New Automated Buffer Management System Developed For Small-Scale Continuous Downstream Bioprocessing

Scientists at Lund University in Sweden have developed a new automated buffer management system for small-scale continuous downstream bioprocessing, according to a study published in the Journal of Chromatography A. Buffer management can become a bottleneck in small-scale operations, but the researchers designed a system that addresses the issue. The system can handle buffer preparation, storage, and restocking automatically, freeing up operator time.

The buffer management system is fully automated and can handle one or several connected buffer-consuming purification systems. The scientists developed a digital twin of the physical system that mirrored the process in real-time, enabling full automation and control of buffer management. The system formulated all buffers from stock solutions and water according to predefined recipes. The system also automatically monitored buffer volumes, buffer order handling, and buffer delivery.

To demonstrate the system's capability, the team integrated the buffer management system with a continuous downstream process. The system supplied all nine required buffers to the process equipment during a ten-day operation. The buffer management system processed 55 orders and delivered 38 liters of buffers, which was 20% of its capacity. The system maintained consistent pH and conductivity profiles during the purification steps. The deviation in conductivity and pH from the measured average value was within ±0.89% in conductivity and ±0.045 in pH, indicating that the prepared buffers had the correct composition.

The operation of the developed buffer management system was robust and fully automated, providing a solution to the buffer management bottleneck on a lab scale for integrated continuous downstream bioprocessing. The system is expected to increase productivity and efficiency in small-scale bioprocessing, contributing to the development of more streamlined and cost-effective biopharmaceutical production processes.

The researchers believe that the new system can also be scaled up and implemented in large-scale bioprocessing to increase efficiency further. They plan to continue developing the buffer management system, improving its capabilities for larger scale bioprocessing, and integrating it with other purification systems.

The new automated buffer management system offers a promising solution to the buffer management bottleneck in small-scale continuous downstream bioprocessing. The development of this system is an important step towards more streamlined and cost-effective biopharmaceutical production processes, which can ultimately help to make life-saving medicines more accessible and affordable for patients.

Reference

Isaksson, M.; Gomis-Fons, J.; Andersson, N.; Nilsson, B. An automated buffer management system for small-scale continuous downstream bioprocessing. Journal of Chromatography A 2023. 1695, 463942.