The bioanalytical team at AXIS Clinicals USA is highly experienced and has an extensive understanding of the specific regulatory requirements of the FDA and other international regulatory agencies, as well as constant oversight from an in-process quality control and an independent quality assurance team. In addition, Incurred Sample Reanalysis (ISR) is performed in strict compliance with protocols and regulatory requirements. Our significant expertise in stringent bioanalytical methodologies promises precise and timely analysis with accurate, high-quality results.
We provide end-to-end bioanalytical services, including custom method development, assay validation, and sample analysis in a variety of biological species and matrices.
The experienced bioanalytical team is competent in conducting all types of bioanalysis, including:
- Liquid-liquid extractions
- Solid-phase extractions
- Pre-and-post-column derivatization procedures
- Chiral separation of optical isomers
- Conjugate and non-conjugate drug level estimations
Our bioanalytical unit is a 10,000 square-foot lab contiguous with our 228-bed clinical unit in the same building. Notably, it is:
- Perfectly designed for a single flow, seamless transfer of samples from the clinical freezers into the bioanalytical freezer area. The design incorporates clinical laboratory PK sample processing directly connected to the bioanalytical laboratory to create a team effort of efficiency in sample transfer from clinical to bioanalytical. The contiguous laboratories minimizes exposure of PK samples to room temperatures but optimizes clinical freezer to bioanalytical freezer transfer / inventory time.
- Equipped with LC-MS/MS with HPLC and UHPLC systems and Hamilton Nimbus workstations for automated sample preparation. Samples are securely stored in -20°C or -80°C freezers that are constantly monitored by Smart-Vue™ Wireless Monitoring system.
- Protected by an uninterrupted power supply (UPS) and backup generator system.
AXIS Clinicals USA uses Analyst 1.6.2 software for data acquisition and data processing, along with Thermo Scientific Watson LIMS for study design and data and sample management. A full chain of custody reports for sample tracking, data review, data transmission between sites, reporting, and document management system results in a reduced timeline for report submission.