AUTHOR=Sivasubramanian Maharajan , Lin Li-Jie , Wang Yu-Chao , Yang Chung-Shi , Lo Leu-Wei 

TITLE=Industrialization’s eye view on theranostic nanomedicine

JOURNAL=Frontiers in Chemistry

VOLUME=Volume 10 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/chemistry/articles/10.3389/fchem.2022.918715

DOI=10.3389/fchem.2022.918715

ISSN=2296-2646

ABSTRACT=The emergence of nanomedicine in the healthcare industry will bring about groundbreaking improvements to the current therapeutic and diagnostic scenario. However, only a few nanomedicines have been developed into clinical applications due to a lack of regulatory experience with nanomedicine. In this article, we highlight existing strategies of nanomedicine from academic research to clinical development. Certain kinds of multifunctional and multistep nanomedicines are discussed in current literature. We propose some challenges presented by transforming nanomedicine from the preclinical to the clinical level, as well as relevant standards issued by the ISO and major regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). From industry’s perspective, multistep nanomedicines are at the stage of clinical development. However, multifunctional nanomedicines remain potentially critical in certain complicated clinical cases, such as spinal cord injury.