Refreshing the immunogenicity testing paradigm: Reflecting on the past, addressing the needs of the present and building towards a sustainable future

About the Article Collection

After over 20 years’ of implementing the current 3-tiered immunogenicity testing paradigm, we have collected adequate data to allow for an informed review of our approaches and take a science-driven approach to revise accordingly. This dedicated series will explore the scientific landscape and assumptions that led to the current testing paradigm and reflect on lessons learned – what works, what doesn’t and provide new thinking and approaches that will allow us to best identify and characterize clinically relevant immunogenicity for both traditional and newer, novel molecules/modalities.

This requires us to develop a scientific framework that possesses both rigor and flexibility. We are in a time of change – our portfolios are filled with ever more complex molecules, yet many organizations across both industry and regulatory bodies are functioning with evolving priorities and resources. It is imperative that we focus on value-added efforts with clinical relevance front of mind.

It is time to collectively evaluate approaches and consider which methodologies best serve the needs of our programs and patients. We must mindfully navigate these waters through collaborative dialogue between drug developers and regulators to ensure scientifically sound and patient-focused immunogenicity assessment strategies.

We are delighted to be working alongside Guest Adviser Lauren Stevenson to bring you this Article Collection. We invite contributions from both industry and regulatory perspectives that offer strategies and technical solutions that will help move our science forward. We welcome a variety of submission formats including:

Together, these contributions will help build the future state of immunogenicity testing through balanced input from all stakeholders involved in ensuring patient safety and product efficacy.

The benefit of publishing as part of an Article Collection is that they often become a key resource, driving a research community forward. This has a synergistic effect on every article in the Collection. The articles often receive more views and higher citation numbers as the Collections receive increased promotion via social media and our marketing team.

If you are interested in contributing, or would like to learn more, then please reach out to the Commissioning Editor, George Leung, who will be happy to assist.