title: Manufacturing genetically modified T cells for clinical trials.
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.
authors: Center for Cell & Gene Therapy, Baylor College of Medicine, Houston, Texas, USA.
authors: A P
authors: AP
authors: Gee
mesh_terms: D060846:Cell Engineering; D019070:Cell Lineage / Q000235:genetics / Q000276:immunology; D002986:Clinical Trials as Topic; D005818:Genetic Engineering; D005822:Genetic Vectors; D006801:Humans; D016219:Immunotherapy, Adoptive; D009369:Neoplasms / Q000276:immunology / Q000628:therapy*; D011948:Receptors, Antigen, T-Cell / Q000276:immunology / Q000627:therapeutic use; D013601:T-Lymphocytes / Q000276:immunology* / Q000637:transplantation; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011948:Receptors, Antigen, T-Cell
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