Throughput Optimization of Continuous Biopharmaceutical Manufacturing Facilities

Area of Science:

• Biopharmaceutical Manufacturing
• Process Optimization
• Mathematical Modeling

Background:

• Traditional biologics manufacturing faces challenges in flexibility and cost due to equipment limitations.
• Modern bioprocessing facilities leverage reduced footprints, disposables, and continuous manufacturing for efficiency.
• Reducing manufacturing costs for recombinant proteins is a key industry goal.

Purpose of the Study:

• To optimize annual production schedules for biopharmaceutical facilities using mathematical modeling.
• To maximize mass output for a single-product facility with a continuous upstream and discrete batch downstream platform.
• To identify process and facility design effects on annual plant throughput.

Main Methods:

• Utilized mathematical modeling to optimize production schedules.
• Employed cell culture duration and volumetric productivity as process variables.
• Generated 3-D surface plots to visualize the impact of design on mass output.

Main Results:

• The model demonstrates a biopharmaceutical plant can process over one metric ton of product annually after debottlenecking.
• Analysis revealed viral pool stability as a significant limiting constraint on plant performance.
• Different scheduling configurations were shown to impact resource availability.

Conclusions:

• Mathematical modeling is effective for optimizing biopharmaceutical manufacturing facility design and scheduling.
• Focusing on viral pool stability during process development can enhance manufacturing efficiency.
• Optimized scheduling and facility design are crucial for profitable biopharmaceutical operations.