Generating iPSCs: Translating Cell Reprogramming Science into Scalable and Robust Biomanufacturing Strategies

Abstract

Induced pluripotent stem cells (iPSCs) have the potential to transform drug discovery and healthcare in the 21(st) century. However, successful commercialization will require standardized manufacturing platforms. Here we highlight the need to define standardized practices for iPSC generation and processing and discuss current challenges to the robust manufacture of iPSC products.

Efficient mRNA delivery with graphene oxide-polyethylenimine for generation of footprint-free human induced pluripotent stem cells

“…Although techniques for preparation of iPSCs are continually evolving in laboratories, significant hurdles remain for the successful production of clinically safe iPSCs [46]. The retrovirus-or lentivirus-based iPSC production procedures show high reprogramming efficiency but have hampered therapeutic applications of iPSCs due to the concerns about insertional mutagenesis, tumorigenesis, and continued expression of potentially oncogenic proteins by the integrated transgenes [11,25].…”

Using stem cell-derived gametes for same-sex reproduction: an alternative scenario

“…There is ongoing discussion about possible tumorigenicity of iPSCs as well as about increased risks for accumulation of chromosomal aneuploidies 11. There is also no consensus about reprogramming and validation methods to obtain iPSCs 12. SCNT, on the other hand, is regarded as a more efficient technique, although it is uncertain whether SCNT-ESCs are any better than iPSCs 13…”

Nuclear Reprogramming by Defined Factors: Quantity Versus Quality

“…Theoretically, iPSCs and directly converted cells are ideal for regenerative medicine and for disease modeling [28][29][30][31]. In contrast to ESCs, their use does not involve ethical issues and,…”

“…Furthermore, the first clinical trials using iPSC technology have been launched [21,22]. However, despite remarkable progress in characterizing the reprogramming process and the resulting iPSCs and directly converted cells [23][24][25][26][27], it remains to be seen if these converted cells are safe and of sufficiently high quality to warrant their immediate use in the clinic.Theoretically, iPSCs and directly converted cells are ideal for regenerative medicine and for disease modeling [28][29][30][31]. In contrast to ESCs, their use does not involve ethical issues and,…”