Agilex Biolabs Pty Ltd

Agilex Biolabs is Australia’s regulated bioanalytical and toxicology CRO offering both large and small molecule development with extensive cell & gene therapy capabilities and expertise. For over 25 years, we are recognised for our scale and proven track record for large and small molecule bioanalysis, including quality method development, method validation and sample analysis services. Our world-class immunoassay and immunobiology laboratories feature state-of-the-art equipment, including Gyrolab xPlore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and the digital droplet quantitative real-time analysis for RNA, siRNA, and miRNA clinical trials, including vaccines and gene therapy trials. Furthermore, Agilex Biolabs has ISO/IEC17025 accreditation and OECD GLP recognition with NATA to ensure the highest quality standards are met for seamless end to end testing for pre-clinical to clinical analysis. Agilex Biolabs also offers a range of toxicology services to support preclinical through to early/late-phase clinical programs through TetraQ, an established GLP facility located in Brisbane, Australia. These services include exploratory toxicology and pharmacokinetics studies, and GLP toxicology services. We have expertise with all types of molecules, laboratory species, routes of administration, and non-clinical studies. Being at the forefront of regulated bioanalysis, Agilex has invested heavily in world-class customised equipment and is continuing to push the boundaries by investment in new infrastructure, and identification of new ways to automate and streamline data acquisition through to reporting to support scientific and regulatory excellence and maintain its position as the leading bioanalytical laboratory within the Asia Pacific Region.