High-speed and high-precision fluorescence-based cell count and viability assays using the Cellaca&[trade] MX high-throughput cell counter

Abstract

Abstract With multiple FDA-approved cell therapy products available and others in pre-clinical and clinical trials, now, more than ever, it is critical to provide fast and accurate measurements of cell concentration and viability. For certain clinical products, cell concentration is synonymous with dosage, and accurate cell viability is crucial for avoidance of harmful side effects. The complex nature of patient-derived samples makes legacy cell analysis methods such as the trypan blue dye exclusion assay difficult to perform. Nonspecific objects such as RBCs and cellular debris can significantly increase cell counting variation. Meanwhile, the need for cell-based products that are custom-tailored to each patient has increased the number of samples requiring analysis, leading to cell counting bottlenecks. With these challenges in mind, we investigate the performance of the Cellaca™ MX. This high-throughput cell counter captures images in up to 5 FL colors for cell count and viability analysis in under 3 min for 24 samples. Comparison among multiple instruments using Jurkat cells and fluorescent beads reveals high consistency between replicate counts, between plates, and between instruments. We also compare cell counts conducted on the Cellaca™ MX with counts performed using other FL-based automated cell counting methods, as well as manual counting. In addition, we illustrate the use of the new ISO cell counting standards to evaluate and compare the performance of cell counting methods. Finally, we include real-world primary T cell linearity results over a 4-log range of concentration. The results of the experiments confirm the suitability of the Cellaca™ MX for general FL-based assays applicable to cell therapy-related workflows.