Replacement Of Traditional Adventitious Virus Testing With Next Generation Sequencing - Leveraging ICH Q5A

For several decades, molecular-based technologies have played a crucial role in evaluating viral safety in biologically derived samples. Traditional methods such as Polymerase Chain Reaction (PCR) have been widely used; however, their utility is inherently limited by their specificity, which allows only a narrow range of viruses to be detected in a single assay. In contrast, the advent of Next Generation Sequencing (NGS) has introduced a transformative approach to viral detection. NGS offers a broad-spectrum, agnostic screening capability, making it a powerful alternative to conventional animal-based methods like the in vivo adventitious virus detection test. This shift is particularly significant given that, in over 50 years of use, the in vivo test has never identified a viral contaminant that was not also detected by another concurrent assay, raising questions about its continued relevance and effectiveness.

In light of recent updates to the International Council for Harmonisation (ICH) Q5A guidelines and the global push for the 3Rs (Replacement, Reduction, and Refinement of animal use in testing), there is growing momentum among manufacturers to transition away from in vivo testing in favor of molecular-based methods such as NGS. In response to this evolving landscape, we have developed an NGS-based assay composed of a suite of validated modules.

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