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Cell quality evaluation

This refers to evaluation of the characteristics of cells in a culture process as well as cells in a final product. The main assessment methods include a confirmation test to determine if the cells have the essential properties of the final product, a purity test to evaluate cell heterogeneity and contamination by non-target cells in the final product, a potency test, an efficacy test, and a pharmacodynamic compatibility test to evaluate whether cells have the predetermined function and performance as a drug. These endpoints are used not only to evaluate the final product, but also to evaluate intermediate products in order to properly manage the manufacturing process.
Cell phenotype is widely recognized as a useful measurement target for the proper assessment of these endpoints, and includes cell morphology, cell proliferation status, and cell migration ability. By analyzing each of these properties, information about cell characteristics such as cell type and viability, biological activity and function, cell cycle, drug reactions, stress, and differentiation/dedifferentiation states can be obtained.
Therefore, it is effective to use cell morphology, cell proliferation status, and cell migration ability as indicators when evaluating whether cells have the intended characteristics during the cell culture process or in the final product.