ASPHALION is proud to be a partner in the ARDAT consortium, led by Pfizer and the University of Sheffield, and supported by Europe’s Innovative Medicines Initiative (IMI), which is jointly funded by the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The ARDAT consortium aims to help standardise and accelerate development of ATMPs, allowing potentially transformative treatments to reach patients sooner.
As part of its ongoing work in the ARDAT consortium, ASPHALION has contributed to a Regulatory Perspective published in the “Cell Reports Medicine” journal.
This review analyzes the global regulatory landscape for assessing immunogenicity and immunomodulation in gene therapy medicinal products (GTMPs). It compares international guidelines from major regulatory agencies, identifies areas of alignment and inconsistency, and highlights significant gaps—particularly the lack of GTMP-specific guidance. The authors propose opportunities for regulatory harmonization and outline key topics that future guidance should address, including pre-existing immunity, immunosuppressive strategies, bioanalytical methods, pediatric considerations, and long-term safety monitoring, with the goal of improving and accelerating the global development of gene therapies.
You can read the complete article, written by experts from the ARDAT consortium and with the collaboration of Asphalion experts Chris Mann, Núria Coderch, and Jon Giblin, here: Current regulatory requirements for assessment of immunogenicity for gene therapy medicinal products
Further information about ARDAT: https://ardat.org/
In case you need further information, you can also contact us at: [email protected]
