This article provides harmonized recommendations for the validation and reporting of neutralizing antibody (NAb) assays, addressing challenges associated with both cell-based and non-cell-based formats. Developed by experts from industry and the FDA through the American Association of Pharmaceutical Scientists’ Therapeutic Product Immunogenicity Community, the recommendations cover key assay performance characteristics including cut point, sensitivity, specificity, drug and target tolerance, sample stability, and robustness. The authors also provide standardized summary tables and practical guidance for presenting method validation data, with the goal of improving consistency, clarity, and completeness in regulatory submissions and facilitating more efficient review by health authorities.
Read the article featured in the July 2023 edition of The AAPS Journal.
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