Immunogenicity of rDNA-derived pharmaceuticals.

Many biopharmaceuticals have been reported to induce the production of antibodies. Several factors influence immunogenicity, including the methods of production, formulation and storage as well as patient characteristics (e.g. type of disease and genetic background). Because immunogenicity is unpredictable, testing for antibodies should always be part of the evaluation of new biopharmaceuticals, although the biological consequences of these antibodies are rarely severe.