Flow cytometry case studies (Eurofins Bioanalytical Services)

29 Apr 2019

Clinical

A clinical sample receptor occupancy assay using flow cytometry
A global pharmaceutical company was conducting a European multi-site Phase I/IIa clinical study across several countries. One of the endpoints was assessment of changes in the amount of therapeutic drug bound to the target cell populations. Clinical protocol required assessment of changes from baseline; to allow correlation with the PK/PD endpoints. The project used a flow cytometry based receptor occupancy (RO) assay.

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Method transfer and optimization of a flow cytometry method following best practice in a regulated environment
A global pharmaceutical company contracted Eurofins Pharma Bioanalytical Services (EPBS) to develop and then apply a fit-for-purpose validation assay utilizing frozen PBMC samples. This was to facilitate analysis of PBMC samples prepared at the clinical sites and shipped to EPBS for the analysis. The clinical study objectives were to determine the safety, tolerability, and recommended intradermal peptide vaccine in a combination therapy regimen with checkpoint inhibitors atezolizumab (anti-PD-L1 monoclonal antibody), or nivolumab (anti-PD-1 monoclonal antibody), in adult subjects with advanced solid tumors. The project required EPBS to identify and quantitate the phenotype and extent of activation in treated PBMC samples. The primary cells of interest within the PBMC samples were the WT1-restricted CD8+ cytotoxic T lymphocytes (CTL). Using a multi-parameter immuno-phenotyping panel and MHCrestricted tetramer reagents of activation state, a number of different HLA-A haplotype CD8+ T cells of varying MHC could be identified. In addition to the identification/ quantitation, EPBS was also asked to generate WT1-restricted CD8+ CTL, using clientprovided vaccine peptides to serve as Process QCs for both method qualification assays and sample analysis QCs.