Exosomes from mesenchymal stem cells (exo-MSCs) have been shown to have many important biological effects, particularly in the treatment of certain diseases. Therefore, they have great potential to become a type of biological product used in disease treatment or supportive therapy. Many processes for exo-MSC production have been established and standardized. Some of these products have been used by humans in various clinical research settings. Generally, the production of Exo-MSCs involves two main stages: the first stage is the production of supernatant from mesenchymal stem cell expansion, and the second stage is exosome isolation, packaging, and storage. This chapter aims to synthesize and introduce the main aspects of the production and quality control process of Exo-MSCs for human use. It serves as an important reference source for developing production processes from mesenchymal stem cells in laboratories and cell processing centers.

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Manufacturing and Quality Control of Mesenchymal Stem Cell–Derived Exosomes for Clinical Application

  • Ngoc Bich Vu,
  • Phuong Thi-Bich Le,
  • Phuc Van Pham

摘要

Exosomes from mesenchymal stem cells (exo-MSCs) have been shown to have many important biological effects, particularly in the treatment of certain diseases. Therefore, they have great potential to become a type of biological product used in disease treatment or supportive therapy. Many processes for exo-MSC production have been established and standardized. Some of these products have been used by humans in various clinical research settings. Generally, the production of Exo-MSCs involves two main stages: the first stage is the production of supernatant from mesenchymal stem cell expansion, and the second stage is exosome isolation, packaging, and storage. This chapter aims to synthesize and introduce the main aspects of the production and quality control process of Exo-MSCs for human use. It serves as an important reference source for developing production processes from mesenchymal stem cells in laboratories and cell processing centers.