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

by Iveta Bottová, PhD, and Lena Lee
Volume 13, Issue 3 (Fall 2014)

Dendritic cell (DC) population is a key functional constituent of cell-based immunotherapy drugs. The correct cell count and adequate viability of DCs are one of the quality control criteria for the final product release. The number of viable DCs is historically determined by microscopy using a 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 procedure, which may contribute to an unstable manufacturing process. The manual method is also timeconsuming for the operator. An automated cell counting process helps remove the variability between operators and can 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 counts and viability for a dendritic cell-based biologic drug. The test for Vi-CELL counting accuracy was performed three times each on known concentration control beads, under the same operating conditions. The diameter and circularity of dendritic and lymphocyte cells was determined by a NIKON™ Eclipse microscope to set up the “correct recognition of DC. The size range for DC was established so that lymphocytes could be excluded. The number of total DC, viable and also non-viable, were analyzed and compared to Bürker chamber counting. There was no significant difference between the DC count obtained by Vi-CELL and by Bürker chamber. Vi-CELL automated cell counting was established as a method which is accurate and suitable for use with dendritic cells.

Bottová I, Lee L. Validation study of the Vi-CELL XR for dendritic cell counting. BioProcess J, 2014; 13(3): 32–7.

Posted online October 13, 2014.