Bioanalytical Services

TetraQ bioanalytical work relies on a dedicated group of highly trained staff, ranging from our experienced senior scientists to the Quality Assurance and sample handling teams. The largest part of our sample analysis work supports Phase 1 clinical trials in Australia (both healthy volunteer studies and cancer trials). However, we can provide support to later-stage trials and international or multi-national clinical trials as requested. We also conduct sample analysis for rodent studies from our in-life facility. TetraQ has supported bioanalytical studies in dogs, sheep and non-human primates and biomarker studies in humans.

Regardless of whether a study involvesĀ small molecules or biologics, it is essential to have a suitable method for determining analyte concentration. For non-proprietary drugs, a validated method may in some cases already be available at TetraQ. However for first-in-human studies, a new method will be needed, generally based on a sponsor method for a preclinical matrix such as plasma or serum. TetraQ can develop a method in the corresponding human matrix, which may involve improvements such as greater sensitivity or a change in internal standard. Once method development is complete, a full validation is run to meet regulatory guidances. This will ensure that sample analysis will meet quality criteria. Once this stage is complete, it is possible to proceed to supporting a clinical trial.

Depending on sponsor requirements, TetraQ can in some cases acquire data at a research-only level for ends other than regulatory submission. This situation can arise with non-GLP preclinical studies, or may involve analysis of biomarkers. Equally, if a method has been fully validated in another facility, TetraQ can carry out partial validation prior to clinical sample analysis, or cross-validation for data integration from different facilities. We are happy to discuss sponsors’ needs and recommend a cost-effective path forward.

We encourage sponsors to engage with TetraQ early to allow efficient scheduling of method development and validation to support sample analysis. Enquiries can be directed to our team via the Contact page or by email to info@tetraq.com.au.