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.
