There is the 2024 version of concerns repeated below.While...

There is the 2024 version of concerns repeated below.

While karyotyping is typically used to evaluate cytogenetic mosaicism in pluripotent stem cells, the method is insensitive to detecting genetic instability. Multi-gene microarrays, whole genomic sequencing and qPCR are more accurate in detecting genetic instability than karyotyping 5,6.More importantly, little is known about how large-scale production of iPSC and differentiated protocols can impact genetic instability, cell heterogeneity and reproducibility. Quantitative analytical and computational approaches will be required to better define genetic instability and define cell phenotype. The extent of cell culturing conditions and scale-up production variables that lead to genetic instability of iPSC have not been defined, which ultimately could impact the ability to produce a reproducible cell product. Taken together, the need for quality controls in iPSC and differentiated cell manufacturing to create reproducible, safe and potent cell lines that minimize deleterious cell mutations will require high quality tissue culture conditions, computational models and avoidance of oncogenes that are used in reprogramming schemes.