There are numerous hurdles hindering the clinical translation of nanomedicines. The major challenges are: reproducible manufacturing and scale-up, availability of appropriate characterization methods, instability under in vivo environments, safety issues, poor understanding of the disease heterogeneity and patient preselection strategies, regulatory barriers and inadequate understanding of the biophysical and chemical interactions of nanoformulations. Thus, a better understanding of key physicochemical attributes and their characterization methods, in vivo behavior and the in-vitro–in-vivo characterization cascade of stability, safety and efficacy testing is needed to accelerate nanomedicine translation. Technologies such as quality-by-design, process analytical techniques and microfluidics could significantly accelerate the translation of nanomedicines. However, these approaches require further learning and an adequate regulatory background. Overall, to achieve an efficient clinical translation, collaboration among academia, industry and regulatory bodies is required to ensure safe and effective nanomedicine products. This review discusses the challenges and opportunities to facilitate the translation of nanomedicines to a commercial product.

有许多障碍阻碍了纳米药物的临床翻译。主要挑战是：可重复生产和扩大规模，适用的表征方法的可用性，体内环境下的不稳定性，安全性问题，对疾病异质性和患者预选策略的了解不足，监管障碍以及对乙醇的生物物理和化学相互作用的了解不足纳米制剂。因此，可以更好地了解关键的理化特性及其表征方法，体内行为和体外-体内需要进行稳定性，安全性和功效测试的表征级联，以加速纳米药物的翻译。通过设计质量，过程分析技术和微流体技术等技术可以显着加速纳米药物的翻译。但是，这些方法需要进一步学习和适当的监管背景。总体而言，为了实现有效的临床翻译，需要学术界，行业和监管机构之间的合作以确保安全有效的纳米药物产品。这篇综述讨论了将纳米药物转化为商业产品的挑战和机遇。