DSP Process in cGMPs

This activity defines cGMPs and their central role in the manufacturing of biological products, emphasizing the responsibilities of industrial stakeholders and the importance of compliance. It explains how these regulatory requirements apply concretely to the DSP process, from clarification to purification.

This activity presents the main separation and filtration techniques used in purification—such as chromatography and ultrafiltration—linking them to the specific objectives of each DSP step. It illustrates their implementation in compliance with cGMPs through a standard example of monoclonal antibody purification.

This activity places learners in a cGMP-compliant industrial environment, retracing the key steps of the DSP process from buffer preparation to diafiltration. It offers real-life scenarios involving incidents, deviations, and quality controls to help develop strong analysis, traceability, and field action reflexes.