EBF recommendation on practical management of critical reagents for antidrug antibody ligand-binding assays

Susanne Pihl, Barry W. A. van der Strate, Michaela Golob, Janka Ryding, Laurent Vermet, Birgit Jaitner, Joanne Goodman, Philip Timmerman*

*Corresponding author for this work

    Research output: Contribution to journalArticleAcademicpeer-review

    2 Citations (Scopus)

    Abstract

    Immunogenicity assays are required to measure antidrug antibodies that are generated against biotherapeutic modalities. As for any ligand-binding assays, critical reagents (CR) play a crucial role in immunogenicity assays, as the robustness and reliability of an assay are defined by the quality and long-term availability of these reagents. The current regulatory guidelines do not provide clear directions on how to implement and verify lot-to-lot changes of CR during an assay life cycle, or the acceptance criteria that should be used when implementing new lots of CR. These aspects were extensively discussed within the European Bioanalysis Forum community. In this paper, CR for immunogenicity assays are identified and the minimum requirements for introducing new lots of CR in immunogenicity assays are described.

    Original languageEnglish
    Pages (from-to)1787-1798
    Number of pages12
    JournalBioanalysis
    Volume11
    Issue number19
    DOIs
    Publication statusE-pub ahead of print - 28-Oct-2019

    Keywords

    • antidrug antibody assay
    • critical reagents
    • major change
    • minor change
    • HOST ANTIBODIES
    • BIOANALYSIS
    • STABILITY

    Cite this