Immunogenic Response

Biological agents are structurally immunogenic, and therefore usually elicit a minor, subclinical and transient response. Occasionally, however, these biologics induce complete cellular and humoral immune responses, with main clinical consequences being hypersensitivity reactions or loss of treatment response. Integrating immunogenicity information and therapeutic monitoring is important to guide therapeutic decisions in clinical practice.

Factors that influence immunogenicity of biologics are presented. Product related factors include Source (Origin), Structure, Impurity, Formulation, Manufacturing process, Storage condition Patient related factors include Dosing factor (dose, frequency, route), Heredity Epoetin and interferon, two clinical products are used to illustrate the predominant role of origin in immunogenicity