Molecules and Cells

Korean Society for Molecular and Cellular Biology (한국분자세포생물학회)
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Manufacturing Therapeutic Exosomes: from Bench to Industry

  • Received : 2021.11.23
  • Accepted : 2022.02.14
  • Published : 2022.05.31
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Abstract

Exosome, a type of nanoparticles also known as small extracellular vesicles are gaining attention as novel therapeutics for various diseases because of their ability to deliver genetic or bioactive molecules to recipient cells. Although many pharmaceutical companies are gradually developing exosome therapeutics, numerous hurdles remain regarding manufacture of clinical-grade exosomes for therapeutic use. In this mini-review, we will discuss the manufacturing challenges of therapeutic exosomes, including cell line development, upstream cell culture, and downstream purification process. In addition, developing proper formulations for exosome storage and, establishing good manufacturing practice facility for producing therapeutic exosomes remains as challenges for developing clinical-grade exosomes. However, owing to the lack of consensus regarding the guidelines for manufacturing therapeutic exosomes, close communication between regulators and companies is required for the successful development of exosome therapeutics. This review shares the challenges and perspectives regarding the manufacture and quality control of clinical grade exosomes.

Keywords

Acknowledgement

This work was supported by the National Research Foundation (NRF) of Korea (2016M3A9B6945931) from Ministry of Science and ICT, Republic of Korea.

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