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Drug immunogenicity and the detection of anti-drug antibodies (ADA) have an important role in the drug discovery process for potential new therapeutics. The clinical effects of these immune responses can affect pharmacokinetics, pharmacodynamics, safety, or efficacy. Detection and analysis of ADA formation is crucial for any therapeutic protein product development program.
Current requirements for screening and confirmatory IgG ADA assays aim to achieve a sensitivity of at least 100 nanograms per millilitre (ng/mL). However, at this sensitivity the primary response to antigen exposure, and resultant pentameric IgM generation, may be missed while IgE ADA may also elude the assay due to its low concentration.
A high sensitivity detection platform would therefore be advantageous in order to detect ADA sooner and at much lower concentrations than the current requirements, thus leading to improved drug safety. Improved sensitivity and dynamic range could also potentially be used to overcome some of the challenges, such as matrix and drug tolerance, that traditional assays exhibit. This presentation aims to show how Single Molecule Counting technology can assist in improving assay sensitivity and therefore therefore improve drug safety.
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