A reliable bioanalysis & toxicology partner for your Australia drug development programs
Agilex Biolabs is Australia’s most established and technologically advanced laboratory offering regulated bioanalysis, GLP toxicology studies, and central lab services.
Started as an LC-MS/MS focused contract research laboratory in 1994, Agilex has developed over 25 years of expertise in supporting small molecule drug candidates in Australian clinical trials with pharmacokinetics (PK) analysis and biomarker support. Along the way, bioanalytical capabilities and scientific expertise grew to include support for psychedelics, biologics, oligonucleotides, biosimilars, and Cell & Gene Therapies. In South Australia, the Agilex bioanalytical campus features many unique support options for drug sponsors not found anywhere else in the country, such as Droplet Digital PCR (ddPCR) for gene therapies and circulating tumor DNA (ctDNA) analysis. Agilex also provides nonclinical studies at the largest GLP-certified toxicology facility in Australia (est. 2006) and has a network of other providers to offer full IND-enabling animal study packages.
Agilex supports drug development programs for biotechs worldwide when they come to Australia to speed up their drug development programs.
Australia has the most streamlined regulatory pathway in the world. No IND is needed to start a first in human clinical trial and study startup can happen 6-8 weeks from the day you file your application.
For eligible companies under $20mil AUD in annual turnover, a tax rebate is available to receive 43.5% cash back on all R&D expenses. This includes expensive clinical trials and nonclinical studies.
The Australian clinical research ecosystem is robust, with a wide selection of Phase 1 research units, remote trial infrastructure, and world-renowned key opinion leaders in many therapeutic areas. Healthy volunteer trials as well as patient studies (e.g. oncology, CNS, immunology) have excellent recruitment and support services to empower new drug sponsors to provide reliable data accepted by the FDA, EMA, and other regulatory agencies worldwide.
Service arenas at Agilex
- Regulated Bioanalysis
- PK, PD, biomarker assays, immunogenicity testing
- Small molecules, biologics, ADCs, C>
- Central Lab Services
- Sample management and logistics, biological sample storage, clinical kits and lab manuals
- GLP/non-GLP in-life studies
- Toxicology, PK, safety pharmacology
- Extensive species list
- Sample analysis (see “Regulated Bioanalysis above for detail)
Find Out More
If you’re interested in learning more about the opportunity to develop your drug faster and for less money or bioanalytical and tox services for your upcoming Australia studies, visit our website at www.AgilexBiolabs.com or get in touch with the Boston representative for Agilex, Madison Esely-Kohlman at Madison.EselyKohlman@agilexbiolabs.com