Harmonizing immunogenicity for AAV and LNP/mRNA modalities: best-practice panels for binding, neutralizing, and cellular assays with pre-existing immunity controls

By implementing this harmonized, matrix-aware panel, which is presented as a fit-for-purpose analytical best-practice proposal rather than an evidence-validated clinical standard, screening-failure bias can be minimized, eligibility criteria can be stabilized, and connections between assay results and dosing, monitoring, and re-dosing/deferral may be strengthened.