Quality criteria for in vitro human pluripotent stem cell-derived models of tissue-based cells

Recommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility

“…This perspective article covers the various stages of early drug discovery and outlines key aspects that should be considered when developing, qualifying, and implementing MPSs ( Ekert et al., 2020 ). In addition, quality criteria for in vitro human pluripotent stem cell (PSC)-derived models have been compiled ( Pistollato et al., 2022 ). Other activities, like the one promoted by the International Society for Stem Cell Research, have focused on reporting standards for stem cells and their progeny ( ISSCR 2023 ).…”

“…A detailed description of the cells (e.g., how they were created, species, origin, special features, karyotype, gender, health state, and age) is important and needs to be well documented and controlled. Documentation of QC on contaminants such as mycoplasma, human viruses, fungi, and other pathogens is very important ( GIVIMP 2018 ; Pamies et al., 2022 ; Pistollato et al., 2022 ). Some studies have shown that misidentification and mycoplasma contamination are still common issues ( Horbach and Halffman, 2017 ; Huang et al., 2017 ; Olarerin-George and Hogenesch, 2015 ; Timenetsky et al., 2006 ).…”

“…These recommendations are intended for academic applications. In addition, detailed quality criteria for in vitro human iPSC-derived models have been recently published ( Pistollato et al., 2022 ) and an ISO standard (ISO 24603) for both human and mouse PSCs for research use has also been published ( ISO 2022b ). This document contains a list of generic minimum QC tests and examples of helpful methodologies and AC for human stem cell selection.…”

“…This document contains a list of generic minimum QC tests and examples of helpful methodologies and AC for human stem cell selection. Furthermore, some of the most common and relevant morphological, biochemical, and functional endpoints that can be used as AC for iPSC-derived models have been discussed ( Pistollato et al., 2022 ).…”

Oligodendrogenesis and myelination tracing in a CRISPR/Cas9-engineered brain microphysiological system

“…hiPSCs are a well-established source of versatile models, including recently emerged organoids. Although broadly used, there are several challenges associated with both hiPSC and 3D cultures ( Zaaijer et al, 2021 ; Pistollato et al, 2022 ). Genetic manipulations of hiPSCs, especially the generation of reporter and fusion KI lines, is a technically difficult process, with much lower transfection efficiencies than those in immortalized cell lines, while robust and reproducible organoid differentiation remains a challenge as well.…”