Khorasani Ali A, Weaver James L, Salvador-Morales Carolina
Department of Chemistry and Biochemistry, George Mason University, Fairfax, VA, USA ; Bioengineering Department, George Mason University, Fairfax, VA, USA ; Krasnow Institute for Advanced Study, George Mason University, Fairfax, VA, USA.
Division of Applied Regulatory Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Int J Nanomedicine. 2014 Dec 8;9:5729-51. doi: 10.2147/IJN.S72479. eCollection 2014.
On the cusp of widespread permeation of nanomedicine, academia, industry, and government have invested substantial financial resources in developing new ways to better treat diseases. Materials have unique physical and chemical properties at the nanoscale compared with their bulk or small-molecule analogs. These unique properties have been greatly advantageous in providing innovative solutions for medical treatments at the bench level. However, nanomedicine research has not yet fully permeated the clinical setting because of several limitations. Among these limitations are the lack of universal standards for characterizing nanomaterials and the limited knowledge that we possess regarding the interactions between nanomaterials and biological entities such as proteins. In this review, we report on recent developments in the characterization of nanomaterials as well as the newest information about the interactions between nanomaterials and proteins in the human body. We propose a standard set of techniques for universal characterization of nanomaterials. We also address relevant regulatory issues involved in the translational process for the development of drug molecules and drug delivery systems. Adherence and refinement of a universal standard in nanomaterial characterization as well as the acquisition of a deeper understanding of nanomaterials and proteins will likely accelerate the use of nanomedicine in common practice to a great extent.
在纳米医学广泛普及的前夕,学术界、产业界和政府已投入大量资金,致力于开发更好治疗疾病的新方法。与它们的宏观或小分子类似物相比,材料在纳米尺度具有独特的物理和化学性质。这些独特性质在为实验室层面的医学治疗提供创新解决方案方面具有极大优势。然而,由于若干限制,纳米医学研究尚未完全渗透到临床环境中。这些限制包括缺乏表征纳米材料的通用标准,以及我们对纳米材料与蛋白质等生物实体之间相互作用的了解有限。在本综述中,我们报告了纳米材料表征的最新进展以及纳米材料与人体蛋白质相互作用的最新信息。我们提出了一套用于纳米材料通用表征的标准技术。我们还讨论了药物分子和药物递送系统开发转化过程中涉及的相关监管问题。坚持并完善纳米材料表征的通用标准,以及更深入地了解纳米材料和蛋白质,很可能会在很大程度上加速纳米医学在常规实践中的应用。