Agilex Biolabs expands GLP Toxicology capacity with the commissioning of its new purpose designed testing facility


With the opening of its new in-vivo testing facility, Agilex Biolabs, Australia’s top provider of toxicology and bioanalytical contract services, has increased its capacity to better serve the biotech, pharmaceutical, and animal health industries.

Agilex has supported its industry for more than 25 years and will now share its wealth of knowledge with even more sponsors from around the world thanks to a 500% capacity increase that came about as a result of the addition of a new, purpose-built GLP toxicology facility. This makes Agilex unquestionably the largest GLP Toxicology service provider in the area.

“We are thrilled to add more talented people to the team, shorten lead times further, be more agile, and enhance our superior level of safety assessment service to the global biotech, pharmaceutical and animal health industries.”

Holly Stefl, Agilex’s Chief Commercial Officer

The new custom-built toxicology facility has more than 10,000 square feet of laboratory space, state-of-the-art individually ventilated, environmentally monitored, high-tech enabled systems, and is slated for accreditation as a Biosafety Level (BSL) 2 facility by Australia’s National Association of Testing Authorities (NATA). The already-installed contemporary industry systems and standards guarantee that our sponsors will keep receiving the best in the business with foresight and outcomes that can be backed by the Agilex brand to the level of accepted regulatory requirements and evaluations of innovative therapeutics and vaccines.

The renowned toxicology team is now better equipped to maintain its tradition of scientific brilliance and ground-breaking accomplishments. Agilex completed several SARS-CoV-2 fast-track initiatives for its sponsors over the past two years, including mRNA, adenovirus, and molecular clamp stabilised protein subunit vaccines. Agilex is the leading Australian bioanalytical partner for the development of COVID vaccines. Agilex is also the sole Australian provider of toxicological studies that can handle CAR-T treatment programmes using immunocompromised mice.

According to mutual acceptance of data (MAD) agreements, services provided at the new testing facility will continue to be compatible with IND-enabling packages for FDA review and/or other international regulatory authorities. Agilex’s Adelaide site also has a number of bioanalytical facilities for small compounds, peptides, biologics, cell and gene therapy, vaccines, and other modalities in addition to the new Brisbane facility. Agilex is able to provide solid and dependable data to a variety of drug developers in both the nonclinical and clinical phases because to the range of its instrumentation and skilled leadership.

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