ArticleThe AAPS journal2025
Substantial Comparability of Singlicate Versus Duplicate Analysis-A Retrospective Evaluation of Clinical Immunogenicity in a Biosimilar PK Study.
Article in The AAPS journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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7 authors.
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Abstract
To investigate the feasibility of a singlicate-based approach for immunogenicity assays in the biosimilar setting by comparing singlicate and duplicate data of an established Anti-Drug Antibodies (ADA) assay and from a biosimilar study. We re-calculated the screening, confirmatory, and titer cut-points using singlicate values. The ADA method validation initially performed in duplicates was re-evaluated based on singlicate data. We performed variance component analysis to investigate the contribution of well-well variance on overall data variability. We re-assessed the clinical immunogenicity study data based on singlicate values. The ADA assay validation parameters were comparable between duplicate and singlicate-based evaluation. The variance component analysis confirmed the negligible influence of well-to-well variability. The use of singlicates would not have impacted the immunogenicity outcome of the clinical study. The singlicate-based analysis in our study would have reduced the analytical workload by about ~ 40%.
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