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Dr. Kamala’s presentation, “Mitigating Target Interference Challenges in Bridging Immunogenicity Assay to Detect Anti-Tocilizumab Antibodies,” provided valuable insights into overcoming challenges in immunogenicity testing. Key takeaways include:
Addressing Target Interference: The presentation highlighted the development of a robust immunogenicity assay to accurately detect anti-tocilizumab antibodies, even in the presence of high levels of circulating IL-6 receptor, mitigating false positives.
Innovative Solutions: Dr. Kamala detailed novel approaches such as using blocking agents and dilutions, ensuring the assay’s high sensitivity, specificity, and precision, which are critical in clinical studies evaluating anti-drug antibodies.
Relevance to Biosimilars: This method also demonstrated antigenic equivalence between biosimilars and originator drugs, allowing the use of a single assay format for streamlined testing in comparative studies.
This presentation is essential for professionals involved in biologics and biosimilar development, offering effective strategies for improving immunogenicity assays and ensuring accurate results in clinical settings.