Detection of Microbiological Contamination in Cell Cultures and their Raw Materials: a 6 years report of this activity.

Abstract

Abstract Contaminations in cell cultures are a source of concern for biotechnology laboratories, bio products manufacturers and cell banks as they involve economical loss, time loss and non-valid results. The main issues are fungi, bacteria (including mycoplasmas) and viruses. In this study, we present a retrospective of cell cultures quality control and their raw materials carried out at INMETRO throughout 6 years. From 2014 to 2019, different cell lines and raw materials derived from LABIO, from partner institutions of research projects, or from cooperation agreements were assessed. The detection of mycoplasmas were made using the biochemical method MycoAlert Plus. Contamination by bacteria and fungi were detected by a microbiological culturing according to the Brazilian Pharmacopoeia. Among the 944 assays carried out to detect bacteria and fungi; 5.6% presented contamination. Among 1143 assays of mycoplasmas detection; 10.8% presented contamination. Regarding raw materials assessment, 0.7% and 7.7% were contaminated with mycoplasmas and bacteria/fungi, respectively. In total, 8% of all samples presented contamination: 5.6% by mycoplasmas, 2.4% by bacteria/fungi and 0.1% by both. The dissemination of Good Practices on Cells Culture, the availability of these assays and the support of the implementation given to laboratories which are interested have been our contribution to improve control quality in the activity of cell cultures.