Manufacturing Therapeutic Exosomes: from Bench to Industry

被引：89

作者：

Ahn, So-Hee ^{[1
]}

Ryu, Seung-Wook ^{[1
]}

Choi, Hojun ^{[1
]}

You, Sangmin ^{[1
]}

Park, Jun ^{[1
]}

Choi, Chulhee ^{[1
,2
]}

机构：

[1] ILIAS Biol Inc, Daejeon 34014, South Korea

[2] Korea Adv Inst Sci & Technol KAIST, Dept Bio & Brain Engn, Daejeon 34141, South Korea

来源：

MOLECULES AND CELLS | 2022年 / 45卷 / 05期

基金：

新加坡国家研究基金会;

关键词：

characterization; exosome; manufacturing; purity; quality control; CELL-DERIVED EXOSOMES; EXTRACELLULAR VESICLES;

D O I：

10.14348/molcells.2022.2033

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

Process of manufacturing therapeutics exosome development for commercialization. The development of exosome treatment starts at the bench, and in order to be commercialized, it goes through the manufacturing, characterization, and formulation stages, production under Good Manufacturing Practice (GMP) conditions for clinical use, and close consultation with regulatory authorities. 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.

引用

页码：284 / 290

页数：7

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