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.
Publication types
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Research Support, N.I.H., Extramural
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Research Support, Non-U.S. Gov't
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Review
MeSH terms
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Cell Engineering*
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Cell Lineage / genetics
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Cell Lineage / immunology
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Clinical Trials as Topic
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Genetic Engineering*
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Genetic Vectors
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Humans
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Immunotherapy, Adoptive
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Neoplasms / immunology
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Neoplasms / therapy*
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Receptors, Antigen, T-Cell / immunology
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Receptors, Antigen, T-Cell / therapeutic use
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T-Lymphocytes / immunology*
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T-Lymphocytes / transplantation
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United States
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United States Food and Drug Administration
Substances
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Receptors, Antigen, T-Cell