Preclinical Kidney Disease R&D Solutions

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Project Description

All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.

In Vitro Nephrotoxicity Screening for Drug Safety

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At Ace Therapeutics, we provide specialized preclinical nephrotoxicity screening services to identify and mitigate renal safety risks in drug candidates. Our platform integrates advanced in vitro models and mechanism-driven assays to evaluate compound-induced kidney injury, supporting informed decision-making in early drug development.

Importance of Nephrotoxicity Screening

Approximately one quarter of serious adverse drug reactions involve nephrotoxicity underscoring the need for sensitive in vitro assays that flag renal liabilities at an early discovery stage.

Traditional animal models and two-dimensional cell cultures often fail to capture human-specific responses leading to costly late-stage failures whereas human-derived in vitro assays offer more predictive insights into mechanism of toxicity. Advanced platforms such as three-dimensional microphysiological kidney systems have shown reduced nephrotoxicity of known compounds and provided mechanistic data on drug effects in controlled microenvironments.

Core Nephrotoxicity Screening Modules

Our scientifically validated assays address key pathways implicated in drug-induced kidney damage.

Assay	Methodology	Application
Dual Cytotoxicity/Apoptosis Panels	LDH release, caspase-3/7 activation, Annexin V staining	Quantify necrosis/apoptosis in renal tubular cells
Transporter-Mediated Toxicity	OAT1/OCT2 inhibition + substrate accumulation assays	Assess transporter dysfunction and intracellular toxicity
Mitochondrial Stress Profiling	Seahorse XF analyzer-based OCR/ECAR measurements	Evaluate mitochondrial dysfunction in proximal tubules
Crystallopathy Risk Assessment	Calcium oxalate/phosphate precipitation assays	Screen for crystal deposition-related nephropathy

Why Prioritize Mechanistic Screening?

Reduced reliance on animal models: Human-relevant in vitro systems improve translational accuracy.
Early risk identification: Detect subclinical toxicity signals before advancing to in vivo studies.
Mechanistic clarity: Pinpoint cellular targets (e.g., transporters, mitochondria) to guide structural optimization.

Technical Advantages

Physiologically Relevant Models

Primary human renal proximal tubular cells (RPTEC)
3D kidney spheroid cultures

Cutting-Edge Platforms

High-content imaging for subcellular injury markers
Real-time metabolic flux analysis

Data Rigor

IC50/EC50 determinations with dose-response curves
Benchmarking against known nephrotoxins

Applications

Hit-to-lead triage to prioritize safer compounds
Lead optimization to mitigate renal liabilities
Formulation screening to select kidney-friendly excipients
Transporter liability profiling for regulatory risk assessment

Frequently Asked Questions (FAQs)

What cell types do you use in your assays

We utilize human renal proximal tubule epithelial cells both in two-dimensional cultures and three-dimensional scaffolds as well as hiPSC-derived models to capture key transporter and metabolic functions.

Can you integrate novel biomarkers

Yes we can measure emerging translational biomarkers such as KIM-1 clusterin osteopontin and Cystatin C to detect subtle tubular injury.

How do you assess transporter-mediated risks

We perform inhibition assays on OAT1 OCT2 and measure intracellular accumulation of fluorescent or radiolabeled substrates to quantify transporter liabilities.

Do you offer microphysiological system testing

Our organ-on-chip platforms mimic tubular shear stress and fluid flow enabling dynamic assessments of nephrotoxicity under more in vivo-like conditions.

What deliverables can I expect

You receive raw and processed data tables dose-response curves a comprehensive report with graphical summaries and expert interpretation tailored to your program's needs.

How is data quality ensured

All assays are run with positive and negative controls on validated platforms and data undergoes rigorous quality checks and statistical analysis by our in-house experts.