“…Immunogenicity assessment may require more explicit evaluation of the intact molecule, each function domain, linkers, the degraded form, metabolites, and the combination thereof. While the continued demand for greater sensitivity, selectivity, detectability, drug tolerance, speed, and cost efficiency is driving the development of new tools such as ultrasensitive and multiplex equipment, a balance needs to be achieved between the use of new and current approaches in the absence of regulatory guidance on the former in order to mitigate the risks carried forward on critical aspects such as data quality, data comparability, and data integrity (92,93). Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.…”