The human body naturally invokes an immune response when exposed to foreign proteins. However carefully designed and constructed, protein therapeutics may be seen as foreign proteins causing the host to produce antibodies that bind to the therapeutic. Such a response may, at best, reduce the efficacy of treatment and, at worst, lead to the build up a life-threatening immune reaction.

Measuring the antibody response to treatment is now a regulatory requirement during the development of protein therapeutics and post-marketing surveillance of immunogenicity of protein therapeutics is an FDA requirement.

Biacore systems offer a unique detection and characterization of immune response in serum samples, providing information on isotype, specificity, kinetic profiles and affinity (pharmacodynamics).

Recent results show that detection by a Biacore system is the only way to reliably detect low affinity antibodies.

Similar immunogenicity studies can be performed during vaccine/ immunotherapeutic development, measuring antibody levels in serum. Of course, in these studies the build-up of a strong antibody response mechanism is desired.

Immunogenicity studies during preclinical and clinical development are subject to the stringent regulatory requirements required when working in GLP/GCP/GMP environments. Both Biacore T100 and Biacore A100  fulfill these requirements