Many biotech, pharma and CRO’s around the world rely on Alderley Analytical for bioanalytical services, from discovery research through GLP regulatory pre-clinical studies to supporting early and late stage clinical development projects. Because we’re an independent CRO, you can keep your bioanalysis studies with us throughout all the stages of your drug development programme without having to transfer assays when you switch pre-clinical or clinical providers. This reduces any loss of knowledge, proving more cost efficient over time and removes risk and hassle from your process.
Bioanalysis to support drug discovery
For clients who need to quantify a new molecule in a biological matrix to determine the pharmacokinetics (PK), toxicokinetics (TK) or in-vivo exposure, we can develop an assay to suit your requirements on the most sensitive instrumentation. We then analyse your biological matrix to determine the drug concentration and where required, calculate the appropriate PK parameters. For standard discovery bioanalysis, we can turn-around full PK data sets in 5 working days following the receipt of your samples.
Our experience includes delivering PK and exposure data to support oncology, infection, cardiovascular, respiratory and neuroscience projects, analysing matrices such as blood, plasma, urine, tumour, spleen, liver, fat, brain, CSF, nasal washes and many other matrices.
GLP compliant pre-clinical bioanalysis
We offer GLP compliant pre-clinical bioanalysis and toxicokinetic interpretation to support your in-vivo drug safety packages, with extensive experience of developing bioanalytical assays in blood, plasma, urine and many other matrices.
Our pre-clinical validations are conducted in accordance with current regulations; to date we have validated more than 300 assays to regulatory guidelines. The vast experience of the management team has meant we have been asked to present and successfully defend historical data to the FDA and the MHRA.
GCP compliant clinical bioanalysis
We are GCP compliant therefore we can support regulatory clinical studies through phase I-IV. We can analyse matrices such as blood, plasma, urine, CSF, nasal washes and many other matrices and if required we can provide expert pharmacokinetic interpretation.
In method development and validation, our focus is always on robustness, using state-of-the-art instrumentation to develop the most sensitive assays. Samples are analysed within agreed timeframes and are handled according to GCP regulations. Our depth and breadth of expertise is underpinned by our in-house quality management system and Labware Laboratory Information Management System (LIMS).
Here at Alderley Analytical we pride ourselves on our fast turnaround service , we can turnaround samples within required timelines to allow rapid decisions during dose escalation studies.