Process Intensification And Connected Processing For Robust, Cost Effective, And Fast Manufacturing Of Monoclonal Antibodies

By Sanket H. Jadhav, Abijar Bhori, Himanshu Gadgil, and Priyanka Gupta

In the rapidly evolving biopharmaceutical industry, the need for accelerated, flexible, and cost-effective manufacturing has become crucial to meet the growing demand for new therapeutics targeting complex diseases. As a result, process intensification has emerged as a key strategy for process development. Process intensification (PI) is a holistic framework designed to maximize the overall productivity of unit operations, the manufacturing process, and biomanufacturing facility output. PI facilitates faster drug development and enhances the efficiency and productivity of manufacturing processes. The increased productivity resulting from PI can lead to more efficient facility use or smaller footprints to achieve target capacities. Implementing various PI approaches often involves changing consumables or equipment, significantly reducing the facility footprint. PI has the potential to make processes more sustainable and cost-effective. Here, we present a proof of concept, demonstrating how a batch process for the purification of mAbs can be transformed into an intensified process and then into a connected process in a strategic, stepwise manner.