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 potential harmful side effects. The complex nature of patient-derived samples makes legacy cell analysis methods such as the trypan blue exclusion assay difficult or impossible 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 multiplied the number of samples requiring analysis, leading to cell counting bottlenecks.

In this work, we demonstrate the capabilities of Cellaca™ MX for high-throughput fluorescence-based cell counting. Comparison among multiple instruments using Jurkat cells and fluorescent beads reveals high consistency between replicate counts and between instruments. We also compare cell counts made on the Cellaca™ MX with both manual and other automated methods. In addition, we illustrate the use of the ISO 20391-II cell counting standard to evaluate and compare the performance of cell counting methods. Finally, we include 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 fluorescence-based live-cell assays.