Scientific Expertise

Aug 31

P030: Development of a qPCR Assay for HHV-7 Monitoring

Presented By Manisha Diaz

A global pharmaceutical company conducted a European Phase I/IIa clinical study using a flow cytometry-based receptor occupancy (RO) assay to assess drug binding to target cells. The study required assay validation, monitoring, and timely sample analysis. QA-audited data were needed after each cohort for dose escalation decisions.

Eurofins Bioanalytical Services developed a Fit-for-Purpose validation assay for analyzing frozen PBMC samples in a clinical study assessing an intradermal peptide vaccine with checkpoint inhibitors in advanced solid tumor patients. They identified and quantified activated WT1-restricted CD8+ cytotoxic T lymphocytes using immuno-phenotyping and MHC tetramer reagents, and generated CTLs as process QCs for method qualification and sample analysis.