Tailoring Viral Clearance Study Design To Development Phase, Modality, And Regulatory Requirements

Take a comprehensive look for guidance on designing and executing viral clearance studies that align with the latest global regulatory standards. Attendees will gain expert insights on building robust study strategies tailored for a range of biologic modalities such as AAV vectors, ensuring safety, and streamlining regulatory submissions.​

Topics include choosing model viruses and spiking strategies for advanced products, reviewing data benchmarks such as log reduction values (LRVs) and mass balance results, and implementing phase-appropriate approaches that balance regulatory compliance with development speed. The session will highlight the impact of recent updates to key guidelines—ICH Q5A(R2), WHO, FDA, and EMA—and discuss how these changes affect study design and execution.​

Case studies drawn from thousands of completed viral clearance projects will illustrate best practices and common pitfalls, offering actionable advice for accelerating timelines and avoiding regulatory setbacks. Practical guidance on presenting study data, crafting submission-ready outputs, and harmonizing elements across CMC filings will help participants strengthen their regulatory submissions. Whether launching early-phase development or preparing for final approval, the strategies shared will equip teams to make informed decisions and successfully navigate the evolving regulatory landscape.​