Manufacturing and characterization of extracellular vesicles from umbilical cord–derived mesenchymal stromal cells for clinical testing

AbstractExtracellular vesicles (EVs) derived from mesenchymal stromal cells (MSCs) may deliver therapeutic effects that are comparable to their parental cells. MSC-EVs are promising agents for the treatment of a variety of diseases. To reach the intermediate goal of clinically testing safety and eff...

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Bibliographic Details
Published in:Cytotherapy (Oxford, England) England), 2019-06, Vol.21 (6), p.581-592
Main Authors: Rohde, Eva, Pachler, Karin, Gimona, Mario
Format: Article
Language:English
Subjects:
Advanced Basic Science
Animals
Biological Products - standards
Biological Products - therapeutic use
Cell Culture Techniques - methods
Cell Culture Techniques - standards
clinical testing of extracellular vesicles
Clinical Trials as Topic
Drug Stability
exosomes
extracellular vesicles (EVs)
Extracellular Vesicles - physiology
extracellular vesicles therapeutics
Humans
Mesenchymal Stem Cells - cytology
Other
pharmaceutical manufacturing
Quality Control
Umbilical Cord - cytology
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Summary:AbstractExtracellular vesicles (EVs) derived from mesenchymal stromal cells (MSCs) may deliver therapeutic effects that are comparable to their parental cells. MSC-EVs are promising agents for the treatment of a variety of diseases. To reach the intermediate goal of clinically testing safety and efficacy of EVs, strategies should strive for efficient translation of current EV research. On the basis of our in vitro an in vivo findings regarding the biological actions of EVs and our experience in manufacturing biological stem cell therapeutics for routine use and clinical testing, we discuss strategies of manufacturing and quality control of umbilical cord–derived MSC-EVs. We introduce guidelines of good manufacturing practice and their practicability along the path from the laboratory to the patient. We present aspects of manufacturing and final product quality testing and highlight the principle of “The process is the product.” The approach presented in this perspective article may facilitate translational research during the development of complex biological EV-based therapeutics in a very early stage of manufacturing as well as during early clinical safety and proof-of-concept testing.
ISSN:1465-3249
1477-2566
DOI:10.1016/j.jcyt.2018.12.006