Case study applied to the development of an Upstream process (USP)

This activity details the steps of the cell culture (Upstream) process for the production of monoclonal antibodies and CAR-T cells, from the cell bank to harvest. It highlights key process elements—host cell, culture medium, equipment—as well as the Quality Attributes (QAs and CQAs) that must be monitored and optimized during development.

This activity applies development methodology to an Upstream (USP) process for cell therapy, focusing on the transduction steps required to obtain CAR(+) TCR(–) T cells. It introduces critical process parameters (CPPs) such as multiplicity of infection and cell density, as well as analytical techniques like flow cytometry to optimize product quality attributes.

This activity puts into practice the Quality by Design (QbD) approach applied to the production of a monoclonal antibody in a bioreactor. It details the identification of Critical Quality Attributes (CQAs), risk analysis, selection of Critical Process Parameters (CPPs), development of the Design Space using Design of Experiments (DoE), and definition of the control strategy to ensure process robustness.