EpiScreen® 2.0 Time Course Assay: A Sensitive & Data-Rich Tool For Pre-Clinical Immunogenicity Testing Of Biologic

By Mercedes Perez-Olivares, Beverley Campbell, Edward Cloake, Erika Kovacs, Rob Holgate, and Campbell Bunce.

Access our latest poster, presented at AAPS PharmSci360, titled “EpiScreen® 2.0 Time Course Assay: A Sensitive & Data-Rich Tool for Pre-Clinical Immunogenicity Testing of Biologics.” This study highlights the development and validation of EpiScreen® 2.0, a next-generation in vitro assay designed to provide a more comprehensive and predictive assessment of immunogenicity risk during early-stage biologic development.

The aim was to create a tool that maintains high sensitivity while also delivering detailed data on T-cell specificity and the potential mechanisms of immune activation. The result is a significantly enhanced assay that offers both depth and reliability — enabling developers to better understand immune responses to therapeutic candidates. By improving the granularity and interpretability of preclinical immunogenicity data, EpiScreen® 2.0 supports more confident lead selection and helps mitigate downstream clinical risks.

Starting with a robust immunogenicity assessment early in development is key to avoiding costly surprises later. EpiScreen® 2.0 empowers teams to make smarter, data-driven decisions — right from the start.