A Methodological Safe-by-Design Approach for the Development of Nanomedicines
A Methodological Safe-by-Design Approach for the Development of Nanomedicines
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DOI：
10.3389/fbioe.2020.00258
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发表时间：
2020-04-02
影响因子：
5.7
通讯作者：
Som, Claudia
中科院分区：
文献类型：
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作者：
Schmutz, Melanie;Borges, Olga;Som, Claudia
设计安全 (SbD) 概念预见到在产品开发的早期阶段识别和减少风险以及有关人类健康和环境安全的不确定性。欧盟的 NANoREG 项目以及 H2020 ProSafe 计划、NanoReg2 和 CALIBRATE 项目进一步开发了用于纳米技术（例如油漆、纺织品等）的通用 SbD 方法。在此基础上，GoNanoBioMat 项目详细阐述了纳米药物的 SbD 方法（GoNanoBioMat SbD 方法），重点关注用于药物输送的聚合纳米生物材料（NBM）。 NBM 具有多种优势，例如提高药物功效和生物利用度的潜力。然而，纳米尺度给产品设计、制造和处理带来了新的挑战。纳米药物成本高昂，需要结合多个领域的知识。在本文中，我们提出了 GoNanoBioMat SbD 方法，该方法允许在设计、表征、人类健康和环境风险评估、制造和处理过程中识别和解决开发聚合物 NBM 时要解决的相关安全问题，并将纳米级和医学领域结合在一种方法下。此外，监管要求也融入到创新过程中。
Safe-by-Design (SbD) concepts foresee the risk identification and reduction as well as uncertainties regarding human health and environmental safety in early stages of product development. The EU's NANoREG project and further on the H2020 ProSafe initiative, NanoReg2, and CALIBRATE projects have developed a general SbD approach for nanotechnologies (e.g., paints, textiles, etc.). Based on it, the GoNanoBioMat project elaborated a methodological SbD approach (GoNanoBioMat SbD approach) for nanomedicines with a focus on polymeric nanobiomaterials (NBMs) used for drug delivery. NBMs have various advantages such as the potential to increase drug efficacy and bioavailability. However, the nanoscale brings new challenges to product design, manufacturing, and handling. Nanomedicines are costly and require the combination of knowledge from several fields. In this paper, we present the GoNanoBioMat SbD approach, which allows identifying and addressing the relevant safety aspects to address when developing polymeric NBMs during design, characterization, assessment of human health and environmental risk, manufacturing and handling, and combines the nanoscale and medicine field under one approach. Furthermore, regulatory requirements are integrated into the innovation process.