Agilex Biolabs, Australia’s most advanced FDA-inspected specialist bioanalytical laboratory for clinical trials, has partnered with Endpoints News to produce an exceptional step-by-step webinar on how to run your trial in Australia, and why Agilex Biolabs is the leading biolabs partner. Watch here (no charge) https://tinyurl.com/yyzf6o44
Agilex Biolabs is known internationally for its continued investment in the latest technology, and for attracting some of the leading scientists from Australia and around the world.
The webinar was launched as part of Agilex Biolabs’ presence at Bio Europe. Click here to meet Agilex Biolabs at Bio Europe via the partneringone tool. https://informaconnect.com/bio-europe-virtual/
Dr Kurt J. Sales, Agilex Biolabs Director, Immunoassay B.Sc (Med)(Hons), M.Sc, PhD, PGCM led with a presentation detailing the rapid trials process in Australia.
He stressed the importance of talking to Agilex Biolabs early, even before selecting a CRO and other partners, due to the depth of advice the scientific team can offer Sponsors, and the time it can take to develop some assays.
The webinar also featured leading clinical research specialist Jane Kelly who has 27 years in the industry. She is CEO of CMAX Clinical Research, a major Phase 1 Unit located near Agilex Biolabs.
Kelly pointed to the significant advantages of having the biolabs close to the Phase 1 Unit in terms of sample transfer and data turnaround, and offering a seamless clinical experience for Sponsors.
Agilex Biolabs, the only FDA-inspected lab of its type in the region, also features a rebate of up to 43.5% on clinical trial bioanalytical services spend as part of the Australian Government clinical trial attraction program.
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.
The company has recently expanded its labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the New Labs Walkthrough Video Here https://www.agilexbiolabs.com/new-labs-video
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 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 (eg: ADCC)
Agilex Biolabs has more than 90 staff including 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 companies from US, Europe and APAC.
Please Book a Briefing with us before you start your next clinical trial. https://calendly.com/agilexbiolabs/15min
Australia: +61 8 8302 8777 | China: +86 21 8036 9483 | South Korea: +82 80 812 1255 | USA: +1 800 247 1909
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.
Agilex Biolabs has 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.
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.
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.