The HUREL Micro Liver platform continues to be the gold standard advanced cell culture model for use in liver metabolism studies, as well as being used regularly for drug induced liver injury (DILI), infectious disease (e.g., HBV) and multiple other applications. The large number of hepatocytes per well as well as the ability to maintain metabolic functionality for up to two months means that the model is highly effective for evaluating low clearance compounds and provides distinct advantages over suspension culture and other 2D or 3D approaches. These models are used extensively within the Visikol suite of contract research services, and today Visikol leverages these models to offer a suite of metabolism assays which include metabolite identification as a readout.
When developing a therapeutic and pulling together an IND, it is critically important to understand how the body metabolizes the drug product of interest and what the associated metabolites are. In many cases, the therapeutic of interest might be safe but the metabolites that are generated can have toxic liabilities themselves. Further, depending on the patient population it is possible that the metabolites that are generated can vary greatly.