W104 - Cell and Gene Therapy Product Manufacturing

With the significant progression of late stage cell and gene therapy products, and the market approval of personal therapies, manufacturing of these complex products requires advanced technologies. With the reality of no inventory (e.g. autologous cell therapies) or the constraint of manufacturing viral reagents, new technologies have emerged to address these issues. This session will review current and future technologies that must meet the rigor of cGMP and provide cost effective efficiencies. The level of qualification/validation with product comparability must be considered to license, regulatory points will be discussed.