A scalable platform for EPSC-Induced MSC extracellular vesicles with therapeutic potential.

ABSTRACT:

Background

Extracellular Vesicles (EVs) derived from mesenchymal stem cells (MSCs) have gained recognition as promising therapeutic and drug delivery agents in regenerative medicine. However, their clinical application is limited by donor variability, low scalability, and inconsistent therapeutic quality. To overcome these challenges, a robust and standardized production platform is urgently needed.

Methods

We developed a scalable biomanufacturing strategy by generating and expanding MSCs from extended pluripotent stem cells (EPSC) using a suspension bioreactor culture system. A fixed-bed bioreactor was integrated for automated, continuous expansion of iMSCs and downstream EV harvesting. EVs were isolated through a streamlined protocol and characterized for size, morphology,

SUBMITTER: Gong S 

PROVIDER: S-EPMC12326622 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature