Assay Development, Qualification, and Validation: Supporting Vaccine Trials with Robust Functional Antibody Testing
June 12, 2025
Summary: To advance SARS-CoV-2 vaccine development, SeromYx developed and GCLP-qualified a Systems Serology assay capable of reliably measuring extra-neutralizing antibody functions. This rigorously validated assay supports late-stage clinical trials and regulatory filings by expanding immune response assessment beyond neutralizing titers alone.
The World Vaccine Congress Europe 2025
Festival of Biologics
The Fc-Mediated Effector Function Summit
Authors: Atyeo et al. Immunity (2020)
Authors: Kaplonek P, et al. Sci Transl Med. 2022 May 18;14(645):eabm2311.
Authors: Hawman, David W. et al. eBioMedicine, Volume 115, 105698
Authors: P. Hsueh, M. Friedman, S. Jatiani (2024) Application Note
