Biotherapeutics are known to have a greater potential for inducing immune response than conventional small molecule drugs. Consequences of this immune response include altered pharmacokinetics, loss of efficacy, crossreactivity and mild to severe clinical side effects. As a significant safety and efficacy problem, immunogenicity is a major concern for regulatory agencies. Current guidelines discuss the development of assays for the preclinical and clinical immunogenicity assessment of biotechnology-derived pharmaceuticals throughout all phases of the product development process.

Quality Assistance provides a range of analytical services in line with the assay strategy recommended for the assessment of immunogenicity, including assay validation following EMA, FDA, ICH guidelines and key papers.