Statistical Methodology for Qualification of a Non-Clinical Risk Assessment Peptide:T Cell Proliferation Assay to Support Decision Making
Sophie Tourdot, Zhiping You, Andrew Ciarla, Rachel Hindin, Benjamin Keenan, Jennifer Calderini, Shea Van den Broek, Christopher S. Lepsy, Timothy Paul Hickling, Gregory S. Steeno
The paper develops a statistical framework to validate a T cell proliferation assay for immunogenicity risk assessment in biologics development.
bioRxiv · Jun 8, 2026 · PreprintImmunology