Immunogenicity is defined as the ability of an antigen to induce an immune response, the antigen being identified as the immunogen. In general, the T-cell response drives the immunogenic reaction which can be transient without clinical significance or lead to adverse effects and maybe life threatening. The hallmarks of an immunogenic response are the production of anti-drug antibodies (ADAs) and/or the triggering of the production of proinflammatory cytokines. After the parenteral administration of a biological molecule, systemic exposure occurs and the molecule might be up taken and processed by antigen-presenting cells (APC). Foreign antigens are presented to CD4+ cells and the interaction MHCII/TCR leads to the activation and proliferation of the T-cells involving also a complex network of cytokines. The activated T-Cells in turn interact with B-Cells triggering their activation and differentiation into plasma cells that produce the antibodies specific to the antigen.

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