Tailoring Viral Clearance Study Design For Monoclonal Antibodies, Recombinant Proteins, And Similar Product Types

Viral clearance studies are a critical component of ensuring the safety of biologics manufactured using cell-based systems, including monoclonal antibodies and recombinant proteins. As regulatory expectations continue to evolve, study designs must balance scientific rigor, risk-based decision making, and development timelines. This presentation provides practical guidance on tailoring viral clearance study design across different phases of development, with a focus on aligning strategy with current regulatory guidance, including ICH Q5A Revision 2.

The discussion will cover key elements of viral risk mitigation, including material sourcing, adventitious agent testing, and demonstration of viral removal or inactivation through orthogonal purification steps. Emphasis will be placed on selecting appropriate virus panels, understanding phase-appropriate regulatory expectations, and leveraging prior knowledge and platform approaches where justified. Assay selection and execution strategies—such as the use of large-volume testing and highly purified virus stocks—will be explored to maximize sensitivity and achievable log reduction values while optimizing cost and timelines.

Real-world case studies will illustrate how flexible study design and execution models can address accelerated timelines, limited material availability, and manufacturing excursions. Attendees will gain actionable insights into designing robust, compliant viral clearance studies that support efficient progression from early development through commercial readiness.