Expanding the Scope of Viral Safety: Integrating Scientific Innovation, Regulatory Evolution, and Evolving Manufacturing Strategies

Abstract

The 2026 PDA Virus Conference, held on 22-23 June 2026 in Vienna, Austria, convened scientists from industry, regulatory agencies, academia, and technology providers to examine the changing landscape of viral safety in biopharmaceutical manufacturing. Against the backdrop of the finalized ICH Q5A(R2) guideline and the continued diversification of biologic modalities, the meeting highlighted a shift from predominantly product-specific approaches toward more integrated, knowledge-driven strategies for viral risk management (1, 2). Across the scientific sessions and structured breakout discussions, recurring themes included implementation of lifecycle approaches to viral safety; scientifically justified use of prior knowledge; optimization of established virus filtration and inactivation technologies for intensified and continuous manufacturing; and broader adoption of molecular methods, particularly next-generation sequencing (NGS), for adventitious virus detection. Presentations also addressed the distinct challenges associated with advanced therapeutic modalities, multi-product facilities, alternative expression systems, and preparedness for emerging viral threats. Collectively, the conference portrayed viral safety as an integrated discipline linking patient protection, process understanding, analytical innovation, risk assessment, and lifecycle management. This proceedings article synthesizes the principal scientific themes and areas of emerging agreement rather than providing a verbatim account of individual presentations. Continued collaboration among manufacturers, regulators, technology providers, and academic researchers will be essential to translate these advances into harmonized, risk-based practice.