Title:Potential Druggability of Mesenchymal Stem/Stromal Cell-derived Exosomes
Volume: 19
Issue: 9
Author(s): Fan Zhang, Leisheng Zhang and Hao Yu*
Affiliation:
- The Postdoctoral
Research Station, School of Medicine, Nankai University, Tianjin, 300071, China
Keywords:
Exosomes, druggability, quality control, autocrine, sucrose, clinical application.
Abstract: Exosomes secreted by mesenchymal stem/stromal cells (MSC-Exos) are advantageous
candidate sources for novel acellular therapy. Despite the current standards of good manufacturing
practice (GMP), the deficiency of suitable quality-control methods and the difficulties in
large-scale preparation largely restrict the development of therapeutic products and their clinical
applications worldwide. Herein, we mainly focus on three dominating issues commonly encountered
in exosomal GMP, including issues upstream of the cell culture process, downstream of the
purification process, exosomes quality control, and the drug properties of exosomes and their druggability
from a corporate perspective. Collectively, in this review article, we put forward the issues
of preparing clinical exosome drugs for the treatment of diverse diseases and provide new references
for the clinical application of GMP-grade MSC-Exos.