Discussion

Unwanted immune responses to biologics can be induced by a combination of different factors. Immunogenicity is the result of the interplay between product and patient related factors which makes it difficult to precisely predict the clinical outcome in a non-clinical setting.
However, incorporating the assessment of the relative immunogenic potential of drug candidates early in the development phase can significantly minimize the risk later on.
Today, more and more drug developers combine in silico and in vitro immunogenicity assessment tools as a criterion to shorten the list of drug candidates and for reduction of development costs later on.