info@247compliance.com +1-(510)-868-1040

News: Biologics receive new tools from the FDA to stimulate the immune response

A new tool developed by the U.S. Food and Drug Administration (FDA), can now predict whether an immune response can be mounted on the body to prevent the activity of biological drugs. The dubbed TCPro simulates how biotherapeutics receive the response from biotherapeutics. It also tells if the body produces anti-drug antibodies.

The FDA writes, "TCPro can be used to assess the potential for antibody formation even before the laboratory testing on biotherapeutics that is routinely done to screen for this risk". The FDA has also said that it can be expensive and time-consuming to conduct traditional immunogenicity tests.