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.
About the speaker
Tim Burns, Senior Manager, Minaris Advanced Testing
Tim Burns is a Senior Manager at Minaris Advanced Testing, where he leads a team of Scientists supporting viral clearance testing for advanced therapy programs. With more than a decade of experience in regulated laboratory environments, Tim brings deep technical expertise in viral safety, cell-based assays, and GMP/GLP operations. Tim has been with Minaris for close to ten years, advancing from Associate Scientist to Senior Manager within the Viral Clearance group. Throughout his career, he has served as a Scientist and Study Director, contributing to complex client programs through strong scientific execution, operational leadership, and cross-functional collaboration. Tim holds a Master’s degree in Coastal Marine and Wetland Studies and a Bachelor of Science in Marine Science and Biology from Coastal Carolina University. His background combines rigorous academic research with practical industry experience, making him a knowledgeable and engaging speaker on viral clearance strategies, laboratory best practices, and biosafety testing.