Recent discussions and proposals on challenging the 3-tier immunogenicity testing strategies from the European bioanalysis forum
Year: 2025
Type: conference-abstract
Abstract: The European Bioanalysis Forum, in discussions with cross-industry experts from pharmaceutical, biotech, and contract research organizations, is continuing the challenge of the traditional 3-Tier immunogenicity testing strategy, proposing a simpler, context-driven 1-Tier approach, a recent paradigm shift that emphasizes clinical relevance and the impact of anti-drug antibodies over mere incidence. In a workshop at the 17th annual Open Symposium, the meeting highlighted using signal-to-noise ratios to assess low-level ADA responses and addressed challenges such as nonspecific binding and assay reliability. Participants debated the need for continued confirmatory testing, and that it should be performed on a case-by-case basis. The shift aims to improve clinical testing strategies while reducing complexity, promoting data-driven decisions. Case studies, particularly from high-risk molecules, will guide implementation. Overall, there’s strong support for the 1-Tier approach, but its success depends on robust data, industry collaboration, and regulatory approval.
Source: Bioanalysis
Authors: Kyra J Cowan, Karien Bloem, Annelies Coddens, Laura Creed, Hannah Higgins, Jonathan Jimenez Novoa, Christopher Jones, Yvonne Katterle, Marco Klinge, Ben Leatherdale, Birgit Jaitner, Peter van Bommel, Saskia van der Lee, Michaela Golob, Rob Nelson, Philip Timmerman
Institution: Bayer (Germany)
Language: English
Subfield: Immunology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: bronze
OpenAlex ID: W4409278750