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Proposal for the International Society for Cell & Gene Therapy position statement on assays for the quality control and potency assessment of adoptive cellular immunotherapies

  • Ben Weil
    Affiliations
    Centre for Cell, Gene & Tissue Therapeutics, Royal Free Hospital, London, UK
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  • Patrick J. Hanley
    Affiliations
    Center for Cancer and Immunology Research, Center for Cancer and Blood Disorders, Children's Research Institute, Children's National Medical Center and The George Washington University, Washington, DC, USA
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  • Mark Lowdell
    Correspondence
    Correspondence: Mark W Lowdell, PhD, FRCPath, FRSB, Department of Haematology, University College London, Rowland Hill Street, NW3 2QG, London, United Kingdom.
    Affiliations
    Centre for Cell, Gene & Tissue Therapeutics, Royal Free Hospital, London, UK

    Department of Haematology, Cancer Institute, University College London, London, UK
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Published:March 16, 2019DOI:https://doi.org/10.1016/j.jcyt.2019.02.001

      Abstract

      Translation of cell and gene therapies from pre-clinical experiments to clinical trials and final drug licensing brings requires the development, verification and even validation of the assays essential for the definition of the drug product. The technical and scientific challenges in doing this are far greater than they seem at first and are compounded by a lack of approved standards for assays used to support (c)GMP manufacture. This paper highlights some of those challenges and proposes solutions based on the experience of our colleagues using similar assay platforms in regulated pathology laboratories.

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