Regulation of exosomes as biologic medicines: Regulatory challenges faced in exosome development and manufacturing processes

• Published in: Clinical and translational science Vol. 17; no. 8; pp. e13904 - n/a
• Main Authors: Wang, Chun‐Kai, Tsai, Teng‐Huang, Lee, Chung‐Hsi
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01.08.2024; John Wiley and Sons Inc; Wiley
• Subjects: Animals; Biological products; Biological Products - metabolism; Biological Products - pharmacokinetics; Chromatography; Cryopreservation; Disease; Drug delivery systems; Drugs; Exosomes; Exosomes - metabolism; Good Manufacturing Practice; Humans; Manufacturing; MicroRNAs; Mini Review; Particle size; Pharmaceuticals; Pharmacokinetics; Protein composition; Protein structure; Quality control; Quality standards; Regulatory approval; Stem cells; Therapeutic applications; United States > US

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 ac...