We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Regulation of exosomes as biologic medicines: Regulatory challenges faced in exosome development and manufacturing processes.
- Authors
Wang, Chun‐Kai; Tsai, Teng‐Huang; Lee, Chung‐Hsi
- Abstract
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.
- Subjects
EXTRACELLULAR vesicles; FRAGMENTED landscapes; EXOSOMES; MOLECULAR structure; MEDICAL technology
- Publication
CTS: Clinical & Translational Science, 2024, Vol 17, Issue 8, p1
- ISSN
1752-8054
- Publication type
Article
- DOI
10.1111/cts.13904