Basic Info

Agilex Biolabs is Australia’s largest and FDA-inspected bioanalytical laboratory, with nearly 30 years of experience supporting global pharmaceutical and biotechnology programs. Across our laboratories in Adelaide, Brisbane and Sydney, we provide regulated bioanalytical services spanning LC-MS/MS, immunoassays, flow cytometry, cell-based assays, biomarker testing, PBMC processing and molecular biology.

Our facilities feature advanced technologies including Sciex Triple Quad 7500+, MSD Quickplex 120, Cytek Aurora, BD FACSymphony A3 and digital PCR platforms. Agilex holds ISO/IEC 17025 accreditation, OECD GLP recognition with NATA, and ISO 27001:2022 certification for information security.

With Australia’s largest dedicated bioanalytical team, Agilex partners with sponsors across the US, EU and APAC to deliver flexible, high-quality solutions that accelerate clinical development timelines. Connect with our team at BIO 2026 to explore how Australia can support your next program.

Why work with us

Agilex Biolabs combines scientific expertise, regulatory quality and operational flexibility to help sponsors accelerate clinical development with confidence. As Australia’s largest and FDA-inspected bioanalytical laboratory, we support more than 110 projects annually for biotechnology and pharmaceutical companies across the US, EU and APAC.

With laboratories in Adelaide, Brisbane and Sydney, Agilex delivers rapid sample processing and fast data turnaround throughout the life of a trial, helping sponsors maintain study momentum and make timely development decisions. Our team has validated more than 1,000 assays across a broad range of therapeutic areas and modalities, supported by advanced LC-MS/MS, immunoassay, flow cytometry and molecular biology capabilities.

Sponsors choose Agilex for our collaborative approach, proven quality systems and consistent delivery, reflected in a 9.6/10 service rating and an 85% repeat client rate.

Brochure

Company focus

Services

Focus

Bioanalytical Services

Clinical/ Specialist CRO Services

Innovation Specialisation

mRNA

Protein

Regenerative Medicine

Small Molecule

Projects or Case studies (4)

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Characterization of an Ultrasensitive MSD S-Plex Neuroscience Panel to Measure NFL, Tau and GFAP in Healthy and ALS Matrix

Neurological disorders are a leading cause of morbidity and mortality globally. Due to this, many neurological drug discovery programs (DDP) now include assessment of relevant CSF biomarkers for patient screening, diagnosis, stratification, and drug product efficacy to improve patient outcomes. While CSF sampling provides valuable insights into the CNS, the invasiveness of the procedure presents a challenge for patients. Recent advancements in ultrasensitive assay platforms allowed detection of minute (≤ fg/mL) levels of neurological biomarkers in complex matrices. This offers a potential avenue for the use of serum as the chosen assay matrix. Neurological disorders, such as Amyotrophic Lateral Sclerosis, Alzheimer’s and Parkinson's disease have been characterised by dysregulated expression of key biomarkers, including NFL, Tau, and GFAP. Here, we focused on the detection of these biomarkers in healthy and disease state CSF and serum samples utilising the MSD S-Plex platform.

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DEVELOPMENT OF HIGHLY DRUG TOLERANT AND TARGET TOLERANT IMMUNOGENICITY ASSAYS

Immunogenicity assessment is a critical safety attribute for biotherapeutics undergoing clinical development. As such, it is a regulatory requirement that anti-drug antibodies (ADA) are assessed throughout the product lifecycle (1). As novel modalities are being investigated, it has become common practice for clinical studies to include the use of high dosing regimens. Generally, this has been overcome using appropriately designed sampling timepoints within the study. However, where this is not possible, development of an ADA assay with high drug tolerance is needed (2). In addition, drug target can further confound the development process (3). Therefore, a holistic approach must be taken to balance drug and target tolerance within method development. Here we discuss three different approaches that have been utilised during the development of an ADA assay to achieve the required level of drug and target tolerance.

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GLP-fully validated PK assay for the determination of five cannabinoids in human plasma by LCMS-MS.

The presented assay was developed and fully validated for the purpose of pharmacokinetic analysis in a medicinal cannabis clinical trial. The assay is GLP/GCLP compliant for use in clinical trials for regulatory submission (FDA/EMA).

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Precision of T cell proliferation activation marker expression analysis in cultured PBMCs using flow cytometry

Flow cytometry is increasingly being used to support clinical trials, however little is understood regarding the influence cell culture has on precision, particularly when using cell permeable dyes for proliferation analysis. Here we determined the between operator and day % Coefficient of Variation (%CV) for flow cytometric analysis of proliferation and activation marker expression on T HELPER (CD4), T CYTOTOXIC (CD8) and mature (CD45RO) CD4 and CD8 populations.

Contacts

Amilia Wee

Senior Business Development Director

Ricky Matias

Senior Business Development Director