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.