Evaluation of Cell Line Identity Using RTCA Profiling for Quality Control of Products Containing Viable Human Cells

Abstract

Introduction. Identity is an important quality attribute of products containing viable human cells, to be tested during the quality control. The verification of identity includes, among other things, determination of the proliferative activity of the cell lines included in such products. The Agilent xCELLigence real-time cell analysis (RTCA) DP (dual purpose) instrument (USA) for continuous, label-free in vitro analysis can be used to assess the cell proliferative activity.Aim. Demonstration of reproducibility of the RTCA profiling technique as a test method for primary verification of the cell line identity.Materials and methods. An xCELLigence RTCA DP cell analyzer (Agilent Technologies, USA) was used to obtain RTCA profiles of dermal fibroblast (DF-2) and adipose tissue-derived mesenchymal stromal (MSC AT_D122) cell lines. The experiment was carried out in triplicate after thawing three different vials from the same batch for each cell line.Results and discussion. The RTCA profiles were obtained for DF-2 and MSC AT_D122 cell lines. The statistical processing of the results was carried out using the Friedman test, confidence intervals, and growth curve parameters obtained by the instrument (doubling time, proliferation rate, and maximum cell index). The obtained data demonstrate no differences in the RTCA profiles after parallel sampling of the contents from three vials for each cell line.Conclusion. The RTCA profiling reproducibility was confirmed in order to assess the cell analyzer’s applicability to cell line identity.

Keywords

• cell line
• identity
• quality control
• biomedical cell product
• high-tech drug