Kidney Toxicity Service

The aProximate™ model has been used in a collaborative drug safety evaluation study with Takeda Pharmaceuticals. The study used 36 compounds with known in vivo safety profiles (toxic or non-toxic) using aProximate™ PTCs as a training set. FDA-qualified kidney-specific biomarkers of kidney toxicity such as KIM-1, NGAL and clusterin can be detected in the model, confirming its suitability to assess renal toxicity and evaluate renal drug safety during drug discovery. The model was then used to assess other compounds and correctly classified four of six true positives and two of three true negatives, showing validation of the in vitro nephrotoxicity model for detection of tubular toxicants. This work thus shows the potential application of quantifying translational biomarkers in freshly isolated aProximate™ PTCs for the assessment of nephrotoxicity within the drug discovery pipeline.

Our service provides insights into drug-induced nephrotoxicity

Newcells offers  in vitro kidney toxicity evaluation by testing your compounds on aProximate™. Evaluation of  proximal tubule Nephrotoxicity in vitro will  assess the renal safety profiles of your compounds, significantly accelerating your drug safety studies.

The data generated from our renal toxicity assays provides a comprehensive understanding of the safety profile of your compounds by testing parameters which follow regulatory guidelines, giving you confidence in your lead candidates ahead of further in vivo animal testing.

aProximate™ also allows the assessment of nephrotoxicity across a range of pre-clinical species such as mouse, rat and dog to help you identify the most appropriate in vivo model for your compound.

Our project timelines are short due to our regular supply of fresh kidney tissue. The robust data generated by our scientific experts will guide you in confidence for key decision-making steps during drug development.

An example of renal toxicity packages includes assessment of FDA-approved biomarkers (KIM-1, NGAL and clusterin) in our aProximate™ proximal tubule cell model . Both kidney tissue models can be used to assess drug-induced cell health and monolayer integrity. Data can be aquired from three separate biological donor kidneys across multiple species.