Redefining the concept of standardisation for pluripotent stem cells

In this report we review the concept of standardization and propose an exhaustive framework for the proper management of technology on pluripotent stem cells. There are two fundamental issues: first, these initiatives and attempts tend to be limited to currently existing categories of pluripotent stem cells, although the technological opportunity to enable clinical/commercial application is equally open to all stem cell types. Second, the subject to be examined for standardization is set to a quite narrow range compared to precedent practices in other industrial sectors. To address these issues, we propose a strategic framework for standardization with an emphasis on comprehensiveness covering various technological opportunities and consistency to learning in the management science. By utilizing this framework it is suggested that development of intellectual property rights not only through patents but through taking leadership in standardization be considered as means for improving research and development competence. Of particular concerns is the formation of quality standards for final products/services and core elemental technology, in particular, specific pluripotent stem cell lines. Furthermore, we inferred two stages of the standardization process, individualization where a particular product/service is firstly accepted by the market, then standardization where the elemental technology is subsequently established as standards.