What is immunogenicity and how does it pertain to biopharmaceuticals?
Immunogenicity is the ability of an antigen (such as a protein) to induce an immune response resulting in the formation of antibodies. Immunogenicity to a biopharmaceutical results from the body’s recognition of therapeutic proteins as foreign to its immune system.25 This recognition incites a protective immune response consisting of cellular and molecular components that will not only attempt to destroy and eliminate the antigen, but also commit to memory the antigenic epitopes to prepare itself for future exposure to the same foreign antigen.