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

Causeway Sensors正在承担一个开发Titan的项目，Titan是一种集成到生物反应器中的先进传感器平台，可以实时监控生物治疗制造中的关键质量属性。Titan系统包括一个仪器和一个专有的试剂盒，该试剂盒具有一个消耗性纳米传感器芯片，用于在基于单克隆抗体的治疗方法的制造和纯化过程中精确有效地监测IgG滴度。试剂套件是商业产品的关键组成部分，促进标准曲线生成，再生解决方案，允许每个芯片和仪器清洗多个样品分析。该项目的主要目标是建立一个本地供应链来生产泰坦测试套件。Causeway将使用分包商来执行套件组装过程的关键要素。世界抗体生产专家Fusion Antibodies将制造和纯化IgG1单克隆抗体，该抗体将用作Titan测试试剂盒的标准。Fortress Diagnostics是一家领先的诊断公司，将被用于其冷冻干燥和试剂盒组装专业知识。该项目旨在通过监测Fusion Antibodies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创建应用程序说明和技术文档，为其性能和应用程序提供有价值的见解。Causeway Sensors预计Titan将显著影响生物制药制造，引入先进的过程分析测试（PAT）传感器，以提高生物治疗药物的生产效率和数据信息。该项目反映了我们对该领域的本地合作和专业知识发展的承诺，有助于增加北爱尔兰不断发展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.