Critical testing and parameters for consideration when manufacturing and evaluating tumor–associated antigen-specific T cells

  • Jay G. Tanna
    Program for Cell Enhancement and Technologies for Immunotherapy, Center for Cancer and Immunology Research
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  • Robert Ulrey
    Program for Cell Enhancement and Technologies for Immunotherapy, Center for Cancer and Immunology Research
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  • Kirsten M. Williams
    Program for Cell Enhancement and Technologies for Immunotherapy, Center for Cancer and Immunology Research

    Center for Cancer and Blood Disorders, and the Division of Blood and Marrow Transplantation

    Children's National Health System and The George Washington University, Washington, DC, USA
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  • Patrick J. Hanley
    Correspondence: Patrick J. Hanley, PhD, 111 Michigan Ave NW Washington, DC 20010 USA.
    Program for Cell Enhancement and Technologies for Immunotherapy, Center for Cancer and Immunology Research

    Center for Cancer and Blood Disorders, and the Division of Blood and Marrow Transplantation

    Children's National Health System and The George Washington University, Washington, DC, USA
    Search for articles by this author
Published:March 28, 2019DOI:


      The past year has seen remarkable translation of cellular and gene therapies, with U.S. Food and Drug Administration (FDA) approval of three chimeric antigen receptor (CAR) T-cell products, multiple gene therapy products, and the initiation of countless other pivotal clinical trials. What makes these new drugs most remarkable is their path to commercialization: they have unique requirements compared with traditional pharmaceutical drugs and require different potency assays, critical quality attributes and parameters, pharmacological and toxicological data, and in vivo efficacy testing. What's more, each biologic requires its own unique set of tests and parameters. Here we describe the unique tests associated with ex vivo–expanded tumor-associated antigen T cells (TAA-T). These tests include functional assays to determine potency, specificity, and identity; tests for pathogenic contaminants, such as bacteria and fungus as well as other contaminants such as Mycoplasma and endotoxin; tests for product characterization, tests to evaluate T-cell persistence and product efficacy; and finally, recommendations for critical quality attributes and parameters associated with the expansion of TAA-Ts.

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