Implementation & digitalisation of Process Analytical Technologies to increase productivity, support rapid release and reduce costs of goods in industrial scale Cell & Gene Therapy (CGT) manufacturing

执行

• 批准号: 10062929
• 金额: $ 125.92万
• 依托单位: AUTOLOMOUS LTD
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10062929
• 关键词: Implementation; digitalisation; Process; Analytical; Technologies

In response to the Innovate UK (IUK) Digitalisation and Automation of Medicines R&D and Manufacture grant call, Autolomous and the Cell and Gene Therapy Catapult (CGTC) are proposing a collaboration that aims to enable key stakeholders in the CGT industry (namely therapy developers) to make meaningful progress towards improving manufacturing productivity and removing key bottlenecks through automation and digitisation. This will consequently reduce costs of CGT products and increase patient access to these life-changing therapies.Advanced Therapy Medicinal Products (ATMP), especially CGTs, are manufactured in per patient or in small batches requiring complex, semi-manual, labour intensive and time consuming manufacturing processes. A consequence of this is high drug product (DP) costs as demonstrated by currently available commercial CGT products ($400,000 to $3.5m per patient).Autolomous is the market leading developer of critical manufacturing management systems for CGTs. Autolomous internationally deploys fully integrated, digitized and automated supply chain software solutions. These solutions utilize emerging technologies such as Ledger Technology (LT) and Internet of Things (IoT) to ensure compliance with current and future regulatory requirements. CGTC is an independent innovation and technology organisation committed to the advancement of CGTs with a vision of a thriving industry delivering life changing advanced therapies to the world.The project aims to demonstrate the digital introduction of novel Process Analytical Technologies (PAT) into an industrial scale CGT manufacturing process within an industrial manufacturing facility. The project outputs will serve as blueprints outlining the key challenges and considerations of introducing new technologies into an industrial manufacturing environment, and the benefits of leveraging digitalisation for the purpose of automation of data collection to enable streamlined batch certification and release. The overall objective is to help ATMP developers and PAT providers mitigate the risk, reduce the costs and expedite the process of introducing and integrating systems and/or new technologies.

In response to the Innovate UK (IUK) Digitalisation and Automation of Medicines R&D and Manufacture grant call, Autolomous and the Cell and Gene Therapy Catapult (CGTC) are proposing a collaboration that aims to enable key stakeholders in the CGT industry (namely therapy developers) to make meaningful progress towards improving manufacturing productivity and removing key bottlenecks through automation and digitisation.因此，这将降低CGT产品的成本，并增加患者使用这些改变生活的疗法。先进的治疗药物（ATMP），尤其是CGT，是用每名患者或小批量制造的，需要复杂，半人工，劳动力密集和耗时的制造过程。结果是当前可用的商业CGT产品所证明的高药品（DP）成本（每位患者40万至350万美元）。自动在国际上部署完全集成，数字化和自动化供应链软件解决方案。这些解决方案利用了新兴技术，例如Ledger Technology（LT）和物联网（IoT）来确保符合当前和未来的监管要求。 CGTC是一个独立的创新和技术组织，致力于促进CGT的发展，愿景蓬勃发展，将改变生活的先进疗法为世界提供了变化。该项目旨在展示新型工艺分析技术（PAT）在工业规模的CGT制造工艺中，将新颖的工艺分析技术（PAT）引入工业制造工厂中。该项目的输出将作为蓝图，概述将新技术引入工业制造环境的关键挑战和考虑因素，以及利用数字化以自动化数据收集以实现精简分批认证和发布的好处。总体目标是帮助ATMP开发人员和PAT提供商降低风险，降低成本并加快引入和集成系统和/或新技术的过程。