A toxicology facility with more than 10,000 sq ft of laboratory space has opened in Australia and will help Agilex Biolabs expand its capacity to serve the biotech, pharma and animal health industries.
After more than 25 years in the industry, Agilex Biolabs says it will now be able to share with an even more increased number of sponsors from around the world. The company says this is a direct result of the 500% increase in capacity subsequent to the addition of the new purpose built GLP toxicology facility.
It said it is the largest Good Laboratory Practice (GLP) Toxicology service provider in the Adelaide region.
Agilex Biolabs to add new talent to the team
“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.” said Holly Stefl, Agilex Biolabs’ chief commercial officer.
The new custom-built toxicology facility is equipped with individually ventilated, environmentally monitored, high-tech enabled systems scheduled for accreditation by Australia’s National Association of Testing Authorities (NATA) as a Biosafety Level (BSL) 2 facility.
Agilex Biolabs said the already installed modern industry systems and standards ensures that their sponsors will continue to receive the best in the industry with forethought, and results that can be backed to the level of accepted regulatory requirements and evaluations of innovative therapeutics and vaccines.
COVID vaccine
Agilex Biolabs also says the increased capacity will enable the toxicology team to continue its track record for ‘groundbreaking successes and scientific acumen’. As the first Australian bioanalytical partner for COVID vaccine development, Agilex 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, the company says it is the only toxicology study provider in Australia to accommodate CAR-T therapy programs with immunocompromised models.
New testing facility
Services performed at the new testing facility will continue to be compatible with IND-enabling packages for FDA review and/or other international regulatory agencies, per mutual acceptance of data (MAD) agreements.
In addition to the new Brisbane facility, Agilex Biolabs’ Adelaide campus houses multiple bioanalytical facilities for new chemical entities (NCEs) small molecules, peptides, biologics, cell and gene therapy, vaccines, and other modalities.