Consistent reagent qualification is essential for reliable cell-based neutralizing antibody assays.

Maintaining assay performance throughout clinical development requires careful qualification of critical reagents. This poster examines strategies for qualifying Ready-to-Assay (RTA) cell reagents for use in previously validated cell-based neutralizing antibody (NAb) assays, demonstrating approaches to support consistent assay performance while maintaining validated method integrity.

Key highlights include:

• Qualification of Ready-to-Assay (RTA) cell reagents for validated cell-based NAb assays
• Evaluation of cell viability, assay sensitivity, and overall assay performance
• Assessment of concordance between RTA cells and existing assay methods
• Strategies for maintaining validated method performance during reagent transitions
• Considerations for supporting reliable immunogenicity testing in regulated clinical studies

As cell-based immunogenicity assays continue to support biologic and gene therapy development, robust reagent qualification is critical for ensuring consistent, reliable results. Learn how thoughtful qualification strategies can help maintain assay performance and support regulatory confidence throughout clinical development.