Cell Therapy Manufacturing and Quality Control: Current Process and Regulatory Challenges

Abstract

Mesenchymal stromal cells (MSC) are multipotent stem cells that have been isolated from multiple tissue sources and are currently being used to demonstrate their therapeutic efficacy against various clinical indications. Dramatic increase in the use of MSCs for tissue engineering applications and in regenerative medicine in past two decades raises an increasing demand for cGMP (current Good Manufacturing Practice) based large-scale manufacturing process of MSCs and characterization of these cells. The challenge is to assure the safety and high-quality of cells that will ultimately be therapeutically effective. GMP compliance processing such as cell culture, expansion and cryopreservation is mandatory for making the cell therapy effective. MSCs from various tissue sources should be cultured for scale-up according to regulatory compliance to optimize culture conditions and to ensure the safety of these manufactured cell populations. This review describes cGMP compliances and manufacturing process of bone marrow derived MSCs; specifically in the context of establishing the process flow and in-process controls for the manufacturing process. Importantly, this review highlights the current manufacturing challenges and opportunities for process improvisation and its relevance’s for MSCs therapeutics potential.