Exosomes in clinical trial and their production in compliance with good manufacturing practice
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...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2020-01-01
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| Series: | Tzu-Chi Medical Journal |
| Subjects: | |
| Online Access: | http://www.tcmjmed.com/article.asp?issn=1016-3190;year=2020;volume=32;issue=2;spage=113;epage=120;aulast=Chen |
| _version_ | 1818198520318918656 |
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| author | Yu-Shuan Chen En-Yi Lin Tzyy-Wen Chiou Horng-Jyh Harn |
| author_facet | Yu-Shuan Chen En-Yi Lin Tzyy-Wen Chiou Horng-Jyh Harn |
| author_sort | Yu-Shuan Chen |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-12T02:07:10Z |
| format | Article |
| id | doaj.art-3ffa698069ec4788987d32cb9de5fdff |
| institution | Directory Open Access Journal |
| issn | 1016-3190 2223-8956 |
| language | English |
| last_indexed | 2024-12-12T02:07:10Z |
| publishDate | 2020-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Tzu-Chi Medical Journal |
| spelling | doaj.art-3ffa698069ec4788987d32cb9de5fdff2022-12-22T00:42:02ZengWolters Kluwer Medknow PublicationsTzu-Chi Medical Journal1016-31902223-89562020-01-0132211312010.4103/tcmj.tcmj_182_19Exosomes in clinical trial and their production in compliance with good manufacturing practiceYu-Shuan ChenEn-Yi LinTzyy-Wen ChiouHorng-Jyh HarnExosomes, 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.http://www.tcmjmed.com/article.asp?issn=1016-3190;year=2020;volume=32;issue=2;spage=113;epage=120;aulast=Chenclinical trialexosomesgood manufacturing practice |
| spellingShingle | Yu-Shuan Chen En-Yi Lin Tzyy-Wen Chiou Horng-Jyh Harn Exosomes in clinical trial and their production in compliance with good manufacturing practice Tzu-Chi Medical Journal clinical trial exosomes good manufacturing practice |
| title | Exosomes in clinical trial and their production in compliance with good manufacturing practice |
| title_full | Exosomes in clinical trial and their production in compliance with good manufacturing practice |
| title_fullStr | Exosomes in clinical trial and their production in compliance with good manufacturing practice |
| title_full_unstemmed | Exosomes in clinical trial and their production in compliance with good manufacturing practice |
| title_short | Exosomes in clinical trial and their production in compliance with good manufacturing practice |
| title_sort | exosomes in clinical trial and their production in compliance with good manufacturing practice |
| topic | clinical trial exosomes good manufacturing practice |
| url | http://www.tcmjmed.com/article.asp?issn=1016-3190;year=2020;volume=32;issue=2;spage=113;epage=120;aulast=Chen |
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