Have you had any issues with regulatory validation of N-1 perfusion processes?
This question is part of the following Ask The Expert session:
Utilizing N-1 Perfusion to Increase Productivity and Intensify Processes
Answered by:
Company: Catalent Biologics
Job Title: Director, Process Development Department
Answer
Perfusion processes have specific aspects to be considered for process validation that are different from traditional fed batch processes such as: extended cell generations and associated genetic stability during production, consistent process operation, and product characterization consistency at all stages of the production process. Other process validation guidance should be considered and properly applied to N-1 perfusion and production perfusion processes.
This post is sponsored by Catalent Biologics.