Validation Study of the Vi-CELL™ XR for Automated Cell Counting of Dendritic Cells

The Vi-CELL XR is an automated cell counting and viability analyzer that uses the trypan blue dye exclusion method…

Dendritic cells population is a key functional constituent of cell based immunotherapy drugs. The correct cell count and adequate viability of DC are one of the quality control criteria for the final product release. Number of viable DC is historically determined by microscopy using manual counting method – Bürker chamber and trypan blue dye for dead cell exclusion. The manual method can have significant variability between cell counts determined by different people performing the manual counting, which may contribute to an unstable manufacturing process. The manual method is also time consuming for the operator. An automated cell counting process would remove the variability between operators and could free up the operator for other tasks. The Vi-CELL XR is an automated cell counting and viability analyzer that uses the trypan blue dye exclusion method. The Vi-CELL was evaluated as a suitable method for Quality Control of DC count and viability for a dendritic cell-based drug…