AI Article Synopsis
- - Immunogenicity assays are essential for detecting antidrug antibodies against biotherapeutics, and the quality of critical reagents (CR) is vital for the reliability of these assays.
- - Current regulations lack clear guidelines on how to manage changes to CR over the life cycle of an assay, leading to discussions within the European Bioanalysis Forum community.
- - This paper outlines the identified CR for immunogenicity assays and establishes minimum requirements for introducing new lots of these reagents in the testing process.
Article 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.
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| http://dx.doi.org/10.4155/bio-2019-0248 | DOI Listing |
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