Agilex Biolabs, Australia’s largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, said biotechs with first-in-human studies can leverage significant quality, speed and cost advantages working with their company TetraQ toxicology for pre-clinical research in Australia.
TetraQ is a NATA-accredited, GLP-recognised rodent toxicology facility.
The TetraQ toxicology team, whose recent COVID-19 vaccine work is featured in PubMed, is one of the most experienced in the region with more than 15 years of success with biotechs and university researchers. In addition, research costs can be offset by 43.5% with the attractive Australian Government clinical research incentive rebate for USA, Asia and European companies.
Agilex Biolabs works closely with Australia’s leading biotech R&D tax rebate specialist, Bentleys R&D Services, to ensure clients are aware of the R&D benefits.
Bentleys’ Managing Director Mike Burfield said the attractive 43.5% R&D rebate on clinical research spend can be applicable for the entire toxicology program.
“The rebate covers rodent toxicology services at TetraQ, while second species toxicology research conducted overseas can also be potentially eligible depending on the company, saving considerable costs in the pre-clinical stage.
Each year we have hundreds of biotech companies from around the world benefiting from this significant refund system operated by The Australian Government to attract clinical research.
However, it is vital that biotechs take advice prior to starting research, and that company documentation is prepared correctly from the start to take full advantage of these savings during the toxicology program, through to phase I and beyond.”
TetraQ toxicology, which was acquired by Agilex Biolabs earlier this year, started in 2005 based out of the University of Queensland and has since earned a strong global reputation for excellence in GLP rodent pre-clinical safety studies.
Agilex Biolabs CEO, Jason Valentine said:
“Biotech clients are discovering the considerable speed and cost advantages of using an Australian-based toxicology facility like TetraQ.”
The 43.5% rebate on toxicology costs is a major benefit, but clients are also keen to then leverage the easy and rapid transition to first-in-human trials available in Australia. Australia is known as the ideal early-phase destination because of the many regulatory and cost advantages – and most importantly that clinical data is accepted by the FDA and other major authorities.
TetraQ’s NATA-accredited, GLP-recognised rodent toxicology facility is highly regarded for its personalized service, rapid response, and innovative solutions for biotechs planning their first-in-human studies.”
TetraQ 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. GLP studies employ a test item manufactured under Good Manufacturing Practice (GMP) and a study design informed by non-GLP exploratory toxicity studies as well as the intended clinical use. GLP studies are subject to Quality Assurance (QA) audit, as their results are intended to facilitate the safe design of clinical studies.
The study management and data collection processes are supported by an FDA 21 CFR Part 11-compliant Provantis software system. Furthermore interim and final report preparation is also facilitated by this centralized data collection system to allow rapid delivery of written reports to clients.
Agilex Biolabs has more than 120 staff which includes 85 dedicated laboratory staff and supports client pharma and biotech companies from the 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 utilizing 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.
Book a confidential briefing with our scientists before you start your next clinical trial.
Agilex Biolabs, Australia’s leading bioanalytical and toxicology laboratory, has more than 24 years of 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 lab video walkthrough here.
Agilex Biolabs specializes in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilizing LC-MS/MS, immunoassay (Mesoscale, Gyrolab, Luminex) and flows cytometry (BD FACSymphony A3, 20 color cell analyzer).
Agilex offers pharmacodynamics services that 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