Autologous and Allogeneic Scale-up
Process Scale-up and Characterization Strategy for an Allogeneic Cell Therapy Product
One of the major challenges with cell therapy products is the development of a robust and scalable process that meets current Good Manufacturing Production (cGMP) requirements to manufacture the product for clinical trials and commercialization. A case study will be presented on the selection of process technologies, process development and scale-up of an allogeneic human somatic cell therapy product to produce material for clinical trials. Also, a control strategy based on QbD principles to consistently meet product quality by controlling the process parameters will be discussed.