NGS is being internationally recognized as an alternative viral adventitious agents detection method for replacing the in vivo animal assays and PCR assays, and for replacing or supplementing the in vitro cell culture assays. The availability of the WHO reference viruses for qualification and validation of NGS can facilitate implementation of the technology for adventitious virus testing at different manufacturing stages to assure virus safety of the final product. Additionally, CBER’s comprehensive Reference Virus Database, which is made publicly available by the University of Delaware, can facilitate detection of known and novel viruses.
The results are expected to optimize NGS for virus detection in complex biological materials. Since there is broadening interest for using NGS to meet the 3R’s objectives and replacing animals and to accelerate product development by shortening the testing time of the in vitro cell culture assays, the overall efforts of this project are aimed to facilitate the establishment of NGS in low-middle income countries and small companies with limited resources.
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Federal Stakeholder: Food and Drug Administration
GlaxoSmithKline, LLC
MilliporeSigma/EMD Serono
University of Delaware
