Implementation of Fully Integrated Continuous Antibody Processing: Effects on Productivity and COGm.

Area of Science:

• Biopharmaceutical Manufacturing
• Process Engineering
• Biotechnology

Background:

• The biopharmaceutical industry is shifting towards continuous manufacturing.
• Integrated continuous bioprocessing has been limited by nascent enabling technologies.

Purpose of the Study:

• To demonstrate a fully integrated continuous bioprocessing workflow.
• To compare product quality and productivity against conventional fed-batch processes.
• To assess the economic viability of continuous manufacturing.

Main Methods:

• Pilot-scale bioreactor to drug substance continuous integration.
• Product quality analysis comparing continuous and fed-batch methods.
• Plant throughput analysis using BioSolve software.

Main Results:

• Successful demonstration of a fully integrated continuous process.
• Comparable product quality between continuous and fed-batch processes.
• 4.6-fold increase in productivity (1 kg purified mAb every 4 days) with continuous manufacturing.
• 15% cost reduction projected for a continuous facility compared to fed-batch.

Conclusions:

• Continuous bioprocessing is a viable and efficient alternative to traditional fed-batch methods.
• Integrated continuous manufacturing can significantly increase productivity and reduce costs.
• The technology enables smaller facility footprints with comparable or improved output.