Evaluating Viral Clearance Trends In Biologics

By Alex Rodriguez, Group Leader III, and Eric Coberly, Senior Scientist I

Viral safety is a critical requirement for all manufactured biologics, making the evaluation and optimization of viral clearance studies essential. Analysis of historical viral clearance data reveals distinct trends in the efficacy and robustness of different process steps against various viruses.

For all product types, Low pH Inactivation demonstrated the highest average Log Reduction Value (LRV) at 6.09, though this is primarily effective against enveloped viruses. When including non-enveloped viruses, Viral Filtration (VF) exhibited the highest average LRV at 5.06. Among column chromatography steps, Anion Exchange Chromatography (AEX) was the most effective across all product types, with an average LRV of 4.57.

Steps like AEX, Low pH inactivation, and VF are identified as the most robust clearance mechanisms. However, non-enveloped viruses like Murine Minute Virus (MMV) proved the most resistant to most removal steps, except for VF. The efficacy of these established viral clearance steps is well-understood, suggesting future improvements will focus on study efficiency, such as continuous manufacturing and multi-column chromatography, to reduce time and cost..