Agilex Biolabs, Australia’s largest and longest-standing bioanalytical laboratory, established its first satellite processing unit on the fifth floor of the CMAX Clinical Research facility in Adelaide.
It is Australia's first bioanalytical laboratory inside a Phase 1 clinical unit.
Agilex said the satellite laboratory will perform time-sensitive sample processing techniques in the same building as clinical trial participants, opening the door for sponsors to reduce risk in their studies by truncating the decline of sample integrity.
Peripheral blood mononuclear cells (PBMCs) include several cell types involved in immune response, such as T cells, B cells, and NK (natural killer) cells. Quantitation by bioanalysis of PBMCs is often a critical piece in assessing the impact of a drug on the immune system.
Immediate processing of blood samples to isolate and prepare these cells for bioanalysis maximises the integrity of bioanalytical data.
“Even when the processing lab is only a few kilometres from the clinical site, risk accumulates every minute,” said the CEO of CMAX, Jane Kelly. “In partnership with Agilex, we are adding speed and reducing risk for new drug sponsors with CMAX clinical trials.”
At CMAX, a blood sample will now go from patient to processing at the specialized laboratory unit in about 15 minutes.
Following onsite processing, samples are shipped to the nearby Agilex Biolabs headquarters also located in Adelaide.
“This is a huge win for clinical trials in Australia,” said Agilex chief scientific officer, Kurt Sales. “Until now, time-critical whole blood stimulation or PBMC processing had to occur at off-site processing units in Adelaide. A clinical research facility with onsite processing capabilities presents an opportunity to achieve faster turnaround of sample processing and more reliable results.”