Redefining the Concept of Standardization for Pluripotent Stem Cells

Shintaro Sengoku, Koichi Sumikura, Toshihiko Oki, Norio Nakatsuji

In this report we review the concept of standardization and propose an exhaustive framework for the proper management of technology on pluripotent stem cells based on studies of global and regional initiatives. We demonstrated detailed observational analysis on global initiatives for the standardization of related technologies as well as regional attempts with particular interest in the cases of the UK, the US and Japan. Consequently, we came up two fundamental issues: first, these initiatives and attempts tend to be limited to each of currently existing categories of pluripotent stem cells, whereas 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 development of intellectual property rights not only through patents but through taking leadership in standardization can 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, especially specific pluripotent stem cell lines. Furthermore, we inferred two stages of the standardization process, individualization where a particular product/service is qualified by the market, then standardization where the elemental technology is subsequently established as compatibility standards.