Toward an Optimized Process for Clinical Manufacturing of CAR-Treg Cell Therapy
Chimeric antigen receptor (CAR) technology and its application to regulatory T cells (Tregs) has garnered interest among researchers in the field of cell and gene therapy. Merging the benefits of CAR technology with Tregs offers a novel and promising therapeutic option for durable reshaping of undes...
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| Veröffentlicht in: | Trends in biotechnology (Regular ed.) 2020-10, Vol.38 (10), p.1099-1112 |
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| creator | Fritsche, Enrico Volk, Hans-Dieter Reinke, Petra Abou-El-Enein, Mohamed |
| description | Chimeric antigen receptor (CAR) technology and its application to regulatory T cells (Tregs) has garnered interest among researchers in the field of cell and gene therapy. Merging the benefits of CAR technology with Tregs offers a novel and promising therapeutic option for durable reshaping of undesired immune responses following solid organ or hematopoietic stem cell transplantation, as well as in immune-related disorders. However, major challenges remain for developing a standardized and robust good manufacturing practice (GMP)-compliant manufacturing process for CAR-Treg cells. We review current progress in the field and recommend ways to improve CAR-Treg manufacturing processes based on lessons learned from first-generation Treg therapeutics as well as from anticancer CAR-T cell development.
Advances in the field of cell therapy have led to promising novel approaches to treat malignancies and other debilitating diseases. Redirecting the target antigen specificity of CAR-Treg cells represents one such promising approach.The clinical success of anticancer CAR-T cells will, in all likelihood, accelerate the clinical translation of CAR-Treg therapeutics aimed at reshaping undesired immune responses following solid organ or hematopoietic stem cell transplantation as well as in immune-related disorders.Current manufacturing processes for CAR-Tregs demonstrate challenges in cell purification, yield, expansion, CAR selection and gene delivery, supply chain, and quality control/product release testing.We propose a GMP-compatible manufacturing framework to enhance the CAR-Treg production process for clinical application. |
| doi_str_mv | 10.1016/j.tibtech.2019.12.009 |
| format | Article |
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Advances in the field of cell therapy have led to promising novel approaches to treat malignancies and other debilitating diseases. Redirecting the target antigen specificity of CAR-Treg cells represents one such promising approach.The clinical success of anticancer CAR-T cells will, in all likelihood, accelerate the clinical translation of CAR-Treg therapeutics aimed at reshaping undesired immune responses following solid organ or hematopoietic stem cell transplantation as well as in immune-related disorders.Current manufacturing processes for CAR-Tregs demonstrate challenges in cell purification, yield, expansion, CAR selection and gene delivery, supply chain, and quality control/product release testing.We propose a GMP-compatible manufacturing framework to enhance the CAR-Treg production process for clinical application.</description><identifier>ISSN: 0167-7799</identifier><identifier>EISSN: 1879-3096</identifier><identifier>DOI: 10.1016/j.tibtech.2019.12.009</identifier><identifier>PMID: 31982150</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Antigens ; automation ; CAR-T ; CAR-Tregs ; Cell therapy ; Chimeric antigen receptors ; Chronic illnesses ; clinical development ; closed systems ; Disease ; gene editing ; Gene therapy ; GMP manufacturing ; Good Manufacturing Practice ; hematopoietic stem cell transplantation ; Hematopoietic stem cells ; Immunoregulation ; immunosuppression ; Lymphocytes ; Lymphocytes T ; Manufacturing ; Manufacturing industry ; regulatory T cells ; solid organ transplantation ; Stem cell transplantation ; Stem cells ; T cell receptors ; Thymus gland ; tolerance induction ; Transplantation ; Transplants & implants</subject><ispartof>Trends in biotechnology (Regular ed.), 2020-10, Vol.38 (10), p.1099-1112</ispartof><rights>2019 Elsevier Ltd</rights><rights>Copyright © 2019 Elsevier Ltd. All rights reserved.</rights><rights>2019. Elsevier Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c506t-b8bf1d3f01b12876c1c5f0ff341feb1df675dc4fb74a4da88e80dabba1c6f3743</citedby><cites>FETCH-LOGICAL-c506t-b8bf1d3f01b12876c1c5f0ff341feb1df675dc4fb74a4da88e80dabba1c6f3743</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2443478332?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976,64364,64366,64368,72218</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31982150$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fritsche, Enrico</creatorcontrib><creatorcontrib>Volk, Hans-Dieter</creatorcontrib><creatorcontrib>Reinke, Petra</creatorcontrib><creatorcontrib>Abou-El-Enein, Mohamed</creatorcontrib><title>Toward an Optimized Process for Clinical Manufacturing of CAR-Treg Cell Therapy</title><title>Trends in biotechnology (Regular ed.)</title><addtitle>Trends Biotechnol</addtitle><description>Chimeric antigen receptor (CAR) technology and its application to regulatory T cells (Tregs) has garnered interest among researchers in the field of cell and gene therapy. Merging the benefits of CAR technology with Tregs offers a novel and promising therapeutic option for durable reshaping of undesired immune responses following solid organ or hematopoietic stem cell transplantation, as well as in immune-related disorders. However, major challenges remain for developing a standardized and robust good manufacturing practice (GMP)-compliant manufacturing process for CAR-Treg cells. We review current progress in the field and recommend ways to improve CAR-Treg manufacturing processes based on lessons learned from first-generation Treg therapeutics as well as from anticancer CAR-T cell development.
Advances in the field of cell therapy have led to promising novel approaches to treat malignancies and other debilitating diseases. Redirecting the target antigen specificity of CAR-Treg cells represents one such promising approach.The clinical success of anticancer CAR-T cells will, in all likelihood, accelerate the clinical translation of CAR-Treg therapeutics aimed at reshaping undesired immune responses following solid organ or hematopoietic stem cell transplantation as well as in immune-related disorders.Current manufacturing processes for CAR-Tregs demonstrate challenges in cell purification, yield, expansion, CAR selection and gene delivery, supply chain, and quality control/product release testing.We propose a GMP-compatible manufacturing framework to enhance the CAR-Treg production process for clinical application.</description><subject>Antigens</subject><subject>automation</subject><subject>CAR-T</subject><subject>CAR-Tregs</subject><subject>Cell therapy</subject><subject>Chimeric antigen receptors</subject><subject>Chronic illnesses</subject><subject>clinical development</subject><subject>closed systems</subject><subject>Disease</subject><subject>gene editing</subject><subject>Gene therapy</subject><subject>GMP manufacturing</subject><subject>Good Manufacturing Practice</subject><subject>hematopoietic stem cell transplantation</subject><subject>Hematopoietic stem cells</subject><subject>Immunoregulation</subject><subject>immunosuppression</subject><subject>Lymphocytes</subject><subject>Lymphocytes T</subject><subject>Manufacturing</subject><subject>Manufacturing industry</subject><subject>regulatory T cells</subject><subject>solid organ transplantation</subject><subject>Stem cell transplantation</subject><subject>Stem cells</subject><subject>T cell receptors</subject><subject>Thymus gland</subject><subject>tolerance induction</subject><subject>Transplantation</subject><subject>Transplants & 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antigen receptor (CAR) technology and its application to regulatory T cells (Tregs) has garnered interest among researchers in the field of cell and gene therapy. Merging the benefits of CAR technology with Tregs offers a novel and promising therapeutic option for durable reshaping of undesired immune responses following solid organ or hematopoietic stem cell transplantation, as well as in immune-related disorders. However, major challenges remain for developing a standardized and robust good manufacturing practice (GMP)-compliant manufacturing process for CAR-Treg cells. We review current progress in the field and recommend ways to improve CAR-Treg manufacturing processes based on lessons learned from first-generation Treg therapeutics as well as from anticancer CAR-T cell development.
Advances in the field of cell therapy have led to promising novel approaches to treat malignancies and other debilitating diseases. Redirecting the target antigen specificity of CAR-Treg cells represents one such promising approach.The clinical success of anticancer CAR-T cells will, in all likelihood, accelerate the clinical translation of CAR-Treg therapeutics aimed at reshaping undesired immune responses following solid organ or hematopoietic stem cell transplantation as well as in immune-related disorders.Current manufacturing processes for CAR-Tregs demonstrate challenges in cell purification, yield, expansion, CAR selection and gene delivery, supply chain, and quality control/product release testing.We propose a GMP-compatible manufacturing framework to enhance the CAR-Treg production process for clinical application.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>31982150</pmid><doi>10.1016/j.tibtech.2019.12.009</doi><tpages>14</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Antigens automation CAR-T CAR-Tregs Cell therapy Chimeric antigen receptors Chronic illnesses clinical development closed systems Disease gene editing Gene therapy GMP manufacturing Good Manufacturing Practice hematopoietic stem cell transplantation Hematopoietic stem cells Immunoregulation immunosuppression Lymphocytes Lymphocytes T Manufacturing Manufacturing industry regulatory T cells solid organ transplantation Stem cell transplantation Stem cells T cell receptors Thymus gland tolerance induction Transplantation Transplants & implants |
| title | Toward an Optimized Process for Clinical Manufacturing of CAR-Treg Cell Therapy |
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