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

为新型在线 IgG 滴度系统建立以 NI 为中心的供应链

• 批准号: 10106193
• 金额: $ 12.52万
• 依托单位: CAUSEWAY SENSORS LIMITED
• 依托单位国家: 英国
• 项目类别: Launchpad
• 财政年份: 2024
• 资助国家: 英国
• 起止时间: 2024 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10106193
• 关键词: Establishing; NI; centric; supply; chain

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.

Causeway Sensors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，可以实时监测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试剂盒，该试剂盒具有可消耗的纳米传感器芯片，用于在单克隆抗体治疗剂的制造和纯化过程中精确有效地监测IgG滴度。该试剂盒是商业产品的关键组成部分，有助于标准曲线生成、再生解决方案，以允许每个芯片进行多个样品分析和仪器清洁。该项目的主要目标是建立一个本地供应链，以生产Titan检测试剂盒。堤道将使用分包商进行套件组装过程的关键要素。Fusion Antibodies是世界抗体生产专家，将生产和纯化IgG1单克隆抗体，该抗体将用作Titan检测试剂盒的标准品。Fortress Diagnostics是一家领先的诊断公司，将利用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创建应用说明和技术文档，为Titan的性能和应用提供有价值的见解。Causeway Sensors预计，Titan将对生物制药制造产生重大影响，引入先进的过程分析测试（PAT）传感器，以实现更高效和数据化的生物治疗制造。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，有助于北方爱尔兰不断增长的生命科学部门的活动增加。