POSTER PRESENTATION Open Access Quality compliance in the development of cell- based medicines in non-pharma environments

Abstract

Academic institutions and transfusion centres are posi-tioned to lead the development of novel cell-based ther-apeutics up to early-stage clinical trials (and further seeking marketing authorisation) or, alternatively, its use under the hospital exemption clause [1,2]. Existing structures, including blood and tissue bank facilities, translational medical programs and skilled personnel experienced in cell culture technologies and transplanta-tion, equips these non-commercial entities to translate research-grade cell materials into safe and commercially viable products suitable for human use. However, devel-opers must negotiate the complex regulatory and quality requirements involving the compulsory compliance of Good Scientific Practice (GxP) regulations in the devel-opment of advanced therapy medicinal product