Characterization of a novel high-throughput, high-speed and high-precision plate-based image cytometric cell counting method

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Bioprocessing applications for cells and biologics have dramatically increased the number of samples needed to test for cell therapy and immunotherapy. The cell counting time is a major bottleneck for traditional counting methods, which can be eliminated by using a high-throughput, high-speed, and high-precision system. Here we characterize and demonstrate the application of Cellaca™ MX high-throughput cell counter in bright field and fluorescence imaging modes. The system was subjected to multiple characterization experiments utilizing microbeads, Jurkat and CHO-S cells. We investigated the bead/cell counting consistency and precision from a count-to-count, plate-to-plate, and instrument-to-instrument level by assessing counting on multiple consumables and instruments. The precision results were acquired by directly comparing as many as 32 Cellaca™ MX instruments over an extended period of 1 year using stable bead reference samples, significantly strengthening confidence in the cell counting results. We further characterized the system under ISO Cell Counting Standard Part 2 guidance to determine the quality of the cell counting method. The system was also compared to the traditional hemocytometer and single-sample-based automatic cell counters. Finally, we demonstrate the use of Cellaca™ MX to measure a 4-log range of T cell concentrations. The Cellaca™ MX high-throughput cell counter can rapidly generate cell counts at 1 and 3 min per 24 counts in bright field and fluorescence, respectively. Its use can significantly reduce cell counting time and effectively eliminate this bottleneck for downstream assays.