Adelaide, Australia – Agilex Biolabs, Australia’s largest specialist bioanalytical laboratory for clinical trials, encouraged biotechs to consider Australia for their clinical trials during a presentation at BIO Digital 2020.
Australia’s impressive COVID-19 management and the world’s most attractive rebate on clinical trials costs are just a few of the reasons that make it an ideal location to restart delayed trials, according to Agilex Biolabs.
Agilex Biolabs has been open throughout the global COVID-19 pandemic. Australia had only 2 new COVID-19 cases in the past 24 hours.
Agilex Biolabs, the only FDA-inspected lab of its type in the region, is located in Adelaide, South Australia in a science and biotech specialist hub.
Watch the BIO Digital 2020 presentation here.
The presentation by CEO Jason Valentine and moderated by VP Business Development Julia Jones details the current trials landscape in Australia and why biotechs wanting to avoid delays caused by COVID-19, can move their trials to Australia.
CEO Jason Valentine said:
“Australia has a group of proven top-tier trial providers that regularly work together so are fully engaged and in sync with processes and each other’s requirements and capabilities.”
“We have worked with all the trials service provider companies so can advise on which ones are the best fit for each study.”
“The Agilex Biolabs team can offer an unbiased approach and advice depending on specific trial requirement.”
“Biotechs are particularly attracted by Agilex Biolabs’ FDA-inspected status, and the 43.5% rebate on clinical trial spend that applies in Australia.”
“Our world-class bioanalytical facilities have OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.”
Agilex Biolabs has also launched a News Video Update about COVID-19 and clinical trials in Australia. Watch here.
The company has just expanded its labs by more than 30% to accommodate biotech demand from APAC and the USA.
Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gurolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).
Agilex also offers pharmacodynamics servicesthat 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
- PBMC assays and cellular mechanism of action assays (eg: ADCC)
The biolabs has more than 65 dedicated laboratory staff, and annually support more than 80 clinical trials. This year they will analyse more than 60,000 samples for pharma/biotechs from US, Europe and APAC.
About Agilex Biolabs https://www.agilexbiolabs.com/
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.
See us featured in Endpoints https://endpts.com/sp/partner-with-the-right-bioanalytics-firm-at-start-up-to-de-risk-drug-development/