With the integration of leading toxicology company TetraQ into Agilex Biolabs’ service offering, Agilex Biolabs is now the only GLP bioanalytical facility in the region to also provide advanced toxicology services.

THIS STRATEGIC ACQUISITION was designed to provide biotech companies with a seamless and comprehensive research route from preclinical through to early- and late- phase clinical research.

Agilex Biolabs is internationally recognised for its sophisticated bioanalytical technology (much of which is custom ordered) and has more than 85 scientists and a 24-year track record in regulated bioanalytical services.

Agilex Biolabs supports biotech and pharmaceutical companies from the United States, Europe and the Asia-Pacific region.

As a testament to its toxicology expertise, the Agilex Biolabs team has been selected as a finalist in the prestigious international Citeline Awards by Informa Pharma Intelligence in the Most Successful Early Phase Research (Preclinical & Phase I) category.

The Citeline Awards were created to recognise accomplishments across the biopharmaceutical industry, providing an opportunity for the industry to honour its highest achievers. Achievements across the spectrum of key research and development activities are celebrated – from successes in early- and late-phase research, to advances in technological tools, and innovations in trial design and execution.

Dr Peter Tapley, Director Toxicology, TetraQ division at Agilex Biolabs, says the research submitted for the Citeline Award focused on preclinical assessment of the safety and tolerability of a SARS-CoV-2 Sclamp protein subunit COVID-19 vaccine in rats.

‘The preclinical toxicity studies conducted by TetraQ were required to enable the rapid approval and safe progression of the novel SARS-CoV-2 Sclamp subunit vaccine into clinical testing in healthy volunteers,’ he says.

‘This research highlights the pathways that biotech companies can take for rapid vaccine development, and how Australian research, regulatory and clinical infrastructure provides a supportive environment.’

Dr Peter Tapley

The TetraQ safety studies conducted in support of the vaccine development were referenced in the article ‘Preclinical development of a molecular clamp-stabilised subunit vaccine for severe acute respiratory syndrome coronavirus 2’ (Watterson et al.) published in Clinical Translational Immunology. The important contributions of TetraQ to the program were acknowledged by the inclusion of Dr Brockman, Dr Tran and Dr Tapley as co-authors.

A description of the clinical study, facilitated by the preclinical toxicity study program, was reported in the article ‘Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein- clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial’ (Chappell et al.) published in The Lancet Infectious Diseases. This publication also included reference to vaccine serum antibody titre analyses conducted by Agilex Biolabs to support the clinical program.

The COVID-19 pandemic has seen the rapid development of a series of novel vaccines targeting SARS-CoV-2 in Australia, facilitated by the availability of high-quality contract research organisations, such as Agilex Biolabs, and a favourable regulatory environment.

Toxicology services

Agilex Biolabs’ TetraQ division offers a range of toxicology services to support preclinical through to early-phase clinical development programs. These services include exploratory toxicology and pharmacokinetics studies, and GLP toxicology services. Studies requiring non-rodent species, including canines and non-human primates, are conducted via our partner labs. Studies are also supported by Agilex Biolabs’ world-class bioanalytical and immunoassay services.

Bioanalytical services

Agilex Biolabs offers services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and immunoassay.

Agilex Biolabs’ world-class immunoassay and immunobiology laboratories feature state-of-the-art equipment, including Gyrolab xPlore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and the digital droplet quantitative real-time RT-PCR.

Australian clinical trials have remained open for business, and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.