Hamid Reza Aghayan - Cell Therapy and Regenerative Medicine Research Center, Endocrinology and Metabolism Molecular Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran

Stem cell research and cell-based therapies have grown rapidly during recent years in Iran. Many academic research centers and knowledge-based companies have been established to promote cell therapy products commercialization. The lack of knowledge and experience in field of Good Manufacturing Practice (GMP) compliant cell manufacturing is a serious concern for patient safety that needs intervention by regulatory bodies. According to the current regulations of the Iran Food and Drug Association (IFDA), cell therapy products should be manufactured under principles of GMP. The main focus of this presentation will be on challenging parts of GMP for cell therapy products manufacturing. Selection of appropriate raw materials and properties of a cell manufacturing facility will be discussed in more details

Cell therapy, Clean room, GMP, Regenerative Medicine, Regulation