A Framework for Evaluating the Ability of NGS to Replace In Vivo Adventitious Virus Testing
Since the use of next generation sequencing (NGS) to detect a previously undetected porcine circovirus contaminant in a live viral vaccine in 2010 Victoria et al. 2010, it has generated extensive interest in the biomanufacturing industry. One area of particular interest is the potential of NGS to replace in vivo virus testing. However, there is a lack of a framework, supported by data, to guide companies through the assessment of if, and in what situations, NGS should be considered as a replacement for in vivo virus testing and what questions each organization must answer when performing this assessment. The goal of the project is to assess if, and in what situations, NGS may be appropriate as a replacement for in vivo virus assays, collect any data that would be relevant to performing that assessment, and outline key considerations that organizations must address to guide them in their own internal assessment.