Agilex Biolabs was founded from CPR Pharma Services. What began as a group of academic scientists providing clinical trial and bioanalytical services to the local Australian pharmaceutical industry in the 1980’s has grown into a business with a global client base.

In our 25 years of performing regulated bioanalysis of small and large molecules, we have accelerated hundreds of preclinical and clinical trials around the world.

Today, our clients include many of the leading pharmaceutical and biotechnology companies in Asia, Europe, and the USA.

Agilex Biolabs

Did you know? You can initiate phase I clinical trials before filing your IND submission by conducting your research in Australia. Learn about the benefits and the myths for conducting your nonclinical and clinical trials in Australia by attending the next expert panel discussion! Learn more: https://www.agilexbiolabs.com/seeking-clarity-the-myths-about-nonclinical-and-clinical-trials-in-australia/

Seeking Clarity: The Myths About Nonclinical and Clinical Trials in Australia

Immunogenicity assessment is a critical safety attribute for biotherapeutics undergoing clinical development. Developing clinically relevant immunogenicity assays is an essential element for providing a route for successful submission. This webinar will discuss some of the challenges faced during the development of immunogenicity methods, as well as present some solutions for resolution of those issues. Our panelists will discuss three different case studies that have been utilized to demonstrate the importance of tailoring the development process to the drug and clinical study requirements.

WHAT WILL YOU LEARN?
Hear about three unique ADA case studies and challenges associated with the development process.
Learn the importance of tailoring assay development process to both the drug and the clinical study requirements.
Find out a few tools to assist in tackling drug and target tolerance in ADA assays.

Solving complex immunogenicity challenges

With increasingly novel drug development programs, meaningful collection of subject samples has never been more relevant. Don’t let potential analyte instability mislead your program as it gets underway, causing costly time delays. Sample integrity knowledge will assist you to ask relevant questions of your potential clinical sites and better understand your bioanalytical needs. In this webinar, we will discuss some of the issues related to subject sample collection to ensure reliable data for your drug program.

Ensuring sample integrity from collection to analysis

Profiling, characterising, and identifying metabolites are key steps in supporting drug discovery and development of novel compounds. Metabolite identification (MetID) studies help you to understand the presence of potential active or reactive metabolites and observe the unique metabolites in your compound to better understand your molecule’s biotransformation capabilities. SEKISUI XenoTech and Agilex Biolabs’ combination of in-depth scientific knowledge in drug metabolism and mass spectrometry, extensive pharmaceutical industry experiences, and advanced software, can quickly identify metabolites in both in vivo and in vitro samples and help accelerate sponsors’ drug development programs through FIH clinical trials.

Bridging In Vitro Data to Clinical Outcomes with MetID

Agilex Biolabs provides world-class toxicology services via its purpose-built GLP compliant facility in Brisbane, Australia. In collaboration with Attentive Science, we provide our clients with a comprehensive solution to conduct full-service IND-enabling toxicology services to support global nonclinical drug development programs. 

Eligible biotechs can take advantage of the 43.5% cash rebate to conduct their toxicology studies in Australia, through this generous Research and Development (R&D) Tax incentive. Australia is a highly attractive destination for first-in-human clinical studies supporting the development of novel therapies and vaccines. Through this streamlined regulatory process, defendable quality data from clinical trials which are globally acceptable to FDA and EMA, along with 43.5% cash rebate on toxicology activities in addition to the clinical trials being run in Australia makes it an ideal designation to accelerate your drug development programs.

Did you know Australia does toxicology?

Learn about the financial and speed advantages for conducting studies in Australia with an emphasis on pathways for rapid vaccine development. Key topics include:
 - A snapshot into the Australian Advantage
 - Overviews of Agilex Biolabs and our toxicology services
 - Considerations in nonclinical vaccine development
 - Case study in nonclinical safety assessment of a molecular clamp-stabilised subunit vaccine for severe acute respiratory syndrome coronavirus 2
 - Clinical landscape: bridging the transition from preclinical to first-in-human
 - Bioanalytical considerations for vaccine trials

Agilex Biolabs

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