Sekisui XenoTech Expands Hepatotoxicity Testing Services
Product News Aug 04, 2016
Sekisui XenoTech has added additional hepatotoxicity screening assays and methodologies to the company’s existing cytotoxicity contract research services. Cytotoxicity studies assess the risk that test articles may cause toxicity in cells, with hepatotoxicity specifically related to the liver.
“Early discovery of hepatotoxicity is essential to screening new drug candidates, but poses many inherent challenges,” commented David Buckley, Ph.D., Sekisui XenoTech’s Chief Scientific Officer. Drug induced liver injury (DILI) or hepatotoxicity is one of the leading causes of adverse events during clinical trials, which often results in failures or clinical holds during the development of new drug candidates, and even withdrawals from the market. DILI observed in a clinical setting is often idiosyncratic with undefined mechanism(s) of toxicity and low incidence rates, even in large populations. However, several mechanisms of DILI have been well-characterized and have the potential to be tested in a non-clinical setting or with in vitro tools.
Dr. Buckley continued, “Sekisui XenoTech has provided in vitro cytotoxicity screening services for many years, often as part of enzyme induction studies. However, considering the prevalence of DILI during clinical trials, we have increased our focus on hepatotoxicity to protect our customers from costly drug candidate failures further down the development pipeline.”
Sekisui XenoTech is widely considered an expert in the field of in vitro hepatic ADME / DMPK / DDI research and has been utilized by 35 of the top 40 pharmaceutical companies worldwide. The company’s extensive knowledge of in vitro drug metabolism, transport and production of liver-based products from over 20 years of research and countless contract studies aids in the development of a pragmatic approach to evaluate hepatotoxicity. Available in vitro ADME assays, in either subcellular fractions and/or cell-based systems, include screening for reactive metabolites to screening for multiple mechanisms of cytotoxicity in primary or immortalized cell lines.