Establishing a NI-centric supply chain for a Novel At-line IgG Titre System

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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.