Validation of cell density and viability assays using Cedex automated cell counter

Area of Science:

• Biotechnology
• Cell Biology
• Immunotherapy

Background:

• Cell-based immunotherapy requires precise quantification of cell density and viability.
• Automated cell counters offer potential for standardized and efficient analysis.
• Evaluating instrument performance and inter-device variability is crucial for reliable results.

Purpose of the Study:

• To develop and validate a method using the Cedex automatic cell counter for cell density and viability assessment.
• To evaluate the assay performance characteristics of the Cedex system.
• To investigate instrument-to-instrument variation for the Cedex cell counter.

Main Methods:

• Method validation included specificity, accuracy, precision, linearity, range, and robustness testing.
• Cell density was assessed across a range of 3.13x10(5) to 1.0x10(7) cells/mL.
• Viability was evaluated by mixing known numbers of non-viable and viable cells across the 50-100% range.

Main Results:

• Cedex demonstrated acceptable accuracy and precision for cell density (RSD ~5%) and viability (RSD <5%, 95.3-106.4% recovery).
• Significant instrument-to-instrument variation was observed for cell density, precluding interchangeable use without further calibration.
• Instrument-to-instrument differences for viability were less than 4.6%, and assays were robust, though cell line-dependent effects were noted.

Conclusions:

• The Cedex system provides a robust method for determining cell density and viability in immunotherapy products.
• Instrument-specific calibration is required to address variability in cell density measurements.
• Performance verification for each specific cell line is recommended for optimal and reliable Cedex assay results.