Formulation, manufacturing and regulatory strategies for extracellular vesicles-based drug products for targeted therapy of central nervous system diseases
Abstract
Introduction: Extracellular vesicles (EVs) are a family of natural nanosize vesicles that transport biological cargos, including DNA, RNA, protein, and lipids. In recent years, EVs have attracted a lot of attention for their capability to function as a drug delivery system (DDS). While clinical trials have been conducted, the techniques to formulate, process, and quality control EVs-based drug products still have the potential to be improved, especially in large scale production. Areas covered: We will introduce and discuss EVs biology, their potential role in CNS pathologies under different conditions, and recent methods of isolation. We will then provide a detailed discussion on current benchtop formulation methods, quality control methods, and regulatory affairs for EVs-based drug products. Expert opinion: Despite being a hot topic, EVs-based drug products have not received any approval from regulatory agencies. In this review, we will provide general guidance to help EVs-based drug products to ‘move from bench to bedside’.
Publication Title
Expert Review of Precision Medicine and Drug Development
Recommended Citation
Zhi, K., Kumar, A., Raji, B., Kochat, H., & Kumar, S. (2020). Formulation, manufacturing and regulatory strategies for extracellular vesicles-based drug products for targeted therapy of central nervous system diseases. Expert Review of Precision Medicine and Drug Development, 5 (6), 469-481. https://doi.org/10.1080/23808993.2020.1812382
