Our Quality Assurance
Agilex Biolabs is committed to the highest levels of regulatory compliance and a Quality program that is integral to our performance.
Our highly experienced Quality Assurance team deliver our core values of data integrity, regulatory compliance and customer focus, to support scientific excellence.
When you partner with Agilex Biolabs, your project will be delivered by the experts on time and with the highest quality results.
Innovative technology platforms tailored to each project
Agilex Biolabs offers the highest level of scientific innovation, customer service, data integrity and Quality Assurance to clients using world-class platform technologies to deliver rapid, precise and robust assay results.
We know that for successful bioanalysis, scientific expertise and world-class technology go hand in hand. Our dedicated laboratory scientists are experts in performing regulated bioanalysis using LC-MS/MS and immunoassay platforms.
This specialised expertise allows us to identify the best assay methodology to meet the clinical and Regulatory needs for each project, for each client. Our platform suite can meet the diverse assay requirements for regulated bioanalysis.
- Our instrumentation includes:
6 Sciex 4000 LC-MS/MS instruments and a Sciex QTRAP 5500 LC-MS/MS
- Meso Scale Discovery (MSD) immunogenicity platform
- SpectraMax Plate Reader
- Conventional HPLC (UV-Visible, fluorescence)
- Gyrolab xPlore
With secure access, our bioanalytical facilities have a vendor assured offsite archive facility with 24-hour security monitoring systems with generator-backed continuous power and on and off-site disaster proof storage capabilities. Our platforms have UPS and generator backup with full preventative maintenance and vendor support contracts to maintain continuous operation and minimise downtime.
Our assays are validated to the latest FDA/EMA bioanalytical guidances and study data reported to each client’s desired format.