First satellite bioanalytical lab offers fastest option for PBMC processing in Australian clinical trials

On 09 September 2022, Australia will welcome its first ever bioanalytical laboratory inside a Phase 1 clinical unit.

- Madison Esely-KohIman

Agilex Biolabs, the leading bioanalytical laboratory supporting Australian clinical trials, has established its first satellite processing unit staffed with highly specialised technicians on the fifth floor of the CMAX Clinical Research facility in Adelaide, SA. The Agilex satellite laboratory will perform time-sensitive sample processing techniques in the same building as clinical trial participants, opening the door for new drug sponsors to reduce risk in their studies by truncating the decline of sample integrity.

Peripheral blood mononuclear cells (PBMCs) include several hallmark cell types involved in immune response, such as T cells, B cells, and NK (natural killer) cells. The count of a certain blood cell type is often a critical piece in assessing the impact of a drug on the immune system. Similarly, cytokines released by immune cells can indicate level of immune response or unwarranted inflammatory response, such as cytokine storm.

As soon as a blood sample is drawn from a person’s body, that sample begins to deteriorate as blood cells are no longer resupplied with oxygen. When a clinical trial hinges on reliable count of PBMCs or cytokines, whole blood from the patient must be processed as quickly as possible to stop deterioration and ensure that quantitative analysis of the sample is an accurate reflection of the cells in the human they came from. The sooner a whole blood sample is treated, the less deterioration of cells has occurred and therefor sample integrity is higher.