In this webinar, industry experts from Precision for Medicine will provide insights on developing gene therapy immunogenicity assays focused on regulatory compliance, minimizing rework, and selecting the right assay approach.
Learn best practices for immunogenicity assay validation, cost-effective strategies, and future-proof assay designs. Compare neutralizing antibody (NAb) and total antibody (TAb) assays and their effects on timelines, costs, and clinical outcomes. Whether you’re in early development or optimizing later-phase trials, this session ensures your assays meet global standards, are robust, compliant, and scalable.
Topics covered
- Understanding the regulatory landscape — key considerations for assay development
- How to understand whether an IDE (Investigational Device Exemption) is required for assays used in your gene therapy trial
- Comparative advantages of NAb and TAb assays
- Best practices for assay validation — Practical strategies to ensure gene therapy immunogenicity assays are robust, reproducible, and compliant
- Future-proofing your assay strategy — Balancing the need for a cost-effective assay to use in a Phase I that can be pivoted to support a later Phase study or post market testing without significant rework
Watch now.
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