The present chapter focuses on the validation of the following analytical methods for the control of mesenchymal stromal cells (MSC) for cell therapy clinical trials: Microbiological control for cellular product Endotoxin assay Mycoplasma assay Cell count and viability Immunophenotype Clonogenic potential (CFU-F assay) In our lab, these methods are in use for product release, process control or control of the biological starting materials. They are described in detail in the accompanying Chapter 19.For each method, validation goals and strategy are presented, and a detailed experimental scheme is proposed.
Keywords: Accuracy; Advanced therapy medicinal products (ATMP); CFU-F assay; Detection limit; Endotoxin; Good manufacturing practice (GMP); Immunophenotype; Microbiological control for cellular product; Mycoplasma assay; Potency assays; Precision; Quality control assays; Quantitative assays; Specificity; Viability.