Application of Dual Virus Spike Approach to Accelerate Early-Stage Viral Clearance Studies.

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.