Immunoassay methods used in clinical studies for the detection of anti ‐drug antibodies to adalimumab and infliximab

Conclusion: Consistent with previous recommendations to improve interpretation of immunogenicity data for biologics, greater consistency in reporting of assay methods and clinical consequences of ADA formation may prove useful. Additional standardization in immunogenicity testing and reporting, application of modern, robust assays that satisfy current regulatory expectations, and implementation of international standards for marketed products may help improve our understanding of the impact of immunogenicity to biologics. This article is protected by copyright. All rights reserved.

Source: Clinical and Experimental Immunology - February 12, 2018 Category: Allergy & Immunology Authors: B. Gorovits, D. J. Baltrukonis, I. Bhattacharya, M. A. Birchler, D. Finco, D. Sikkema, M. S. Vincent, S. Lula, L. Marshall, T. P. Hickling Tags: Original Article Source Type: research