Introduction to the methodology of development for cell culture (USP) and purification (DSP) processes

This activity introduces Upstream (cell culture) and Downstream (purification) processes through two therapeutic approaches: monoclonal antibodies and CAR-T cell therapy. It describes the role of the CMC team throughout the development lifecycle and presents the foundations of the Quality by Design (QbD) approach, aiming to strengthen understanding of bioprocesses and improve control over the quality of biological products.

This activity outlines the main steps involved in implementing the Quality by Design (QbD) approach in bioproduction: defining the Quality Target Product Profile (QTPP), identifying Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), and building the Design Space using Design of Experiments (DoE), with the goal of ensuring process robustness and final product quality.

This activity presents the key documents generated during the development of USP and DSP processes, such as analytical reports, characterization studies, and specifications. It highlights their central role in building an overarching control strategy, compiling the regulatory dossier, and facilitating knowledge transfer between development and manufacturing.