Viral Clearance Testing For Biologics, Vaccines & AAV Therapies

Viral clearance is a critical safeguard in biologics and gene therapy manufacturing, preventing adventitious viral contamination and ensuring compliance with global regulatory standards such as ICH Q5A, FDA, and EMA. Effective strategies combine inactivation methods—like low pH, solvent/detergent, and heat—with removal techniques such as chromatography and nanofiltration.

High-quality, in-house virus spikes and large-volume testing enhance detection sensitivity and deliver stronger log reduction values (LRVs), accelerating regulatory submissions. Comprehensive GLP documentation supports IND and BLA filings, including cytotoxicity analyses, scaled-down model justification, and regulatory-ready reporting.

With rapid scheduling, dedicated client suites, and scientist-to-scientist collaboration, these studies provide confidence in viral safety while streamlining timelines for complex therapies. See how advanced methodologies and proven expertise can optimize your clearance strategy and speed your path to approval.