We are proud to announce that ARDAT colleagues from work package 5 have published an important open access paper in Cell Reports Medicine on the regulatory requirements for assessment of immunogenicity and the implementation of immunomodulation protocols for development of advanced therapy medicinal products (ATMPs), in particular gene therapy. This paper completes one of the key regulatory deliverables of the ARDAT project and represents an important nexus of discussion and experience sharing between industry and academic partners. In brief, the paper summarises all the key global regulatory guidance documents that are directly and indirectly related to assessment of immunogenicity and immunomodulation. These are broken down into key areas to identify where such issues are covered and where future guidance may address specific issues. This is considered important given the growing diversity or therapeutic technologies and mechanisms of action. The paper can be accessed via the link.
