Christopher J Hall, Mark Schofield, Kurt Boenning, Christina Caporale, Aydin Kavara, Kevin Hill-Byrne, Joanna Pezzini
As global demand for biologics and advanced therapeutics accelerates, the transition from batch to continuous biomanufacturing has gained popularity as a strategy to meet the needs for scalability, flexibility, and cost-efficiency. In this work, we showcase how strategic collaboration between Cytiva and PAK BioSolutions enables rapid deployment of continuous downstream processing using commercially available technologies.Central to this approach is the connection and organization of the PAK Pilot system. This powerful orchestration platform streamlines the integration and automation of unit operations, including the ÄKTA pcc™ continuous chromatography system, which utilizes MabSelect PrismA™ resin for capture and Capto™ adhere resins for polishing, alongside the implementation of continuous low pH virus inactivation and virus filtration.We show how this collaboration unlocks the potential of Cytiva process intensification tools across the manufacturing process and leverages the PAK Pilot system to significantly reduce the time it takes to develop and operate an interconnected process. We also show aspects of the seamless control and simplification of continuous processing workflows with PAK Pilot system. These combined Cytiva and PAK BioSolutions technologies demonstrate a practical and scalable path to connected, continuous biomanufacturing, transforming what was once complex and time-consuming into a manageable and efficient reality.