MSCs as Biological Drugs: From Manufacturing to Commercialization

Pp: 160-173 (14)

* (Excluding Mailing and Handling)

Abstract

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

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