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Immunogenicity Concerns

Meaning

Immunogenicity Concerns refer to the potential clinical risk that a therapeutic substance, particularly a protein-based drug or a peptide hormone replacement, will be recognized by the recipient’s immune system as foreign, thereby eliciting an undesirable and unintended immune response. This response can range from mild local reactions to severe systemic hypersensitivity or, more commonly, the generation of neutralizing antibodies. These antibodies can bind to and inactivate the therapeutic agent, significantly reducing its clinical efficacy and potentially cross-reacting with the patient’s own endogenous hormones.