Literature DB >> 25633481

Manufacturing genetically modified T cells for clinical trials.

A P Gee1.   

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.

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Year:  2015        PMID： 25633481     DOI： 10.1038/cgt.2014.71

Source DB:  PubMed          Journal:  Cancer Gene Ther        ISSN： 0929-1903            Impact factor:   5.987


  9 in total

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Review 4.  Driving CAR-based T-cell therapy to success.

Authors:  Bipulendu Jena; Judy S Moyes; Helen Huls; Laurence J N Cooper
Journal:  Curr Hematol Malig Rep       Date:  2014-03       Impact factor: 3.952

Review 5.  A new approach to gene therapy using Sleeping Beauty to genetically modify clinical-grade T cells to target CD19.

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Journal:  Immunol Rev       Date:  2014-01       Impact factor: 12.988

6.  Production of lentiviral vectors by large-scale transient transfection of suspension cultures and affinity chromatography purification.

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Review 7.  CAR T cells for solid tumors: armed and ready to go?

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Journal:  Cancer J       Date:  2014 Mar-Apr       Impact factor: 3.360

8.  Eligibility determination for donors of human cells, tissues, and cellular and tissue-based products. Final rule.

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Journal:  Fed Regist       Date:  2004-05-25

9.  The use of retroviral vectors for gene therapy-what are the risks? A review of retroviral pathogenesis and its relevance to retroviral vector-mediated gene delivery.

Authors:  Donald S Anson
Journal:  Genet Vaccines Ther       Date:  2004-08-13
  9 in total
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Journal:  Adv Ther (Weinh)       Date:  2018-05-08

Review 2.  The promise of CD4+FoxP3+ regulatory T-cell manipulation in vivo: applications for allogeneic hematopoietic stem cell transplantation.

Authors:  Sabrina Copsel; Dietlinde Wolf; Krishna V Komanduri; Robert B Levy
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3.  GMP-Compliant Manufacturing of NKG2D CAR Memory T Cells Using CliniMACS Prodigy.

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Journal:  Front Immunol       Date:  2019-10-10       Impact factor: 7.561

Review 4.  Update for Advance CAR-T Therapy in Solid Tumors, Clinical Application in Peritoneal Carcinomatosis From Colorectal Cancer and Future Prospects.

Authors:  Siyuan Qian; Pedro Villarejo-Campos; Ismael Guijo; Sergio Hernández-Villafranca; Damián García-Olmo; Sara González-Soares; Héctor Guadalajara; Santos Jiménez-Galanes; Cheng Qian
Journal:  Front Immunol       Date:  2022-03-25       Impact factor: 7.561

Review 5.  Clinical development of gene therapy: results and lessons from recent successes.

Authors:  Sandeep Rp Kumar; David M Markusic; Moanaro Biswas; Katherine A High; Roland W Herzog
Journal:  Mol Ther Methods Clin Dev       Date:  2016-05-25       Impact factor: 6.698

Review 6.  Clinical manufacturing of CAR T cells: foundation of a promising therapy.

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Journal:  Mol Ther Oncolytics       Date:  2016-06-15       Impact factor: 7.200
  6 in total

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