Mesenchymal stem/stromal cells (MSCs) can be used as a therapeutic agent
in regenerative medicine, owing to their unique self-renewal, multi-lineage
differentiation, and immunoregulation properties. The manufacturing of authorized
MSC products should depend on good manufacturing practices (GMP), Good
Laboratory Practice (GLP), and Good Clinical Practice (GCP). Until now, many
biotech companies have invested in developing the clinical application of MSC product
all over the world. Meanwhile, the application of MSC products for human use must
comply with regulations and guidance for a biotech company. In this chapter, we
discuss the process and development of MSC products from production-manufacturing
to commercialization.
Keywords: Commercialization, GMP, GLP, GCP, Mesenchymal stem/stromal cells, Regulations
