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Redefining the concept of standardisation for pluripotent stem cells

机译:重新定义多能干细胞标准化的概念

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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.
机译:在本报告中,我们回顾了标准化的概念,并提出了详尽的框架,以对多能干细胞进行适当的技术管理。存在两个基本问题:首先,这些倡议和尝试往往仅限于当前存在的多能干细胞类别,尽管实现临床/商业应用的技术机会对所有干细胞类型都是同等开放的。其次,与其他工业部门的先例相比,要进行标准化检查的主题范围很窄。为了解决这些问题,我们提出了一个标准化战略框架,重点是全面性,涵盖各种技术机会以及管理科学学习的一致性。通过利用该框架,建议不仅通过专利而且通过在标准化方面发挥领导作用来发展知识产权,应被视为提高研究和开发能力的手段。特别令人关注的是最终产品/服务和核心元素技术,尤其是特定的多能干细胞系的质量标准的形成。此外,我们推断出标准化过程的两个阶段,即首先将特定产品/服务接受市场的个性化,然后是随后将基本技术确立为标准的标准化。

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