ISO/AWI 25824

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Abstract

This document specifies definitions and requirements for the selection and design of cell-mediated cytotoxicity assay for the characterization and testing of cellular therapeutic products. The document also provides general considerations for validation and sources of variability in assay design. This document is primarily applicable to T-cell and NK cell-mediated cytotoxicity. This document is applicable for use by researchers, developers, and manufacturers of cell and gene therapy products. This standard is not applicable to cells in complex extracellular matrices. Matrices refer to three-dimensional network of molecules and structural components to mimic the natural extracellular matrix and to provide support to surrounding cells.