Best Practices for Designing Robust Assays and Navigating Regulatory Pathways
As AAV-based gene therapies advance into clinical development, managing immunogenicity risk has become essential to ensuring patient eligibility, therapeutic durability, and regulatory approval. This expert-authored white paper delivers a practical, science-backed framework for building immunogenicity assays that are analytically rigorous, clinically relevant, and globally aligned.
Whether you’re designing early-phase protocols or preparing for global filings, this guide provides actionable insights to strengthen your assay strategy and advance your gene therapy program with confidence.
Topics covered:
- TAb vs. NAb Assays: In-depth comparison of formats, throughput, sensitivity, and translational relevance
- Assay Strategy Across Phases: Guidance on assay selection and validation from preclinical studies to CTA and companion diagnostic development
- Navigating Global Regulations: Insights into evolving regulatory expectations in the US (IDE, SRD, Q-submissions) and EU (IVDR)
- Validation Best Practices: Technical considerations for cutoff determination, reagent qualification, and global deployment
- Linking Immunogenicity & Efficacy: Approaches for integrating immune response data with therapeutic endpoints to refine patient stratification and study design
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