Redefining the Concept of Standardization for Pluripotent Stem Cells
Redefining the Concept of Standardization for Pluripotent Stem Cells
复制标题
重新定义多能干细胞标准化概念
DOI：
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发表时间：
2011
影响因子：
4.8
通讯作者：
N. Nakatsuji
中科院分区：
文献类型：
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作者：
S. Sengoku;K. Sumikura;T. Oki;N. Nakatsuji
在本报告中，我们回顾了标准化的概念，并根据对全球和区域倡议的研究，提出了一个详尽的多能干细胞技术适当管理框架。我们展示了对相关技术标准化的全球倡议的详细观察分析，以及对英国、美国和日本的案例特别感兴趣的区域尝试。因此，我们提出了两个基本问题：首先，这些倡议和尝试往往仅限于目前现有的每一种多能干细胞，而使临床/商业应用的技术机会对所有类型的干细胞都是平等开放的。其次，与其他工业部门的先例做法相比，标准化审查的主题范围相当狭窄。为了解决这些问题，我们提出了一个标准化的战略框架，重点是涵盖各种技术机会的全面性和管理科学学习的一致性。通过利用这一框架，不仅通过专利，而且通过在标准化方面发挥领导作用，知识产权的发展可以被视为提高研发能力的手段。特别值得关注的是最终产品/服务和核心基本技术，特别是特定多能干细胞系的质量标准的形成。此外，我们推断了标准化过程的两个阶段，即个性化，即特定的产品/服务被市场认可，然后是标准化，即基本技术随后被建立为兼容性标准。
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.
影响因子：
20.3
作者：
Hu, Kejin;Yu, Junying;Slukvin, Igor I.
通讯作者：
Slukvin, Igor I.