Viral clearance

This activity presents the mechanisms of viral inactivation and removal, explaining how these steps are integrated into the DSP to ensure the safety of products derived from cell lines. It details the characteristics of target viruses, common methods such as low pH treatment and nanofiltration, and the design criteria for an effective process.

This activity explores the potential sources of viral contamination, particularly through raw materials of biological origin, and the means to prevent them. It introduces the three pillars of viral safety—raw material selection, virological testing, and clearance steps—emphasizing their complementarity and central role in controlling viral risk.

This activity explains the objectives and key stages of viral clearance validation studies performed on the DSP to demonstrate its effectiveness in removing or inactivating model viruses. It describes the criteria for virus selection, spiking methods, regulatory requirements, and interpretation of results.