R&D Scientist Nexcelom Bioscience, NH, United States
Cell therapy has been hailed as a medical revolution, and its rise has only increased the importance of accuracy and precision in cell counting. Ensuring the identity, purity, and viability of cell therapy products is critical for increasing efficacy and avoiding potentially harmful side effects. The burden of sample analysis often rests on fleets of automated cell counters, leading to the need for confidence that multiple cell counters will give similar results. In this work, we compare groups of two distinct cell counting instruments. The first type is a well-established single-sample counter (Cellometer K2), similar to those often found in R&D laboratories. The second type of instrument (Cellaca MX) is a high-throughput cell counter that is often more suitable for a manufacturing environment than its single-sample counterparts. The consistency of these cell counters is tested using both live cells and fluorescent beads. Jurkat cell samples were used to simulate immunotherapy products and the beads prepared in fixed reference samples to allow the comparison of multiple instruments over extended periods. The beads were used to investigate agreement among sixty Cellometer K2 instruments and thirty Cellaca MX instruments, which we believe is the largest group of cell counting instruments to ever be involved in a single comparison study. Our work illustrates experimental approaches suitable for the comparison of multiple cell counting methods. Consistency was measured among the cell counters, both within groups of similar instruments and between instrument types. This consistency encourages optimism for “future-proof” assays that can survive the transition from R&D to production with minimal adjustment
