Impact of COVID-19 on Next Generation Sequencing Applications for Adventitious Agent Detection in Viral Vaccine Manufacturing

Next generation sequencing (NGS) has capabilities for sensitive and broad virus detection and therefore can potentially substitute or replace the current adventitious virus detection assays. Using NGS to substitute for in vivo assays can support the global efforts to reduce animal use and NGS can address the limitations of the in vitro assays related to interference by the vaccine virus in the absence of a potent neutralizing antibody. Furthermore, NGS can shorten the testing time from months down to weeks. Recent efforts for using NGS for adventitious virus detection in biologics has focused on method standardization and assay validation. This presentation will highlight the rapid progress for NGS implementation as a rapid adventitious virus detection assay to accelerate SARS-CoV-2 vaccine development in OVRR submissions.