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

Autolomous是一家由高级治疗药物产品(ATMP)和软件开发专家创建的公司，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，以便能够安排患者在医院收集他们的细胞；将这些细胞运输到生产现场；跟踪生产过程以满足生产的监管义务；合法释放药物；以及按计划将针对患者的药物及时交付到医院，以满足患者正在进行的治疗。该软件将实现更多的过程自动化(由于这种治疗类型的时间敏感性，提高了必要的效率)，降低了出错的风险(第一次正确，RFT)，并确保正确的产品返回给正确的患者(错误的产品送到错误的患者手中是灾难性的；在最好的情况下，药物不起作用，在最坏的情况下，它会杀死患者)。ATMP处于个性化药物的第一线，已经推动了多个医学领域的临床实践的显著变化，包括新的癌症疗法、再生治疗和增强的伤口愈合。几乎所有的ATMP都是由患者自己的细胞制成的，创造了一种针对他们特定疾病的真正个性化的药物。这使得制造和供应具有独特的挑战性，不同于任何其他类型的药物，使得这些疗法非常昂贵。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275 GB。最近一种针对血液疾病的基因疗法ATMP每次治疗费用为100万美元。其中大部分是制造成本。普通药物不需要制药公司组织收集患者细胞，将其转移到制造现场，这是一个复杂的制造过程，测试一批只能治疗一名患者的药物，然后准确定时地将治疗方法及时送回医院，以便按照他们现有的治疗路径治疗同一名患者。该项目旨在通过增强NHS ATMP订购系统(NHS-TOOP)的制造洞察力来增强/建立现有的ATTC基础设施，进一步提高调度的稳健性，最大限度地利用昂贵的GMP制造资源，并促进在NHS ATMP工艺内进行正确的首次(RFT)ATMP制造。

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.