Application of a dual virus spike strategy shows efficiency in viral clearance studies, indicating improved IND filing timelines for early-stage biotechnology products.
Biotechnology products derived from cell lines carry a risk of viral infection. Given this potential risk, an assessment of the virus removal/inactivation that can be achieved by a product's established purification process is required per ICH Q5A guidelines. This viral safety assessment is a critical component of filing an investigational new drug (IND) application for an early‐stage product. A viral clearance study must evaluate purification steps in a manufacturing process that are effective in inactivating/removing viruses. The traditional approach to viral clearance studies includes spiking in one virus at a time and quantifying the level of reduction of individual virus by a validated assay for that virus. This paper discusses an approach to spiking in multiple viruses in the same load and quantifying clearance in virus‐specific assays to help accelerate the timeline to IND filing for an early‐stage product while also reducing support and material requirements for executing viral clearance studies.
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Horne et al. (2025) studied this question.
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