Practicing safe cell culture: applied process designs for minimizing virus contamination risk

Area of Science:

• Biologics Manufacturing
• Viral Safety
• Process Engineering

Background:

• Biologics manufacturing facilities are susceptible to viral contamination events.
• Such events can significantly impact product safety and manufacturing timelines.
• Proactive strategies are essential to mitigate these risks.

Purpose of the Study:

• To describe Genentech's response to a viral contamination incident.
• To detail the implementation of multi-layered barriers to prevent recurrence.
• To share lessons learned in minimizing virus contamination risk in cell culture processes.

Main Methods:

• Development and implementation of inactivation and removal steps for raw materials.
• Establishment of analytical testing barriers for downstream processing protection.
• Integration of robust virus clearance capabilities into manufacturing.

Main Results:

• Successful implementation of a comprehensive barrier system.
• Demonstrated ability to inactivate/remove potential virus particles.
• Enhanced assurance of viral safety in biologics products.

Conclusions:

• A multi-layered barrier approach is effective in minimizing virus contamination risk.
• Targeted barriers enhance the safety and success rate of biologics production.
• Continuous improvement and risk mitigation are crucial in biologics manufacturing.