Current good manufacturing practice considerations for mesenchymal stromal cells as therapeutic agents

Clara Sanz-Nogués; Timothy O'Brien

doi:10.1016/j.bbiosy.2021.100018

Current good manufacturing practice considerations for mesenchymal stromal cells as therapeutic agents

Biomater Biosyst. 2021 May 5:2:100018. doi: 10.1016/j.bbiosy.2021.100018. eCollection 2021 Jun.

Authors

Clara Sanz-Nogués¹, Timothy O'Brien¹

Affiliation

¹ Regenerative Medicine Institute (REMEDI), CÚRAM, Biomedical Science Building, National University of Ireland, Galway, Ireland.

Abstract

Producing human mesenchymal stromal cells (MSCs) for clinical use requires adherence to current good manufacturing practice (cGMP) standards. This is necessary for ensuring standardization and reproducibility through the manufacturing process, but also, for product quality and safety. However, the large-scale production of clinical-grade MSCs possesses unique regulatory challenges and hurdles related to the heterogeneous nature of MSC cultures as well as the complex manufacturing process. Following is a compilation of the major issues encountered in the manufacturing of MSCs for clinical use, and our views on the optimal characteristics of the final MSC product.

Keywords: Cell therapy; Clinical grade; Good manufacturing practice; Mesenchymal stromal cells.