Mitigating the risk of Zika virus contamination of raw materials and cell lines in the manufacture of biologicals

Abstract

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.

Oligodendrocytes are susceptible to Zika virus infection in a mouse model of perinatal exposure: Implications for CNS complications

“…The origin and history of ZIKV PE243 have been previously described (Donald et al, 2016 ). ZIKV MR766 was obtained from BEI Resources, NIAID, NIH: Genomic RNA from ZIKV Virus, MR766, NR‐50085 (Zmurko et al, 2018 ). The viral stocks were generated using either the Vero E6 cell line (ATCC, CCL‐81), A549/BVDV‐NPro cell line (kindly gifted by R.E.…”