Cell Counting Method Considering Cell Type, Precision, And Accuracy Requirements For Robust Process Development

By Behnam Ahmadian Baghbaderani, Global Head of Process Development, Cell & Gene Technologies

Cell count and viability measurements are routine in cell therapy manufacturing, yet they can have important implications for dose accuracy, process characterization, and product release. Selecting a suitable analytical method is therefore essential, particularly when measurements must remain reliable across different cell types and sample conditions. This study evaluates the performance of four approaches to cell counting and viability assessment to determine how consistently they meet predefined analytical requirements.

The investigation compares two automated platforms with two manual hemocytometer methods using mesenchymal stem cells (MSCs), T cells, and induced pluripotent stem cells (iPSCs). Testing was conducted with cells in media and in a post-thaw cryoformulation, with performance assessed against established acceptance criteria for accuracy, precision, and specificity. The findings reveal differences in method performance across cell types and highlight particular challenges when analyzing aggregated cells and samples with low viability. These results underscore the importance of evaluating analytical methods under conditions that reflect their intended use rather than assuming that one approach will perform equally well across all samples. Conducted by Lonza process development scientists, the study lists Behnam Ahmadian Baghbaderani as corresponding author. Explore the data to compare platform performance and understand the factors that can inform cell counting and viability method selection for cell therapy manufacturing.