Preclinical / Non-clinical In Vivo Toxicology
Agilex Biolabs offers a range of toxicology services to support non-clinical through to early/late-phase clinical programs through our state-of-the-art, custom-built GLP facility located in Brisbane, Australia. These services include exploratory (non-GLP) toxicology and pharmacokinetics studies, and GLP toxicology services. We have extensive experience working with a wide range of therapeutic modalities and routes of administration.
Our scientific experience includes:
As the premier Australian bioanalytical partner for COVID vaccine development, Agilex has completed multiple SARS-CoV-2 fast-track programs on behalf of its sponsors in the last two years, including mRNA, adenovirus, and molecular clamp stabilized protein subunit vaccines. In addition, Agilex is the only toxicology study provider in Australia to accommodate CAR-T therapy programs with immunocompromised models.
Agilex Biolabs’ team have extensive experience in successfully designing and executing regulatory toxicology studies for submission to various international regulatory bodies including FDA and EMA.
Agilex has established a partnership throughout USA and APAC, making it easy for our clients to not have to choose between price, quality, and timelines. With this collaboration, our sponsors can fulfill the global requirement for two species for standard toxicology testing as stated in the international conference for hominization guidelines.
Agilex Biolabs and its Partners
|All in-vivo activities||Histopathology|
|Necropsy||hERG / Ames|
|Dose Solution Analysis||Second species studies|
Drug sponsors from all over the globe are coming to Australia for their first-in-human (FIH) clinical trials to take advantage of the most efficient regulatory pathway in the world. Increased access to critical nonclinical testing in Australia allows additional efficiencies, as studies performed by reputable organizations in Australia can enable more streamlined regulatory approval for clinical trial startup.
Additionally, eligible companies can receive a 43.5% tax rebate on clinical spend and all R&D work placed in Australia preceding an Australia clinical trial – including pharmacokinetics (PK), toxicology testing, and supportive bioanalysis.
Agilex’s growing team of qualified study directors and technicians use Provantis software system for study management and data collection, compliant with FDA 21 CFR Part 11. Provantis is used for recording of body weights, clinical observations, dosing, food and water consumption, and blood or urine sampling as well as other user-specified outcomes. Interim and final reporting is facilitated by centralized data collection, allowing rapid delivery of written reports to clients.
If you are interested in learning more about Agilex’s nonclinical study offerings or would like to get your study in the queue, use our Contact Us form and a representative will be in touch with you shortly.