Identification of viral contamination of a biopharmaceutical product using nanopore sequencing

Contamination events in cell culture-derived biopharmaceuticals are very rare due to the implementation of strict testing procedures for the characterization of cell banks. However, they occurred regularly over the last decades and some of the more famous events included the detection of porcine circovirus in a rotavirus vaccine and simian virus 40 found in a poliovirus vaccine. This talk will describe the detection of contamination in a cell culture-derived biopharmaceutical observed at ViruSure. This contamination event was discovered using a cell-based in vitro adventitious agent testing approach, which is highly sensitive for the detection of virus present in underlying samples but is unable to identify the virus. Therefore, this sample was subjected to nanopore sequencing, which, after optimization of the sample preparation protocol, led to the identification of the contaminant as the epizootic haemorrhagic disease virus.