As biologic drug providers endeavor to create effective protein-based medicines, immunogenicity remains a complex challenge. Immunogenicity is an immune response against a therapeutic antigen causing that medication to
lose its effectiveness over time and potentially resulting in serious illness. In some cases immunogenicity is wanted, such as in
a vaccine. Unwanted immunogenicity is a hot topic today, partly
because it still isn’t completely understood.
There are many reasons the human body may have an im-
mune response to a biotherapeutic. Genetics can be a contribut-
ing factor, as a drug may not produce the same response in every-
body. Chemical modifications to the biologic, including antibody
drug conjugates may be seen as a non-self antigen by the body
and cause immunogenicity. Manufacturing can also contribute.
For example, if there is a small amount of aggregation (clump-
ing or binding) or if a protein folds differently than expected, the
body may identify it as a foreign substance.
Because biotherapeutic development becomes increasingly
How Can We Predict Immunogenicity
Earlier in Drug Discovery?
Scientists can make better-informed decisions and identify potential immune
responses earlier by giving virtual and real experiments equal weight in the
development of biotherapeutics.