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

铜锣湾传感器公司正在进行一个项目，开发TITAN，这是一个先进的传感器平台，用于集成到生物反应器中，允许实时监测生物治疗药物制造中的关键质量属性。TITAN系统由一台仪器和一个专利试剂盒组成，该试剂盒具有消耗性纳米传感器芯片，用于在基于单抗的治疗药物的制造和纯化过程中精确和高效地监测免疫球蛋白滴度。试剂盒是商业产品的关键组成部分，有助于标准曲线的生成、再生解决方案，以允许每个芯片进行多个样本分析和仪器清洗。该项目的主要目标是建立当地供应链，生产泰坦测试试剂盒。Causeway将使用分包商来执行套件组装过程的关键要素。融合抗体公司是世界上抗体生产的专家，该公司将制造和提纯一种IgG1单抗，该抗体将作为泰坦检测试剂盒的标准。堡垒诊断公司是一家领先的诊断公司，将用于其冷冻干燥和试剂盒组装专业知识。该项目旨在通过监控Fusion抗体的抗体生产和纯化过程来生成实时数据。这些数据将用于为Titan创建应用笔记和技术文档，为其性能和应用提供有价值的见解。Causeway传感器预计Titan将对生物制药制造产生重大影响，推出先进的过程分析测试(PAT)传感器，以实现更高效和数据知情的生物疗法制造。该项目反映了我们对这一领域的地方合作和专业知识发展的承诺，有助于增加北爱尔兰不断增长的生命科学部门的活动。

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.