Assessment of immunogenicity is a major aspect in evaluating the safety of biological
therapeutic proteins. It is important to evaluate the immunogenic potential of the
biologics in an appropriate fashion using clearly defined strategy and clinical trials.
The studies must include the appropriate risk assessment procedures using validated
methods. The immune responses against the therapeutic biologics can be studied using
various methodologies. These include enzyme linked immunoassays (ELISA), surface plasmon
resonance (SPR), chemiluminescence, and flowcytometry assays for binding antibodies
and cell based assays for neutralizing antibodies. The immune responses to the biologics
can widely vary in various cross section of the population, thus a combination of
techniques are necessary to fully evaluate the immunogenic potential of the biologics.
This review outlines various commonly used technology platforms, its merits and shortcomings
for the evaluation of the immune responses.