The observation of drug-specific IgE antibodies which may cause anaphylaxis prompts the need to test for these antibodies - but because IgE are 2000-fold less prevalent than IgG antibodies, a very sensitive detection method is required. We discuss why the ImmunoCAP platform provides an ideal system to analyze IgE-mediated drug hypersensitivities.
What are the advantages of using the Biacore™ T200 SPR System for immunogenicity assessments with a tiered approach? Our experts discuss.
The answer to the question is “it depends”. Commonly a combination of 510K approved kits (in Europe known as assays that need to follow IVD-directive 2017/746) and research use only (RUO) kits are used to support the biomarker analysis needed in clinical trials because both types of assays have different strengths and limitations. To select the appropriate kit requires an understanding of these pros and cons in the context of the intended study the assay must support.
Target interference can cause false positive ADA assay results and stall out promising drugs. This could have been the case for one study involving an MAb binding to a target protein which contained the dimerization interface – that is, until BioAgilytix stepped in.
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