Downstream 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.

Causeway Sensors is undertaking a project to develop Titan, an advanced sensor platform for integrating into bioreactors that allows real-time monitoring of critical quality attributes in biotherapeutics manufacturing. The Titan system comprises an instrument and a proprietary reagent kit featuring a consumable nanosensor chip for precise and efficient monitoring of IgG titre during the manufacturing and purification of monoclonal antibody-based therapeutics. The reagents kit is a critical component of the commercial offering, facilitating standard curve generation, regeneration solutions to allow multiple sample analyses per chip and instrument cleaning. The project's primary objective is to establish a local supply chain to produce Titan test kits. Causeway will use subcontractors to carry out critical elements of the kit assembly process. Fusion Antibodies, world experts in antibody production, will manufacture and purify an IgG1 monoclonal antibody, which will be used as the standard in the Titan test kits. Fortress Diagnostics, a leading diagnostics company, will be used for its freeze-drying and kit assembly expertise. The project aims to generate real-time data by monitoring antibody production and purification processes at Fusion Antibodies. This data will be used to create application notes and technical documentation for Titan, providing valuable insights into its performance and applications. Causeway Sensors anticipates that Titan will significantly impact biopharmaceutical manufacturing, introducing advanced process analytical testing (PAT) sensors for more efficient and data-informed manufacturing of biotherapeutics. The project reflects our commitment to local collaboration and expertise development in this field, contributing to increased activity in Northern Ireland's growing Life Sciences sector.

The Smart Nano-Manufacturing Corridor (SNMC) will bring together organisations from across Northern Ireland, using local strengths in Smart and Nano-Manufacturing to create a consortium with over 2000 jobs, providing value add of £220m to the local economy and increasing skill levels in local communities. Companies in Northern Ireland will get access to new innovation capabilities, addressing market opportunities in the healthcare, internet communications and cloud data storage sectors.

To develop a novel biosensing chip technology for application in the evaluation of protein-protein interactions.