In Vitro Intestinal Toxicity Testing

 

 HemoGenix® is a Compliant Contract Research Service Supplier through Scientist.com

 

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The cells of the intestine represent one of the five primary, continuously proliferating cells systems of the body, the other being the lympho-hematopoietic system, the corneal cells of the eye, cells of the reproductive system and the skin. All five systems demonstrate the same stem cell heiarachy as epitomized by the lympho-hematopoietic system. However, unike the lympho-hematopoietic system, the assays presently available to understand the response of cells to perturbations are not as well developed. Nevertheless, with the availability of primary human intestinal cell populations, in vitro toxicity testing can be performed using the HemoGenix® EpiGlo™-Tox HT Platform.

 

For more information on in vitro intestinal toxicity testing, please contact HemoGenix® at contractresearch@hemogenix.com or call (719) 264-6250. 

 

 

The majority of studies performed by HemoGenix® incorporate a Complete Service, Full Report that can be used for an IND application. More recently, Sponsors have requested a more streamlined study and studies involving high-throughput screening. For this reason, HemoGenix® now provides 3 types of study format. 

 

  1. Complete Service, Full Report Study: Fully customized study that includes the Study Plan, Draft Text and Final Text Report with QA audit.
  2. Rapid Toxicity Study: A customized study that includes the Study Plan and full protocol, raw results and graphical data in a single Excel Workbook. No formal text report and no QA audit is performed. This type of study is designed for early drug development. No interpretation or conclusions are provided.
  3. High-Throughput Screening Study (presently only available for human studies): A screening study is designed for high-throughput screening of compounds during ADME/Tox screening in multiples of 5 on specific cell populations to provide the most important ranking information. The full protocol, raw results and graphical data are provided in an Excel Workbook. No interpretation or conclusions are provided. This type of Screening Study is part of the ComparaTOX™ HT Platform.

With the introduction of standardized and validated ATP bioluminescence in vitro toxicity assays starting with HALO®-Tox HT for bone marrow toxicity/stem cell hematotoxicity testing in 2002, HemoGenix® has developed a number of in vitro toxicity testing assay platforms. EpiGlo™-Tox HT for in vitro intestinal toxicity testing joins the family of ATP bioluminescence toxicity testing assays that also include HepatoGlo™-Tox HT, CardioGlo™-Tox HT, RenalGlo™-Tox HT and SkinGlo™-Tox HT. All of these can be performed in parallel with each other, since they all use the same readout. This extended toxicity testing platform is called the ComparaTox™ Platform.

 

  • Many primary intestinal cell populations, e.g. epithelial cells and myofibroblasts, exhibit proliferation that correlates with the intracellular ATP concentration measured using EpiGlo™-Tox HT .
  • EpiGlo™Tox HT can be used for intestinal cells from various species..
  • EpiGlo™-Tox HT incorporates a validated ATP bioluminescence readout to measure intestinal toxicity.
  • EpiGlo™-Tox HT is a calibrated and standardized assay platform that allows results to be directly compared between different drugs, as well as different cell types over time.
  • EpiGlo™-Tox HT is a high-throughput assay platform using 96- or 384-well plate formats allowing ADME-Tox drug or compound screening, thereby significantly reducing unexpected results during pre-clinical testing.
  • EpiGlo™-Tox HT can be used to investigate cellular drug-drug interactions or multiplexed with assay readouts.
  • Incorporates the most sensitive ATP bioluminescence readout available.
  • Study Turnaround time: Usually within 4-5 days.
  • Validated assay readout according to FDA Bioanalytical Method Guidelines.
  • Supports the 3Rs (Reduction, Refinement, Replacement) assay platform for animal testing.

  • Cryopreserved
  • Cell lines of the intestinal tract

EpiGlo™-Tox HT can be used with proliferating intestinal cells from a variety of animal species.

 

Please contact HemoGenix® for more information.

  • Membrane integrity: LDH or PI dye exclusion
  • Apoptosis: Biochemical caspase detection
  • Mitochondrial dysfunction: Mitochondrial ToxGlo™
  • Glutathione Assay (GSH): Oxidative stress
  • OxyFLOW™: Oxidative DNA damage

 

Please also view the Mechanism of Action page.

This unique in vitro toxicity testing platform called ComparaTOX™. It is based on the fact that other HemoGenix® toxicity assays all use a common readout, namely a standardized and validated ATP bioluminescence signal detection system. For example, HALO®-Tox HT, ImmunoGlo™-Tox HT, MSCGlo™-Tox HT, HepatoGlo™-Tox HT and NeuroGlo™-Tox HT. When combined together into the ComparaTOX™Platform, the results from each assay platform can be directly compared with each other. This allows the response to drugs and other agents to be ranked according to:

 

  1. Drug toxicity
  2. Cell type
  3. Species

You can perform in vitro intestinal toxicity testing in-house using assay kits sold by Preferred Cell Systems™. Please click on the links below to take you to the assay kit page on the Preferred Cell Systems website.