Axol Bioscience Introduces CiPA-Validated Human Stem Cell-Derived Ventricular Cardiomyocytes To Help Improve Drug Discovery
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Axol Bioscience Ltd. (Axol) has announced that its human induced pluripotent stem cell (iPSC)-derived ventricular cardiomyocytes have undergone comprehensive in vitro pro-arrhythmia assay (CiPA) validation. Using this assay, the cells were shown to be suitable for measuring cardiotoxicity, offering scientists a robust cardiac model for drug discovery and screening.
Axol’s human iPSC-derived ventricular cardiomyocytes are manufactured at scale according to strict quality control standards using ISO 9001-accredited quality management systems, providing a continuous source of cells from the same genetic background for use in multiple experiments. This offers a physiologically relevant in vitro research model of human heart cells to reliably and repeatably test drug candidates for cardiotoxicity at scale.
With the advent of human iPSC-derived cardiomyocytes, the US Federal Food and Drug Administration Agency (FDA) launched a working group to assess the utility of these cells in reproducing cardiotoxicity in a dish, known as CiPA*. The assay tests cells with 28 compounds that are known to be cardiotoxic and induce the fatal arrhythmia “Torsades de Pointes”. Clyde Biosciences, a CRO that specializes in cardiotoxicity assays, used this assay to validate Axol’s cardiomyocytes for cardiac safety testing. Using these cells could help researchers to identify unsuitable drug candidates earlier in the drug discovery process and improve the number of promising pre-clinical drug candidates that translate through to clinical trials and to patients.
Liam Taylor, CEO, Axol Bioscience, said: “Scientists need cells and reagents they can rely on to make meaningful assessments of drug candidate toxicity, before progressing candidates to the clinic.
We’re both excited and proud to demonstrate the suitability of our human iPSC-derived ventricular cardiomyocytes for toxicity testing. Axol’s stringent quality control standards mean we have the capability to produce reliable, validated cells that scientists can use to assess a compound’s cardiac liability and, ultimately, help to improve the drug discovery process.”
Prof. Godfrey Smith, CSO, Clyde Biosciences, added: “As a core member of the CiPA initiative, we’re pleased to have supported Axol’s cell development and helped the team assess the performance of its cardiomyocytes. Having run the CiPA protocol on Clyde’s proprietary CellOPTIQ platform, and provided analysis and interpretation of the data, we confirm our data indicates that Axol’s cardiomyocytes meet the requirements for predictive in vitro pro-arrhythmia screening.”