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​The development and clinical application of human mesenchymal stromal cells (hMSCs) as a therapeutic modality require strict adherence to Good Manufacturing Practices (GMP) to ensure product safety, efficacy, and consistency. GMP guidelines are essential in maintaining high-quality standards throughout the production, processing, and distribution of hMSCs for therapeutic use. In GMP-compliant manufacturing of hMSCs, various critical quality attributes (CQAs) must be systematically controlled. This includes rigorous characterization of hMSCs to confirm phenotypic markers (such as CD73, CD90, and CD105) and to ensure the absence of hematopoietic markers (such as CD34, CD45), ensuring the purity and identity of the cell product. Comprehensive in vitro differentiation assays for adipogenic, osteogenic, and chondrogenic potential assess multipotency. The elimination of microbial contamination is ensured through microbiological testing, including sterility testing, mycoplasma testing, and endotoxin detection. GMP also mandates monitoring of genetic stability, where karyotyping or genetic sequencing methods are used to confirm the absence of chromosomal abnormalities. Furthermore, the functional capacity of hMSCs is validated by assessing their immunomodulatory effects, including cytokine secretion profiles and their ability to modulate T-cell proliferation. A GMP-compliant production environment requires close control over the cell expansion process, aseptic techniques, and proper documentation, all contributing to the creation of a reproducible, safe, and effective MSC product. These stringent GMP protocols help ensure that hMSCs meet regulatory standards, providing a foundation for their safe application in clinical trials and beyond.