Method Evaluation Guidance For Transferring A Process From The Cedex® HiRes Analyzer To The Vi-CELL BLU Cell Viability Analyzer

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When an analyzer is retired, regulated workflows still need documented evidence that results before and after the change remain comparable. This application note from Andrew Wu, Senior Application Scientist at Beckman Coulter Life Sciences, shows one way to build that evidence for a cell counting method transfer. The study uses NISTCHO suspension cells and adherent HEK293 cells to assess repeatability, intermediate precision, and dilutional linearity, with study design informed by ISO 20391-1 and ICH Q2(R2). It lays out the acceptance criteria, system suitability checks, and dilution scheme, and it describes a cell type setting adjustment that the adherent cell work required. The criteria are presented as an illustrative example, not a prescription.

Explore the data to see how the two instruments compared at each dilution and how you might frame your own comparability study.