Multi-Spike 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 that virus by a validated assay for that virus.  A multi-spike viral clearance study approach utilizes multiple viruses at a time and measuring virus titer using 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.