title: The implementation of tissue banking experiences for setting up a cGMP cell manufacturing facility.
abstract: Cell manufacturing for clinical applications is a unique form of biologics manufacturing that relies on maintenance of stringent work practices designed to ensure product consistency and prevent contamination by microorganisms or by another patient's cells. More extensive, prolonged laboratory processes involve greater risk of complications and possibly adverse events for the recipient, and so the need for control is correspondingly greater. To minimize the associate risks of cell manufacturing adhering to international quality standards is critical. Current good tissue practice (cGTP) and current good manufacturing practice (cGMP) are examples of general standards that draw a baseline for cell manufacturing facilities. In recent years, stem cell researches have found great public interest in Iran and different cell therapy projects have been started in country. In this review we described the role of our tissue banking experiences in establishing a new cGMP cell manufacturing facility. The authors concluded that, tissue banks and tissue banking experts can broaden their roles from preparing tissue grafts to manufacturing cell and tissue engineered products for translational researches and phase I clinical trials. Also they can collaborate with cell processing laboratories to develop SOPs, implement quality management system, and design cGMP facilities.
authors.affiliation: Endocrinology and Metabolism Research Center and Brain and Spinal Injury Repair Research Center, Tehran University of Medical Sciences, Shariati Hospital, North Kargar Avenue, Tehran, Iran. b_arjmand@farabi.tums.ac.ir
authors.forename: Babak
authors.initials: B
authors.lastname: Arjmand
authors.forename: Seyed Hassan
authors.initials: SH
authors.lastname: Emami-Razavi
authors.forename: Bagher
authors.initials: B
authors.lastname: Larijani
authors.forename: Abbas
authors.initials: A
authors.lastname: Norouzi-Javidan
authors.forename: Hamid Reza
authors.initials: HR
authors.lastname: Aghayan
mesh_terms: D000818:Animals; D064987:Cell- and Tissue-Based Therapy / Q000592:standards*; D006801:Humans; D007492:Iran; D007753:Laboratories; D011786:Quality Control; D014015:Tissue Banks / Q000592:standards*