Assay Development, Qualification, and Validation: Supporting Vaccine Trials with Robust Functional Antibody Testing
June 12, 2022
Summary:
As the therapeutic antibody landscape evolves, the ability to accurately measure extra-neutralizing functions, such as ADCC, ADCP, and complement activation, has become critical for candidate selection, MOA characterization, and regulatory submissions. This case study from SeromYx outlines the formal development and GCLP qualification of a SARS-CoV-2–specific functional assay, offering a model for how Systems Serology assays can be adapted and validated to meet the rigorous demands of late-stage development.
Learn how thoughtful assay design, systematic optimization, and formal qualification can yield highly reproducible, regulatory-ready assays to support your antibody therapeutic pipeline, from IND through BLA.
Authors: Stefanutti E, Ramani R, Whitener B, Dang H, Bélanger S, Somasundaram L, Cortina K, De Marco A, Tam T, Chai Q, Cameroni E, Gupta R, Schmid MA, Miller JL, Zumsteg AB, Purcell LA, Drewry LL. 0. Analysis of Fc-dependent effector functions of anti-malaria circumsporozoite protein antibodies. Microbiol Spectr 0:e00863-25. Journal: Microbiology Spectrum
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Woburn, MA / Newark, DE – October 1st, 2024 - SeromYx Systems, a cutting-edge immunology technology company, and ACROBiosystems, a leading provider for life science solutions and tools, are excited to announce the release of their joint study on the...
