Agilex Biolabs, Australia’s largest and most technologically advanced specialist bioanalytical laboratory for clinical trials announced for BIO Korea 2021 that their upgraded and expanded biolabs at the Australian headquarters is now complete.
The labs have been expanded by 30% to cater for increased demand for bioanalysis and biomarkers in clinical studies from clinical stage biotechs.
In addition, Agilex Biolabs has acquired TetraQ’s toxicology facility from University of Queensland (UQ) in Brisbane so biotechs with first-in-human studies can now leverage significant quality, speed and cost advantages for their pre-clinical research in Australia.
TetraQ is a NATA-accredited, GLP-recognised rodent toxicology facility.
Clinical research costs in both labs can be offset by 43.5% with the attractive Australian Government clinical research incentive rebate for USA, Asia and European companies.
Agilex Biolabs CEO, Jason Valentine said:
“Australia offers many regulatory and cost advantages, and Australian clinical data is accepted by the FDA and other major authorities.
Our labs offer the full range of services for biotechs from toxicology through to Phase II and even Phase III clinical studies.
TetraQ’s non-GLP toxicology study results can be used to support the design of both key efficacy studies and formal GLP toxicology studies in rodents. Formal GLP toxicity studies can in turn support first-in-human studies.”
Agilex Biolabs has more than 130 staff which includes 85 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.
Agilex Biolabs’ world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and soon to be released, digital droplet quantitative real-time RT-PCR.
The company offers services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.
Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.
About Agilex Biolabs https://www.agilexbiolabs.com/
Agilex Biolabs, Australia’s leading bioanalytical and toxicology laboratory, has more than 24 years’ experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. It has successfully supported hundreds of preclinical and clinical trials from around the world where customers choose Australia for the streamlined regulatory process and access to the world’s most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.
Agilex Biolabs has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.
The company has recently acquired TetraQ biolabs and toxicology, and also expanded its main labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the New Labs Walkthrough Video Here https://www.agilexbiolabs.com/new-labs-video
Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).
Agilex offers pharmacodynamics servicesthat include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
- Receptor occupancy
- Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling
- PBMC assays and cellular mechanism of action assays