Seoul, South Korea – Agilex Biolabs, Australia’s largest specialist bioanalytical laboratory for biotech clinical trials, is presenting the Australian Advantage including the world’s most attractive rebate on clinical trials costs, at BIO Korea 2020.
The presentation by Kurt Sales (B.Sc; B.Sc (MED) Hons; M.Sc, Ph.D, PGCM)
Director, Immunoassay at Agilex Biolabs, also detailed how well the Australian clinical trials industry had managed during the COVID-19 crisis with most sites, CROs, and labs including Agilex Biolabs, staying open.
The presentation is at 13.50 on Friday 22, May 2020 via the virtual conference platform. https://www.biokorea.org/index.asp
Agilex Biolabs also launched a News Video Update on the COVID-19 impact on clinical trials in Australia. Watch here.
Agilex Biolabs specializes in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments.
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.
Agilex Biolabs CEO Jason Valentine said:
“Aglilex Biolabs has just expand its labs by more than 30% to accommodate biotech demand from APAC and the USA.”
He said more than 38% of Agilex Biolabs’ biotech clients already come from the APAC region – primarily from China and South Korea.
“APAC clients are particularly attracted by Agilex Biolabs’ FDA-inspected status, and the more than 40% rebate on clinical trial spend that applies in Australia,” he said.
“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 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 FDA-inspected facilities have 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://stagexlab.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/