to new investigators. One of the biggest obstacles is the requirement to manufacture the therapeutic products under current Good Manufacturing Practices—a system that is usually poorly understood by both basic researchers and clinicians. This article reviews the major points that must be addressed when manufacturing genetically modified T cells for therapeutic use.</description><identifier>ISSN: 0929-1903</identifier><identifier>EISSN: 1476-5500</identifier><identifier>DOI: 10.1038/cgt.2014.71</identifier><identifier>PMID: 25633481</identifier><language>eng</language><publisher>New York: Nature Publishing Group US</publisher><subject>692/699 ; Biomedical and Life Sciences ; Biomedicine ; Cancer treatment ; Cell Engineering ; Cell Lineage - genetics ; Cell Lineage - immunology ; Clinical trials ; Clinical Trials as Topic ; Gene Expression ; Gene Therapy ; Genetic aspects ; Genetic Engineering ; Genetic Vectors ; Humans ; Immunotherapy ; Immunotherapy, Adoptive ; Innovations ; Lymphocytes T ; Manufacturing ; Neoplasms - immunology ; Neoplasms - therapy ; Receptors, Antigen, T-Cell - immunology ; Receptors, Antigen, T-Cell - therapeutic use ; review ; T cells ; T-Lymphocytes - immunology ; T-Lymphocytes - transplantation ; United States ; United States Food and Drug Administration</subject><ispartof>Cancer gene therapy, 2015-02, Vol.22 (2), p.67-71</ispartof><rights>Nature America, Inc. 2015</rights><rights>COPYRIGHT 2015 Nature Publishing Group</rights><rights>Copyright Nature Publishing Group Feb 2015</rights><rights>Nature America, Inc. 2015.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c550t-1ffd3170f20843cef1e2ae112fa306431cfeba493d82cddcb2d4b284622751a23</citedby><cites>FETCH-LOGICAL-c550t-1ffd3170f20843cef1e2ae112fa306431cfeba493d82cddcb2d4b284622751a23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1038/cgt.2014.71$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1038/cgt.2014.71$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25633481$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gee, A P</creatorcontrib><title>Manufacturing genetically modified T cells for clinical trials</title><title>Cancer gene therapy</title><addtitle>Cancer Gene Ther</addtitle><addtitle>Cancer Gene Ther</addtitle><description>Compliance with Food and Drug Administration regulations relating to initiating early phase clinical trials of new cellular therapy products often presents a hurdle to new investigators. One of the biggest obstacles is the requirement to manufacture the therapeutic products under current Good Manufacturing Practices—a system that is usually poorly understood by both basic researchers and clinicians. This article reviews the major points that must be addressed when manufacturing genetically modified T cells for therapeutic use.</description><subject>692/699</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Cancer treatment</subject><subject>Cell Engineering</subject><subject>Cell Lineage - genetics</subject><subject>Cell Lineage - immunology</subject><subject>Clinical trials</subject><subject>Clinical Trials as Topic</subject><subject>Gene Expression</subject><subject>Gene Therapy</subject><subject>Genetic aspects</subject><subject>Genetic Engineering</subject><subject>Genetic Vectors</subject><subject>Humans</subject><subject>Immunotherapy</subject><subject>Immunotherapy, Adoptive</subject><subject>Innovations</subject><subject>Lymphocytes T</subject><subject>Manufacturing</subject><subject>Neoplasms - immunology</subject><subject>Neoplasms - therapy</subject><subject>Receptors, Antigen, T-Cell - immunology</subject><subject>Receptors, Antigen, T-Cell - therapeutic use</subject><subject>review</subject><subject>T cells</subject><subject>T-Lymphocytes - immunology</subject><subject>T-Lymphocytes - transplantation</subject><subject>United States</subject><subject>United States Food and Drug Administration</subject><issn>0929-1903</issn><issn>1476-5500</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqNks9rFTEQx4NY7Gv15F0WBBF0n5kkm929CKVULVS81HPIy05eU7KbZ7J76H9vwmtLK0XKMAwkn_nxhS8hb4GugfLui9nOa0ZBrFt4QVYgWlk3DaUvyYr2rK-hp_yQHKV0TTPUtvwVOWSN5Fx0sCJff-ppsdrMS3TTttrihLMz2vubagyDsw6H6rIy6H2qbIiV8W4q_9UcnfbpNTmwueCb23pMfn87uzz9UV_8-n5-enJRm3zKXIO1A4eWWkY7wQ1aQKYRgFnNqRQcjMWNFj0fOmaGwWzYIDasE5KxtgHN-DH5uJ-7i-HPgmlWo0vlKj1hWJIC2UouoeXwLJR2krMmo-__Qa_DEqcsRDHOQQoKPfyPAilBUl7yntpqj8pNNsxRm7JanQjadEW4yNT6CSrHgKMzYULr8vujhg8PGq5Q-_kqBb_MLkzpMfhpD5oYUopo1S66UccbBVQVn6jsE1V8otqi6d2tpmUz4nDP3hkjA5_3QNoVY2B8IPqJeX8By-LBvw</recordid><startdate>20150201</startdate><enddate>20150201</enddate><creator>Gee, A P</creator><general>Nature Publishing Group US</general><general>Nature Publishing Group</general><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>7QP</scope><scope>7TK</scope><scope>7TM</scope><scope>7TO</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88A</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>RC3</scope><scope>7X8</scope><scope>7QO</scope></search><sort><creationdate>20150201</creationdate><title>Manufacturing genetically modified T cells for clinical trials</title><author>Gee, A P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c550t-1ffd3170f20843cef1e2ae112fa306431cfeba493d82cddcb2d4b284622751a23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>692/699</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Cancer treatment</topic><topic>Cell Engineering</topic><topic>Cell Lineage - genetics</topic><topic>Cell Lineage - immunology</topic><topic>Clinical trials</topic><topic>Clinical Trials as Topic</topic><topic>Gene Expression</topic><topic>Gene Therapy</topic><topic>Genetic aspects</topic><topic>Genetic Engineering</topic><topic>Genetic Vectors</topic><topic>Humans</topic><topic>Immunotherapy</topic><topic>Immunotherapy, Adoptive</topic><topic>Innovations</topic><topic>Lymphocytes T</topic><topic>Manufacturing</topic><topic>Neoplasms - immunology</topic><topic>Neoplasms - therapy</topic><topic>Receptors, Antigen, T-Cell - immunology</topic><topic>Receptors, Antigen, T-Cell - therapeutic use</topic><topic>review</topic><topic>T cells</topic><topic>T-Lymphocytes - immunology</topic><topic>T-Lymphocytes - transplantation</topic><topic>United States</topic><topic>United States Food and Drug Administration</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gee, A P</creatorcontrib><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>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Biology Database (Alumni Edition)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research 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>ProQuest Central (Alumni Edition)</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>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biological Science Database</collection><collection>Biotechnology and BioEngineering Abstracts</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 China</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>Biotechnology Research Abstracts</collection><jtitle>Cancer gene therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gee, A P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Manufacturing genetically modified T cells for clinical trials</atitle><jtitle>Cancer gene therapy</jtitle><stitle>Cancer Gene Ther</stitle><addtitle>Cancer Gene Ther</addtitle><date>2015-02-01</date><risdate>2015</risdate><volume>22</volume><issue>2</issue><spage>67</spage><epage>71</epage><pages>67-71</pages><issn>0929-1903</issn><eissn>1476-5500</eissn><abstract>Compliance with Food and Drug Administration regulations relating to initiating early phase clinical trials of new cellular therapy products often presents a hurdle to new investigators. One of the biggest obstacles is the requirement to manufacture the therapeutic products under current Good Manufacturing Practices—a system that is usually poorly understood by both basic researchers and clinicians. This article reviews the major points that must be addressed when manufacturing genetically modified T cells for therapeutic use.</abstract><cop>New York</cop><pub>Nature Publishing Group US</pub><pmid>25633481</pmid><doi>10.1038/cgt.2014.71</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0929-1903 |
| ispartof | Cancer gene therapy, 2015-02, Vol.22 (2), p.67-71 |
| issn | 0929-1903 1476-5500 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1676361731 |
| source | MEDLINE; EZB-FREE-00999 freely available EZB journals; SpringerLink Journals - AutoHoldings |
| subjects | 692/699 Biomedical and Life Sciences Biomedicine Cancer treatment Cell Engineering Cell Lineage - genetics Cell Lineage - immunology Clinical trials Clinical Trials as Topic Gene Expression Gene Therapy Genetic aspects Genetic Engineering Genetic Vectors Humans Immunotherapy Immunotherapy, Adoptive Innovations Lymphocytes T Manufacturing Neoplasms - immunology Neoplasms - therapy Receptors, Antigen, T-Cell - immunology Receptors, Antigen, T-Cell - therapeutic use review T cells T-Lymphocytes - immunology T-Lymphocytes - transplantation United States United States Food and Drug Administration |
| title | Manufacturing genetically modified T cells for clinical trials |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-29T18%3A34%3A25IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_proqu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Manufacturing%20genetically%20modified%20T%20cells%20for%20clinical%20trials&rft.jtitle=Cancer%20gene%20therapy&rft.au=Gee,%20A%20P&rft.date=2015-02-01&rft.volume=22&rft.issue=2&rft.spage=67&rft.epage=71&rft.pages=67-71&rft.issn=0929-1903&rft.eissn=1476-5500&rft_id=info:doi/10.1038/cgt.2014.71&rft_dat=%3Cgale_proqu%3EA405808434%3C/gale_proqu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1661603160&rft_id=info:pmid/25633481&rft_galeid=A405808434&rfr_iscdi=true |