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The term Immune system – immunogenic interaction refers to a broad physiological process rather than a specific molecular entity like a receptor or enzyme. It describes the complex cascade of events triggered when the host immune system recognizes a therapeutic agent—such as a vaccine, monoclonal antibody, or recombinant protein—as foreign (FDA, 2019). This interaction involves multiple components of the immune system, including antigen-presenting cells, T-lymphocytes, and B-lymphocytes, which work together to mount an immune response (Janeway et al., 2001). In the context of vaccinology, this interaction is the intended mechanism to confer long-term immunity against pathogens. However, for many biopharmaceuticals, immunogenicity is an unintended side effect that can lead to the formation of anti-drug antibodies, potentially neutralizing the drug's therapeutic effect or causing adverse hypersensitivity reactions (EMA, 2017). Because it represents a systemic biological outcome rather than a single drug-binding site, it is often categorized in pharmacological databases as a non-discrete target. Understanding these interactions is vital for the design of safer biologics and the development of effective immunization strategies.
Induction of a systemic immune response through the activation of innate and adaptive immune pathways, including T-cell and B-cell stimulation.
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