Drug Induced Toxicity Assay

The Drug-Induced Intestinal Toxicity Assay evaluates the potential harmful effects of drug candidates on gastrointestinal (GI) tissues, ensuring early detection of adverse reactions that could compromise drug safety.

Purpose of the Test

By employing advanced in vitro models that mimic human gut physiology, this assay identifies GI toxicities, such as inflammation, barrier disruption, mucus alteration, and tissue damage. These models may integrate multiple cell types—including epithelial, immune, and bacterial cells—providing a more comprehensive representation of the GI tract’s complexity and function.

Aligned with the requirements of regulatory bodies, this assay is vital in predicting gastrointestinal toxicity of drugs at different doses. It plays a crucial role in the submission process for new drug candidates, contributing to the development of safer pharmaceuticals and minimizing the chances of GI complications in clinical trials.

The MIVO® Advantage: A Superior Predictive Model

The MIVO® platform elevates traditional GI toxicity assays by introducing dynamic fluid flow, simulating blood circulation and luminal conditions to better replicate in vivo GI environments. Unlike static in vitro models, MIVO® allows for real-time assessment of drug interactions, providing a more accurate evaluation of drug-induced toxicity. This dynamic culture system enhances the physiological relevance of the assay, offering improved predictions of gastrointestinal responses.

Our Unique Value Proposition

Humanized Multicellular Intestinal Toxicity Model: The MIVO® platform integrates a multicellular in vitro intestinal model, replicating the complex interactions between epithelial, immune, and other key cell types found in the human gastrointestinal tract. This advanced system offers a more precise prediction of drug-induced intestinal toxicity, providing superior insights into the safety profiles of pharmaceutical compounds.
Dynamic Fluid Flow for Realistic GI Simulations: MIVO® introduces a double-flow gut-on-chip system, mimicking both luminal and vascular conditions, creating a dynamic environment that mirrors real-life gut interactions. This constant bidirectional flow enhances the physiological accuracy of toxicity assessments by capturing key factors such as epithelial integrity, inflammatory responses, and permeability, delivering more reliable insights.
Comprehensive, Multicellular Testing for Drug Safety: Designed to test a broad range of substances—from small molecules to biologics—the MIVO® system supports diverse compounds with varying chemical and physical properties.

Drug-Induced Toxicity Assay

In summary

READOUTS

  • Intestinal Cellular toxicity
  • Epithelial barrier integrity (TEER measurement)
  • Tight junctions specific staining
  • FITC-dextran permeability
  • Inflammation (i.e. IL6, IL8)
ldhd Drug induced toxicity assay

TEER measurement is performed before and after exposure to test drug, as indirect measurement of barrier integrity.

TEER measurement is performed before and after exposure to test drug, as indirect measurement of barrier integrity Drug induced toxicity assay

TEER measurement is performed before and after exposure to test drug, as indirect measurement of barrier integrity.

FITC-dextran permeability assay is performed to measure membrane integrity Drug induced toxicity assay

FITC-dextran permeability assay is performed to measure membrane integrity .

The ability of testing formulation to induce gut inflammation is assessed by quantification of pro-inflammatory cytokines (i.e. IL6, IL8) through ELISA Drug induced toxicity assay

The ability of testing formulation to induce gut inflammation is assessed by quantification of pro-inflammatory cytokines (i.e. IL6, IL8) through ELISA.

ZO-1 immunostaining is performed to investigate the effect of testing compound on tight junctions Drug induced toxicity assay

ZO-1 immunostaining is performed to investigate the effect of testing compound on tight junctions.

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