Manufacturers must address scale-out challenges of autologous cell therapy for commercial manufacturing. Although only a few cell-therapy treatments have regulatory approval, recent years have seen a sharp increase in the number of treatments in development, many are now moving rapidly from late clinical stage to commercialization. Most approved autologous (i.e., patient-specific) cell therapies are being produced for small numbers of patients in laboratory facilities. To support the accelerating commercialization of autologous cell-therapy products and to provide wider access to these innovative treatments globally, cell-therapy manufacturers are increasingly scaling out production. Click Here For Complete Article Text
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