Integrated | Connected Downstream Processing Of mAbs With Resolute® BioSC For Improved Productivity, Cost, Footprint, And Facility Utilization

By Sanket Jadhav, Ganesh Kumar, Buwadas Raut, Madhav Naik, Harshita Londhe, and Abijar Bhori

Monoclonal antibody (mAb) manufacturing processes have continued to evolve over the last few decades. Improvements in cell line engineering, media, and upstream processing have resulted in higher product titers, creating downstream process limitations. Manufacturers require novel and more efficient platform technologies to meet ever-increasing product demands while being mindful of costs, processing times, and regulatory requirements. Downstream process intensification is one strategy to improve the efficiency of mAb processing. However, a lack of guidance on developing, scaling, and maintaining process and product quality is blocking the more widespread implementation of downstream intensification across the biopharmaceutical industry.

In this application note, we describe how intensifying two chromatography polishing steps by developing unit operations using Sartobind® Q and CMM HyperCel saves buffer volumes and accelerates the downstream process. The downstream platform was then used to develop a connected process by parallel processing multiple unit operations. This resulted in >35% time savings, 2 – 3x footprint reduction, and 16% higher facility capacity than the traditional process (resin-based sequential process). This approach guides mAb developers to apply single unit operation and platform intensification approaches to achieve cost-effectiveness, footprint gains, and high productivity for downstream processes.