Are There Differences in iPSC Manufacturing Procedures?
There are major differences in the technologies that produce iPSC. However, the safest iPSC manufacturing approach is one free of viruses and oncogenes or cancer-causing genes. First, eliminating viruses from the reprogramming process is an important consideration because an individual could unnecessarily be exposed to a serious immunological reaction. Second, it is a critical step to eliminate the oncogenes, (c-Myc, Nanog, Lin28 and T-antigen gene) that are commonly used in current iPSC methodologies. Third, it is critical that the growth conditions for iPSC are free of animal proteins.
CET was the first to achieve these requirements in 2017 when we published the first and only virus-free and oncogene-free iPSC method in for neonatal skin cells (1). Subsequently, this same method has been successfully applied to adult skin cells and stem cells derived from umbilical cord blood and placenta. The process also is free of animal proteins. The production process satisfies FDA requirements in to create a master stock of personalized (or autologous) IPSC bio-banking, which can be transferred to FDA-approved manufacturing procedures for creating a cell therapy as part of a clinical trial.
More recently, CET and the John Paul II Medical Research Institute and the University of Iowa conducted a study that is in press in the stem cell journal Regenerative Medicine, which demonstrated that our method is adapted to cord blood (2). Thus, these peer-reviewed studies validate the science of these claims.
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