Bioanalysis Zone

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


In this White Paper from Bioanalysis, the authors discuss the European Bioanalysis Forum’s recommendations for critical reagents (CR) for immunogenicity assays. They present the requirements for CR and describe the consequences of introducing new lots of CR to immunogenicity assays. 

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.

Keywords: antidrug antibody assay, critical reagents, major change, minor change
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