Although in vitro immunogenicity assays are proposed to discriminate between low- and high-immunogenic biologics, they face numerous challenges. These include selecting the most appropriate test(s), lack of standardization in methods and technical parameters, defining positivity thresholds, high costs, the need for specialized equipment and trained personnel, the complexity and labor-intensive nature of assays, and the difficulty of translating in vitro results into clinical immunogenicity outcomes. Additional assay validation studies are undoubtedly required to better define the implementation and robustness of in vitro immunogenicity prediction for biologics, which could be advantageously combined with in silico approaches.
Fardel et al. (Fri,) studied this question.