The clinical translation of Mesenchymal Stem Cells requires navigating a complex Regulatory Landscape, as these products are typically classified as advanced therapy medicinal products (ATMPs) in Europe and similar high-level biologics in other jurisdictions. Regulatory agencies, including the US FDA, EMA, and MFDS (South Korea), demand stringent controls over the entire manufacturing process, from donor screening and cell isolation to ex vivo expansion and final product release testing.

A major challenge for manufacturers is demonstrating consistent potency and stability—ensuring that the cells retain their therapeutic function (e.g., immunomodulation or differentiation potential) throughout storage and upon administration. Due to the inherent variability of cellular products, the regulatory pathway is lengthy and expensive, contributing to the extremely high cost of approved MSC therapies. This environment fosters significant investment in industrial-scale Good Manufacturing Practice (GMP) facilities to produce safe, high-quality, and reproducible cell doses for clinical application.

Related Reports