Integrated Summary of Immunogenicity (ISI) – an effective approach for reducing regulatory risk

Paul Chamberlain and Gabriele Dallmann summarise in the following the main aspects of the Integrated Summary of Immunogenicity as presented during a one-day workshop. 

All therapeutic proteins, even those that share a common structure sequence with endogenous human proteins, have an intrinsic potential to induce undesirable immunogenicity in human subjects. An exogenous medicinal product can cause an immune response, i.e. immunogenicity, involving: