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.
Reduction in the use of animals for adventitious agent testing
Optimize NGS for virus detection in complex biological materials.
Optimization of NGS bioinformatics for enhancing efficiency of database generation and accuracy of data analysis for adventitious and endogenous virus detection.
Reduced cost and time of adventitious virus testing, leading to more rapid product development
Assist regulatory agencies with decision-making and policy development regarding the use of NGS for replacing the in vivo animal assays and for replacing or supplementing the in vitro assays currently used for virus testing
Decrease cost and time required for adventitious virus testing, helping to facilitate more rapid product development
By replacing traditional in vivo animal assays with Next-Generation Sequencing (NGS), this project enables manufacturers to reduce viral testing timelines from several weeks to just a few days, accelerating vaccine development by an estimated 75% to 80%. The implementation of optimized bioinformatics and the RVDB database directly addresses the high cost and complexity of traditional assays, providing a scalable alternative for small companies and low-middle income countries. This transition not only fulfills the "3Rs" objectives by eliminating animal usage but also ensures 100% broader detection of both known and novel viruses through standardized, publicly available reference pipelines.
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Federal Stakeholder: Food and Drug Administration
EMD Millipore Corporation
GlaxoSmithKline, LLC
University of Delaware
