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Poster

Method qualification for the preparation of PBMC cells from human blood with a view to evaluate safety, tolerability, dosimetry and preliminary activity of radioligands on cancer patients

September 2, 2024
DMDG Open 2024 -- Peripheral blood mononuclear cell (PBMC) isolation is a widely used technique within clinical analysis. Their isolation leads to a host of downstream applications, including measurement of biomarkers and measurement of the immune response to a given treatment. Preparation of human PBMC cells from blood samples containing radioligands are required to support multisite clinical trials (a Phase I, open-label, multi-centre study). This study involved collaboration across both our US and UK sites and the qualification of the human PBMC method was adapted from that used at the Labcorp Madison facility to isolate animal PBMCs. The ultimate aim of this study was to demonstrate method robustness and produce the required yield of PBMC cells to support subsequent clinical analysis by ensuring reproducibility of the method and enabling any modifications to account differences of equipment between sites. Furthermore, the US team also investigated the effects of processing at set times post-blood draw to simulate the effects of the shipping process from multiple sites and the effects this had on PBMC yield.