Current good manufacturing practice considerations for mesenchymal stromal cells as therapeutic agents
Sanz-Nogués, Clara ; O'Brien, Timothy
Sanz-Nogués, Clara
O'Brien, Timothy
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Repository DOI
Publication Date
2021-05-05
Type
Article
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Citation
Sanz-Nogués, Clara, & O'Brien, Timothy. (2021). Current good manufacturing practice considerations for mesenchymal stromal cells as therapeutic agents. Biomaterials and Biosystems, 2, doi:https://doi.org/10.1016/j.bbiosy.2021.100018
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.
Publisher
Elsevier
Publisher DOI
10.1016/j.bbiosy.2021.100018
Rights
Attribution 4.0 International (CC BY 4.0)