Scalable manufacturing of gene-modified human mesenchymal stromal cells with microcarriers in spinner flasks.

ABSTRACT: Due to their immunomodulatory properties and in vitro differentiation ability, human mesenchymal stromal cells (hMSCs) have been investigated in more than 1000 clinical trials over the last decade. Multiple studies that have explored the development of gene-modified hMSC-based products are now reaching early stages of clinical trial programmes. From an engineering perspective, the challenge lies in developing manufacturing methods capable of producing sufficient doses of ex vivo gene-modified hMSCs for clinical applications. This work demonstrates, for the first time, a scalable manufacturing process using a microcarrier-bioreactor system for the expansion of gene-modified hMSCs. Upon isolation, umbilical cord tissue mesenchymal stromal cells (UCT-hMSCs) were transduced using a lentiviral 

SUBMITTER: Couto PS 

PROVIDER: S-EPMC10439856 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature