Agilex Biolabs, the leading bioanalytical laboratory in Australia, announced its expansion in the U.S. with an office based in San Diego as it opens its new South Australian-based laboratory for the analysis of large molecule therapeutics. With 25 years in business, Agilex is one of the only FDA-inspected labs located in the southern hemisphere.

The new facility more than doubles the geographic area of Agilex’s Biolabs Adelaide campus, allowing it to better serve international biotechnology companies, such as those based in the U.S.  Companies that work with Agilex benefit from an efficient regulatory path to first-in-human (FIH) studies, as well as the Research and Development (R&D) Tax Scheme, which offers qualified drug developers a 43.5% cash rebate for conducting studies in its facility there.

“As we celebrate 25 years in business, Agilex continues to grow,” said Jason Valentine, chief executive officer, Agilex Biolabs. “The launch of Agilex’s new facility means we have doubled in size. Now, we can better serve our clientele from all over the world with state-of-the-art instrument platforms and increased capacity to help drug developers succeed as they expand into the novel, promising world of large molecule therapeutics. Using our services offers distinct financial and regulatory advantages for U.S.-based clients, as we offer qualified companies a significant cash rebate and a clear path to first-in-human studies.”

In areas of medicine such as oncology, there are new ways of approaching treatment due to innovative modalities like antibody-drug conjugates (ADCs) and allogeneic cell therapies. Gene therapies and vaccines created using genetic platforms such as RNA, miRNA, and siRNA require specialized tools and technology to measure critical safety and efficacy endpoints in human clinical trials. The new Agilex large molecule facility features cutting-edge bioanalytical techniques and equipment specifically designed for these fast-growing therapeutic areas, such as digital droplet quantitative RT-PCR analysis and an EliSPOT/FluoroSPOT multi-spot reader for high-sensitivity molecule detection.

“Our recent additions of toxicology study capabilities and cell and gene therapy analytical techniques have us poised to accelerate our growth as a trusted partner to drug developers worldwide as more and more sponsors turn to Australia as their First-in-Human clinical trial destination for new molecular entities (NMEs) and novel vaccines,” said Valentine. “There is so much value in the collective experience of our scientists. They have worked on therapies that have gone on to change patients’ lives.”