The Citeline Awards were created to recognize accomplishments across the biopharmaceutical industry, providing an opportunity for the industry to honor its highest achievers. Achievements across the spectrum of key R&D activities are celebrated, from successes in early and late-stage research, to advances in technological tools, to innovations in trial design and execution.
Agilex Biolabs offers advanced bioanalytical services for biotech companies and delivers toxicology services to support pre-clinical and early phase research within their TetraQ, division.
Dr. Peter Tapley, Director Toxicology at TetraQ, said the research submitted for the Citeline Award focussed 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 said.
“This research highlights the pathways that biotech companies can take for rapid vaccine development, and how the Australian research, regulatory and clinical infrastructure provides a supportive environment.”
The TetraQ safety studies conducted in support of the vaccine development were referenced in Watterson et al ‘Preclinical development of a molecular clamp-stabilised subunit vaccine for severe acute respiratory syndrome coronavirus 2’ Clin Transl Immunology. 2021 Apr 5;10(4): e1269. doi: 10.1002/cti2.1269. eCollection 2021. The important contributions of TetraQ to the program were acknowledged by the inclusion of Drs. Brockman, Tran and Tapley as co-authors.
A description of the clinical study facilitated by the preclinical toxicity study program was reported in Chappell et al ‘Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial’ Lancet Infect Infect Dis. 2021 Apr 19; S1473-3099(21)00200-0. doi: 10.1016/S1473-3099(21)00200-0. This publication also included reference to vaccine serum antibody titre analyses conducted by Agilex Biolabs to support the clinical program. This contribution was acknowledged by the inclusion of Drs Tran and Tapley as co-authors. Although the development of this version of the SARS-CoV-2 Sclamp vaccine was ultimately discontinued the clinical study demonstrated the potential of the Sclamp vaccine technology.
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 organizations such as Agilex Biolabs, and a favorable regulatory environment.
Agilex Biolabs’ TetraQ division offers a range of toxicology services to support early to late stage development programs. These services include exploratory toxicology and pharmacokinetics studies and GLP toxicology services. Studies requiring non-rodent species including dogs and non-human primates are conducted via our partner labs. Studies are also supported by Agilex Biolabs’ world class bioanalytical and immunoassay 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 soon to be released, 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.
Agilex Biolabs has more than 140 staff which includes 85 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.
Agilex Biolabs, the Australian specialist bioanalytical and toxicology laboratory facilities for clinical trials, has more than 24 years’ experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. It has successfully supported hundreds of preclinical and clinical trials from around the world where eligible customers choose Australia for the streamlined regulatory process, quality data and access to the world’s most attractive R&D rebate of up to 43.5% on both nonclinical and clinical trial work conducted in Australia.
Agilex Biolabs also offers toxicology services through TetraQ an Agilex Biolabs company, an established GLP toxicology facility in Australia.
Agilex Biolabs has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.
The company has recently expanded its main labs by more than 30% to accommodate biotech demand from APAC and the USA. In addition Agilex Biolabs has launched a new Immunobiology lab – watch the video here. https://www.agilexbiolabs.com/launch-of-immunobiology-laboratory/
Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).
Agilex offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
– Receptor occupancy
– Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling
– PBMC assays and cellular mechanism of action assays