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

为了响应创新英国（IUK）药物研发和制造的数字化和自动化拨款呼吁，autotolous和细胞和基因治疗Catapult （CGTC）提出了一项合作，旨在使CGT行业的主要利益相关者（即治疗开发商）在提高制造生产力和通过自动化和数字化消除关键瓶颈方面取得有意义的进展。因此，这将降低CGT产品的成本，并增加患者获得这些改变生活的疗法的机会。先进治疗药物产品（ATMP），特别是cgt，是按每位患者或小批量生产的，需要复杂、半手工、劳动密集型和耗时的制造过程。其结果是高药物产品（DP）成本，正如目前可用的商业CGT产品所证明的那样（每名患者40万至350万美元）。autolous是cgt关键制造管理系统的市场领先开发商。在全球范围内部署全面集成、数字化和自动化的供应链软件解决方案。这些解决方案利用分类账技术（LT）和物联网（IoT）等新兴技术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，致力于推动cgt的发展，并将其作为一个蓬勃发展的行业，为世界提供改变生活的先进疗法。该项目旨在展示新型过程分析技术（PAT）在工业制造设施内的工业规模CGT制造过程中的数字化引入。项目成果将作为蓝图，概述在工业制造环境中引入新技术的主要挑战和考虑因素，以及利用数字化实现数据收集自动化的好处，以实现简化的批量认证和发布。总体目标是帮助ATMP开发人员和PAT供应商降低风险，降低成本，加快引入和集成系统和/或新技术的过程。

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.