Cellular and Molecular Therapies have progressed significantly over the last years introducing novel methods of clinical intervention to replace, repair or restore the lost function of tissues and organs. Life sciences and engineering would allow the translation from the concept of a medical intervention in a complex disease scenario, to the manufacture of safe and effective innovative medicinal products towards and realization of the economical and societal impact of these strategies for disease intervention.
The robust and scalable cell manufacturing for the cost-effective delivery of safe and potent cell-derived Advanced Therapy Medicinal Products (ATMPs) (either with autologous origin (i.e. cells from the patient) or allogeneic relies on process engineering tools to understand the impact of biological and biochemical features on product function and performance, and how do process variables influence the critical quality attributes of the cell-derived product.