BioAgilytix has opened a laboratory in Sydney through its Australian subsidiary, 360biolabs, expanding its capacity to process clinical trial samples and support early-phase drug development.
The facility is located in the Macquarie Park Innovation District, near clinical research sites, hospitals and research institutions. It adds a permanent Sydney presence to the company’s Australian operations in Melbourne and Brisbane.
The biosafety level 2 laboratory supports peripheral blood mononuclear cell isolation and flow cytometry. It was designed to handle time-sensitive clinical samples and complex early-phase studies.
The site includes dedicated areas for sample reception and storage, ultra-low-temperature freezers, vapor-phase nitrogen cryostorage and continuous temperature monitoring.
Its scientific team provides assay development and validation expertise, with support from 360biolabs’ wider network. Shared procedures, equipment and quality systems allow assays to move from development into clinical sample analysis.
BioAgilytix said assays developed at 360biolabs can also be transferred across its laboratories in Australia, Europe and the United States. The arrangement supports programs from first-in-human studies through later-stage international trials, including pharmacokinetic, immunogenicity and biomarker analysis.
Chief Executive Davide Molho said the Sydney site expands the company’s ability to support sponsors as their development programs advance across regions.
Alistair Draffan, president of 360biolabs, said establishing a permanent presence in Sydney would expand local client support and build on existing partnerships.
The laboratory has received accreditation from Australia’s National Association of Testing Authorities to ISO/IEC 17025. Across its Australian operations, 360biolabs also holds NATA accreditation for Good Laboratory Practice and Good Clinical Laboratory Practice, according to the announcement.