Thebarton /PRNewswire/ - On 09 September 2022, Australia welcomed its first bioanalytical laboratory inside 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.
The Agilex 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 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. Quantitation 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 maximizes 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 quickly to the nearby Agilex Biolabs headquarters also located in Adelaide. With their rapid-turnaround sample analysis team, Agilex provides reliable quantitative data within just a few days of sample collection at CMAX.
"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."
is Australia's largest and most technologically advanced regulated bioanalytical and toxicology laboratory, providing reliable and defendable data to biotech and pharmaceutical companies worldwide in support of their drug development programs.
CMAX Clinical Research
has been a leader in delivering early phase clinical trials for over 28 years, making it one of the most respected clinical trial businesses in Australia. CMAX's modern facility is equipped with 78 inpatient beds and has ready access to state-of-the-art facilities, equipment, and world-class medical and pharmacology specialists.