Bravo Elena, Franchin Tiziana, Santoro Filippo, Conti Laura, Carrara Stefania, Marino Mirella, Di Caro Antonino, Cigliana Giovanni, Mandoj Chiara, Baselice Simona, Daniele Nicola, Giampaoli Simona, Quintarelli Concetta, Salerno Massimiliano, Zinno Francesco, Russo Giandomenico, Errico Maria Cristina, Minghetti Luisa, Ricciardi Walter, Napolitano Mariarosaria
Istituto Superiore di Sanità, Roma.
IRCCS Ospedale Pediatrico Bambino Gesù, Roma.
Recenti Prog Med. 2019 Feb;110(2):68-74. doi: 10.1701/3112.31001.
Smart Specialization Strategy (S3) of Lazio defines smart specialization strategies to bring out the excellence of the territory with prospects of success on the global market. Chemical-pharmaceutical, biomedical and biotechnological field is one of the 7 sectors considered of greatest interest for the S3. Key engine of biotechnology development are biological materials and associated data, stored in biobanks. However, to ensure that the research and product development carried out with that resources gives statistically significant and reproducible results, it is essential that they are collected, manipulated and stored using standardized and traced methods. Implementation of the recent published standard ISO 20387- "Biotechnology-Biobanking-General requirements for biobanking" is bridging biobanks toward to storage and distribution of qualified biological material only. Human biobanks are also an essential part of the assistance and care of the citizen and constitute an unavoidable cost of the regional health system. However, biobanks organization, rationalization of their territorial distribution, completion of the process of recognition and regional accreditation, parallel to the implementation of the offer of remunerated services for biobanking, can turn the cost of the necessary preservation of the samples, into an opportunity of territorial development. The paper describes the necessity, shared by a working group represented by several Lazio biobanks, of including biobank activities in the virtuous circle designed by the S3,concretizing the framework prefigured by the S3 document on infrastructures for research, innovation and technology transfer. To allow inclusion of biobank activities in the virtuous circle, we underline the need to quickly start the process of recognition of the territorial research biobanks, to implement at regional level the process of optimization and rationalization of the management of biological samples, in accordance with the international harmonization standards and with the territorial indications of sustainability.
拉齐奥大区的智能专业化战略（S3）定义了智能专业化战略，以发挥该地区的优势，在全球市场上取得成功。化学制药、生物医学和生物技术领域是S3认为最具潜力的7个领域之一。生物技术发展的关键驱动力是存储在生物样本库中的生物材料及相关数据。然而，为确保利用这些资源开展的研究和产品开发能够得出具有统计学意义且可重复的结果，必须使用标准化且可追溯的方法对其进行收集、处理和存储。最新发布的ISO 20387标准——“生物技术——生物样本库——生物样本库通用要求”的实施，正促使生物样本库朝着仅存储和分发合格生物材料的方向发展。人类生物样本库也是公民医疗救助的重要组成部分，并构成了地区卫生系统一项不可避免的成本。然而，生物样本库的组织建设、其地域分布的合理化、认可和地区认证流程的完善，以及与有偿生物样本库服务提供并行开展，能够将样本必要保存的成本转化为地区发展的机遇。本文描述了由几个拉齐奥生物样本库组成的工作组所认同的一种必要性，即将生物样本库活动纳入S3所设计的良性循环中，具体落实S3文件中关于研究、创新和技术转让基础设施所预先设定的框架。为了将生物样本库活动纳入良性循环，我们强调需要迅速启动对地区研究生物样本库的认可程序，按照国际协调标准和可持续性的地域指标，在地区层面实施生物样本管理的优化和合理化进程。
