Cyprotex announce the launch of an enhanced hepatocyte stability testing service. Hepatocytes are an ideal system for evaluating drug metabolism and clearance as they contain the full complement of hepatic drug metabolising enzymes maintained within the intact cell. The FDA recommends using hepatocytes as a model in vitro system for metabolite profiling of potential new drugs (FDA Draft Guidance for Industry – Drug Interactions - Study Design, Data Analysis, and Implications for Dosing and Labeling).
Cyprotex have developed a 96 well system that improves the assay’s throughput and shortens the turnaround time. Consequently, Cyprotex is now offering new, lower pricing for this service especially for larger order volumes.
Data from the new system have been validated against literature data. When scaled and compared to in vivo clearance data, Cyprotex data were found to be more predictive of human clearance than corresponding literature data (using the Cyprotex values, the fold under-prediction was 1.3 fold; using literature values, the fold under-prediction was 2.6 fold).
More details of this evaluation can be found here.
Dr Katya Tsaioun, Cyprotex's Chief Scientific Officer, comments on the launch of the improved service. ‘As well as expanding our service portfolio, we are continually adapting our existing assays to improve quality, turnaround time, capacity and, ultimately cost - the benefits of which we pass to our customers. Developing fast, reliable, cost-efficient in vitro assays which help us to understand and predict in vivo drug metabolism is our ultimate goal.’