ADELAIDE, AUS, May 17, 2021 - (ACN Newswire) - 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 TetraQ toxicology for pre-clinical research in Australia. TetraQ, acquired by Agilex Biolabs earlier this year, 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 research, and has earned a strong global reputation for excellence in GLP rodent pre-clinical safety studies.
TetraQ research costs can be offset by 43.5% with an Australian Government clinical research incentive rebate for foreign companies. Agilex Biolabs works closely with leading biotech tax rebate specialist Bentleys R&D Services to ensure clients are aware of the R&D benefits. Bentleys MD Mike Burfield said the rebate 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. We have hundreds of biotech companies benefiting from the refund system, but it's vital they take advice prior to starting research in order to take full advantage of these savings."
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 rebate on toxicology costs is a major benefit, but clients are also keen to leverage the 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 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.
Additionally, TetraQ study management and data collection processes are supported by an FDA 21 CFR Part 11-compliant Provantis software system. Interim and final report preparation is also facilitated by this centralized data collection system to allow rapid delivery of written reports to clients.
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. https://calendly.com/agilexbiolabs/15min
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' 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.
Agilex Biolabs has 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 at https://youtu.be/WNdPGkdr9FA.
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Topic: Press release summary
Source: Agilex Biolabs
Sectors: Healthcare & Pharm, Clinical Trials
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