BioAgilytix Expands Global Bioanalytical Capabilities Through New 360biolabs Sydney Laboratory

Expansion strengthens 360biolabs' Australian laboratories and supports early-phase clinical development with continuity into global programs.

DURHAM, NC, UNITED STATES, October 26, 2026 /EINPresswire.com/ -- BioAgilytix, a global bioanalytical Contract Research Organization (CRO), announces the expansion of its Australian laboratories through the opening of a new purpose-designed facility for 360biolabs, a BioAgilytix company, in Sydney, Australia.

Located within the Macquarie Park Innovation District, the new laboratory strengthens 360biolabs' established Australian bioanalytical footprint providing a permanent presence in one of New South Wales' established science, health and technology precincts. The location places 360biolabs close to clinical research sites, hospitals and research institutions, supporting collaboration and timely processing of clinical trial samples.

“Australia is a primary destination for early-phase clinical research, supported by a streamlined regulatory pathway, rapid study start-up timelines, globally accepted data and quality standards, and an R&D tax incentive for eligible sponsors,” said Davide Molho, CEO of BioAgilytix. “The new Sydney laboratory expands BioAgilytix’s Australian footprint through 360biolabs, alongside Melbourne and Brisbane, and strengthens our ability to support sponsors as their programs advance across global regions.”

Designed for time-sensitive clinical samples and complex early-phase studies, the BSL-2 facility supports PBMC isolation and flow cytometry. It also includes dedicated sample reception and storage areas, ultra-low-temperature freezer capacity, vapor-phase nitrogen cryostorage and continuous temperature monitoring.

The Sydney team brings assay development and validation expertise, supported by 360biolabs’ broader scientific network. Shared procedures, instrumentation and quality systems support assay transfer and continuity from development through clinical sample analysis and later-stage global programs.

Through shared scientific leadership, procedures and quality systems, assays developed at 360biolabs can be transferred across BioAgilytix’s laboratories in Australia, Europe and the United States. This supports continuity from first-in-human studies through later-stage global programs, including integrated PK, immunogenicity and biomarker analysis.

“The Sydney laboratory marks an important milestone in the continued development of 360biolabs in Australia,” said Alistair Draffan, President of 360biolabs. “New South Wales has a strong and growing clinical research sector, and establishing a permanent presence in Sydney allows us to invest alongside that growth. It expands our ability to support clients locally, strengthens our national business, builds on our established partnerships and creates a stronger foundation for continued growth in the region.”

The Sydney facility has achieved accreditation from Australia’s National Association of Testing Authorities (NATA) to ISO/IEC 17025. Across its Australian operations, 360biolabs also holds NATA accreditation for Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP).

The Sydney expansion reinforces 360biolabs' commitment to supporting clinical research in Australia while strengthening BioAgilytix's ability to provide coordinated bioanalytical expertise across global drug development programs.

About BioAgilytix
BioAgilytix is a global bioanalytical laboratory partner supporting pharmaceutical and biotechnology companies throughout drug development. With laboratories in North America, Europe and Australia, BioAgilytix provides scientific and operational expertise across pharmacokinetics, immunogenicity, biomarkers, GMP testing and analytical services for complex clinical development programs. Over 1,100 employees are supporting projects from pre-clinical to post marketing.

About 360biolabs
360biolabs, a BioAgilytix company, is Australia's most comprehensive bioanalytical laboratory, supporting the development of therapeutics, vaccines and diagnostics.

With laboratory operations in Melbourne, Brisbane and Sydney, 360biolabs supports clinical studies across pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, biomarkers, vaccines, infectious diseases, flow cytometry, molecular biology and central laboratory services.

360biolabs is accredited by Australia's National Association of Testing Authorities (NATA) for compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP) and ISO/IEC 17025.

Noelle Brawner
BioAgilytix LLC
+1 202-674-6190