ABOUT US
Pioneering Bioanalytical Excellence
Agilex Biolabs is Australia’s most advanced regulated bioanalytical laboratory, serving global biotechnology and pharmaceutical companies with exceptional scientific support for preclinical and clinical trials. With a legacy spanning more than 30 years, we are recognized internationally for our precision, responsiveness, and dedication to excellence in bioanalysis.
ABOUT US
Our Mission
To accelerate the development of safe and effective medicines by delivering trusted, scientifically rigorous bioanalytical and services.
We pride ourselves on achieving quality results, every time, for every project.
RAPID ACCURATE RESULTS
The Agilex Difference
At Agilex, we believe in a science-first approach to streamline your bioanalytical studies. This results in direct cost savings to our clients, while maintaining excellence and regulatory acceptance.
Our Team
Agilex Biolabs is powered by a multidisciplinary team of over 150 highly trained professionals—scientists, analysts, study directors, and regulatory experts—committed to scientific excellence and client success. Our leadership combines global industry experience with a passion for innovation and quality.
Global Reach with a Local Foundation
While headquartered in Australia, Agilex Biolabs supports studies across North America, Europe, and Asia-Pacific. Our reputation for proactive communication, flexible service models, and fast turnaround makes us trusted partners for sponsors pursuing novel therapeutics and biosimilars alike.
OUR HISTORY
High-Quality Bioanalytical Support
Founded in the late 1990s, Agilex Biolabs was established to fill a critical need in Australia for high-quality bioanalytical support in clinical research. Starting as a modest analytical laboratory in Adelaide, the company rapidly gained recognition for its scientific expertise and regulatory compliance.
From its early days, Agilex invested heavily in liquid chromatography–mass spectrometry (LC-MS/MS) technologies. This foundational commitment to advanced instrumentation set the stage for its emergence as a premier provider of bioanalytical services across therapeutic areas, including oncology, neurology, infectious disease, and metabolic disorders.
As the demand for biologics and targeted therapies grew, Agilex expanded into ligand-binding assays and immunoassays. The laboratory adopted new technologies including ELISA, MSD, Gyrolab. Over the following years, Agilex Immunoassay and Immunobiology divisions grew quickly, recruiting international talent with large CRO experience. With the additions of PCR and flow cytometry service lines, biotechs can now partner with Agilex for a broad range of soluble, molecular and cellular biomarkers.
OUR HISTORY
Key Milestones in Agilex’s Journey
Key expansions in our bioanalytical capabilities have included:
- 2000s: Establishment of GLP and GCP-compliant LC-MS/MS services
- 2010s: Addition of immunoassay platforms to support large molecule analysis
- 2019: Major facility expansion and automation upgrades for high-throughput capacity
- 2020–2022: Onboarding of cutting-edge ultra-sensitive detection platforms and method validations for biosimilars and gene therapy trials
- 2025: The opening of Agilex Brisbane Bioanalytical lab, which further expanded Agilex’s flow cytometry and PBMC isolation capabilities to another major Australian city.
Agilex Biolabs now supports full PK, immunogenicity, biomarker, and pharmacodynamic assessments, enabling data-driven decision-making from first-in-human studies to late-phase trials.
SERVICE GROWTH
Expansion of Flow Cytometry to Brisbane
In 2025, Agilex Biolabs expanded its bioanalytical services with the launch of a new state-of-the-art flow cytometry laboratory in central Brisbane. The facility is equipped with two Cytek Aurora instruments enabling advanced immune profiling and biomarker analysis to support increasingly complex clinical trial demands.
Strategically co-located wit Nucleous Network, Australia’s largest Phase 1 clinical trial unit provider, the lab offers a unique advantage – sample transfer times of mere minutes. This proximity streamlines workflows, reduces variability, and ensures high-quality data generation at speed, a critical factor in early-phase trials.
Flow Cytometry plays a vital role in oncology, immunology, and cell and gene therapy research, and this expansion significantly enhances Agilex’s ability to deliver regulatory-compliant data, rapid turn-around, and scientific insight for global biotech and pharmaceutical clients. The new Brisbane facility further cements Agilex’s commitment to innovation and strengthens Australia’s reputation as a premier destination for clinical research.
