Proceedings of the 2019 Viral Clearance Symposium, Session 3: Continuous Processing

Area of Science:

• Biotechnology
• Pharmaceutical Manufacturing
• Viral Safety

Background:

• Continuous processing offers advantages in biopharmaceutical manufacturing.
• Integrating viral clearance into continuous processes is crucial for product safety.
• Small-scale models are essential for evaluating viral clearance in continuous systems.

Purpose of the Study:

• To assess the impact of continuous processing conditions on viral safety.
• To explore strategies for designing continuous viral inactivation and removal steps.
• To evaluate the use of existing batch data for continuous viral clearance demonstration.

Main Methods:

• Investigating endogenous retroviral-like particle production during extended continuous cell culture.
• Assessing multicolumn capture chromatography and continuous viral filtration for viral particle clearance.
• Leveraging batch processing data and scientific knowledge for continuous process validation.

Main Results:

• Continuous processing conditions can impact viral safety, including endogenous particle production.
• Multicolumn chromatography and continuous viral filtration demonstrate robustness in viral clearance.
• Batch data and scientific knowledge can support viral clearance claims for continuous processes.

Conclusions:

• The session provided valuable scientific insights into viral clearance for continuous biomanufacturing.
• Effective viral clearance strategies are key to successful continuous process implementation.
• Further research supports the integration of viral safety measures in continuous manufacturing.