Agilex Biolabs, the Australian specialist bioanalytical and toxicology laboratory facilities for clinical trials is partnering with Endpoints News to share the latest on “Non-clinical and clinical pathways for rapid vaccine development in Australia”, in a webinar hosted by Endpoints News Editor Arsalan Arif.
Agilex Biolabs’ Director, Immunoassay, Kurt J. Sales (B.Sc; B.Sc (MED) Hons; M.Sc, Ph.D, PGCM) said:
“The COVID-19 pandemic has seen the rapid development of a series of novel vaccines targeting SARS-CoV-2.
Development of multiple COVID-19 vaccine candidates has been facilitated within Australia by the availability of high-quality contract research organizations such as Agilex Biolabs, and a favorable regulatory environment.
This webinar will cover the pathways that biotech companies can take for rapid vaccine development, and why Australia is the ideal location.
I am joined by my toxicology expert colleagues Dr. Peter Tapley and Dr. Drew Brockman for this detailed vaccine development webinar. ”
In this webinar Dr Sales and specialists from Agilex Biolabs’ toxicology firm, TetraQ Toxicology will provide an overview of strategies to conduct vaccine development within Australia.
It will cover Australian research, and regulatory and clinical infrastructure, which provides a favorable environment for rapid vaccine development. It will also include discussion of a case study for rapid vaccine development based on non-clinical research conducted with a novel COVID-19 protein subunit vaccine.
This case study will review key aspects of non-clinical design required to facilitate approval for first-in-human studies.
September 7, 2:00 pm – 3:00 pm EDT
Dr. Kurt Sales: Director, Immunoassay, Agilex Biolabs
Dr. Peter Tapley: Director, TetraQ, an Agilex Biolabs company
Dr. Drew Brockman: Head of Toxicology, TetraQ, an Agilex Biolabs company.
Agilex Biolabs’ world-class 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.
Latest News – new Immunobiology Lab – watch launch video.
Agilex Biolabs CEO Jason Valentine said the new laboratory focuses on new and emerging areas of therapeutic interest, including RNA vaccines, siRNA/miRNA clinical targets, and gene therapy studies.
“This new facility adds digital droplet quantitative RT-PCR analysis for RNA, siRNA and miRNA clinical trials, including vaccines and gene therapy trials,” he said.
“We are also installing an EliSPOT/FluoroSPOT multi-spot reader for vaccine studies to enable extrapolation of recall immune responses, which coupled with our state-of-the-art BD FACSymphony 5 laser, 20 colour flow cytometer, offers unparalleled sensitivity for immunology and vaccine trials.”
The company 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.
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 130 staff which includes 85 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.
About Agilex Biolabs https://www.agilexbiolabs.com/
Agilex Biolabs, the Australian specialist bioanalytical and toxicology laboratory facilities for clinical trials, has more than 24 years of 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 customers choose Australia for the streamlined regulatory process and access to the world’s most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.
Agilex Biolabs also offers toxicology services through its company TetraQ, 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, it has launched a new Immunobiology lab – watch the video here.
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