GCLP-Qualified Functional Assays for Regulatory Confidence

Robust immune profiling beyond neutralization for clinical trials.

SeromYx developed and qualified a Systems Serology assay under WHO and GCLP standards to measure antibody-dependent functions in SARS-CoV-2 vaccine trials. The assay delivers precise, specific, and sensitive measurement of Fc effector activities (ADCP, ADCD, ADNKA), supporting secondary endpoints in Phase 3 studies and regulatory filings. This validated platform is adaptable for diverse vaccine programs requiring advanced immune monitoring.

• Ensures reproducible, regulatory-grade immune data across cohorts
• Measures extra-neutralizing Fc functions linked to protection
• Scalable qualification framework for broad vaccine applications
  

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