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<p>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%.</p> Graphical Abstract <p></p>

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Substantial Comparability of Singlicate Versus Duplicate Analysis—A Retrospective Evaluation of Clinical Immunogenicity in a Biosimilar PK Study

  • 期刊论文

  • 发表日期：

    2025年12月18日

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  • Maike Lichtenfels,
  • Jamie Fan,
  • Davide Guerrieri,
  • Mathias W. Hackl,
  • Ana Villalba Izquierdo,
  • Liyi Cen,
  • Johann Pötzl

摘要

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%.

Graphical Abstract