Viral Safety Testing In Biologics: Detecting What Current Methods Miss

Viral safety testing in biologics was traditionally built to identify known and well-characterized risks. However, today’s development landscape is shifting rapidly. Increasing molecular complexity, novel modalities, and globally distributed supply chains are introducing less predictable and harder-to-detect viral threats. At the same time, conventional testing methods remain constrained by predefined targets, creating a growing gap between what is tested and what may actually be present. Recent updates to ICH Q5A(R2) emphasize the need for broader, more sensitive detection approaches while reducing dependence on animal-based methods. For CMC, quality, and analytical teams, the key challenge is not awareness but implementation—understanding limitations, expanding detection capabilities, and maintaining regulatory alignment without delaying development.

Watch to see highlights of real-world applications of emerging testing strategies, demonstrating how expanded detection can improve visibility, enhance viral safety assurance, and support innovation across biologics and advanced therapies. It also offers practical perspectives for integrating these approaches into existing workflows.

Speaker: Christine Mitchell, Ph.D., Principal Scientist, Minaris Advanced Testing

Christine has been with Minaris since 2007, beginning in viral clearance where she developed qPCR assays. She later joined Analytical Sciences, contributing to advanced NGS-based viral detection, cell line identity, rcAAV analysis, and gene therapy assays using qPCR and ddPCR. She holds a Ph.D. in Molecular Genetics from SUNY Stony Brook.