Facing bioanalytical challenges when evaluating the immunogenicity profile of protein-based therapeutic drugs

Given their complexity, it is a regulatory requirement to evaluate the immunogenicity profile of protein-based therapeutic drug products. Multiple factors can impact the bioanalytical immunogenicity assay used to characterize the immune response generated against the drug, such as the assay format used, the sensitivity of the assay, the dilution scheme, the clinical sampling strategy, or the matrix interference. For bioanalytical analysis, all these factors are crucial and need to be considered. Consequently, having the appropriate approach during method development is essential. This issue of The Altascientist illustrates some of the bioanalytical challenges that exist when assessing the clinical immunogenicity profile of oncology drug products and how Altasciences overcomes those challenges.