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Updated: Apr 28, 2026

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
Published on: September 15, 2023
Detection of anti-cytokine antibodies and their clinical relevance
1Regaem Consultants, 62 Whitchurch Gardens, Edgware, Middlesex, HA8 6PD, UK.
Abstract:
Cytokines regulate many aspects of cell growth and differentiation and play pivotal roles in the orchestration of immune defence against invading pathogens. Though 'self' proteins, they are potentially immunogenic and can give rise to anti-cytokine autoantibodies (aCA). The main foci of the article are a critical summary of the various methodologies applied for detecting and measuring aCA and a broad review of studies of the occurrence, characterization and clinical relevance of aCA in normal healthy individuals, patients with autoimmune diseases or microbial infections and aCA in patients whose disease is treated with recombinant cytokine products. The need for technical and methodological improvement of assays, including validation and standardization, together with approaches to harmonize calculation and reporting of results is also discussed.
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