1 research outputs found
Mitigating the risk of Zika virus contamination of raw materials and cell lines in the manufacture of biologicals
Ensuring the virological safety of biologicals is challenging due to the risk of viral contamination of raw materials and cell
banks, and exposure during in-process handling to known and/or emerging viral pathogens. Viruses may contaminate raw
materials and biologicals intended for human or veterinary use and remain undetected until appropriate testing measures
are employed. The outbreak and expansive spread of the mosquito-borne flavivirus Zika virus (ZIKV) poses challenges to
screening human- and animal -derived products used in the manufacture of biologicals. Here, we report the results of an in
vitro study where detector cell lines were challenged with African and Asian lineages of ZIKV. We demonstrate that this
pathogen is robustly detectable by in vitro assay, thereby providing assurance of detection of ZIKV, and in turn underpinning
the robustness of in vitro virology assays in safety testing of biologicals