The DOI matches its Crossref record; 16 of the 16 references it cites were found in a registry or an index.
Regulation of exosomes as biologic medicines: Regulatory challenges faced in exosome development and manufacturing processes
Open accessAbstract
With advances in medical technology, extracellular vesicles, also known as exosomes, are gaining widespread attention because of their potential therapeutic applications. However, their regulatory landscape is complex and varies across countries because of their unique intracellular mechanisms of action. The diversity of manufacturing techniques renders their standardization challenging, leading to a fragmented regulatory landscape. The current global regulatory framework of exosomes can be broadly classified into two strategies: one involves elucidating constituent components within exosomes and the other involves examining the physiological repercussions of their secretion. When using exosomes as therapeutic agents, they should be governed similarly to biological medicinal products. Similar to biologics, exosomes have been analyzed to determine their particle size and protein composition. An exosome‐based therapeutic agent should be clinically approved after understanding its molecular composition and structure and demonstrating its pharmacokinetics and therapeutic efficacy. However, demonstrating the pharmacokinetics and therapeutic efficacy of exosomes is challenging for regulatory agencies. This article reviews the technical characteristics of exosomes, analyzes the trends in regulatory laws in various countries, and discusses the chemistry, manufacturing, and control requirements of clinical applications.
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Cites
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Cited by
Verma, N., & Arora, S. (2025) · Pharmaceutics · doi:10.3390/pharmaceutics17080990 · Cited by 173
Domaszewska-Szostek, A., Krzyżanowska, M., Polak, A., & Puzianowska-Kuźnicka, M. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26052354 · Cited by 32
Tanaka, M., Araujo, A. C., Valenti, V. E., Guiguer, E. L., Catharin, V. C. S., Gualhardi, C. M., de Souza Bastos Mazuqueli Pereira, E., de Alvares Goulart, R., de Argolo Haber, R. S., de Carvalho, A. C. A., et al. (2026) · International Journal of Molecular Sciences · doi:10.3390/ijms27052370 · Cited by 13
Metadata
- Authors
- Wang, C., Tsai, T., & Lee, C.
- Venue
- Clinical and Translational Science
- Publisher
- Wiley
- Published
- 2024-08
- Volume
- 17
- Issue
- 8
- Pages
- e13904-e13904
- ISSN
- 1752-8054 (ISSN-L)
- 1752-8062
- OpenAlex
- W4401425344
- Cited by
- 280
- References
- 16
- FWCI
- 32.53
- Type
- journal article
- Language
- en
- Open access
- gold
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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