10106268Automated Process Development of Downstream mAbs Purification using novel PAT SensorsClosedCollaborative R&DInnovate UKDownstream processing within the biomanufacturing industry has faced sustained challenges over several decades, driven by increased patient demand for therapeutics and the notable scalability of upstream production. Upstream scalability is achieved by enhancing cell productivity without increasing equipment size or media volume. In contrast, downstream processing scalability is tied to product mass. This results in a linear relationship between product mass and equipment size, buffer volume, filter area, and the number of chromatography resins needed. This lack of scalability efficiency translates to no inherent economy of scale in downstream processing. Accommodating larger-scale upstream processes incurs higher costs due to adding further downstream process trains to meet the augmented demand, often called "numbering up." The consortium members have identified the need for innovation in downstream processing to enhance process efficiency and sustainability. Innovations encompass streamlining existing processes, integrating cost-effective technologies from other industries, substituting fixed equipment with intensified modules, and developing high-tech solutions serving as game-changers in process redesign. There is a compelling need for novel approaches, including continuous processing, the integration of Process Analytical Technology (PAT) and advanced control and automation to address these challenges. The consortium strategically leverages the CPI's end-to-end continuous biomanufacturing system as a foundation, aiming to seamlessly integrate Causeway Sensor's innovative nanosensor devices for real-time product analysis and ISC's expertise in automation and process control. This collaborative effort emphasises a dedication to advancing technology and highlights the consortium's commitment to developing highly sophisticated hardware tailored for state-of-the-art continuous biomanufacturing solutions. Downstream purification is a multi-stage process including affinity chromatography and ion exchange chromatography. In this project, the partners will focus on the ion exchange stages, often called polishing. The partners will explore via a design of experiments and real-time sensor feedback, the optimal process conditions for maximising the yield and purity of the final biotherapeutic product. The ultimate aim of the project is to reduce water and energy consumption, minimise waste generation, and establish intensified purification processes that are cheaper, faster and more environmentally conscious.