Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production

Figure 1

Strategy design for cell count validation. (a) Two samplings of cell suspension () were counted each by two qualified operators (Op.) in hemocytometer (Burker chamber) for the manual method and by two cartridges for the automated method (Nucleocassette-NC.). The mean of all the values was used to calculated the accuracy (as accuracy error between the manual and the automated total and viable cell count) and the intermediate precision (interassay coefficient of variation, CV). The intra-assay CV was calculated considering the values of each cell suspension count for each method. (b) The cell suspension was then serially diluted and counted for comparing linearity of the three methods and the optimal range of cell concentration to count.