Recommendations for Comparison of Productivity Between Fed-Batch and Perfusion Processes

Area of Science:

• Biopharmaceutical Manufacturing
• Chemical Engineering
• Process Intensification

Background:

• Growing interest in integrated continuous processing within the biopharmaceutical industry.
• Challenges exist in comparing productivity between batch-based and continuous manufacturing approaches.
• Interdisciplinary collaboration is crucial for integrated continuous biopharmaceutical manufacturing.

Purpose of the Study:

• To address confusion arising from differing definitions of productivity metrics, such as volumetric productivity.
• To reiterate standard definitions and underlying assumptions for productivity metrics.
• To provide recommendations for comparing the productivity of upstream bioprocesses.

Main Methods:

• Review and clarification of standard definitions for productivity in biopharmaceutical manufacturing.
• Application of definitions to an exemplary model scenario.
• Analysis of differences in productivity calculations between batch and continuous processes.

Main Results:

• Demonstration of how differing definitions of volumetric productivity impact process comparisons.
• Identification of key assumptions associated with standard productivity metrics.
• Development of a framework for consistent productivity evaluation.

Conclusions:

• Standardized definitions are essential for accurate productivity comparisons in biopharmaceutical manufacturing.
• Clear understanding of assumptions underlying productivity metrics is critical for interdisciplinary teams.
• Recommendations are provided to facilitate effective comparison of batch and continuous upstream processes.