Establishing a functional standard for stem-derived model electrophysiology using the Maestro MEA assay.
Background
Human induced pluripotent stem cell (hiPSC) -derived cardiomyocytes and neurons are widely established as robust model systems for safety pharmacology and disease modelling. The International Society for Stem Cell Research (ISSCR) recently released the 'Standards for Human Stem Cell Use in Research', a document that outlines a set of recommendations to establish the minimum characterization and reporting criteria for working with human stem cells. The goal of these criteria is to standardize practices, and in doing so, improve the quality of results. However, there are still no agreed-upon minimum acceptance criteria for the functional activity of hiPSC cardiomyocyte and neural models. Rather, it is left to the end-user to determine whether the electrophysiological phenotype of their cell model is fit for purpose.
Axion iPSC Model Standards (AIMS)
The goal of the Axion iPSC Model Standards (AIMS) framework is to set the minimum acceptance criteria for stem-derived model functional activity when used in the Maestro MEA assay. Axion BioSystems has over a decade of experience developing hiPSC-cardiomyocyte and neural assays on the Maestro MEA system with a broad range of cell types. With key opinion leaders in the field, we have developed the following Axion iPSC Model Standards (AIMS). It is important to stress:
- The AIMS detailed here are not intended to define the ideal cell activity, but rather to establish the cell activity that can be reliably used in the Maestro MEA assay.
- In addition to cell functional activity, other important criteria related to cell quality, (e.g., cell viability, sterility, absence of mycoplasma, etc.) can have a significant impact on cell activity. However, the methods used to measure these characteristics and determine associated acceptance criteria have been reviewed elsewhere and fall outside of the scope of the AIMS framework.
