Standardization and quality process in research grade banking of induced pluripotent stem cells - an application model: "pedi-stem"

Induced pluripotent stem cell (iPSC) is generated by genetic modification of any cell type of the body in laboratory conditions by transferring of embryonic stem cell-like pluripotent properties. iPSC is a cell model that requires multiple production/banking to be used for the understanding of many disease mechanisms, especially rare/hereditary diseases, the development of organoid technologies and new drug/cell/gene research and therapies. It is known that, besides research purposes, iPSC banking is evolving in the world for pre-clinical and clinical studies as gene therapy and the regulations of biological/biotechnological drugs are valid for the banking of iPSC for their therapeutic use. However, the standardization and quality process of the iPSC for research-use have not been completed yet. Within the scope of this thesis, the first standard in biobanking (ISO 20387:2018), prepared for the research-based biobanking and that will not be used for human-beings is planned to be referenced in the formation of a (iPSC) biobank. Specific evaluations, cause-effect analysis (Ishawa diagrams) and laboratory studies were performed in order to determine the quality-based elements related to the distinctive "iPSC derivation". In this context, the basic components based on scientific and literary research such as workflow, organizational chart and units of the bank are presented for a national research-based iPSC bank model. Additionally, mitochondrial mass and activity evaluations were performed in the process of iPSC derivation/reprogramming with the idea that parameters based on metabolic/mitochondrial changes in cells can be utilized to separate the defined cells in early stages. As a result, the sensitivity of ROS brightness to changing environmental conditions was noteworthy. It is suggested that a ROS-based measurement system could be a component of the quality process that can be used for the preparation of iPSCs. However, supportive further studies are needed. This is the first representative national thesis study for research-based iPSC banking.