Empowering the NHS advanced therapies ordering prototype IT system with Manufacturing insight from an electronic batch manufacturing system

通过电子批量制造系统的制造洞察力，为 NHS 先进疗法订购原型 IT 系统提供支持

• 批准号: 93094
• 金额: $ 63.8万
• 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: 2021
• 资助国家: 英国
• 起止时间: 2021 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=93094
• 关键词: Empowering; NHS; advanced; therapies; ordering

Autolomous is a company founded by Advanced Therapy Medicinal Product (ATMP)- and software development experts, who have combined their skills to deliver elegant solutions to the ATMP supply-chain. The company is creating a platform of software solutions to enable the scheduling of the patient for collection of their cells in a hospital; the transport of those cells to the production site; the tracking of the manufacturing process to meet regulatory obligations of production; the legal release of the medicine; and the scheduled delivery of the patient-specific medicine to the hospital in time to meet the on-going treatment of the patient. The software will enable increased automation of the process (increase efficiency necessary due to the time sensitiveness of this type of treatment), reducing the risk of errors (Right-First-Time, RFT) and ensuring that the correct product is returned to the right patient (The wrong product going to the wrong patient is catastrophic; in the best case the medicine won't work, in the worst case it will kill the patient).ATMPs are at the frontline of personalised medicines and are already driving remarkable changes in clinical practice across multiple fields of medicine, including new cancer therapies, regenerative treatments, and enhanced wound healing. Nearly all ATMPs are made from a patient's own cells, creating a truly personalised medicine targeted at their specific disease. This makes the manufacture and supply uniquely challenging, unlike any other type of medicine, making these therapies very expensive. The first ATMP for cancer treatment was Kymriah, produced by Novartis, costing £275k per dose in the UK. One recent gene therapy ATMP for a blood disorder costs $1m per treatment. Most of this is the cost of manufacture.Ordinary drugs don't require the drug company to organise the collection of patient cells, transfer to the manufacturing site, a complex manufacturing process, testing of a batch which will only treat one patient, and then the precisely timed delivery of the therapy back to the hospital in time to treat the same patient in line with their existing treatment pathway.This project aims to enhance/build upon existing ATTC infrastructure through enhancement of the NHS ATMP ordering system (NHS-ATOP) with manufacturing insights, further increasing the robustness of the scheduling and maximising the utilisation of expensive GMP manufacturing resources and facilitate Right-First-Time (RFT) ATMP manufacturing within the NHS ATMP process.

Autolomous是一家由高级治疗药物产品（ATMP）和软件开发专家创立的公司，他们结合自己的技能为ATMP供应链提供优雅的解决方案。该公司正在创建一个软件解决方案平台，以便安排患者在医院收集细胞;将这些细胞运输到生产现场;跟踪生产过程以满足生产监管义务;药物的法律的发布;以及及时将患者专用药物按计划输送到医院以满足患者的持续治疗。该软件将提高该过程的自动化程度（由于这种治疗的时间敏感性，提高了必要的效率），降低了错误的风险（Right-First-Time，RFT）并确保将正确的产品返还给正确的患者（错误的产品给错误的病人是灾难性的;在最好的情况下，药物不会起作用，在最坏的情况下，它会杀死病人）。ATMP处于个性化药物的前沿，已经在多个医学领域的临床实践中推动了显着的变化，包括新的癌症疗法，再生治疗和增强伤口愈合。几乎所有的ATMP都是由患者自己的细胞制成的，创造了一种针对特定疾病的真正个性化药物。这使得制造和供应具有独特的挑战性，不像任何其他类型的药物，使这些疗法非常昂贵。第一个用于癌症治疗的ATMP是Kymriah，由诺华公司生产，在英国每剂成本为27.5万英镑。最近一种治疗血液病的基因疗法ATMP每次治疗花费100万美元。其中大部分是生产成本。普通药物不需要制药公司组织收集患者细胞，转移到生产地点，复杂的生产过程，测试一批只治疗一名患者的细胞，然后将治疗准时送回医院，按照现有的治疗途径治疗同一名病人。这项计划旨在提高/在现有ATTC基础设施的基础上，通过增强NHS ATMP订购系统（NHS-ATOP）与生产洞察力，进一步提高调度的鲁棒性，最大限度地利用昂贵的GMP生产资源，并促进NHS ATMP过程中的Right-First-Time（RFT）ATMP生产。