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

Abstract

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 CellacaTM 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 CellacaTM 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 CellacaTM MX to measure a 4-log range of T cell concentrations. The CellacaTM 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.