Exosomes in clinical trial and their production in compliance with good manufacturing practice

Yu-Shuan Chen; En-Yi Lin; Tzyy-Wen Chiou; Horng-Jyh Harn

doi:10.4103/tcmj.tcmj_182_19

Exosomes in clinical trial and their production in compliance with good manufacturing practice

Ci Ji Yi Xue Za Zhi. 2019 Dec 5;32(2):113-120. doi: 10.4103/tcmj.tcmj_182_19. eCollection 2020 Apr-Jun.

Authors

Yu-Shuan Chen^{1

2}, En-Yi Lin^{1

3}, Tzyy-Wen Chiou³, Horng-Jyh Harn^{1

4}

Affiliations

¹ Bioinnovation Center, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan.
² Department of Medical Research, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan.
³ Department of Life Science and Graduate Institute of Biotechnology, National Dong Hwa University, Hualien, Taiwan.
⁴ Department of Pathology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.

Abstract

Exosomes, 60-200-nm extracellular vesicles secreted from cells, have been used as an active pharmaceutical ingredient or drug carrier in disease treatment. Human- and plant-derived exosomes are registered in clinical trials, but more complete reports are available for human-derived exosomes. Because exosomes act as vesicles and carry cell secreting components, they have been used as drug or peptide vehicles to treat diseases. The dendritic cells (DCs) and mesenchymal stem cells (MSCs) are two popular cell sources for exosome preparation. Exosomes from DCs can initiate inflammation in patients, particularly in patients with cancer, as they contain the tumor antigen to induce specific inflammation response. A well-established cell bank of MSCs is available, and these cells can be used as an alternative source for exosome preparation. The major application of MSC-derived exosomes is in inflammation treatment. Exosomes in clinical trials need to comply with good manufacturing practice (GMP). Three important issues are prevalent in GMP for exosomes, i.e., upstream of cell cultivation process, downstream of the purification process, and exosome quality control. This paper concisely reviews exosome development, including exosome generation and clinical trial application.

Keywords: Clinical trial; Exosomes; Good manufacturing practice.

Publication types

Review