Identification of critical process parameters and quality attributes for bioreactor-based expansion of human MSCs.

ABSTRACT: Mesenchymal stem/stromal cells (MSCs) have been identified as a promising therapeutic option for osteoarthritis, graft vs. host disease and cardiovascular diseases, among others. For widespread application of these therapies, robust and scaled manufacturing processes are required that reliably yield high amounts of high quality MSCs. One of the primary challenges in MSC manufacturing is achieving robustness, due to the high donor-to-donor and batch-to-batch variability seen in MSC manufacturing. To achieve more consistent manufacturing, standardization of the manufacturing process and analytical methods to determine cell quality and control process parameters will be needed. Traditionally, MSCs are cultivated in two dimensional (2D) systems, such as flasks or plates. However, these systems

SUBMITTER: Herbst L 

PROVIDER: S-EPMC12408662 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature