Developing assays to address identity, potency, purity and safety: cell characterization in cell therapy process development

Ever since scientists began culturing cells in the laboratory they have been working on ways to characterize the cells they were maintaining ex vivo. Some early characterization methods were simply analyses of cell morphology and growth rates, but as biochemistry and molecular biology became more sophisticated, and understanding of protein and gene expression advanced, powerful analytical tools became available for characterization of phenotype and genotype of cell cultures. The increasingly quantitative nature