Early-Stage Viral Clearance: A Strategic Advantage In Biopharmaceutical Development

Viral clearance is a regulatory requirement for products made in mammalian cells, yet the early-stage work is often treated as a box to check, and timelines are routinely underestimated.

Alex Harley, Global Subject Matter Expert for Viral Clearance at FUJIFILM Biotechnologies, argues that this phase carries more strategic weight than it usually gets. He addresses why studies rarely fit into a few weeks, how unexpected results such as chromatogram deviations or low product recovery can ripple through a schedule, and why non-mAb and less well-characterized modalities call for viral safety planning from the start. He also covers analytical approaches, including NGS and qPCR, used to understand viral loading in downstream processes.

Explore Harley's perspective on how early studies can shape what comes after.