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Immunogenicty
Bioanalytical methods used to assess immunogenicity typically involve multi-tiered ADA testing strategies, including screening, confirmatory, and characterization assays. Techniques such as enzyme-linked immunosorbent assay (ELISA) and electrochemiluminescence (ECL), are commonly employed for detecting and characterizing ADAs. Additionally, cell- or plate-based neutralizing antibody (NAb) assays are conducted to determine if ADAs can impact the drug’s biological activity. Properly designed immunogenicity assessments help mitigate risks by guiding dose adjustments, identifying potential adverse reactions, and supporting regulatory submissions for therapeutic biologics.
ICON’s bioanalytical laboratories have years of experience in developing ADA assays for different types of molecules (e.g. antibodies, bi- or trispecific antibodies, oligos, Fab fragments, ADCs and other proteins) in both pre-clinical and clinical studies. ICON follows the FDA guidance for immunogenicity assays (2019) with separate screening, confirmation and titer assay tiers and all relevant white papers, but also actively participates in discussions on leaner approaches, e.g. by using screening assay signals as an alternative to titers, or by measuring samples in single wells. ICON can provide cutpojnt calculations based on an external dedicated commercial software solution or using in-house developed software.
New opportunities in immunogenicity
ICON experts explore opportunities in immunogenicity approaches, best practices for achieving high-quality ADA assays and emerging trends in this evolving field.
Immunogenicity assays from a CRO perspective
Immunogenicity assessments for cell-based biotherapeutics, multi-domain antibody therapeutics, using a LBA / LC-MS/MS hybrid approach.
Current industry practices for in-study cut point setting for clinical immunogenicity assays
ICON’s observations of current practices for in-study CP verification and calculation.
Practical limitations of using a 1.0% failure rate of low positive control in ADA assays
Detection and characterisation of anti-drug antibodies (ADAs) is essential in developing and testing new biopharmaceuticals.
Scientific poster article: Assessing the impact of ultra-low cut points in immunogenicity assays
With advances in immunogenicity assay techniques and technology, low screening assay cut points below 1.20 and ultra-low cut points (ULCP) below 1.10 are often observed. The validity of these cut points and their ability to accurately assess immunogenicity risk in preclinical and clinical studies is often questioned.
Webinar: Singlicate ADA analysis
With the adoption of ICH M10, many sponsors are embracing single-well analysis for ligand binding PK assays. The wide support of singlicate analysis for PK assays has fed the discussion of single-well analysis in ADA assays. This webinar discusses the benefits of such an approach and provide examples of where singlicate ADA analysis was successfully applied.
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