Performance Comparison between Semi‐Automated and Manual Cell Counting for Animal Cell Culture

Abstract Determining cell density and viability with (semi‐)automated methods enables rapid cell cultivation analysis. However, scientific validation is required, typically by comparing results to manual counting. To address this, we present a method to evaluate and compare two cell counting methods exemplified by a manual and a semi‐automated method (Countstar BioTech). Experiments followed validation parameters aligned with the International Council for Harmonization (ICH) Q2(R1) guideline and a dilution series design based on ISO 20391‐2:2019. Both the semi‐automated and manual methods showed comparable specificity and linearity for Chinese hamster ovary (CHO)‐K1 cells. The semi‐automated method exhibited superior repeatability for total cell density, whereas cell viability results showed no significant difference.