A harmonized immunogenicity panel minimizes screening-failure bias and strengthens assay result use for dosing and monitoring in AAV and LNP/mRNA therapies.
Implementing a harmonized immunogenicity assay panel for AAV and LNP/mRNA modalities may minimize screening-failure bias and improve clinical decision-making.
Absolute Event Rate: 0% vs 0%
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.
Meslamani et al. (Sat,) reported a other. A harmonized immunogenicity panel minimizes screening-failure bias and strengthens assay result use for dosing and monitoring in AAV and LNP/mRNA therapies.