Predictive and investigative kidney toxicity and drug safety evaluation, in vitro
Drug-induced nephrotoxicity is one of the leading causes of drug failure as the prediction of kidney toxicity during new drug development remains inaccurate. Therefore, early detection of in vitro nephrotoxicity is key to reducing both costs and timelines. Nephrotoxicity assays, which evaluate kidney toxicity using human-relevant models, provide essential data to improve drug safety. The FDA recommends in vitro nephrotoxicity assessment of new drugs and biologics prior to in vivo assessments in animal models. These in vitro nephrotoxicity assays allow researchers to better predict renal safety profiles earlier in the drug development process.
Additional regulatory guidance from both the FDA and EMA also recommends the detection of early markers of kidney toxicity such as KIM-1 and clusterin, which can only be quantified in more complex in vitro nephrotoxicity models. Such models are therefore needed for reliably predictive and early evaluation of renal safety profiles. Newcells aProximate™ proximal tubule cell model is an advanced model designed to asses renal toxicity with unparalleled accuracy. It enables detection of early and late toxic effects, fulfilling a critical need in the field of in vitro nephrotoxicity assessment, through detection of early nephrotoxic markers and transporter activity.
Service outputs
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aProximate™
Assessment of FDA-approved biomarkers of kidney toxicity: KIM-1, NGAL and clusterin
Cell viability: ATP, LDH and TEER measurements
