-First satellite bioanalytical laboratory offers fastest option for PBMC processing in Australian clinical trials
THEBARTON, Australia, Oct. 26, 2022 /PRNewswire/ -- On September 9, 2022, Australia hosted its first bioanalytical laboratory within a Phase 1 clinical unit.
Agilex Biolabs, Australia's largest bioanalytical laboratory, has established its first satellite processing unit on the fifth floor of the CMAX Clinical Research facility in Adelaide, SA.
Agilex's satellite laboratory will perform time-sensitive sample processing techniques in the same building as clinical trial participants, opening the door for drug sponsors to reduce risk in their studies by truncating the decline in the integrity of the samples.
Peripheral blood mononuclear cells (PBMCs) include several distinctive cell types that are involved in the immune response, such as T cells, B cells, and NK (natural killer) cells. The quantification of PBMC is often a fundamental piece to assess the impact of a drug on the immune system.
Immediate processing of blood samples to isolate and prepare these cells for bioanalysis maximizes the integrity of bioanalytical data.
"Even when the processing lab is just a few miles from the clinical center, the risk adds up by the minute," said CMAX CEO 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 now moves from the patient to processing in the specialized laboratory unit in about 15 minutes.
After processing on-site, the samples are quickly shipped to the nearby Agilex Biolabs headquarters, also located in Adelaide. With its rapid response sample analysis equipment, Agilex provides reliable quantitative data in just days from sample collection at the CMAX.
"This is a huge win for clinical trials in Australia," said Agilex Chief Scientific Officer Kurt Sales. "Until now, whole blood stimulation or time-critical processing of PBMCs had to be performed in external processing units in Adelaide. A clinical research center with on-site processing capacity represents an opportunity to achieve greater faster sample processing and more reliable results."
Agilex Biolabs is Australia's largest and most advanced regulated bioanalysis and toxicology laboratory, providing credible and defensible data to biotech and pharmaceutical companies around the world in support of their drug development programs.
CMAX Clinical Research has been a leader in conducting early phase clinical trials for over 28 years, making it one of Australia's most respected clinical trial companies. CMAX's modern facilities are equipped with 78 inpatient beds and have easy access to state-of-the-art facilities and equipment, as well as world-class medical and pharmacological specialists.
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