Adelaide, Australia – Award-winning Agilex Biolabs, the Asia-Pacific region’s leading bioanalytical laboratory for clinical trials, based in Australia, has developed the world’s most accurate cannabinoid assay.
The announcement was made at BioPharm America (September 21-24, 2020).
The assay is already being used by 4 sponsors in drug development.
Agilex Biolabs CEO Jason Valentine said the company was now very much at the forefront of assay development for cannabis clinical trials, with more assays in the pipeline.
“We have developed a high sensitivity, quantitative assay for the detection of CBN, CBD and THC and metabolites in human plasma.”
The Agilex Biolabs cannabinoids assay achieves >98% of ISR (Incurred Sample Reanalysis) samples within the acceptance criteria, which demonstrates that it is robust and reproducible.
The FDA and EMA criteria is 67% of samples within 20%.
This is the best-in-class because we have resolved interferences that over-state THC concentrations that can potentially skew reported data. The improved accuracy and sensitivity means we now have a precise low level assay for our clients.
This competes with anything in the world for accuracy, and cuts the risk of flawed results.
Due to high client demand a CBD and metabolites assay is in development and will be ready before end of the year.”
Agilex is also now offering additional 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:
· Immunophenotyping
· Receptor occupancy
· Cytokine release assays (whole blood or PBMC stimulation assays) and
cytokine/biomarker profiling
· PBMC assays and cellular mechanism of action assays (eg: ADCC)
Agilex Biolabs, the only FDA-inspected lab of its type in the Asia-Pacific, offers bioanalysis for small molecules and biologics for PK, immunogenicity and biomarkers utilising the two platforms of LC-MS/MS and Immunoassay (MesoScale, Gyrolab).
The FDA-inspected facilities have more than 90 dedicated laboratory staff, and annually support more than 80 clinical trials. This year Agilex Biolabs will analyse more than 60,000 samples for pharma/biotechs from US, Europe and APAC.”
By combining specialised expertise, technological innovation and a 20-year track record, Agilex Biolabs have supported hundreds of preclinical and clinical trials around the world.
Agilex Biolabs’ world-class bioanalytical facilities have OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.”
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About Agilex Biolabs
Agilex Biolabs, Australia’s leading bioanalytical laboratory, has more than 20 years’ experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. We have successfully supported hundreds of preclinical and clinical trials 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.
We offer 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 operates a fully quality-assured laboratory ensuring that, within the principles of GLP, assays are validated to the latest FDA/EMA guidance and study samples are assayed and reported to the sponsor’s desired format using WATSON LIMS. Laboratory certifications include OECD GLP and ISO/IEC17025.
Our highly experienced team consists of over 65 dedicated laboratory staff with >15 years average industry experience across senior scientists. Expertise includes development of robust compliant PK and PD assays de novo or by method transfer.
Our laboratory is fitted with 7 SCIEX tandem mass spectrometers, 6 API 4000 and 1 QTRAP 5500 as our standard platform for LC-MS/MS analysis. For immunoassay, we employ the state-of -the-art systems of Meso Scale Discovery (MSD) and Gyrolab xPlore.
Agilex Biolabs owns a suite of validated biosimilar assays that have already supported biosimilar studies executed in the region. These assays include Avastin/Bevacizumab, Lucentis/Ranibizumab, Actemra/Tocilizumab, Xolair/Omalizumab, Herceptin/Trastuzumab and Solaris/Eculizumab. We would like to discuss how we can support companies with biosimilar pipelines looking to conduct trials in the region. Our validated biosimilar assays require less setup saving time and money.
Agilex Biolabs also have a suite of biomarker assays that have been developed to support studies in the areas of endocrinology (estrone, estradiol, progesterone, testosterone and others).
Recently, Agilex Biolabs has added a comprehensive cannabinoid assay to its suite of validated assays to support clinical trials. The fully validated assay includes the five cannabinoids THC, CBD, CBN and the two THC-metabolites OHTHC and COOHTHC.
Our LC-MS/MS experience includes NCEs, sugars, nucleotides, enantiomers, steroids, prodrugs, peptides, immunosuppressants, nanoparticles, neurotransmitters, oligonucleotides and polymeric mixtures.
Our biologics experience entails PK analysis using colorimetric, fluorescence or chemiluminescence detection for recombinant or fusion proteins, monoclonal antibodies, ADCs, immunogenicity testing, biomarker analysis and PBMC blood stimulation assays.
