The updated ICH Q5A(R2) guidelines recommend next-generation sequencing (NGS) as the preferred approach for detecting adventitious agents. This forms the basis for implementation by leading regulatory authorities, including the FDA, EMA, PMDA, and MFDS, signaling a global shift in biosafety testing.

A thorough risk assessment remains the foundation of a compliant biosafety testing program. Identifying and characterizing all potential sources of contamination is critical to developing an effective testing strategy. With technological advancements, NGS can now supplement – and eventually replace –conventional in vivo and in vitro methods for adventitious agent detection without requiring direct comparative studies. This paradigm shift enhances sensitivity, reproducibility and operational efficiency.

Meet evolving regulatory standards with confidence by leveraging a platform designed for complete transparency and end-to-end traceability throughout your biologics production pipeline.